october 2010, vol 3, no 7

As early as 3000 BC, descriptionscan be found on Egyptianpapyruses documenting recon-

structive techniques used by priest doctorsto restore altered appearances to normali-ty. The upper echelons of Egyptian societyplaced great importance on appearance,and this seems to have been the stimulusfor development of modern-day plasticsurgery. From a beginning of simply reduc-ing fractures and transferring local skin,

plastic surgery today encompasses free-tis-sue transfers and microvascular surgery,allowing great strides in the ability torestore not only appearance but functionas well.1In patients with cancer, the goals of

reconstructive surgery are to allow foradequate resection of tumor with clearmargins, facilitate initiation of adjuvanttherapy, maximize quality of life byimproving function and esthetics, and

OCTOBER 2010 www.TheOncologyNurse.com VOL 3, NO 7

Breast Cancer Support Groups Helpful forYoung Breast Cancer Patients0

Managing Metastatic BreastCancer PatientsPage 14

Identifying Newly DiagnosedIndividuals with Breast Cancer atRisk for Hereditary Breast CancerPage 34

Continuing EducationBar Coding: An Effective Strategy forPreventing Medication ErrorsPage 40

Journal ofOncology Navigation &Survivorship™

between pages 12 and 13

Journal of Oncology ™

The Official Journal of the Academy of Oncology Nurse Navigators

NAVIGATION & SURVIVORSHIP®

OCTOBER 2010 www.AONNonline.org VOL 1, NO 5

Lung Cancer Navigator of the Year—Laura Hunnibell, RN, MSN, ARNP,AOCN, of the Veterans Affairs (VA)Connecticut Healthcare System WestHaven Campus works to develop andimplement the navigator role, andassists her facility in improving thestage at diagnosis for patients withlung cancer. She speaks nationally and

leads an advisory group to develop a standard positiondescription for cancer care coordinators/navigators in theVA Healthcare System.

Gastrointestinal Cancer Navigator ofthe Year—Julie Pope, RN, BSN, ofthe Derrick L. Davis Forsyth RegionalCancer Center, Winston-Salem, NorthCarolina, empowers patients and theirfamilies with knowledge about theircare and resources. In addition, shesupports them through her caring andcompassion.

Breast Cancer Navigator of theYear—Susan Bowman, RN, OCN,MSW, of Wellspan Health at YorkCancer Center, York, Pennsylvania,has been a nurse navigator for nearly10 years. She offers information, sup-port, and clinical coordination for herpatients. She has also ex tended herrole into survivorship care by devel-

oping a curriculum to support survivors with their lifelongrecovery process.

Lillie Shockney, RN, BS, MASJohns Hopkins Breast CenterJohns Hopkins UniversitySchool of MedicineBaltimore, Maryland

Sharon Gentry, RN, MSN, AOCN,CBCNDerrick L. Davis ForsythRegional Cancer CenterWinston-Salem, North Carolina

Nicole Messier, RNVermont Cancer CenterBurlington, Vermont

Pamela Matten, RN, BSN, OCNSt. Joseph HospitalOrange, California

Elaine Sein, RN, BSN, OCN, CBCNFox Chase Cancer Center PartnersRockledge, Pennsylvania

Tricia Strusowski, MS, RNHelen F. Graham Cancer CenterChristiana Care Health SystemNewark, Delaware

Linda Fleisher, MPH, PhD(c)Fox Chase Cancer CenterCheltenham, Pennsylvania

Susan M. Gardner, RN, CBEC, CBCNValley Medical CenterRenton, Washington

Jay R. Swanson, RN, BSN, OCNSaint Elizabeth Cancer InstituteLincoln, Nebraska

Carol Lewis, RN, BSN, OCN, CRNIMemorial HermannThe Woodlands, Texas

Sean T. WalshExecutive [email protected]

Leadership Council

©2010 Green Hill Healthcare Communications, LLC

Continued on page 2AONN Staff

CONFERENCE NEWS

First AnnualConferenceHonors Excellencein Navigation

www.AONNonline.org

GUIDE OUR PATHStart a Local, State, or Regional Affiliate,

Join a Committee

As a key part of the inaugural conference, the Academy present-ed the Excellence in Navigation & Survivorship Awards. Re cognizing excellence in patient navigation and survivorshipcare, six recipients were selected from more than 50 nominations.

GETTING STARTED

Launching theNavigation Program thatIs Best for You. Part 2:Justifying Your ProgramBy Dawn Lagrosa

Your cancer center offers patient navigation. You areguiding patients through the healthcare system, over-coming barriers as they present themselves. Regardless

of the navigation model you are using, you will need to trackand report clinical outcomes and the financial impact ofpatient navigation. You will have to show a return on invest-ment, as well as sustainability and patient satisfaction. Mostimportant—you will need to show that navigation is makingan impact on the bottom line.Strategies to justify a navigation program were presented

by a panel of nurses and administrators at the third annualOncology Update of the American College of OncologyAdministrators. Because each presenter’s navigation programwas designed for its community’s specific needs, the outcomesmeasures tracked and the methods of doing so vary.

FINANCIAL CHALLENGES

Oncology SocialWorkers Can HelpPatients with FinancialChallenges of TreatmentBy Karen Rosenberg

Financial challenges are a key issue for patients with can-cer and can interfere with treatment protocols andpatient adherence. According to a study presented at the

2010 annual meeting of the American Society of ClinicalOncology, however, only about one third of patients turn tooncology social workers to help them overcome these barriers.In a collaborative project by Kelton Research, Los Angeles,

and the Association of Oncology Social Workers (AOSW),Martin Eichholz and his associates surveyed newly diagnosedcancer patients, caregivers, and AOSW members about thefinancial impact of cancer treatment. Surveys were completed

Continued on page 2

Continued on page 2

Navigator of the Year

Reducing Disparities in Cancer Care:St. Luke’s Mountain States TumorInstitute Embraces NCCCP PillarBy Dawn Lagrosa

St. Luke’s Mountain States TumorInstitute (MSTI) provides ad -vanced cancer care to patients at

clinics in Boise, Fruitland, Meridian,Nampa, and Twin Falls, Idaho. Spanningmore than 180 miles across southwesternIdaho, MSTI cares for patients from ruralareas and from metropolitan areas.Because of geographic isolation, manypeople in rural areas present at later

stages of disease. In addition, largeHispanic populations in the rural coun-ties of the state are not getting screenedfor cancers on recommended timelines.“Reduce cancer healthcare disparities”

is the first of seven pillars with whichNational Cancer Institute CommunityCancer Centers Program (NCCCP) sitesare tasked. These inequalities of care

BREAST CANCER

Reconstructive Surgery forPatients with Cancer Part 1: Breast ReconstructionBy Deena Damsky Dell, MSN, RN-BC, AOCN; Linda Schiech, MSN, RN, AOCN-RClinical Nurse Specialists, Fox Chase Cancer Center,

Philadelphia


Fostering a Dialogue to Improve Patient Care & Outcomes

Submit your cases online today at

www.myelomacases.com

Continued on page 8

CANCER CENTER PROFILE

Continued on page 20

Nurse Navigators Learn fromEach Other First Annual Navigation and Survivorship Conference HelpsAdvance the Patient Navigation Profession

More than 400 navigators came together for 2 days of education,networking, and professional development, all with the goal ofimproving oncology patient care and quality of life. At its First

Annual Navigation and Survivorship Conference, the Academy ofOncology Nurse Navigators (AONN) welcomed all team membersinvolved in these crucial aspects of patient care—nurses, social workers, laynavigators, navigation and survivorship program administrators—fromthroughout the country and around the world.From providing nurses with tips for incorporating best practices into their

navigation to detailing procedures to prove the value and impact of navi-gation services to implementing survivorship clinics and navigation pro-grams, the conference kept navigators engaged and interacting with thespeakers and among themselves.From more than 50 nominations, the Academy recognized three out-

standing programs and three nurse navigators for the contributions to thefield. To read why they were chosen, see the Journal of Oncology Navigation& Survivorship (between pages 12 and 13).

In-depth coverage of the material presented will be available in a spe-cial issue of the Journal of Oncology Navigation & Survivorship andonline at www.AONNonline.org.

Breast Cancer Awareness Month

Inside

TON_October 2010_v6_TON 10/15/10 2:57 PM Page Cov1

* High-risk features for patients with ER/PR+ breast cancer include: tumor size >2 cm, age <35 years, and histologic and/or nuclear grade 2/3.

When treating patients with HER2+ breast cancer

HER2-positive status is associated with more aggressive disease and poorer outcomes than HER2-negative breast cancer. Women who received 1 year of Herceptin had a lower risk of HER2+ breast cancer returning.

We applaud you for playing such a critical role in helping patients with HER2+ breast cancer complete the full course of treatment with Herceptin.

No one touches their

©2009 Genentech USA So. San Francisco, CA All rights reserved. 9 01/09

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Adjuvant indicationsHerceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer: As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel With docetaxel and carboplatin As a single agent following multi-modality anthracycline-based therapy

a

Metastatic indicationsHerceptin is indicated: In combination with paclitaxel for first-line treatment ofHER2-overexpressing metastatic breast cancer

As a single agent for treatment of HER2-overexpressingbreast cancer in patients who have received one or morechemotherapy regimens for metastatic disease

Boxed WARNINGS and Additional Important Safety InformationHerceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF). The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens. Discontinue Herceptin treatment in patients receiving adjuvant therapy and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function.

Patients should undergo monitoring for decreased left ventricular function before Herceptin treatment, and frequently during and after Herceptin treatment. More frequent monitoring should be employed if Herceptin is

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So. San Francisco, CA All rights reserved. 9568900 01/09

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Please see brief summary of full Prescribing Information, including Boxed WARNINGS and additional important safety information, on the following pages.

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withheld in patients who develop significant left ventricular cardiac dysfunction. In one adjuvant clinical trial, cardiac ischemia or infarction occurred in the Herceptin-containing regimens.

Serious infusion reactions and pulmonary toxicity have occurred; fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Exacerbation of chemotherapy-induced neutropenia has also occurred. Herceptin can cause oligohydramnios and fetal harm

when administered to a pregnant woman. The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

TON_October 2010_v6_TON 10/15/10 2:58 PM Page 1

HERCEPTIN® (trastuzumab)Brief Summary For full Prescribing Information, see packageinsert.

INDICATIONS AND USAGE Adjuvant Breast Cancer Herceptinis indicated for adjuvant treatment of HER2 overexpressingnode positive or node negative (ER/PR negative or with onehigh risk feature [see Clinical Studies]) breast cancer • as part of a treatment regimen consisting of doxorubicin,cyclophosphamide, and either paclitaxel or docetaxel • withdocetaxel and carboplatin • as a single agent following multi-modality anthracycline based therapy. Metastatic BreastCancer Herceptin is indicated: • In combination with paclitaxelfor first-line treatment of HER2-overexpressing metastaticbreast cancer • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have receivedone or more chemotherapy regimens for metastatic disease.CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONSCardiomyopathy Herceptin can cause left ventricular cardiacdysfunction, arrhythmias, hypertension, disabling cardiacfailure, cardiomyopathy, and cardiac death [see BoxedWarning: Cardiomyopathy ]. Herceptin can also causeasymptomatic decline in left ventricular ejection fraction(LVEF). There is a 4–6 fold increase in the incidence ofsymptomatic myocardial dysfunction among patients receivingHerceptin as a single agent or in combination therapycompared with those not receiving Herceptin. The highestabsolute incidence occurs when Herceptin is administeredwith an anthracycline. Withhold Herceptin for �16% absolutedecrease in LVEF from pre-treatment values or an LVEF valuebelow institutional limits of normal and �10% absolutedecrease in LVEF from pretreatment values. [see Dosage andAdministration] The safety of continuation or resumption ofHerceptin in patients with Herceptin-induced left ventricularcardiac dysfunction has not been studied. Cardiac MonitoringConduct thorough cardiac assessment, including history,physical examination, and determination of LVEF byechocardiogram or MUGA scan. The following schedule isrecommended: • Baseline LVEF measurement immediatelyprior to initiation of Herceptin • LVEF measurements every 3 months during and upon completion of Herceptin • RepeatLVEF measurement at 4 week intervals if Herceptin is withheldfor significant left ventricular cardiac dysfunction [see Dosageand Administration] • LVEF measurements every 6 months forat least 2 years following completion of Herceptin as acomponent of adjuvant therapy. In Study 1, 16% (136/844) ofpatients discontinued Herceptin due to clinical evidence ofmyocardial dysfunction or significant decline in LVEF. In Study3, the number of patients who discontinued Herceptin due to cardiac toxicity was 2.6% (44/1678). In Study 4, a total of 2.9% (31/1056) patients in the TCH arm (1.5% during thechemotherapy phase and 1.4% during the monotherapy phase)and 5.7% (61/1068) patients in the AC-TH arm (1.5% during thechemotherapy phase and 4.2% during the monotherapy phase)discontinued Herceptin due to cardiac toxicity. Among 32patients receiving adjuvant chemo therapy (Studies 1 and 2)who developed congestive heart failure, one patient died ofcardiomyopathy and all other patients were receiving cardiacmedication at last follow-up. Approximately half of thesurviving patients had recovery to a normal LVEF (defined as� 50%) on continuing medical management at the time of lastfollow-up. Incidence of congestive heart failure is presentedin Table 1. The safety of continuation or resumption ofHerceptin in patients with Herceptin-induced left ventricularcardiac dysfunction has not been studied.Table 1 Incidence of Congestive Heart Failure in AdjuvantBreast Cancer Studies

a Includes 1 patient with fatal cardiomyopathy.b Anthracycline (doxorubicin) and cyclophosphamide

Table 2 Incidence of Cardiac Dysfunctiona in Metastatic BreastCancer Studies

a Congestive heart failure or significant asymptomaticdecrease in LVEF. b Anthracycline (doxorubicin or epirubicin)and cyclophosphamide c Includes 1 patient with fatalcardiomyopathy.Infusion Reactions Infusion reactions consist of a symptomcomplex characterized by fever and chills, and on occasionincluded nausea, vomiting, pain (in some cases at tumor sites),headache, dizziness, dyspnea, hypotension, rash, and asthenia.[see Adverse Reactions]. In postmarketing reports, serious andfatal infusion reactions have been reported. Severe reactionswhich include bronchospasm, anaphylaxis, angioedema,hypoxia, and severe hypotension, were usually reported duringor immediately following the initial infusion. However, the onsetand clinical course were variable including progressiveworsening, initial improvement followed by clinical deterioration,or delayed post-infusion events with rapid clinical deterioration.For fatal events, death occurred within hours to days following a serious infusion reaction. Interrupt Herceptin infusion in all patients experiencing dyspnea, clinicallysignificant hypotension, and intervention of medical therapyadministered, which may include: epinephrine, corticosteroids, diphen hydramine, bronchodilators, and oxygen. Patients shouldbe evaluated and carefully monitored until complete resolutionof signs and symptoms. Permanent discontinuation should bestrongly considered in all patients with severe infusion reactions.There are no data regarding the most appropriate method ofidentification of patients who may safely be retreated withHerceptin after experiencing a severe infusion reaction. Prior toresumption of Herceptin infusion, the majority of patients whoexperienced a severe infusion reaction were pre-medicatedwith antihistamines and/or corticosteroids. While some patientstolerated Herceptin infusions, others had recurrent severeinfusion reactions despite pre-medications. Exacerbation ofChemotherapy-Induced Neutropenia In randomized, controlledclinical trials in women with metastatic breast cancer, the per-patient incidences of NCI CTC Grade 3-4 neutropenia and offebrile neutropenia were higher in patients receiving Herceptinin combination with myelosuppressive chemotherapy ascompared to those who received chemotherapy alone. Theincidence of septic death was not significantly increased. [seeAdverse Reactions]. Pulmonary Toxicity Herceptin use canresult in serious and fatal pulmonary toxicity. Pulmonary toxicityincludes dyspnea, interstitial pneumonitis, pulmonary infiltrates,pleural effusions, non-cardiogenic pulmonary edema, pulmonaryinsufficiency and hypoxia, acute respiratory distress syndrome,and pulmonary fibrosis. Such events can occur as sequelae ofinfusion reactions [see Warnings and Precautions (5.2)].Patients with symptomatic intrinsic lung disease or withextensive tumor involvement of the lungs, resulting in dyspneaat rest, appear to have more severe toxicity. HER2 TestingDetection of HER2 protein overexpression is necessary forselection of patients appropriate for Herceptin therapy becausethese are the only patients studied and for whom benefit hasbeen shown. Assessment for HER2 overexpression and of HER2gene amplification should be performed by laboratories withdemonstrated proficiency in the specific technology beingutilized. Improper assay performance, including use ofsuboptimally fixed tissue, failure to utilize specified reagents,deviation from specific assay instructions, and failure to includeappropriate controls for assay validation, can lead to unreliableresults. Several FDA-approved commercial assays are availableto aid in the selection of patients for Herceptin therapy. Theseinclude HercepTestTM and Pathway® HER-2/neu (IHC assays)and PathVysion® and HER2 FISH pharmDxTM (FISH assays).Users should refer to the package inserts of specific assay kitsfor information on the validation and performance of each assay.Limitations in assay precision (particularly for the IHC method)and in the direct linkage between assay result andoverexpression of the Herceptin target (for the FISH method)make it inadvisable to rely on a single method to rule outpotential Herceptin benefit. A negative FISH result does not ruleout HER2 overexpression and potential benefit from Herceptin.Treatment outcomes for metastatic breast cancer (Study 5) as afunction of IHC and FISH testing are provided in Table 9.Treatment outcomes for adjuvant breast cancer (Studies 2 and3) as a function of IHC and FISH testing are provided in Table 7.HER2 Protein Overexpression Detection Methods HER2 proteinoverexpression can be established by measuring HER2 proteinusing an IHC method. HercepTest®, one test approved for thisuse, was assessed for concordance with the Clinical Trial Assay (CTA), using tumor specimens collected and storedindependently from those obtained in Herceptin clinical studiesin women with metastatic breast cancer. Data are provided inthe package insert for HercepTest®. HER2 Gene AmplificationDetection Method The presence of HER2 protein overexpressionand gene amplification are highly correlated, therefore the useof FISH to detect gene amplification may be employed forselection of patients appropriate for Herceptin therapy.PathVysion®, one test approved for this use, was evaluated inan exploratory, retrospective assessment of available CTA 2+ or3+ tumor specimens collected as part of patient screening forclinical studies in metastatic breast cancer (Studies 5 and 6).Data are provided in the package insert for PathVysion®.Embryo-Fetal Toxicity (Pregnancy Category D) Herceptin cancause fetal harm when administered to a pregnant woman. Post-marketing case reports suggest that Herceptin use duringpregnancy increases the risk of oligohydramnios during thesecond and third trimesters. If Herceptin is used duringpregnancy or if a woman becomes pregnant while takingHerceptin, she should be apprised of the potential hazard to a

fetus. [see Use in Specific Populations]. ADVERSE REACTIONSThe following adverse reactions are discussed in greater detail in other sections of the label: • Cardiomyopathy [seeWarnings and Precautions] • Infusion reactions [see Warningsand Precautions] • Exacerbation of chemotherapy-inducedneutropenia [see Warnings and Precautions] • Pulmonarytoxicity [see Warnings and Precautions] The most commonadverse reactions in patients receiving Herceptin are fever,nausea, vomiting, infusion reactions, diarrhea, infections,increased cough, headache, fatigue, dyspnea, rash, neutropenia,anemia, and myalgia. Adverse reactions requiring interruptionor discontinuation of Herceptin treatment include CHF,significant decline in left ventricular cardiac function, severeinfusion reactions, and pulmonary toxicity [see Dosage andAdministration]. Clinical Trials Experience Because clinicaltrials are conducted under widely varying conditions, adversereaction rates observed in the clinical trials of a drug cannot bedirectly compared to rates in the clinical trials of another drugand may not reflect the rates observed in practice. AdjuvantBreast Cancer Studies The data below reflect exposure toHerceptin across three randomized, open-label studies, Studies1, 2, and 3, with (n= 3355) or without (n= 3308) trastuzumab in theadjuvant treatment of breast cancer. The data summarized inTable 3 below, from Study 3, reflect exposure to Herceptin in 1678patients; the median treatment duration was 51 weeks andmedian number of infusions was 18. Among the 3386 patientsenrolled in Study 3, the median age was 49 years (range: 21 to80 years), 83% of patients were Caucasian, and 13% were Asian.Table 3 Adverse Reactions for Study 3, All Gradesa:

a The incidence of Grade 3/4 adverse reactions was <1% in botharms for each listed term. b Higher level grouping term.The data from Studies 1 and 2 were obtained from 3206 patientsenrolled, of which 1635 patients received Herceptin; the mediantreatment duration was 50 weeks. The median age was 49.0years (range: 24-80); 84% of patients were White, and 7% wereBlack, 4% were Hispanic, and 4% were Asian. In Study 1, onlyGrade 3-5 adverse events, treatment-related Grade 2 events, andGrade 2-5 dyspnea were collected during and for up to 3 monthsfollowing protocol-specified treatment. The following non-cardiac adverse reactions of Grade 2-5 occurred at an incidenceof at least 2% greater among patients randomized to Herceptinplus chemotherapy as compared to chemotherapy alone:arthralgia (31% vs. 28%), fatigue (28% vs. 22%), infection (22%vs. 14%), hot flashes (17% vs. 15%), anemia (13% vs. 7%), dyspnea (12% vs. 4%), rash/desquamation (11% vs. 7%),neutropenia (7% vs. 5%), headache (6% vs. 4%), and insomnia(3.7% vs. 1.5%). The majority of these events were Grade 2 inseverity. In Study 2, data collection was limited to the followinginvestigator-attributed treatment-related adverse reactions NCI-CTC Grade 4 and 5 hematologic toxicities, Grade 3–5 non-hematologic toxicities, selected Grade 2–5 toxicities associatedwith taxanes (myalgia, arthralgias, nail changes, motorneuropathy, sensory neuropathy) and Grade 1–5 cardiactoxicities occurring during chemotherapy and/or Herceptintreatment. The following non-cardiac adverse reactions of

Grade 2–5 occurred at an incidence of at least 2% greateramong patients randomized to Herceptin plus chemotherapy ascompared to chemotherapy alone: arthralgia (11% vs. 8.4%),myalgia (10% vs. 8%), nail changes (9% vs. 7%), and dyspnea(2.5% vs. 0.1%). The majority of these events were Grade 2 inseverity. Safety data from Study 4 reflect exposure to Herceptinas part of an adjuvant treatment regimen from 2124 patientsreceiving at least one dose of study treatment [AC-TH: n = 1068;TCH: n = 1056]. The overall median treatment duration was 54 weeks in both the AC-TH and TCH arms. The median numberof infusions was 26 in the AC-TH arm and 30 in the TCH arm,including weekly infusions during the chemotherapy phase andevery three week dosing in the monotherapy period. Amongthese patients, the median age was 49 years (range 22 to 74years). In Study 4, the toxicity profile was similar to that reportedin Studies 1, 2, and 3 with the exception of a low incidence ofCHF in the TCH arm. Metastatic Breast Cancer Studies The databelow reflect exposure to Herceptin in one randomized, open-label study, Study 5, of chemotherapy with (n=235) or without(n=234) trastuzumab in patients with metastatic breast cancer,and one single-arm study (Study 6; n=222) in patients withmetastatic breast cancer. Data in Table 5 are based on Studies5 and 6. Among the 464 patients treated in Study 5, the medianage was 52 years (range: 25–77 years). Eighty-nine percent wereWhite, 5% Black, 1% Asian and 5% other racial/ethnic groups.All patients received 4 mg/kg initial dose of Herceptin followedby 2 mg/kg weekly. The percentages of patients who receivedHerceptin treatment for �6 months and �12 months were 58%and 9%, respectively. Among the 352 patients treated in singleagent studies (213 patients from Study 6), the median age was50 years (range 28–86 years), 100% had breast cancer, 86% wereWhite, 3% were Black, 3% were Asian, and 8% in other racial/ethnic groups. Most of the patients received 4 mg/kg initial doseof Herceptin followed by 2 mg/kg weekly. The percentages ofpatients who received Herceptin treatment for �6 months and�12 months were 31% and 16%, respectively.Table 4 Per-Patient Incidence of Adverse Reactions Occurringin �5% of Patients in Uncontrolled Studies or at IncreasedIncidence in the Herceptin Arm (Studies 5 and 6) (Percent ofPatients)

a Data for Herceptin single agent were from 4 studies, including213 patients from Study 6. b Anthracycline (doxorubicin orepirubicin) and cyclophosphamideThe following subsections provide additional detail regardingadverse reactions observed in clinical trials of adjuvant breast,metastatic breast cancer, or post-marketing experience.Cardiomyopathy Serial measurement of cardiac function (LVEF)was obtained in clinical trials in the adjuvant treatment of breastcancer. In Study 3, the median duration of follow-up was 12.6 months (12.4 months in the observation arm; 12.6 months inthe 1-year Herceptin arm); and in Studies 1 and 2, 23 months in

Incidence of CHF Study Regimen Herceptin Control 1 & 2a ACb�Paclitaxel+ Herceptin 2% (32/1677) 0.4% (7/1600)

3 Chemo�Herceptin 2% (30/1678) 0.3% (5/1708)

4 ACb�Docetaxel+ Herceptin 2% (20/1068) 0.3% (3/1050)

4 Docetaxel+Carbo+ Herceptin 0.4% (4/1056) 0.3% (3/1050)

Incidence NYHA I-IV NYHA III-IV Study Event Herceptin Control Herceptin Control 5 Cardiac (AC)b Dysfunction 28% 7% 19% 3%

5 Cardiac (paclitaxel) Dysfunction 11% 1% 4% 1%

Cardiac 6 Dysfunctionc 7% N/A 5% N/A

MedDRA (v. 7.1) 1 Year Herceptin Observation Adverse Event Preferred Term (n= 1678) (n= 1708)

CardiacHypertension 64 (4%) 35 (2%)Dizziness 60 (4%) 29 (2%)Ejection Fraction Decreased 58 (3.5%) 11 (0.6%)Palpitations 48 (3%) 12 (0.7%)Cardiac Arrhythmiasb 40 (3%) 17 (1%)Cardiac Failure Congestive 30 (2%) 5 (0.3%)Cardiac Failure 9 (0.5%) 4 (0.2%)Cardiac Disorder 5 (0.3%) 0 (0%)Ventricular Dysfunction 4 (0.2%) 0 (0%)Respiratory Thoracic Mediastinal DisordersNasopharyngitis 135 (8%) 43 (3%)Cough 81 (5%) 34 (2%)Influenza 70 (4%) 9 (0.5%)Dyspnea 57 (3%) 26 (2%)URI 46 (3%) 20 (1%)Rhinitis 36 (2%) 6 (0.4%)Pharyngolaryngeal Pain 32 (2%) 8 (0.5%)Sinusitis 26 (2%) 5 (0.3%)Epistaxis 25 (2%) 1 (0.06%)Pulmonary Hypertension 4 (0.2%) 0 (0%)Interstitial Pneumonitis 4 (0.2%) 0 (0%)Gastrointestinal DisordersDiarrhea 123 (7%) 16 (1%)Nausea 108 (6%) 19 (1%)Vomiting 58 (3.5%) 10 (0.6%)Constipation 33 (2%) 17 (1%)Dyspepsia 30 (2%) 9 (0.5%)Upper Abdominal Pain 29 (2%) 15 (1%)Musculoskeletal & Connective Tissue DisordersArthralgia 137 (8%) 98 (6%)Back Pain 91 (5%) 58 (3%)Myalgia 63 (4%) 17 (1%)Bone Pain 49 (3%) 26 (2%)Muscle Spasm 46 (3%) 3 (0.2%)Nervous System DisordersHeadache 162 (10%) 49 (3%)Paraesthesia 29 (2%) 11 (0.6%)Skin & Subcutaneous Tissue DisordersRash 70 (4%) 10 (.6%)Nail Disorders 43 (2%) 0 (0%)Pruritis 40 (2%) 10 (0.6%)General DisordersPyrexia 100 (6%) 6 (0.4%)Edema Peripheral 79 (5%) 37 (2%)Chills 85 (5%) 0 (0%)Aesthenia 75 (4.5%) 30 (2%)Influenza-like Illness 40 (2%) 3 (0.2%)Sudden Death 1 (.06%) 0 (0%)InfectionsNasopharyngitis 135 (8%) 43 (3%)UTI 39 (3%) 13 (0.8%)Immune System DisordersHypersensitivity 10 (0.6%) 1 (0.06%)Autoimmune Thyroiditis 4 (0.3%) 0 (0%)

Herceptin Single + Paclitaxel Herceptin ACb

Agenta Paclitaxel Alone +ACb Alone n = 352 n = 91 n = 95 n = 143 n = 135

Body as a Whole Pain 47 61 62 57 42 Asthenia 42 62 57 54 55 Fever 36 49 23 56 34 Chills 32 41 4 35 11 Headache 26 36 28 44 31 Abdominal pain 22 34 22 23 18 Back pain 22 34 30 27 15 Infection 20 47 27 47 31 Flu syndrome 10 12 5 12 6 Accidental injury 6 13 3 9 4 Allergic reaction 3 8 2 4 2 Cardiovascular Tachycardia 5 12 4 10 5 Congestive 7 11 1 28 7 heart failure Digestive Nausea 33 51 9 76 77 Diarrhea 25 45 29 45 26 Vomiting 23 37 28 53 49 Nausea and 8 14 11 18 9 vomiting Anorexia 14 24 16 31 26 Heme & Lymphatic Anemia 4 14 9 36 26 Leukopenia 3 24 17 52 34 Metabolic Peripheral edema 10 22 20 20 17 Edema 8 10 8 11 5 Musculoskeletal Bone pain 7 24 18 7 7 Arthralgia 6 37 21 8 9 Nervous Insomnia 14 25 13 29 15 Dizziness 13 22 24 24 18 Paresthesia 9 48 39 17 11 Depression 6 12 13 20 12 Peripheral neuritis 2 23 16 2 2 Neuropathy 1 13 5 4 4 Respiratory Cough increased 26 41 22 43 29 Dyspnea 22 27 26 42 25 Rhinitis 14 22 5 22 16 Pharyngitis 12 22 14 30 18 Sinusitis 9 21 7 13 6 Skin Rash 18 38 18 27 17 Herpes simplex 2 12 3 7 9 Acne 2 11 3 3 < 1 Urogenital Urinary tract 5 18 14 13 7 infection

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS,and PULMONARY TOXICITY Cardiomyopathy Herceptin can result in sub-clinical and clinical cardiacfailure manifesting as CHF and decreased LVEF. Theincidence and severity of left ventricular cardiac dysfunctionwas highest in patients who received Herceptin concurrentlywith anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to andduring treatment with Herceptin. Discontinue Herceptintreatment in patients receiving adjuvant therapy and stronglyconsider discontinuation of Herceptin treatment in patientswith metastatic breast cancer for clinically significantdecrease in left ventricular function. [see Warnings andPrecautions and Dosage and Administration]

Infusion Reactions; Pulmonary Toxicity Herceptin administration can result in serious infusionreactions and pulmonary toxicity. Fatal infusion reactionshave been reported. In most cases, symptoms occurredduring or within 24 hours of administration of Herceptin.Herceptin infusion should be interrupted for patientsexperiencing dyspnea or clinically significant hypotension.Patients should be monitored until signs and symptomscompletely resolve. Discontinue Herceptin for infusionreactions manifesting as anaphylaxis, angioedema,interstitial pneumonitis, or acute respiratory distresssyndrome. [see Warnings and Precautions]


www.theOncologyNurse.com OctOber 2010 I VOL 3, NO 7 3

the AC-T arm, 24 months in the AC-TH arm. In Studies 1 and2, 6% of patients were not permitted to initiate Herceptinfollowing completion of AC chemotherapy due to cardiacdysfunction (LVEF <50% or �15 point decline in LVEF frombaseline to end of AC). Following initiation of Herceptintherapy, the incidence of new-onset dose-limitingmyocardial dysfunction was higher among patientsreceiving Herceptin and paclitaxel as compared to thosereceiving paclitaxel alone in Studies 1 and 2, and inpatients receiving Herceptin monotherapy compared toobservation in Study 3 (see Table 5, Figures 1 and 2).Table 5a Per-patient Incidence of New Onset MyocardialDysfunction (by LVEF) Studies 1, 2, 3 and 4

a For Studies 1, 2 and 3, events are counted from thebeginning of Herceptin treatment. For Study 4, events arecounted from the date of randomization. b Studies 1 and 2regimens: doxorubicin and cyclophosphamide followed bypaclitaxel (AC�T) or paclitaxel plus Herceptin (AC�TH) c Study 4 regimens: doxorubicin and cyclophosphamidefollowed by docetaxel (AC�T) or docetaxel plus Herceptin(AC�TH); docetaxel and carboplatin plus Herceptin (TCH)Figure 1 Studies 1 and 2: Cumulative Incidence of Time toFirst LVEF Decline of �10 Percentage Points from Baselineand to Below 50% with Death as a Competing Risk Event

Time 0 is initiation of paclitaxel or Herceptin + paclitaxeltherapy.

Figure 2 Study 3: Cumulative Incidence of Time to First LVEFDecline of�10 Percentage Points from Baseline and toBelow 50% with Death as a Competing Risk Event

Time 0 is the date of randomization.

Figure 3 Study 4: Cumulative Incidence of Time to First LVEFDecline of �10 Percentage Points from Baseline and toBelow 50% with Death as a Competing Risk Event

Time 0 is the date of randomization.

The incidence of treatment emergent congestive heartfailure among patients in the metastatic breast cancertrials was classified for severity using the New York HeartAssociation classification system (I–IV, where IV is themost severe level of cardiac failure) (see Table 2). In themetastatic breast cancer trials the probability of cardiacdysfunction was highest in patients who receivedHerceptin concurrently with anthracyclines. InfusionReactions During the first infusion with Herceptin, thesymptoms most commonly reported were chills and fever,occurring in approximately 40% of patients in clinical trials. Symptoms were treated with acetaminophen,diphenhydramine, and meperidine (with or withoutreduction in the rate of Herceptin infusion); permanentdiscontinuation of Herceptin for infusional toxicity wasrequired in <1% of patients. Other signs and/or symptomsmay include nausea, vomiting, pain (in some cases attumor sites), rigors, headache, dizziness, dyspnea,hypotension, elevated blood pressure, rash, and asthenia.Infusional toxicity occurred in 21% and 35% of patients,and was severe in 1.4% and 9% of patients, on second or

subsequent Herceptin infusions administered asmonotherapy or in combination with chemotherapy,respectively. In the post-marketing setting, severe infusionreactions, including hypersensitivity, anaphylaxis, andangioedema have been reported. Anemia In randomizedcontrolled clinical trials, the overall incidence of anemia(30% vs. 21% [Study 5]), of selected NCI-CTC Grade 2–5anemia (12.5% vs. 6.6% [Study 1]), and of anemia requiringtransfusions (0.1% vs. 0 patients [Study 2]) were increasedin patients receiving Herceptin and chemotherapycompared with those receiving chemotherapy alone.Following the administration of Herceptin as a single agent(Study 6), the incidence of NCI-CTC Grade 3 anemia was < 1%. Neutropenia In randomized controlled clinical trialsin the adjuvant setting, the incidence of selected NCI-CTCGrade 4–5 neutropenia (2% vs. 0.7% [Study 2]) and ofselected Grade 2–5 neutropenia (7.1% vs. 4.5 % [Study 1])were increased in patients receiving Herceptin andchemotherapy compared with those receivingchemotherapy alone. In a randomized, controlled trial inpatients with metastatic breast cancer, the incidences ofNCI-CTC Grade 3/4 neutropenia (32% vs. 22%) and offebrile neutropenia (23% vs. 17%) were also increased in patients randomized to Herceptin in combination with myelosuppressive chemotherapy as compared tochemotherapy alone. Infection The overall incidences ofinfection (46% vs. 30% [Study 5]), of selected NCI-CTCGrade 2–5 infection/febrile neutropenia (22% vs. 14%[Study 1]) and of selected Grade 3–5 infection/febrileneutropenia (3.3% vs. 1.4%) [Study 2]), were higher inpatients receiving Herceptin and chemotherapy comparedwith those receiving chemotherapy alone. The mostcommon site of infections in the adjuvant setting involvedthe upper respiratory tract, skin, and urinary tract. In study4, the overall incidence of infection was higher with theaddition of Herceptin to AC-T but not to TCH [44% (AC-TH),37% (TCH), 38% (AC-T)]. The incidences of NCI-CTC grade3-4 infection were similar [25% (AC-TH), 21% (TCH), 23%(AC-T)] across the three arms. In a randomized, controlledtrial in treatment of metastatic breast cancer, the reported incidence of febrile neutropenia was higher (23% vs. 17%) in patients receiving Herceptin incombination with myelosuppressive chemotherapy ascompared to chemo therapy alone. Pulmonary ToxicityAdjuvant Breast Cancer Among women receiving adjuvanttherapy for breast cancer, the incidence of selected NCI-CTC Grade 2–5 pulmonary toxicity (14% vs. 5% [Study 1])and of selected NCI-CTC Grade 3–5 pulmonary toxicity andspontaneous reported Grade 2 dyspnea (3.4 % vs. 1%[Study 2]) was higher in patients receiving Herceptin andchemotherapy compared with chemotherapy alone. Themost common pulmonary toxicity was dyspnea (NCI-CTCGrade 2–5: 12% vs. 4% [Study 1]; NCI-CTC Grade 2–5: 2.5%vs. 0.1% [Study 2]). Pneumonitis/pulmonary infiltratesoccurred in 0.7% of patients receiving Herceptin comparedwith 0.3% of those receiving chemotherapy alone. Fatalrespiratory failure occurred in 3 patients receivingHerceptin, one as a component of multi-organ systemfailure, as compared to 1 patient receiving chemotherapyalone. In Study 3, there were 4 cases of interstitialpneumonitis in Herceptin-treated patients compared tonone in the control arm. Metastatic Breast Cancer Amongwomen receiving Herceptin for treatment of metastaticbreast cancer, the incidence of pulmonary toxicity wasalso increased. Pulmonary adverse events have beenreported in the post-marketing experience as part of thesymptom complex of infusion reactions. Pulmonaryevents include bronchospasm, hypoxia, dyspnea,pulmonary infiltrates, pleural effusions, non-cardiogenicpulmonary edema, and acute respiratory distresssyndrome. For a detailed description, see Warnings andPrecautions. Thrombosis/Embolism In 4 randomized,controlled clinical trials, the incidence of thromboticadverse events was higher in patients receiving Herceptinand chemotherapy compared to chemotherapy alone inthree studies (3.0% vs. 1.3% [Study 1], 2.5% and 3.7% vs.2.2% [Study 4] and 2.1% vs. 0% [Study 5]). Diarrhea Amongwomen receiving adjuvant therapy for breast cancer, theincidence of NCI-CTC Grade 2–5 diarrhea (6.2% vs. 4.8%[Study 1]) and of NCI-CTC Grade 3–5 diarrhea (1.6% vs. 0%[Study 2]), and of grade 1-4 diarrhea (7% vs. 1% [Study 3])were higher in patients receiving Herceptin as comparedto controls. In Study 4, the incidence of Grade 3–4 diarrheawas higher [5.7% AC-TH, 5.5% TCH vs. 3.0% AC-T] and ofGrade 1–4 was higher [51% AC-TH, 63% TCH vs. 43% AC-T] among women receiving Herceptin. Of patientsreceiving Herceptin as a single agent for the treatmentof metastatic breast cancer, 25% experienced diarrhea.An increased incidence of diarrhea was observed in patients receiving Herceptin in combination withchemotherapy for treatment of metastatic breast cancer.Glomerulopathy In the postmarketing setting, rare cases of nephrotic syndrome with pathologic evidenceof glomerulopathy have been reported. The time to onset ranged from 4 months to approximately 18 monthsfrom initiation of Herceptin therapy. Pathologic findings included membranous glomerulonephritis, focalglomerulosclerosis, and fibrillary glomerulonephritis.Complications included volume over load and congestiveheart failure. Immunogenicity As with all therapeuticproteins, there is a potential for immuno genicity. Among903 women with metastatic breast cancer, human anti-human antibody (HAHA) to Herceptin was detectedin one patient using an enzyme-linked immuno sorbentassay (ELISA). This patient did not experience an allergicreaction. Samples for assessment of HAHA were notcollected in studies of adjuvant breast cancer. Theincidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay.Additionally, the observed incidence of antibody(including neutralizing antibody) positivity in an assaymay be influenced by several factors including assaymethodology, sample handling, timing of sample

collection, concomitant medications, and underlyingdisease. For these reasons, comparison of the incidenceof antibodies to Herceptin with the incidence of antibodiesto other products may be misleading. USE IN SPECIFICPOPULATIONS Pregnancy Teratogenic Effects: CategoryD [see Warnings and Precautions] Herceptin can causefetal harm when administered to a pregnant woman. Post-marketing case reports suggest that Herceptin use duringpregnancy increases the risk for oligohydramnios duringthe second and third trimester. If Herceptin is used duringpregnancy or if a woman becomes pregnant while takingHerceptin, she should be apprised of the potential hazardto a fetus. In the postmarketing setting, oligohydramnioswas reported in women who received Herceptin during pregnancy, either alone or in combination withchemotherapy. In half of these women, amniotic fluid indexincreased after Herceptin was stopped. In one case,Herceptin was resumed after the amniotic fluid indeximproved, and oligohydramnios recurred. Women usingHerceptin during pregnancy should be monitored foroligohydramnios. If oligohydramnios occurs, fetal testingshould be done that is appropriate for gestational age andconsistent with community standards of care. Additionalintravenous (IV) hydration has been helpful whenoligohydramnios has occurred following administration ofother chemotherapy agents, however the effects ofadditional IV hydration with Herceptin treatment are notknown. Reproduction studies in cynomolgus monkeys atdoses up to 25 times the recommended weekly humandose of 2 mg/kg trastuzumab have revealed no evidenceof harm to the fetus. However, HER2 protein expression ishigh in many embryonic tissues including cardiac andneural tissues; in mutant mice lacking HER2, embryos diedin early gestation. Placental transfer of trastuzumab duringthe early (Days 20-50 of gestation) and late (Days 120-150of gestation) fetal development period was observed inmonkeys. [See Nonclinical Toxicology] Because animalreproduction studies are not always predictive of humanresponse, Herceptin should be used during pregnancy onlyif the potential benefit to the mother justifies the potentialrisk to the fetus. Registry Pregnant women with breastcancer who are using Herceptin are encouraged to enrollin MotHER- the Herceptin Pregnancy Registry: phone 1-800-690-6720. Nursing Mothers It is not known whetherHerceptin is excreted in human milk, but human IgG isexcreted in human milk. Published data suggest that breastmilk antibodies do not enter the neonatal and infantcirculation in substantial amounts. Trastuzumab waspresent in the breast milk of lactating cynomolgus monkeysgiven 12.5 times the recommended weekly human dose of2 mg/kg of Herceptin. Infant monkeys with detectableserum levels of trastuzumab did not have any adverseeffects on growth or development from birth to 3 monthsof age; however, trastuzumab levels in animal breast milkmay not accurately reflect human breast milk levels.Because many drugs are secreted in human milk andbecause of the potential for serious adverse reactions innursing infants from Herceptin, a decision should be madewhether to discontinue nursing, or discontinue drug, takinginto account the elimination half-life of trastuzumab andthe importance of the drug to the mother. Pediatric UseThe safety and effectiveness of Herceptin in pediatricpatients has not been established. Geriatric Use Herceptinhas been administered to 386 patients who were 65 yearsof age or over (253 in the adjuvant treatment and 133 inmetastatic breast cancer treatment settings). The risk ofcardiac dysfunction was increased in geriatric patients ascompared to younger patients in both those receivingtreatment for metastatic disease in Studies 5 and 6, oradjuvant therapy in Studies 1 and 2. Limitations in datacollection and differences in study design of the 4 studiesof Herceptin in adjuvant treatment of breast cancerpreclude a determination of whether the toxicity profile ofHerceptin in older patients is different from youngerpatients. The reported clinical experience is not adequateto determine whether the efficacy improvements (ORR,TTP, OS, DFS) of Herceptin treatment in older patients isdifferent from that observed in patients <65 years of age for metastatic disease and adjuvant treatment.OVERDOSAGE There is no experience with overdosagein human clinical trials. Single doses higher than 8 mg/kg have not been tested. PATIENT COUNSELINGINFORMATION • Advise patients to contact a health careprofessional immediately for any of the following: newonset or worsening shortness of breath, cough, swellingof the ankles/legs, swelling of the face, palpitations,weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Boxed Warning:Cardiomyopathy]. • Advise women with reproductivepotential to use effective contraceptive methods duringtreatment and for a minimum of six months followingHerceptin [see Pregnancy]. • Encourage pregnantwomen who are using Herceptin to enroll in MotHER- theHerceptin Pregnancy Registry [see Pregnancy].

LVEF <50% and Absolute Decrease Absolute LVEF from Baseline Decrease

<20% LVEF ≥10% ≥16% and <50% decrease decrease ≥10% ≥20%

Studies 1 & 2b AC�TH 22.8% 18.3% 11.7% 33.4% 9.2% (n=1606) (366) (294) (188) (536) (148) AC�T 9.1% 5.4% 2.2% 18.3% 2.4% (n=1488) (136) (81) (33) (272) (36) Study 3 Herceptin 8.6% 7.0% 3.8% 22.4% 3.5% (n=1678) (144) (118) (64) (376) (59) Observation 2.7% 2.0% 1.2% 11.9% 1.2% (n=1708) (46) (35) (20) (204) (21) Study 4c TCH 8.5% 5.9% 3.3% 34.5% 6.3% (n=1056) (90) (62) (35) (364) (67) AC�TH 17% 13.3% 9.8% 44.3% 13.2% (n=1068) (182) (142) (105) (473) (141) AC�T 9.5% 6.6% 3.3% 34% 5.5% (n=1050) (100) (69) (35) (357) (58)

HERCEPTIN® [trastuzumab]Manufactured by: 4839803Genentech, Inc. Initial US Approval: Sept. 19981 DNA Way Revision Date: March 2009South San Francisco, CA LK0726 717291194080-4990 7172713

©2009 Genentech, Inc.

News NotesPatient Navigators DiscussEnhancing their Profession

“The largest ever gathering of patient naviga-tors was a major step in institutionalizing bestpractices and empowering attendees to imple-ment changes to improve patient care,” said SeanT. Walsh, executive director, Academy ofOncology Nurse Navigators.

The First Annual Navigation and SurvivorshipConference covered all aspects of navigation—program implementation and maintenance, prov-ing value, community outreach, and survivorshipcare—and was geared to all types of navigators—nurses, social workers, lay persons. Breakout ses-sions on prostate, lung, breast, and gastrointestinalcancers focused on the specific challenges in pro-viding optimal patient care.

Through interactive discussions and learningsfrom panels of experts, attendees sought ways toexpand and enhance the role of navigation in allcancer types. Afterward, 55% of attendees indi-cated that expanding the scope of their programwas the number one priority.

Final Rule on Safety InformationDuring Clinical Trials

The US Food and Drug Administration issueda final rule that clarifies what safety informationmust be reported during clinical trials of investi-gational drugs and biologics. The rule requires cer-tain safety information that previously had notbeen required to be reported:

• Findings from clinical or epidemiologic stud-ies that suggest a significant risk to study par-ticipants

• Serious suspected adverse reactions thatoccur at a rate higher than expected

• Serious adverse events from bioavailabilitystudies.

NCCN Guidelines for PatientsThe National Comprehensive Cancer Net -

work (NCCN) offers a series of NCCN Guide -lines for Patients, consumer-friendly translationsof the NCCN Clinical Practice Guidelines inOncology. The first two guidelines released coverbreast and lung cancers.

“While there are a number of good resourcesavailable to these women, only the NCCNGuidelines for Patients provide the level of high-ly specific, current information that patients wantand need,” said Diana Rowden, Survivorship andOutcomes Vice President at Susan G. Komen forthe Cure, which supported the breast cancerguidelines through grant funding.

“When my sister, Dana, was diagnosed withlung cancer, I assumed, as a physician, that wewould be able to find the information we need-ed to sort through all the various treatmentoptions,” said Deborah Morosini, MD, sister ofDana Reeve, for whom the lung cancer guide-lines are named. “It turned out to be much moredifficult than I thought. These guidelines willfill a huge gap for patients and the people whoare supporting them and will be an incrediblyvaluable tool in making them more knowledge-able partners in their own treatment.”

The NCCN Guidelines for Patients are avail-able at NCCN.com, which also features enhancedcontent for patients and caregivers. �


www.theOncologyNurse.com4 OctOber 2010 I VOL 3, NO 7

Editorial Board

EDITOR-IN-CHIEFBeth Faiman,RN, MSN, APRN,BC, AOCNCleveland Clinic TaussigCancer InstituteCleveland, OH

Elizabeth Bilotti,RN, MSN, APRN,BC, OCNJohn Theurer Cancer CenterHackensack UniversityMedical CenterHackensack, NJ

Catherine S.Bishop, DNP, NP,AOCNPHematology-OncologyAssociates of FredericksburgFredericksburg, VA

Deena DamskyDell, RN, MSN,AOCN, BCFox Chase Cancer CenterPhiladelphia, PA

Wendy DiSalvo,DNP, APRN, AOCNGenentechNew London, NH

DeniceEconomou, RN,MN, CNS, AOCNCity of Hope NationalMedical CenterDuarte, CA

ConstanceEngelking, RN,MS, CNS, OCNThe CHE ConsultingGroup, Inc.Mt. Kisco, NY

Amy Ford, RN,BSN, OCNInnovexDallas, TX

Sharon S. Gentry,RN, MSN, AOCNDerrick L. Davis ForsythRegional Cancer CenterWinston-Salem, NC

Cassandra J.Hammond, RN,MSN, CRNPAvid Education Partners,LLCSharpsburg, MD

Shannon Hazen,RN, BSN, OCNNovant HealthPresbyterian CancerCenterChapel Hill, NC

Patricia IrouerHughes, RN, MSN,BSN, OCNPiedmount HealthcareRex, GA

Taline Khoukaz,NP, MSN, ACNP-CUniversity of SouthernCaliforniaNorris Cancer Center &HospitalLos Angeles, CA

Sandra E. Kurtin,RN, MS, AOCN,ANP-CArizona Cancer CenterTucson, AZ

Elizabeth Lima,PA-CCleveland Clinic TaussigCancer InstituteCleveland, OH

Ann McNeill,MSN, RN, NP-C,OCNThe Cancer Center atHackensack University Medical CenterHackensack, NJ

Kena C. Miller,RN, MSN, FNPRoswell Park CancerInstituteBuffalo, NY

Patricia Molinelli,MS, RN, APN-C,AOCNSSomerset Medical CenterSomerville, NJ

Dolores “Jeff”Nordquist, RN, MS,CS, FNPMayo ClinicRochester, MN

MelindaOberleitner, RN,DNS, APRN, CNSCollege of Nursing andAllied Health ProfessionsUniversity of LouisianaLafayette, LA

Gary Shelton,MSN, ARNP,AOCNNYU Cancer InstituteNew York, NY

Lori Stover, RN,BSNWestern PennsylvaniaCancer Institute Pittsburgh, PA

Pamela HallquistViale, RN, MS,CS, ANP, AOCNSaratoga, CA

Connie Visovsky,RN, PhD, APRNUniversity of NebraskaCollege of NursingOmaha, NE

Rita Wickham,OCN, PhD, RNRush University College ofNursingRush-Presbyterian-St. Luke’s Medical CenterChicago, IL

Karla Wilson, RN,MSN, FNP-C, CPONCity of Hope NationalMedical CenterDuarte, CA

PharmacyJohn F. Aforismo,BSc Pharm, RPh,FASCPR. J. Health SystemsInternational, LLCWethersfield, CT

NutritionKaren Connelly,RD, CSOSomerset Medical CenterSomerville, NJ

Patient AdvocatePeg FordCoronado, CA

Social WorkCarolyn Messner,DSW, MSW, LCSW-R, BCDCancerCareNew York, NY

Managed Care andPharmaceuticalManagementBurt Zweigenhaft,BSBioPharma Partners LLCNew York, NY

Isabell Castellano, RNBristol-Myers Squibb Children’s HospitalRobert Wood Johnson University HospitalNew Brunswick, NJ

Jeanne Westphal, RNMeeker County Memorial HospitalLitchfield, MN


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THE PATIENT’S VOICE10 Young breast cancer patients find support

groups good source of information,advice

CLINICAL NURSING REVIEW14 Managing metastatic breast cancer

patients treated with ixabepilone:practical guidance

LUNG CANCER28 In metastatic NSCLC, early palliative care

improves survival as well as QOL

HEMATOLOGIC CANCERS28New “tip sheets” help NHL patients

communicate with the oncology team29 More cycles of decitabine equals better

MDS outcomes

GENETICS34 Identifying newly diagnosed individuals

with breast cancer at risk for hereditarybreast cancer

34 Genetic profiling changing clinicalpractice in some areas of oncology

NURSING PRACTICE36 Split scheduling for chemotherapyincreases efficiency, reduces costs

CONTINUING EDUCATION40 Bar coding: an effective strategy forpreventing medication errors

SUPPORTIVE CARE42 Palonosetron demonstrates benefits over

other 5-HT3 receptor antagonists in lungcancer patients

NURSING EDUCATION AND TRAINING44 Doctor of Nursing Practice: an oncology

nurse practitioner’s journeyResidency programs for nurses surging in popularity

BREAST CANCER46 Targeted intraoperative radiotherapy

may be as good as whole breast radio therapy at reducing breast cancer recurrence

DEPARTMENTS3 News Notes22 Oncology Drug Codes30 International News38 Recent FDA Approval48 Nursing Life49 Meetings

OcTOber 2010 • VOL 3, NO 7

PUBLISHING STAFFPublisherPhilip [email protected]

Editorial DirectorKaren [email protected]

Associate EditorDawn [email protected]

Director, Client ServicesJohn W. [email protected]

Production ManagerStephanie Laudien

Business ManagerBlanche [email protected]

Executive AdministratorAndrea Boylston

Circulation [email protected]

Editorial Contact:Telephone: 732-992-1891 Fax: 732-656-7938

The Oncology Nurse®-APN/PA, ISSN 1944-9798 (print);ISSN 1944-9801 (online) is published 8 times a year byGreen Hill Healthcare Communications, LLC, 241Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831.Telephone: 732.656.7935. Fax: 732. 656.7938. Copyright©2010 by Green Hill Health care Com munications,LLC. All rights reserved. The Oncology Nurse®-APN/PAlogo is a registered trademark of Green Hill HealthcareCommunications, LLC. No part of this publication maybe reproduced or transmitted in any form or by anymeans now or hereafter known, electronic or mechan-ical, including photocopy, recording, or any informa-tional storage and retrieval system, without writtenpermission from the Publisher. Printed in the UnitedStates of America.

EDITORIAL CORRESPONDENCE should beaddressed to EDITORIAL DIRECTOR, The OncologyNurse®-APN/PA, 241 Forsgate Drive, Suite 205C,Monroe Twp, NJ 08831. E-mail: [email protected] SUBSCRIPTION RATES: United Statesand possessions: individuals, $105.00; institutions,$135.00; single issues, $17.00. Orders will be billed atindividual rate until proof of status is confirmed. Pricesare subject to change without notice. Correspondenceregarding permission to reprint all or part of any articlepublished in this journal should be addressed toREPRINT PERMISSIONS DEPARTMENT, GreenHill Healthcare Communications, LLC, 241 ForsgateDrive, Suite 205C, Monroe Twp, NJ 08831. The ideasand opinions expressed in The Oncology Nurse®-APN/PAdo not necessarily reflect those of the Editorial Board, theEditorial Director, or the Publisher. Publication of anadvertisement or other product mention in The OncologyNurse®-APN/PA should not be construed as an endorse-ment of the product or the manufacturer’s claims.Readers are encouraged to contact the manufacturer withquestions about the features or limitations of the productsmentioned. Neither the Editorial Board nor the Publisherassumes any responsibility for any injury and/or damageto persons or property arising out of or related to any useof the material contained in this periodical. The reader isadvised to check the appropriate medical literature andthe product information currently provided by the manu-facturer of each drug to be administered to verify thedosage, the method and duration of administration, orcontraindications. It is the responsibility of the treatingphysician or other healthcare professional, relying onindependent experience and knowledge of the patient, todetermine drug dosages and the best treatment for thepatient. Every effort has been made to check generic andtrade names, and to verify dosages. The ultimate respon-sibility, however, lies with the prescribing physician.Please convey any errors to the Editorial Director.

CONTENTS

We’re going pink thismonth in recognition ofNational Breast Cancer

Awareness Month and our continu-ing commitment to providing ourreaders with up-to-date informationon this still overwhelming problem. A recent survey showed that 43%

of women who are candidates forreconstruction after breast cancersurgery are not informed about theiroptions at the time of diagnosis.The article by Deena Damsky Delland Linda Schiech in this issuedescribes the many types of breast

reconstruction surgery now available, and women need

to be informed about for them so that they can makeinformed decisions about treatment. The Patient’s Voicearticle profiles two young breast cancer patients whodecided early on to take a proactive role in their owntreatment and are now working hard to share the knowl-edge they gained with other women. New medical therapies have become available recent-

ly too. The Clinical Nursing Review by Una Hopkinsprovides detailed guidance on educating and managingpatients treated with one of the newer breast canceragents, ixabepilone. Provisions of the Affordable Care Act will make

breast cancer screening and treatment available to agreater number of people. We hope the articles in thisissue will help you provide the information and guidanceyour patients need. �

Beth Faiman, RN,MSN, APRN,BC, AOCNEditor-in-Chief

Green Hill Healthcare Communications LLCGreen Hill Healthcare Communications, LLCHGYour Innovative Partners in Medical Media™

™

241 Forsgate Drive, Suite 205C

Monroe Twp, NJ 08831

FROM THE EDITOR

6 OcTOber 2010 I VOL 3, NO 7 www.TheOncologyNurse.com

FEATURE ARTICLES1 Launching the navigation program that

is best for you. Part 2: justifying yourprogram

1 Oncology social workers can helppatients with financial challenges oftreatment

1 First annual conference honorsexcellence in navigation

4 Targeting young survivors




Between pages 12 and 13

TON_October 2010_v6_TON 10/18/10 10:07 AM Page 6

www.BioOncology.com

© 2010 Genentech USA, Inc. All rights reserved. 10201400 Printed in USA.

At Genentech BioOncology, not only are we leading the fi ghtagainst cancer with innovative science, but we’re also dedicatedto supporting patients and others within the oncology community.

A commitment to patients — We created Genentech BioOncology™

Access Solutions™, a single source for all access and reimbursementissues, so healthcare providers can remain focused on patient care.

Reducing barriers to treatment — We help make treatment possiblefor patients in fi nancial need through our BioOncology Co-Pay CardProgram and ongoing charitable donations to various independentnonprofi t organizations in support of co-pay assistance.

A commitment to care — Our fi rst product was approved in 1985, and since then we have donated approximately $1.5 billion inmedicine to uninsured patients through the Genentech® Access to Care Foundation and other donation programs.

Our goal is to fundamentally change the way that cancer is treated by personalizing solutions to patient care.

Taking a broader view —char ting a unique course in cancer care



Breast Cancer

minimize donor site complications.Therefore, considerations for timingand type of reconstruction includepatient age, sex, and body habitus;tumor stage and prognosis; functionalstatus of patient; available donor sites;and psychosocial state. The patient de -fect should be matched with the mostappropriate reconstructive methods.Part 1 of this article will focus on breastreconstruction surgery.

Breast reconstructionIn 2007, only 29.3% of patients in

California undergoing mastectomy hadreconstructions. Insurance status (pub-lic), race (African American), and hos-pital type (community) are all signifi-cant limiting factors.2 Surgical optionsfor breast reconstruction include theuse of tissue expanders, implants, andautologous tissue. Reconstruction canbe done at the time of the mastectomyor after completion of cancer treat-ment. The goal is to produce symmetryby matching the remaining breast incontour, dimension, and position. Eventhe best reconstruction, however, can-not replace the natural breast. In general, implant-based recon-

structions require less surgery initiallybut have limitations and are not alwaystrouble free. Quality of long-termresults is directly related to implant tol-erability. The esthetic results fromautologous reconstruction are consid-ered superior because of their versatili-ty, more natural appearance, and dura-bility. They can also better withstandradiotherapy.3Contraindications to breast recon-

struction include uncontrolled andnonresectable chest wall disease, rapid-ly progressing systemic disease, seriouscomorbidity, and psychological insta-bility. Relative contraindications aresmoking and obesity (body mass index

>30-35). The National Comp rehensiveCancer Network guidelines state that“Smoking increases the risk of compli-cations for all types of re construction…patients should be made aware of theincreased rates of wound healing com-plications and partial or complete flapfailure among smokers.”4The best cosmetic result is achieved

with a skin-sparing mastectomy (SSM).This procedure takes only the skin thatmust be removed to prevent cancer recur-rence: the nipple, areola, and biopsy sites.The incision is smaller, and the resultingskin tone is more even. Evidence suggeststhat the risk of local and regional recur-rence with SSM is equivalent to thatwith traditional mastectomy when per-formed by an experienced breast sur-geon.4 Some surgeons are performing nipple-areolar complex (NAC)-sparingmastectomies, but current data are insuf-ficient to support their use in oncologic

surgery.4 Nipple function is not salvagedin these procedures.

Tissue expansion/implantreconstructionIn this simple method of reconstruc-

tion, an inflatable silicone balloon (the

expander) is placed in a submuscularpocket deep to the pectoralis major mus-cle. The expander is only partially inflat-ed when inserted to allow safe closure ofthe overlying muscle and skin. It isexpanded by a series of postoperativesaline injections. The “fills” start 1 to 4weeks postoperatively and are done every1 to 2 weeks until the desired size isreached. Reconstruction can be done in aone-stage surgery if a combination vol-ume expander–implant is placed. Mostsurgeons, however, believe that a bettercosmetic result is achieved if the tissueexpander is replaced by a permanentimplant in a second outpatient proce-dure. Alternatively, surgeons may be ableto insert a fixed-volume implant withoutan expander in some small-breastedwomen. Acellular dermal matrix (ADM)can be used to support expanders orimplants, which allows more volume tobe instilled at the time of mastectomy.This process allows some patients tobypass the use of an expander and othersto receive fewer fills.5,6Operating time for the initial surgery

is short, approximately 1 hour. Hospitalstay is between 1 and 3 days. Candidatesfor this type of reconstruction are womenwith small nonptotic breasts; those hav-ing bilateral reconstruction; those whowill accept a mastoplexy procedure onthe opposite breast if necessary; thosewho desire minimal scarring; and thoseunable to tolerate extensive surgery.Contraindications include chest wall tis-sues that are thin or damaged, radicalmastectomy, and extensive infraclavicu-lar tissue deformity. The main complica-tions are capsular contraction, implantrupture, and wound infections. Recoverytime is generally 4 to 6 weeks.7,8The US Food and Drug Ad min -

istration has approved four breast im -plants. Two of these are silicone implantsthat were approved in 2006 for breastreconstruction in women of any age. Allother silicone im plants, including themore cohesive “gummy bear” implants,are considered investigational devices,

and women must be enrolled in a clinicaltrial to receive them.7Postoperatively, patients will have

one or two drains and moderate pain,fatigue, and discomfort. Each surgeonhas his or her individual preferences,but generally patients are told not tolift more than 5 lb for 4 weeks and notto raise the arm above the shoulder orreach straight out to the side for 1 to 2weeks. It is also important for patientsto know that they should not undergomagnetic resonance imaging while theexpander is in place because in mostdevices the ports are metal.

Autologous reconstructionMusculocutaneous flaps, which consist

of a segment of vascularized muscle withthe overlying skin and fat, form the foun-dation for autologous reconstructions(Figure). In pedicle flaps, the vascular ori-gin remains intact, so a microvascular sur-geon is not required for the procedure.Two types of pedicle flaps are used inbreast reconstruction. The latissimusdorsi (LD) flap contains the thoracodor-sal artery and vein and is tunneled underthe axilla to create a breast mound. Itmay be combined with an implant to cre-ate a larger breast. The transverse rectusabdominis myocutaneous (TRAM) pedi-cle flap contains the entire rectus muscleand the superior epigastric artery andvein. It is tunneled under the skin andsubcutaneous tissue of the diaphragm.9,10Free flaps require a microvascular sur-

geon. This flap is harvested along with itsblood supply. The flap’s artery and veinare then anastomosed to local vessels inthe breast by microvascular techniques.Less muscle is used, resulting in less donorsite morbidity (hernias, bulging, abdomi-nal weakness). Although a free TRAMflap is the most common, the transverseupper gracilis free flap is another option.Skilled microvascular reconstructive

surgeons are now performing perforatorflaps. These flaps harvest the blood ves-sels that traverse the muscle and perforatethe fascia to supply the skin and fat above

Linda Schiech, MSN, RN, AOCN-R

Figure. Free TRAM Flap Breast Reconstruction

Photograph courtesy of Neal Topham, MD.

Reconstructive Surgery for Patients with Cancer... Continued from cover

Table Circulatory Assessment of Reconstructed Flap

Clinical assessment

Normal assessment

Venous circulationocclusion

Arteriole circulation occlusion

Color Pink Redness and dusky Pale or mottled

Time for capillaryrefill

1-3 seconds Rapid; <1 second Slow; >3 seconds

Doppler reading Positive for normalarterial circulation;positive for normalvenous circulation

Weak or absentDoppler reading

Weak or absentDoppler reading

Temperature Warm Warm to cool Cool

Flap or tissue fullness

Full Swollen or taut Depressed or hollow

Sources: References 13 and 14.


it. No muscle is removed. Perforator flapscan use the deep inferior epigastric perfo-rator (DIEP) artery, the superficial inferi-or epigastric artery, the superior glutealartery, and the inferior gluteal artery.Stacked DIEP flaps can be used to createa very large breast mound.11,12

Operating time for these surgeries is 4to 8 hours per breast. Perforator flaps takethe most time. Hospitalization is usually 3days with an LD flap and 4 to 5 days withthe other flaps. Candidates are womenwho desire a breast mound with a morenatural appearance and texture; want tomatch a large ptotic breast; have suffi-cient donor tissue; and are healthyenough to tolerate a longer operatingtime and a more strenuous recovery.Contraindications include lack of trainednursing staff to monitor for vessel throm-bosis, previous liposuction or surgery todonor site, active smoking (within 1month), and, possibly, diabetes andobesity. Major complications includeflap loss (2%-3% for high-volume sur-geons), flap necrosis, abdominal hernia,and infections. Recovery time is gener-ally 6 to 8 weeks.5,8,11,12

Postoperatively, it is important tocheck the flaps for perfusion (Table).13,14Free flaps require hourly checks initially,whereas pedicle flaps can be checkedevery 4 hours. Patients having abdominalflaps are kept in a flexed position postop-eratively to prevent strain on the abdom-inal incision. This position plus surgicaltightening of the abdominal wall mayresult in diaphragmatic restriction andthe potential for ineffective gas ex -change, making pulmonary toilet veryimportant. Adequate hydration is neces-sary to ensure adequate perfusion of theflap. If the patient becomes hypotensive,fluid boluses, not vasopressors, should beused. Tightness, pulling, numbness inabdominal and rib cage areas, and backpain are common complaints in additionto postoperative mastectomy pain.9,15

NAC reconstructionNAC reconstruction leads to in -

creased patient satisfaction with theresults. It is usually a secondary proce-dure performed 2 to 3 months after theinitial surgery. This allows time for theswelling to subside and the breastmound to “settle.” The nipple is recon-

structed first. Nipple placement isextremely important in producing a sat-isfying outcome.

Nipple reconstruction is most com-monly accomplished by a local flap.The surgeon elevates one or two flapsof skin and fat from the breast moundto create a projecting hub. The donorsites are generally closed by suturingthe opposing edges together. A major

problem can be loss of projection overtime, so some surgeons will use anADM injection or a piece of rib tomaintain projection over time.5,8

The reconstructed nipple needs tobe protected and supported for about2 weeks. A standard maternity plasticnipple shield, a plastic medicine cup,or the last inch of a 10-mL syringecan be secured with tape over the

nipple to protect it.Areola reconstruction can be done via

a full-thickness skin graft. However,this is painful and expensive. Excellentresults are obtained today by tattooing,because of the wide variety of pigmentsavailable. This quick and simpleprocess has minimal morbidity. In fact,it has been reported that in a skilled

OcTOber 2010 I VOL 3, NO 7 9www.TheOncologyNurse.com

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The esthetic results fromautologous reconstructionare considered superiorbecause of theirversatility, more naturalappearance, anddurability.



The Patient’s Voice

After coping with the initialshock of a cancer diagnosis,many women decide to take a

proactive approach and seek soundinformation and advice so that they canmake informed decisions about theirhealthcare. The Oncology Nurse recent-ly spoke with two young women whofound that support groups were a valu-able resource for obtaining informationand forming bonds with other patientsand survivors. One went on to createher own group to help women withspecific needs she felt werenot being met based onher own experience.

Breast reconstructionan option for some

Sharishta Shourie wasjust 25 years old when shedetected a lump in herright breast on self-exami-nation. She consulted herprimary care physician,who arranged re ferrals to a medicaloncologist and surgical oncologist. Lessthan a month after she detected the

lump in her breast, she was diagnosedwith stage II breast cancer.

Sharishta was grateful that her doctortook her concerns seriously, took imme-diate action, and helped coordinate hertreatment. But right from the start, shefelt it was important to take a pro activerole in her care. She researched the dis-ease and the treatment options andinterviewed oncologists and surgeonsuntil she found ones who she felt werethe right fit. “I had a gut feeling that Ishould see different doctors. I learned

that getting multiple opinionsis essential for making thecorrect treatment decision,”she says. “These were doctorsthat I was going to be work-ing with very closely for quitea long time. I was able to finddoctors that I knew I wouldbe able to work with andwould provide the informa-tion I needed.”

In addition to her ownresearch and the information providedby her doctors, Sharishta learned a lotabout the disease and the available

treatment options from the women shemet through the West Los Angelesaffiliate of the Cancer SupportCommunity (CSC). She joined abreast cancer support group and soonformed strong bonds with the patientsand survivors she met there. “As muchas family and friends are there for you,there is something unique about hav-ing a conversation with a woman whounderstands exactly what you’re goingthrough, who understands the fearsand the questions. There’s a uniquebond that we all share,” she says.

Sharishta found that being diagnosedwith breast cancer was “like having asecond full-time job.” She explains,“You’re busy making ap pointments deal-ing with the insurance, doing research,and talking with the doctors. It’s verytime-consuming and very draining. I waslucky to have the women in the supportgroup who I could ask questions and goto for support.”

Sharishta’s surgeon referred her to abreast reconstruction surgeon, and sheultimately decided on a bilateral mas-tectomy followed by breast reconstruc-tion. She’s learned from other women,however, that not everyone is givenenough information about reconstruc-tion options to make an informed deci-sion, as was shown in a recent CSCsurvey. She thinks that FranklySpeaking about Cancer: Spotlight onBreast Re construction, a CSC educa-tional program being launched inJanuary with support from MentorWorldwide, LLC, in 2011 will help tofill this gap (www.cancersupportcommunity.org). “Lots of factors go intodeciding what options are right for anyparticular patient, and knowing upfront what doctors are able to do ishugely important,” she says.

Sharishta is doing well 1 year afterher diagnosis and she continues herinvolvement with the West LosAngeles affiliate of CSC, working toraise awareness of breast cancer and toempower women to take an active partin their treatment.

Pink-Link grows out ofpersonal experience

Vicki Tashman was 44 yearsold when her breast cancerwas detected on a routinemammogram 6 years ago. LikeSharishta, she consulted sev-eral surgeons until she foundthe one she felt most com-fortable with. And also likeSharishta, she did not stop

there. She set out to inform herselfabout the disease and the availabletreatments by reading about it andtalking to friends and relatives.

She sought out several supportgroups but found that she was alwaysone of the youngest people in thegroup and, unlike most of the othersshe met there, had had a lumpectomyinstead of a mastectomy or double mas-tectomy. “I noticed there were somedifferences in what was being talkedabout, and how I was feeling versushow they were feeling and differentquestions that I wanted to haveanswered that the women in the sup-port group couldn’t answer.” She cameup with the idea for an online forumthat would allow a woman to search adatabase and connect with a survivorwho had a similar breast cancer profileor had had her specific type of treat-ment. “That’s how Pink-Link was born[www.pink-link.org]. The initialthought behind it was to be able tohave survivors connect with eachother, online, 24/7, on their own.” Shepoints out that al though there areother supports that will match patientsand survivors, with “Pink-Link it is thesurvivor herself that’s searching thedatabase, viewing other members’ pro-files, and then deciding who she wantsto connect with.”

Pink-Link is a nonprofit member-ship-based organization and its servicesare free to members. Vicki explainsthat “a member can set up their per-sonal journal and have it completelyprivate so she can use it as a diary or itcan be public to Pink-Link members. Itcan also be password protected so thatshe can give that password to familyand friends and they can log on toPink-Link and read her entries. So ifshe wants to keep them updated on aweekly basis, she can do that.”

In addition, five experts donate theirtime to run forums that answer mem-bers’ questions about nutrition, physi-cal exercise, skin care, lymphedema,and holistic health.

Since the group wasstarted 4 years ago, about4000 members have signedup and more than 1000connections have beenmade. Vicky hopes one dayto have a Pink-Link con-ference so that memberscan meet in person and toset up similar sites for pa -tients with other kinds ofcancers. �

Young Breast Cancer Patients Find Support GroupsGood Source of Information, AdviceBy Karen Rosenberg

Reconstructive Surgery for Patientswith Cancer... Continued from page 9

tattoo artist’s hands, a 3-dimensionalNAC can be created.

SummaryBreast reconstruction can maximize

quality of life for patients who haveundergone mastectomy. The patientand the healthcare team has numerousoptions for reconstruction, which canimprove appearance, increase func-tional ability, and enhance patientwell-being. �

References1. Lin SJ, Rabie AN. Head and neck cancer—recon-struction. March 9, 2009. emedicine.medscape.com/article/1289799-overview. Accessed September 15, 2010.2. Holt A, Duan L, Hendersen K, et al. Disparities inreconstruction rates after mastectomy. Presented at:American Society of Breast Surgeons Proceedings2010; April 28, 2010; Las Vegas, NV.3. Berry T, Brooks S, Sydow N, et al. Complicationrates of radiation on tissue expander and autologous tis-sue breast reconstruction. Presented at: AmericanSociety of Breast Surgeons Proceedings 2010; April 28,2010; Las Vegas, NV.4. National Comprehensive Cancer Network. ClinicalPractice Guidelines in Oncology: Breast Cancer. V.2.2010.www.nccn.org/professionals/physician_gls/PDF/breast.pdf. Accessed September 15, 2010.5. Weiler-Mithoff E. Breast reconstruction. In: Dixon JM,ed. Breast Surgery. The Netherlands: Elsevier Limited;2006:117-132.6. Sbitany H, Sandeen S, Amalfi A, et al. Acellular der-mis-assisted prosthetic breast reconstruction versus sub-

muscular coverage: a head-to-head comparison of out-comes. Plast Reconstr Surg. 2009;124:1735-1740.7. US Food and Drug Administration. Breast implantquestions and answers. May 20, 2009. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063719.htm.Accessed September 15, 2010.8. Wilkins E, Atisha D. Breast reconstruction in womenwith breast cancer. May 2010. www.uptodate.com/online/content/topic.do?topicKey=br_surg/2258&selectedTitl=1%7E63&source=search_result. Accessed September15, 2010.9. Dell DD, Weaver C, Kozempel J, Barsevick A.Recovery after transverse rectus abdominis myocutaneousflap breast surgery. Oncol Nurs Forum. 2008;35:189-196.10. Kim J, Bullocks JM, Armenta A. Breast reconstruc-tion, latissimus flap. June 15, 2009. emedicine.com/plastic/topic137.htm. Accessed September 15, 2010.11. Granzow JW, Levine JL, Chiu ES, Allen RJ. Breastreconstruction using perforator flaps. J Surg Oncol.2006;94:441-445.12. Horton KM. Reconstruction of the breast after can-cer: an overview of procedures and options. www.breastcancerawareness.com/files/BreastCancerAwareness.com_Reconstruction%20of%20the%20Breast%20Afte%20Cancer_An%20Overview.pdf. Accessed September 15, 2010.13. Nahabedian MY. Flaps, free tissue transfer. July 7,2010. emedicine.medscape.com/article/1284841-overview. Accessed September 15, 2010.14. Flint PW, Haughey BH, Lund VL, et al. Free tissuetransfer. In: Cummings Otolaryngology: Head & NeckSurgery. 5th ed. Philadelphia, PA: Mosby; 2010.15. Dell D. Postoperative recovery after TRAM flap sur-gery. Perspectives: Recovery Strategies from the OR to Home.2004;5:1-8.

Part 2 of this article will focus on surgeryfor head and neck cancer reconstruction.

Sharishta Shourie

Vicki Tashman


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1 Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane).Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550.2 Totect® package insert. 3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009.4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009.5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658.© 2010 Topotarget USA. All rights reserved. TOT0112/7-10Totect and its logo mark are registered trademarks of Topotarget A/S

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Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: Totect is a cytotoxic drug. Vial contents must be mixed and diluted before use. Totect should not be mixed or administered with any other drug during the infusion. Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasa-tion. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the �rst day. The Totect dose should be reduced 50% for patients with creati-nine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the a�ected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administration. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guide-lines on this subject have been published.3-5 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water. Contraindications: None.Warnings and Precautions: Myelosuppression: treatment with Totect is asso-ciated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Use in Pregnancy: Pregnancy Category D. Totect can cause fetal harm when administered to a pregnant woman. There is no adequate information about the use of Totect in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Adverse reactions: The most common adverse reactions (≥ 16%) are nausea, pyrexia, injection site pain and vomiting.

Drug Interactions: No drug interactions have been identi�ed. Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treat-ment with topical DMSO decreases the efficacy of systemic dexrazoxane. Use in Speci�c Populations: Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. Renal Impairment: Reduce the Totect dose by 50% In patients with creatinine clearance values <40 mL/min. Pediatric Use: The safety and e�ectiveness of Totect in pediatric patients have not been established. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Be-cause elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Overdosage: There are no data on overdosage. There is no known antidote for dexrazoxane. Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of dexrazoxane has not been investigated. Nevertheless, a study by the National Cancer Institute has reported that long term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused signi�cant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Thus, dexrazoxane is mutagenic and clastogenic. The possible adverse effects of Totect on the fertility of humans and experimental animals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (about half the human dose on a mg/m2 basis).





OCTOBER 2010 www.AONNonline.org VOL 1, NO 5

Lung Cancer Navigator of the Year—Laura Hunnibell, RN, MSN, ARNP,AOCN, of the Veterans Affairs (VA)Connecticut Healthcare System WestHaven Campus works to develop andimplement the navigator role, andassists her facility in improving thestage at diagnosis for patients withlung cancer. She speaks nationally and

leads an advisory group to develop a standard positiondescription for cancer care coordinators/navigators in theVA Healthcare System.

Gastrointestinal Cancer Navigator ofthe Year—Julie Pope, RN, BSN, ofthe Derrick L. Davis Forsyth RegionalCancer Center, Winston-Salem, NorthCarolina, empowers patients and theirfamilies with knowledge about theircare and resources. In addition, shesupports them through her caring andcompassion.

Breast Cancer Navigator of theYear—Susan Bowman, RN, OCN,MSW, of Wellspan Health at YorkCancer Center, York, Pennsylvania,has been a nurse navigator for nearly10 years. She offers information, sup-port, and clinical coordination for herpatients. She has also ex tended herrole into survivorship care by devel-

oping a curriculum to support survivors with their lifelongrecovery process.

Lillie Shockney, RN, BS, MASJohns Hopkins Breast CenterJohns Hopkins UniversitySchool of MedicineBaltimore, Maryland

Sharon Gentry, RN, MSN, AOCN,CBCNDerrick L. Davis ForsythRegional Cancer CenterWinston-Salem, North Carolina

Nicole Messier, RNVermont Cancer CenterBurlington, Vermont

Pamela Matten, RN, BSN, OCNSt. Joseph HospitalOrange, California

Elaine Sein, RN, BSN, OCN, CBCNFox Chase Cancer Center PartnersRockledge, Pennsylvania

Tricia Strusowski, MS, RNHelen F. Graham Cancer CenterChristiana Care Health SystemNewark, Delaware

Linda Fleisher, MPH, PhD(c)Fox Chase Cancer CenterCheltenham, Pennsylvania

Susan M. Gardner, RN, CBEC, CBCNValley Medical CenterRenton, Washington

Jay R. Swanson, RN, BSN, OCNSaint Elizabeth Cancer InstituteLincoln, Nebraska

Carol Lewis, RN, BSN, OCN, CRNIMemorial HermannThe Woodlands, Texas

Sean T. WalshExecutive [email protected]

Leadership Council


Continued on page 2AONN Staff

CONFERENCE NEWS

First AnnualConferenceHonors Excellencein Navigation

www.AONNonline.org

GUIDE OUR PATHStart a Local, State, or Regional Affiliate,

Join a Committee

As a key part of the inaugural conference, the Academy present-ed the Excellence in Navigation & Survivorship Awards. Re cognizing excellence in patient navigation and survivorshipcare, six recipients were selected from more than 50 nominations.

GETTING STARTED

Launching theNavigation Program thatIs Best for You. Part 2:Justifying Your ProgramBy Dawn Lagrosa

Your cancer center offers patient navigation. You areguiding patients through the healthcare system, over-coming barriers as they present themselves. Regardless

of the navigation model you are using, you will need to trackand report clinical outcomes and the financial impact ofpatient navigation. You will have to show a return on invest-ment, as well as sustainability and patient satisfaction. Mostimportant—you will need to show that navigation is makingan impact on the bottom line.Strategies to justify a navigation program were presented

by a panel of nurses and administrators at the third annualOncology Update of the American College of OncologyAdministrators. Because each presenter’s navigation programwas designed for its community’s specific needs, the outcomesmeasures tracked and the methods of doing so vary.


Oncology SocialWorkers Can HelpPatients with FinancialChallenges of TreatmentBy Karen Rosenberg

Financial challenges are a key issue for patients with can-cer and can interfere with treatment protocols andpatient adherence. According to a study presented at the

2010 annual meeting of the American Society of ClinicalOncology, however, only about one third of patients turn tooncology social workers to help them overcome these barriers.In a collaborative project by Kelton Research, Los Angeles,

and the Association of Oncology Social Workers (AOSW),Martin Eichholz and his associates surveyed newly diagnosedcancer patients, caregivers, and AOSW members about thefinancial impact of cancer treatment. Surveys were completed

Continued on page 2

Continued on page 2

Navigator of the Year

TON_October 2010_v6_TON 10/15/10 2:59 PM Page A1

Regardless of the model of navigationimplemented, it is important to measurethe program’s impact, noted BonnieMiller, RN, BSN, OCN, ad ministrativedirector of the Women’s Can cerCenter at Fox Chase, Philadelphia,who chaired the panel.Miller began the presentation by list-

ing the basic measures that will helpreveal the impact of a navigation pro-gram. The other presenters providedmore detail on how such measures can betracked. Miller noted that tracking neednot be difficult; it can be done in anExcel spreadsheet or through navigationsoftware, such as Nursenav Oncology.Miller listed the basic measures they

capture at Fox Chase.• Improvement in coordination ofcare

• Enhancement of access to servicefor patients

• Barriers removed• Outcomes improved• Resources shared, internal orexternal

• Enhancement of relationshipswithin the community

• Increase in referrals into the system.

Fox Chase also tracks:

• Demographics, looking at stage anddiagnosis

• Whether appointments are laiddown, kept or missed and why, andwhether the navigators have animpact in that

• Whether patients accept naviga-tion, as some patients don’t want to

be navigated, which needs to beidentified up front

• Education provided• Barriers and their resolutions.

Pitt County Memorial HospitalGreenville, North CarolinaAt Pitt County Memorial Hospital

(PCMH), part of University HealthSystems of Eastern Carolina, patientsatisfaction, physician satisfaction, andpatient volume are used to gauge theprogram’s success at reaching its maingoals: improved illness status, im -proved coordination of services forpatients, increased patientadaptation to their illness,and timelier delivery ofservices, explained PhyllisDeAntonio, RN, MSN,FAAMA, the cancer serv-ices administrator who pre-sented the outcome meas-ures used at her center.PCMH has 861 licensedbeds and serves a 29-coun-ty referral area. The navi-gation program DeAntoniodiscussed serves gynecology and breastcancer patients.

Quality measuresA patient satisfaction survey is

mailed semiannually with a self-addressed envelope. DeAntonio recom-mended making the survey as simple aspossible. “We use a scale from 1 to 5. Itasks the patient how well the nurse nav-igator addressed or listened to their con-cerns and provided them with informa-tion about their diagnosis and treatmentand any support groups and programs. Italso asks how well the navigator man-aged side effects if any, and worked as aliaison between them and the physicians.The patients also are asked to rate thenurse navigator overall and how theythink their navigator helped them tocope better with these treatments. Thenwe ask an open-ended question aboutthe nurse navigator, how she cared aboutyou and your well-being.” At PCMHmost patients rate the navigators as “verygood” or “excellent.”Physician satisfaction is also impor-

tant to measure. Using the same scale, aphysician survey asks oncology physi-cians whether they use the navigator, torate her overall and, most importantly,whether she is eliminating barriers,helping patients understand and copebetter, and providing patients theappropriate resources. An open-endedquestion on the benefits of having anavigator is also included. The physi-cians’ ratings have been in the “verygood” to “excellent” range as well.Another outcome measured is patient

volume. “Our patient volume hasclimbed quite a bit through the past sev-eral years, and basically as we see the vol-

ume climbing, we look at the level ofnavigation,” said DeAntonio. What theyfound is that as volume increased, thetime a navigator can spend with eachpatient has decreased. PCMH is not justtracking this information because itcan. DeAntonio is using the informa-tion to keep the program on target. “Inthese tight economic times, my goal isto maintain a level of service and sup-port that helps to meet the needs of thepatient, so we’re currently looking athow a navigator functions and whetherthere are some duties that can be dele-gated even more to social workers,

other clinical staff, or addi-tional secretarial and regis-tration support.”Some outcome measures

are captured and used tobenchmark PCMH’s pro-gram against others. Theseinclude referrals to the can-cer program because of thepatient navigator, and inthe future, looking at timereductions from mammo-gram to biopsy and then

from biopsy to surgery.

Financial measuresOther measures are tracked annually

to show PCMH’s administration thereturn on investment for the navigatorposition. Most important is to look atthe underinsured and uninsured, andwhether state-based or federally fundedprograms helped cover the cost of theirtreatment, according to DeAntonio.“Our navigator does an excellent jobwith trying to link patients with theseprograms.” In addition, the programtracks each patient’s length of stay inthe hospital, charges, costs, and pay-ments to note how the navigator’sefforts connected with coordination ofcare correlate to decreased length ofstay, keeping patients out of the emer-gency department, and preventingunnecessary admissions to the hospital.

MarketingAt PCMH, multiple marketing oppor-

tunities help the navigation programthrive. To educate the community aboutthe program, the breast/gynecologiconcology navigator was highlighted inan insert to the Sunday paper’s healthsection. The navigator’s role was ex -plained, and one of her breast cancerpatients told her story. “You will find thatyour satisfied patients are the best way tomarket your navigation program, so, ifthey’re willing, use them to market yourprogram,” DeAntonio noted. In addi-tion, the hospital website places patientnavigation on its home page. That pagethen links to a navigation page thatexplains the role of the nurse navigatorand what services are available throughthe navigator. The navigation program

Launching the Navigation Program that Is Best for You... Continued from cover

www.AONNonline.org2 OctOber 2010 I VOL 1, NO 5

First Annual Conference HonorsExcellence in Navigation Continued from cover

Outstanding Community Outreach InitiativeLynn Lutwin, BSN, MA, OCN, CBCN, of Steeple chaseCan cer Cen ter at Somerset Med ical Center, Somer ville,New Jersey, raises awareness among senior citizens about theimportance of screening mammograms even later in life.Her “Pink Parties” were a great success and are being con-ducted for a second year.

Outstanding Survivorship InitiativeThe Survivor PLACE (Programs for Living After theCancer Experience) initiative of Lehigh Valley HealthNetwork in Allentown, Pennsylvania, provides multidiscipli-nary care in the form of a clinic and enables survivors to visitwith a variety of allied healthcare professionals. KathleenSevedge, BSN, MA, AOCN, accepted the award on behalf ofthe team, which continues to strive to provide superior sur-vivorship care for all those in their area affected by cancer.

Outstanding ProgramSaint Thomas Health Services Centers for Breast HealthNurse Navigation in Nashville, Tennessee, continues togrow in its ability to provide care for breast cancer patientsand acts as a model for those beginning other navigationprograms. The award was accepted by Kim Parham, RN,BSN, CBPN.

“Regardless of themodel of navigationimplemented, it isimportant to measurethe program’s impact.”—Bonnie Miller, RN, BSN, OCN

Phyllis DeAntonio, RN, MSN, FAAMA


OctOber 2010 I VOL 1, NO 5 3www.AONNonline.org

also is highlighted in Cancer Services’annual reports.

Crozer-Keystone Health SystemDelaware County, Pennsylvania;New Castle County, Delaware;Gloucester County, New JerseyCrozer-Keystone Health System

(CKHS), a five-hospital health system,also began its navigation program fortheir breast cancer patients. This pastyear, it has also launched navigation forlung and colon cancer patients. CKHShas two main campuses for cancer care,at which they diagnose about 2000 can-cer cases per year. The measures trackeddirectly relate to the goals of the navi-gation program—quality care, inpatientreferrals, increased patient satisfaction,decreased hospital costs, and decreasedoutmigration for treatment.

Quality indicatorsMetrics are tracked for all three dis-

ease sites with navigation services. Inaddition to patient satisfaction, metricsare monitored in conjunction with FoxChase Cancer Center, with whichCKHS has a partnership that providespatients access to clinical trials and pro-grams. Marie DeStefano, RN, MSN,FAAMA, administrative director ofoncology, who presented the CKHSmodel for navigation services, explainedhow breast cancer data are gatheredusing the American College of Surgeons’Commission on Cancer database met-rics. For example, the number of corebiopsies as well as the number of inci-sional biopsies are captured and thenused to determine a ratio. In addition,CKHS looks at the length of time fromscreening mammogram to traditionalstart of treatment, whether the patientswere offered radiation therapy, and if thepatients were given tamoxifen, accordingto DeStefano. For lung and colon cancer,CKHS looks at the numbers for screen-ing colonoscopy, pathology, radiation,patients referred to CyberKnife treat-ments, patients contacted, and in- andoutmigration.Gaining accreditation not only indi-

cates quality, but also can help justify aprogram. “Both breast navigators wereintegral in helping us to obtainNational Accreditation Program forBreast Centers accreditation, which isvery important for our institution,”DeStefano said.

Financial indicatorsBecause of its location in a competi-

tive market CKHS needs to financiallyjustify every hire. Every month,DeStefano sends data to the hospital’spresidents, including the number ofscreening mammograms, the numberof diagnostic mammograms, the num-ber of breast pathologies, and the num-ber of fractions of radiation for breast.

“All of those are revenue generating,and we capture those from year to yearto see, for example, if fiscal year 2009 isthe same as fiscal year 2010, if it’s up orif it’s down,” explained DeStefano.CKHS also monitors outmigration for

treatments. To do this, the navigatorssend the number of breast patients theycontacted to DeStefano, who alsoreceives diagnostic statistics from theradiology and pathology departments,and fractions radiated from the radiationdepartment. If there is an outmigration,the navigators must supply her with thereason. “Sometimes it’s a very good rea-son; sometimes we assist with the referralout; sometimes the patient will say ‘Mymother is a nurse at the hospital up thestreet and I want to be where my motheris,’ or ‘I have this doctor who operated onme 5 years ago, and I want to go back tothe same surgeon,’” DeStefano said. It isimportant to track why the patientsleave to clarify the numbers for the hos-pital’s presidents, she noted. “Sincewe’ve put our breast nurse navigators inplace, we’ve gone from 16% outmigra-tion to 2% outmigration overall. So, dothose positions justify themselves?Absolutely,” DeStefano exclaimed.

Community Cancer CenterNormal, IllinoisLocated in a community of about

120,000 people, the Community CancerCenter is a joint venture of the twohealthcare systems in its communitythat houses outpatient cancer servicesand offers a full complement of support-ive services. With a goal of affectingpatient care both inside and outside ofits facility, the center implementedpatient navigation to help the continu-um of breast care services.

Outcome measures“We can make very timely decisions

and be monitoring how we’re doingwith care looking at the community notjust the people we serve,” said BarbNathan, executive director, who pre-sented her center’s model. This isbecause the Community Cancer Centerholds a common database for its com-munity. This database houses a multi-tude of useful information to direct thenavigation program toward success.

The Community Cancer Centertracks the reduction in the number ofdays to definitive diagnosis. In addition,it tracks the increase in the number ofconsults seen in medical oncology andradiation oncology, as well as the num-ber of screening mammograms. “Wehave seen double-digit per-year growthin the number of cases. Our core biopsyrate has improved. Our days for abnor-mal mammogram to biopsy have beencut in half; they are now at 15. And ourconsults to medical oncology and radia-tion oncology have been growing by18% per year,” said Nathan.This information is used for more

than just financial justification. Ithelps improve the program and to set

its direction. Using the database, theCommunity Cancer Center found thatin 2008, 57% of eligible women had ascreening mammogram, but in 2009that percentage dropped to 51%. Inaddition, among the Hispanic popula-tion, only 7% of the eligible womenhad a mammogram in 2009. Workingwith the administration, the navigatoris spearheading an effort to add somelay navigators to work in this specificpopulation, noted Nathan.

Continuing your commitment topatient careOnce again, “One Size Does Not Fit

All.” The metrics captured must direct-ly relate to the goals of your navigationprogram and the financial needs of yourcenter’s administration. Showing yourprogram’s clinical quality, financial sus-tainability, and positive impact on thebottom line should help all nurses con-tinue to deliver the essential service ofpatient navigation. �

To read about how these navigation pro-grams were designed and launched, seePart 1 of this series, which appeared in theAugust 2010 issue of the Journal ofOncology Naviga tion & Survivorship.

by 169 cancer patients and 131 care-givers identified from national researchpanels and 153 AOSW members.Patients’ and caregivers’ responses wereaggregated.Fifty-seven percent of patients said

they had experienced a serious financialhardship related to bills for cancer treat-ment, including depleted bank accounts(40%) and bankruptcy (6%). Of thosewho had experienced a financial hard-ship, 87% reported that treatment costshad had a negative impact on their abil-ity to focus on recovery, and 75% saidthey were constantly worried aboutfinancial problems. Among the social workers, 73%

reported discussing financial issues withall or most of their patients, and 58%believed that discussing financial issues

with patients always or frequently leadsto a positive outcome.Although 62% of patients said they

were familiar with the treatmentoptions covered by their health plan,social workers reported that only 4% oftheir newly diagnosed cancer patientswere aware of these options.Sixty-nine percent of social workers

perceived themselves to be theirpatients’ primary resource for dealingwith financial issues. Only 34% ofpatients, however, said they had inter-acted with a social worker, and 55%indicated that they were comfortablediscussing financial matters with asocial worker. Moreover, 61% ofpatients with a major catastrophicfinancial burden said they had neverseen a social worker. �


Oncology Social Workers Can HelpPatients... Continued from cover

“Since we’ve put ourbreast nurse navigators inplace, we’ve gone from16% outmigration to 2%outmigration overall. So,do those positions justifythemselves? Absolutely.”

—Marie DeStefano, RN,

MSN, FAAMA

“Our days for abnormal mammogramto biopsy have been cut in half; theyare now at 15. And our consults tomedical oncology and radiationoncology have been growing by 18%per year.” —Barb Nathan


Adolescent and young adult(AYA) survivors of cancer are,like their older counterparts, a

growing population. And like mostother cancer survivors, many are notreceiving necessary survivorship care,as outlined by the Institute of Med -icine’s (IOM) 2005 report on the sub-ject. Youth issues were the subject of anumber of presentations and abstractsat the 5th Biennial Cancer SurvivorshipResearch Conference. Top AYA issuesinclude communication about long-term care, and interventions to pro-mote exercise and discourage risk-tak-ing behavior.Researchers at the University of

California Los Angeles assessed thestate of AYA survivorship informationprovided at community-based organiza-tions (CBOs), because accurate knowl-edge can empower people to seek need-ed care. The study relied on qualitativeanalysis of interviews with CBO leaders,including CEOs, program directors, andfounders. The researchers found thatCBO leaders were knowledgeable andinterested in providing survivorshipeducation. CBO leaders suggested thatsuch communication should beginbefore the end of treatment and thatcommunication with young people bepositively framed and sensitive to youth

“culture” to help prevent the survivorfrom tuning it out.AYA survivors are often “lost in tran-

sition” when they cease treatment andbegin a lifetime of survivorship. A sur-vey of 376 survivors recruited fromLIVESTRONG Survivorship Centersof Excellence found that 33% lackedcopies of medical records, 48% lacked awritten treatment study, and another48% lacked a survivorship care plan.

The lack of a survivorship care plan andnonwhite ethnicity were found to beassociated with less confidence in seek-ing survivorship care.The University of Colorado Denver

and its affiliate, the Children’s Hospital,are collaborating, “with a unique empha-sis on transitioning into primary care.”Each patient is seen by a multidiscipli-

nary team trained in survivorship care,including a primary care internal medi-cine physician, a pediatric oncologist, ahealth psychologist, and an oncologynurse. Each patient receives a survivor-ship care plan that outlines a strategy forlife after cancer, with the goal of promot-ing comprehensive preventive and fol-low-up care. Feedback from participatingsurvivors has been highly positive. “Aschildhood cancer survivors become

young adults, it is imperative to assist intheir successful transitioning to an adultcare venue in which their completehealthcare needs can be met,” theresearchers concluded.Researchers at Oslo University Hos -

pital, Norway, found that survivors ofchildhood malignant lymphoma arewell informed about their diagnoses andtreatment, but mostly unaware of thepotential for long-term medical risks.These survivors are at risk for infertility,fatigue, reduced memory or concentra-tion, heart problems, breast cancer, den-tal caries, reduced muscle growth, andreduced metabolism. Based on inter-views with 129 adult survivors of child-hood cancer, the study points to theneed for more and longer term commu-nication with survivors. A team at MassGeneral Hospital for

Children, Boston, is developing a tool toassess the health-related quality of life(QOL) of AYA survivors of central nerv-ous system (CNS) cancer. Much re -search has focused on survivors of pedi-atric CNS cancer, but AYA survivorsface different social, physical, emotional,and school/work outcomes. In addition,CNS cancer survivors have worsehealth-related QOL than survivors ofother cancers and chronic conditions.A team from British Columbia found

low levels of adherence among child-hood cancer survivors to long-term fol-low-up guidelines developed by theChildren’s Oncology Group. The re -searchers followed a cohort (n = 976) of5-year survivors of childhood cancer,and found that only 13.4% received alladvocated tests, 49.7% some, and36.9% none. Male and older survivorshad particularly low rates of adherence.The researchers suggested that future

research examine major barriers to fol-low-up care and surveillance.A study of decision making and sub-

stance use in 243 adolescent survivorsof childhood cancer relied on inter-views with survivors who had been dis-ease-free for at least 5 years. The studyfound that the rate of cigarette use wasslightly higher among those surveyedthan in the general population. Ratesof alcohol use were slightly lower, andmarijuana use was higher. The findingssuggest that risk-taking behaviorsamong survivors of childhood cancerare still high, pointing to the need forfurther educational interventions.Childhood cancer can have a major

impact on parents and families, includ-ing siblings. Siblings of childhood cancerpatients can experience a heightenedsense of responsibility and independ-ence, but they are also at a higher risk ofemotional and behavioral problems,including posttraumatic stress disorder.A study of the importance of social sup-port for siblings of children with cancerfound that siblings identified friends asproviding more support than parents,and cited support from friends as mostimportant. But the study found thatparental support had a greater impact onsibling adjustment. According to leadresearcher Melissa Alderfer, PhD,Children’s Hospital of Philadelphia,“greater support from parents is related tofewer symptoms of depression, withdraw-al, and aggressive behavior, better schoolperformance, and more involvement insocial activities for siblings.”Researchers in New York and Texas

explored the possibility of involving par-ents and young survivors in joint pro-grams to encourage physical activity anda healthy diet. The researchers examined87 minor survivors and their parents, andfound a strong intraclass correlationbetween survivor and parent level ofphysical activity and body mass index.The next step is designing interventionsthat promote healthy lifestyles for par-ents and child survivors alike. Of thosesurveyed, 80% of survivors and parentsexpressed interest in web-based exerciseand diet programs. Researchers at Copenhagen Uni -

versity, Denmark, are taking a moredirect approach to exercise, recruiting 12survivors of AYA cancer aged 22 through39 years to train for an “extreme sportevent” called The KiliMAN AdventureChallenge. The event consists of a 6-daysummit of Mt. Kilimanjaro, followed by abike race around the mountain and amarathon run. The study found that“goal-directed exercise may enableadherence to physical activity andstimulate empowering and mutual sup-portive networks.” �

www.AONNonline.org4 OctOber 2010 I VOL 1, NO 5

SURVIVORSHIP

Targeting Young SurvivorsBy Daniel Denvir


The Official Journal of the Academy of Oncology Nurse NavigatorsNAVIGATION & SURVIVORSHIP

®

Academy of Oncology Nurse Navigators (AONN) is pleased to announce the extension of its official publication into 2011.

If you have ever wanted to be a published author or have simply been looking for the right journal to publish your work,

regarding these two specific topic areas, the wait is over.

Please submit manuscripts online at www.AONNonline.org/manuscripts

Want to get more involved?Submit your CV/Bio to be considered for expert advisory

board positions to [email protected].

If you have any questions about AONN or the Journal of Oncology Navigation & Survivorship, please contact

Sean T. Walsh, Executive Director of AONN, at

[email protected].

Submit a Manuscript Today!




The ONLY journal focused on patient navigation and survivorship care in oncology patients.

“A greater support from parents isrelated to fewer symptoms ofdepression, withdrawal, andaggressive behavior, better schoolperformance, and more involvement in social activities for siblings.” —Melissa Alderfer, PhD



Clinical Nursing Review

Cytotoxic chemotherapy is one ofthe cornerstones for the treat-ment of metastatic breast cancer

(MBC). Drug resistance remains themost common cause of treatment fail-ure; in particular, resistance to anthra-cyclines and taxanes hin-ders the management ofMBC.1 With increasingfrequency, these agents arebeing used to treat early-stage breast cancer, mean-ing that these patientshave fewer effective cyto-toxic treatment options ifthey progress to MBC.1-3As such, a great deal ofactive clinical research isfocused on developing novel cytotoxicswith reduced susceptibility to commondrug-resistance mechanisms.One result of research into novel

cytotoxics has been the development ofa new class of drugs known as theepothilones. The epothilones have asimilar mode of action to taxanes inthat they disrupt microtubule functionwithin tumor cells.4 The epothiloneshave a different chemical structure andhave demonstrated antitumor activityin patients who have developed resist-ance to taxanes.5,6 Ixabepilone is thefirst epothilone to be approved by theUS Food and Drug Administration. Itsinitial indications are7:• In combination with capecitabinefor the treatment of metastatic orlocally advanced breast cancer inpatients after failure of an anthra-cycline and a taxane

• As monotherapy for the treatmentof metastatic or locally advancedbreast cancer in patients after fail-ure of an anthracycline, a taxane,and capecitabine.

In the MBC setting, ixabepilone hasbeen shown to be effective in patientsirrespective of their estrogen/proges-terone receptor status or their humanepidermal growth factor receptor type 2status.8 The recommended dose ofixabepilone is 40 mg/m2 infused intra-venously over 3 hours every 3 weeks.7The taxanes have well-characterized

side effect profiles. Because ixabepiloneand the other epothilones act in a waythat is similar to the taxanes, ixabepi-lone therapy is associated with many ofthe same side effects that oncology nurs-es have come to expect during taxanetherapy (Table 1). With any new classof agents, however, comes new informa-tion and considerations for patient

management. Important differencesbetween taxanes and epothilones yielddifferent treatment-specific issues thatnurses should understand to help ensurethat patients receive the intended ben-efit from ixabepilone therapy.

Ixabepilone toxicity profileand appropriate nursinginterventionThe most common adverse

events seen with ixabepiloneused as monotherapy or incombination with capecita bineare presented in Table 1. Otherimportant adverse events thathave been associated withixabepilone include severe

hyper sensitivity reactions (HSRs) dur-ing drug ad ministration7 and, whenixabepilone is given in combinationwith cap ecitabine, palmar-plantar ery-throd ysesthesia (hand-foot syndrome)and cardiac events.7Side effects during ixabepilone thera-

py can be effectively managed with dosereduction and supportive care (Table 1).Some common side effects associatedwith ixabepilone therapy, particularlyneutropenia and peripheral neuropathy,can be manageable with proactive inter-vention but can be debilitating if theyprogress to severe events. Therefore,nurses can improve treatment out-comes, adherence, and patient qualityof life during treatment with ixabepi-lone by providing information topatients and their families. Patientsreceiving ixabepilone should be educat-ed as to what to expect during treat-ment, and they should be alert to signsand symptoms that should be reportedto their healthcare team (Table 2).In addition to patient education, spe-

cific nursing activities to supportpatients receiving ixabepilone includemonitoring laboratory values, particu-larly liver function tests, completeblood counts (CBCs), and platelets;assessing for preexisting allergies,administering premedications and mon-itoring for HSRs during infusions;administering prescribed growth factorsupport; assessing preexisting neu-ropathies, and monitoring for new orworsening neuropathy (Table 3).

Pretreatment assessmentExtensive clinical testing has re -

vealed contraindications to ixabepi-lone therapy, as well as situationsunder which a lower dose of ixabepi-lone should be used.8-11 Even though

Managing Metastatic Breast Cancer PatientsTreated with Ixabepilone: Practical GuidanceBy Una Hopkins, FNPMontefiore Medical Center, Weiler-Einstein Division, East Campus, Bronx, New York

Table 1 Management of Toxicities and Dosing Recommendations with Ixabepilone

Hematologic toxicitiesLeukopeniaNeutropeniaFebrile neutropeniaAnemiaThrombocytopenia

• Ixabepilone should not be administered to patientswith baseline neutrophils <1500 cells/mm3 or platelets <100,000/mm3,a

• Hematopoietic growth factors (eg, G-CSF)• Decrease ixabepilone dose by 20% for the followinga:

• Neutrophil <500 cells/mm3 for ≥7 days• Febrile neutropenia• Platelets <25,000/mm3 or <50,000/mm3 withbleeding

Nonhematologic toxicities

• For any grade 3 toxicity other than neuropathy,decrease ixabepilone dose by 20%a

Peripheral neuropathy • Early recognition important• Reversible with ixabepilone dose reduction or delay• Dose adjustments recommended as followsa:

• Grade 2 lasting ≥7 days—decrease dose by20%

• Grade 3 lasting <7 days—decrease dose by20%

• Grade 3 lasting ≥7 days or disabling—discontinue

Gastrointestinal symptoms

• Intensive fluid management

Diarrhea • Antidiarrheal medications• Prophylactic antibiotics (in patients also experiencing neutropenia)

Constipation • Increase fiber intake• Laxatives

Anorexia • Nutritional support

Nausea/vomiting • Antiemetics

Mucositis/stomatitis • Soothing mouthwashes• Pain relief• Nutritional support

Myalgias and arthralgias

• Dose reduction• Transient grade 3—no change in dose• Prolonged grade 3—decrease dose by 20%• Analgesics (eg, NSAIDs) if patient has normal platelet counts

Fatigue • Correction of known causes (eg, anemia, sleep disorders, anxiety)

• Regular exercise• Antidepressants• Antianxiety medications• Attention-restoring exercises• Psychological counseling• Physical therapy

Alopecia • Plan for hair-loss management• Cut hair short prior to treatment• Use of wig

Cardiac adverseevents

• Temporary or permanent discontinuation of ixabepilone

aReference 7.G-CSF indicates granulocyte colony-stimulating factor; NSAID, nonsteroidal anti-inflammatory drug.

Una Hopkins, FNP




ixabepilone is not hepatotoxic, patientswith preexisting impaired liver func-tion who were treated with theixabepilone/capecitabine doublet wereshown to be at increased risk of toxici-ty and neutropenia-related death in apivotal phase 3 trial.8 For this reason,ixabepilone plus capecitabine must notbe given to patients with aspartateaminotransferase (AST) or alanineaminotransferase (ALT) >2.5 × theupper limits of normal (ULN) orbilirubin >1 × ULN. Liver function isalso an important consideration forthose receiving ixabepilone monother-apy. Hepatic function should beassessed periodically during ixabepi-lone therapy, with the dose adjusted as

necessary.7 Before administration ofixabepilone, the nurse should be awareof the current liver function values andcheck doses accordingly. The followingguidelines are listed in the packageinsert and refer to the first course oftherapy; further dose reductions in sub-sequent courses should be based onindividual tolerance7:• AST and ALT ≤2.5 × ULN andbiliru bin ≤1 × ULN—administerixabepilone monotherapy at 40mg/m2 (full dose)

• AST and ALT ≤10 × ULN andbilirubin ≤1.5 × ULN—administerixabepilone monotherapy at 32mg/m2

• AST and ALT ≤10 × ULN andbilirubin >1.5 × ULN to ≤3 × ULN—administer ixabepilone mono -therapy at 20 mg/m2 to 30 mg/m2

• AST or ALT >10 × ULN or biliru-bin >3 × ULN—use of ixabepilonemonotherapy is not recommended.

The CBC and platelets should bechecked before the first dose is givenand periodically during therapy, becauselow blood cell counts may preclude theuse of ixabepilone or necessitate a dosereduction. As with preexisting hepatictoxicity, patients with a baseline neu-trophil count <1500 cells/mm3 or aplatelet count <100,000 cells/mm3

should not be given ixabepilone.7During therapy, if the neutrophil countis <500 cells/mm³ for ≥7 days, thepatient has febrile neutropenia, or theplatelet count is <25,000/mm³ (or<50,000/mm³ with bleeding), the doseof ixabepilone should be decreased by

20%.7 A new treatment cycle shouldbegin only when the neutrophil count is≥1500 cells/mm³ and if nonhematologictoxicities have improved to grade 1(mild) or resolved.7

Preventing HSRsLike standard formulations of pacli-

taxel and docetaxel, ixabepilone is for-

mulated with polyethoxylated castor oil.To avoid HSRs to this vehicle duringixabepilone infusion, patients should bepremedicated approximately 1 hourbefore infusion with both an H1 blockerand an H2 blocker.7Corticosteroid premedication is not

mandatory for ixabepilone; in contrast,the taxanes paclitaxel and docetaxel

exhibit greater potential for HSRs andsteroid premedication is required.12-14However, patients who have experi-enced an HSR in a previous ixabepilonecycle should be premedicated with cor-ticosteroids (eg, dexamethasone 20 mgintravenously 30 minutes before infu-sion or orally 60 minutes before infu-

ISTODAX® is a registered trademark of Astellas Pharma, Inc.©2010 Celgene Corporation 04/10 IST10041

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Hepatic function shouldbe assessed periodicallyduring ixabepilonetherapy, with the doseadjusted as necessary.





sion) in addition to the H1 and H2

blockers. If possible, extending the infu-sion time should also be considered inthese patients. Patients with a history ofa severe HSR to agents containing poly-ethoxylated castor oil should not betreated with ixabepilone.7,13,14During the infusion, nurses should

closely monitor patients for signs ofHSR, including flushing, rash, dyspnea,

and bronchospasm. Should a severeHSR occur, the ixabepilone infusionshould be stopped and aggressive sup-portive treatment (eg, epinephrine orcorticosteroids) started immediately.7,13

Neutropenia and thrombocytopeniaNurses should assess patients for

myelosuppression frequently duringixabepilone therapy.7 With grade 3/4

neutropenia rates of almost 70% withthe ixabepilone/capecitabine doubletand around 54% with ixabepilonemonotherapy,8,9 effective managementof this side effect is critical for optimiz-ing patient outcomes. Risk factors forneutropenia include older age, bonemarrow involvement, immune systemdysfunction, hepatic or renal impair-ment, and malnutrition.15,16 Patientsshould be assessed at baseline for thesefactors to determine whether they are athigher risk, and the treatment teamshould be informed accordingly.In patients who develop neutropenia,

nurses should watch for symptoms thatmay increase the risk of or herald infec-tious complications. These symptomsmay be specific to the gastrointestinalsystem (eg, mucositis and diarrhea), res-piratory tract (eg, cough and dyspnea),urinary tract, or indwelling devices, orthey may consist of more generalizedflulike symptoms (eg, fever, chills, andmalaise).17 It is especially important toeducate patients about recognizing andmanaging febrile neutropenia, and they

should be strongly advised to seek med-ical attention immediately if they expe-rience fever, chills, and/or rigors. Inaddition, patients should be educatedregarding steps that can be taken tohelp minimize the risk of neutropenia,including continuing to eat well andavoiding behaviors and situations thatcould increase their exposure to infec-tious agents.17 Although routine admin-istration of growth factor support is notindicated by the ixabepilone prescribinginstructions,7 it may be necessary insome patients, and nurses should beaware of the appropriate use of thesedrugs to maximize their effectiveness.Thrombocytopenia is less common

than neutropenia in patients receivingixabepilone, although it was observed in2% to 6% of patients during the regis-trational trials.7 Therefore, nursesshould monitor patients for signs thatcould indicate this problem, includingbleeding from the gums, bruising,petechiae, and blood in the stool orurine. Patients with low platelet countsshould not be subjected to intramuscu-lar injections or rectal temperature

measurements, and pressure should beapplied to venipuncture sites for 5 min-utes. Furthermore, enemas and supposi-tories should be avoided to decrease thelikelihood of bleeding.18

Peripheral neuropathyAffecting as many as 50% of cancer

patients, chemotherapy-induced per -ipheral neuropathy (CIPN) most likelyresults from the injury, inflammation, or degeneration of peripheral nervefibers.19 CIPN often occurs in a stock-ing-and-glove distribution pattern, withsymptoms originating at the tips of thefingers or toes and progressing toward thetrunk. CIPN is a common serious sideeffect of many cytotoxic agents, and it isa major cause of chemotherapy dosereductions, treatment delays, and discon-tinuation during ixabepilone therapy.20,21In fact, CIPN was the primary cause oftreatment discontinuation in theixabepilone registrational trials.8,9CIPN during ixabepilone therapy is

primarily sensory, cumulative, and re -versible in most patients.21-24 Althoughthe risk of CIPN increases with accu-mulating exposure to ixabepilone, ap -proximately 75% of cases of new-onsetor worsening neuropathy occur withinthe first three cycles.7 In clinical trials,ixabepilone-associated peripheral neu-ropathy re solved to baseline or grade 1within a median of 5.4 weeks aftermonotherapy and 6.0 to 6.2 weeks aftercombination therapy with capecitabine.24To manage CIPN in patients receiv-

ing ixabepilone, nurses need to identifypreexisting conditions that may affectsensory function and, if necessary, alertthe treatment team to the possibility ofincreased risk of developing CIPN dueto preexisting peripheral neuropathy orcomorbidities such as diabetes melli-tus.7,21 In addition, nurses should per-form regular neurologic assessments,first to establish baseline neurologicfunction before treatment begins andthen to detect any worsening functionin a timely fashion. Patients with stabi-lization of disease may be less forthcom-ing with self-reports of CIPN symptoms.A brief assessment that may helpreveal symptoms of CIPN may includetesting the patient’s ability to button ashirt or pick up objects.21 Initiation ofa handwriting sample may also behelpful in identifying patients withCIPN. Ad ditional signs of CIPN thatshould be monitored include a tinglingor burning sensation, hyperesthesia,hypo esthesia, paresthesia, discomfort,and neuropathic pain.Antidepressants, antiseizure medica-

tions, and glutamine have demonstrat-ed some success in treating neuropathyonce it has developed.25,26 Most experts

Managing Metastatic Breast Cancer... Continued from page 15


Table 2 Ixabepilone: Key Points for Patient and Family Education

Blood will be drawn periodically for tests to evaluate:• Liver function; preexisting liver dysfunction may necessitate reducing thedose of ixabepilone monotherapy, or it may contraindicate ixabepilone combination therapy with capecitabine

• Blood cell counts, to be sure they are high enough to protect against infec-tion and bleeding.

The ixabepilone solution contains alcohol and may cause drowsiness or dizziness.After the infusion, patients should refrain from driving and other activities requir-ing alertness until they know how they will respond to the medication.

The healthcare team should be notified promptly if any of the following occur:• Fever >100.5°F or chills• Cough, hoarseness, sore throat, or lower back/side pain• Burning, painful, or difficult urination• Bleeding gums; bruising; petechiae; blood in stools, urine, or vomit• Increased fatigue, dyspnea (shortness of breath), or orthostatic hypotension(dizziness upon standing).

The healthcare team should also be notified promptly if the following signs andsymptoms occur:• Hives, urticaria, pruritus, rash, flushing, swelling, dyspnea, chest tightness; these may be associated with a hypersensitivity (allergic) reaction to ixabepi-lone; it is especially important to let the nurse know immediately if these occurduring the ixabepilone infusion

• Numbness and tingling in hands and feet; these symptoms are associated withperipheral neuropathy

• Chest pain, difficulty breathing, palpitations, unusual weight gain; these symp-toms could be associated with heart problems.

Ixabepilone and certain other medicines may affect each other, causing sideeffects. It is important for your healthcare team to know what other medica-tions you are taking:

• A healthcare professional should be consulted before taking any prescription,over-the-counter, herbal, or vitamin products, especially St John’s wort, during ixabepilone therapy

• Patients should avoid drinking grapefruit juice during therapy; it couldincrease the risk of side effects from ixabepilone.

To help prevent infections, patients should avoid crowds and persons withknown infections. Further, no vaccinations should be recieved without theadvice of a healthcare professional.

Patients who are thrombocytopenic should not drink alcoholic beverages ortake medication containing aspirin or NSAIDs; these agents might precipitatebleeding. Patients should also be careful to avoid falls. Patients should also usesoft tooth brushes and electric razors.

Women of childbearing potential should use effective contraception duringixabepilone therapy and avoid breastfeeding during ixabepilone therapy.

Hair loss may occur; regrowth usually occurs 2 to 3 months after discon tinuationof therapy. Explore methods of coping with this side effect, such as prescrip-tions for head prostheses and referral to community-based programs such asLook Good…Feel Better (www.lookgoodfeelbetter.org), sponsored by theAmerican Cancer Society.

NSAID indicates nonsteroidal anti-inflammatory drug.

It is especially importantto educate patients about recognizing and managing febrileneutropenia.


TARGET AUDIENCEThis activity is intended for hematologists, oncologists and others whoare involved with the care of patients with Chronic LymphocyticLeukemia (CLL).

STATEMENT OF NEEDCLL is the most common type of leukemia in the United States, withover 15,000 new cases per year, characterized by the accumulation ofmonoclonal B cells in the bone marrow, peripheral blood, and lymphoidtissue. Primarily a disease of the elderly, the median survival for CLLvaries substantially: many patients survive more than 10 years after diagnosis, but a subset of symptomatic patients have shorter lifeexpectancies—in the range of 1.5 to 6 years. The clinical/research bodyof knowledge in CLL is rapidly changing and represents a challenge forthe whole treatment team.

EDUCATIONAL OBJECTIVESOn completion of this activity, participants should be able to:

• List the essential steps in diagnosis and treatment planning of theCLL patient

• Select CLL treatment regimens based on patient characteristics• Define data supporting the benefit/risk ratio of upfront, relapsed,

and refractory CLL setting• Define strategies to manage fludarabine-resistant CLL• Describe emerging therapies in CLL

www.coexm.com/ace02.aspLOG ON TODAY TO PARTICIPATE

Release Date: April 29, 2010Expiration Date: April 28, 2011

In collaboration with

FACULTYNeil E. Kay, MD Professor Department of Medicine Mayo ClinicRochester, Minnesota

Michael Keating, MDCourse ChairProfessor of Medicine �Deputy Department Chairman�Department of Leukemia�M.D. Anderson Cancer Center�Houston, Texas

This activity has been approved for 1.5 AMA PRA Category 1 Credits™. For further information and to participate, please go to: www.coexm.com/ace02.asp

This activity is supported by an educational grant fromGenentech BioOncology and Biogen Idec.

Chronic Lymphocytic LeukemiaThe Essentials of Patient Care

A TON_October 2010_v6_TON 10/15/10 3:00 PM Page 17



agree, however, that the best strategy tominimize the impact of CIPN is earlydetection coupled with chemothera-py dose reductions and/or delays.25,27

Accordingly, patients experiencingnew or worsening symptoms of CIPN

may require a reduction or delay inthe dose of ixabepilone, as follows7:

• If CIPN is grade 2 (moderate)lasting for ≥7 days or grade 3(severe) lasting for <7 days—decrease dose by 20%

• If CIPN is grade 3 lasting ≥7days or is disabling—discontinuetreatment.

Several groups are investigating theability of neurologic tests to detect earlyneuropathic changes in patients treatedwith ixabepilone.21,23 The availability ofsuch tests could theoretically help toprevent the development of severeCIPN, which would be especially valu-able in patients with earlier stage dis-ease who might receive ixabepilone inthe future.

Ixabepilone administrationAt many clinics and private prac-

tices, nurses are directly involved inpreparing and administering chemo -therapy, and therefore, they need tobecome familiar with the proceduresunique to ixabepilone administration.Timing is critical, because a number ofixabepilone administration steps aretime-limited. To minimize risk of dermalexposure when handling ixabepilonevials, nurses should wear imperviousgloves during unpacking and inspection,transport within a facility, dose prepara-tion, and administration.7

SummaryBecause ixabepilone has reduced sus-

ceptibility to multiple mechanisms ofresistance to taxanes and anthracyclinesand has proved efficacious in drug-resis-tant MBC, it provides a much-neededtreatment option for patients in whommany other therapies have failed.Oncology nurses should be familiar withthe unique aspects of providing ixabepi-lone therapy, that is, the toxicity profileof which is similar to yet distinct fromthat associated with taxane therapy.Nurses play a key role in maximizing theclinical benefit of ixabepilone therapyand encouraging adherence, so thatpatients may achieve optimal outcomes.

AcknowledgmentsThe author takes full responsibility

for the content of this publication andconfirms that it reflects her viewpointand medical expertise. She also wishesto acknowledge StemScientific, fund-ed by Bristol-Myers Squibb, for providing writing and editing support.Neither Bristol-Myers Squibb nor Stem-Scientific influenced the content of themanuscript, nor did the author receivefinancial compensation for authoringthe manuscript. �

References1. Valero V, Hortobagyi GN. Are anthracycline-taxaneregimens the new standard of care in the treatment ofmetastatic breast cancer? J Clin Oncol. 2003;21:959-962.2. O’Shaughnessy J. Extending survival with chemo -therapy in metastatic breast cancer. Oncologist. 2005;10(suppl 3):20-29.3. Bernard-Marty C, Cardoso F, Piccart MJ. Facts andcontroversies in systemic treatment of metastatic breast

cancer. Oncologist. 2004;9:617-632.4. Goodin S, Kane MP, Rubin EH. Epothilones: mech-anism of action and biologic activity. J Clin Oncol.2004;22:2015-2025.5. Lee FY, Borzilleri R, Fairchild CR, et al. BMS-247550: a novel epothilone analog with a mode ofaction similar to paclitaxel but possessing superior anti-tumor efficacy. Clin Cancer Res. 2001;7:1429-1437.6. Lee FY, Smykla R, Johnston K, et al. Preclinical effi-cacy spectrum and pharmacokinetics of ixabepilone.Cancer Chemother Pharmacol. 2009;63:201-212.7. Ixempra (ixabepilone) [package insert]. Princeton,NJ: Bristol-Myers Squibb Company; 2009.8. Thomas ES, Gomez HL, Li RK, et al. Ixabepiloneplus capecitabine for metastatic breast cancer progress-ing after anthracycline and taxane treatment. J ClinOncol. 2007;25:5210-5217.9. Perez EA, Lerzo G, Pivot X, et al. Efficacy and safetyof ixabepilone (BMS-247550) in a phase II study ofpatients with advanced breast cancer resistant to ananthracycline, a taxane, and capecitabine. J Clin Oncol.2007;25:3407-3414.10. Thomas E, Tabernero J, Fornier M, et al. Phase II clin-ical trial of ixabepilone (BMS-247550), an epothilone Banalog, in patients with taxane-resistant metastatic breastcancer. J Clin Oncol. 2007;25:3399-3406.11. Low JA, Wedam SB, Lee JJ, et al. Phase II clinicaltrial of ixabepilone (BMS-247550), an epothilone Banalog, in metastatic and locally advanced breast can-cer. J Clin Oncol. 2005;23:2726-2734.12. Markman M. Management of toxicities associatedwith the administration of taxanes. Expert Opin DrugSaf. 2003;2:141-146.13. Myers JS. Hypersensitivity reaction to paclitaxel:nursing interventions. Clin J Oncol Nurs. 2000;4:161-163.14. Lenz HJ. Management and preparedness for infu-sion and hypersensitivity reactions. Oncologist.2007;12:601-609.15. Scott S. Identification of cancer patients at high riskof febrile neutropenia. Am J Health Syst Pharm.2002;59(15 suppl 4):S16-S19.16. Alexandre J, Gross-Goupil M, Falissard B, et al.Evaluation of the nutritional and inflammatory status incancer patients for the risk assessment of severe haema-tological toxicity following chemotherapy. Ann Oncol.2003;14:36-41.17. Marrs JA. Care of patients with neutropenia. Clin JOncol Nurs. 2006;10:164-166.18. Camp-Sorrell D. Myelosuppression. In: Itano JK,Taoka KN, eds. Core Curriculum for Oncology Nursing.4th ed. Philadelphia, PA: WB Saunders; 2005:259-274.19. Wilkes G. Peripheral neuropathy related tochemotherapy. Semin Oncol Nurs. 2007;23:162-173.20. Quasthoff S, Hartung HP. Chemotherapy-inducedperipheral neuropathy. J Neurol. 2002;249:9-17.21. Lee JJ, Swain SM. Peripheral neuropathy inducedby microtubule-stabilizing agents. J Clin Oncol.2006;24:1633-1642.22. Cortes J, Baselga J. Targeting the microtubules inbreast cancer beyond taxanes: the epothilones.Oncologist. 2007;12:271-280.23. Goel S, Goldberg GL, Kuo DYS, et al. Novel neu-rosensory testing in cancer patients treated with theepothilone B analog, ixabepilone. Ann Oncol. 2008;19:2048-2052.24. Perez EA, Pivot X, Vrdoljak E, et al. A prospectivecharacterization of the resolution of ixabepiloneinduced peripheral neuropathy: data from a large regis-trational program in patients with metastatic breast can-cer. Cancer Res. 2009;69(suppl):Abstract 6140.25. Makino H. Treatment and care of neurotoxicityfrom taxane anticancer agents. Breast Cancer. 2004;11:100-104.26. Eisenberg E, River Y, Shifrin A, Krivoy N.Antiepileptic drugs in the treatment of neuropathicpain. Drugs. 2007;67:1265-1289.27. Lee JJ, Low JA, Croarkin E, et al. Changes in neu-rologic function tests may predict neurotoxicity causedby ixabepilone. J Clin Oncol. 2006;24:2084-2091.

Managing Metastatic Breast Cancer... Continued from page 16

Table 3 Nursing Activities Associated with Management of Patients ReceivingIxabepilone Therapy

Issue Nursing activities

Liver function • Assess liver function tests at baseline and periodicallyduring therapy

• Ensure that ixabepilone/capecitabine combinationtherapy is not administered to patients with preexist-ing impaired liver function above the recommendedthreshold

• Ensure that ixabepilone monotherapy is given inreduced doses to patients with preexisting mild tomoderate impairment in liver function, as recom-mended

• Closely monitor patients with impaired liver functionfor neutropenia and neutropenic complications

Hypersensitivity reactions (during infusions)

• Evaluate patient for risk of allergic response• Administer premedications 1 hour prior to infusion• Closely monitor patient for signs of hypersensitivity

during infusion, including flushing, rash, dyspnea, andbronchospasm

• Promptly alert treatment team if signs of hypersensi-tivity are detected

• Slow or stop infusion as appropriate, and administersupportive measures as required

Neutropenia (also thrombocytopenia)

• Evaluate patient at baseline for risk of neutropeniaand neutropenia-related complications (eg, older age,bone marrow involvement, immune system dysfunc-tion, hepatic or renal impairment, malnutrition)

• Inform treatment team of increased risk if so determined

• Monitor CBC frequently to detect neutropenia andother cytopenias (ie, anemia, thrombocytopenia)

• Administer growth factor support as prescribed• Ensure that ixabepilone dose is reduced or stopped as

prescribed for neutropenia or thrombocytopenia• Strongly advise patients to seek prompt attention

from the treatment team if fever and chills develop• Provide patient and family education regarding

mea sures to reduce risk of neutropenic and/or bleeding complications

Peripheral neuropathy • Evaluate patient for preexisting conditions that mayincrease risk of neuropathy (eg, diabetes, preexisting neuropathy)

• Inform treatment team of increased risk if so deter-mined

• Perform neurologic assessment at baseline to establishpretreatment status

• Perform neurologic assessments frequently duringtreatment to monitor for early signs of new-onset orworsening neuropathy, including burning sensation,hyperesthesia, hypoesthesia, paresthesia, discomfort,and neuropathic pain

• Ensure that ixabepilone dose is reduced or stopped asprescribed for neuropathy

• Educate patients with neuropathy about safety (eg,when dealing with hot objects), fall prevention, andskin care

CBC indicates complete blood count.

Erratum: In the article in the Augustissue on cabazitaxel for prostatecancer, the dosage was incorrectlystated as “three times weekly.” Itshould read “every 3 weeks,” as in -dicated in the package insert.


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Cancer Center Profile

include access to cancer screening, treat-ment, and research. The staff at MSTIhopes to reduce disparities in care fortheir patients with help from their newcontract as a member of the NCCCP.

Making it a realityMSTI has “plans to beef up programs

that are partly already in place but needgreater funding, whether that is gettingearly screening with mammography at agreater intensity or getting more educa-tion within the communities,” said PaulG. Montgomery, MD, FACP, a medicaloncologist. “There has been some edu-cation, there needs to be more. Therehas been some mobile mammographyunits going to rural areas, there needs tobe more.” Funding from the NCCCPcontract should help MSTI providethese additional services and “allow usto make an impact.”

The action plans start by analyzingdata on their patients. These data showwhere MSTI needs to focus, includinggeographic areas and ethnic popula-tions. Then, areas with disparities aretargeted for what is needed. Mont -gomery gave this example: Geographicareas where patients disproportionatelypre sent in the later stages of cancers canbe targeted for patient education, hope-fully leading to improved early diagnosisand screening.

To help get information and servicesout to people, MSTI plans to expand itsservices beyond the Boise clinic, wheremost of the specialized clinics are cur-rently housed. With the high-risk breastcancer clinic, for example, all patientsmust travel to Boise. But, the plan is toexpand into the Twin Falls area, whichis about 130 miles away, and at a futuredate, perhaps into the Fruitland area,according to Jill Winschell, RN, abreast cancer nurse navigator.

Navigation services will expandbeyond the new clinic. MSTI is cur-rently looking to fill several positionsfor new navigators, starting with a nav-igator for the Twin Falls area and onefor the Fruitland area in the western end

of the Treasure Valley, which is home toa large Hispanic and rural population. Athird breast care navigator will be hiredfor additional western Idaho locations.

“These rural navigators will be situat-ed in those areas and begin to developcommunity resources and communityoutreach to occur directly in their com-munities,” said Winschell.

A second mobile mammographycoach also is in the works. The currentcoach is booked every day, except whenit is down for service, according toWinschell. “In fact, they have traveledup to Grangeville, which is 220 milesnorth. And we will be traveling intoOregon, which will be new for us.”

Disparities meet supportive carePsychosocial and survivorship re -

sources are expected to expand into allfive sites as well, which will help MSTIembrace another of the NCCCP pil-lars—“Enhance cancer survivorshipand palliative care services.” In addi-tion, “we have the opportunity to pro-vide supportive oncology clinics tomeet the advanced disease population,”said Alicia Rosales, LMSW, an oncolo-gy social worker.

A supportive care oncology clinicwas opened in May in the Boise loca-tion. “It is not in replacement of thepatients’ visits to their primary oncol-

ogist, but something that is linked inparallel,” said Dan Zuckerman, MD,medical director for the supportivecare and survivorship clinics. Withthis clinic, patients who require helpfrom multiple supportive disciplinesnow have a place to go. The clinicoffers dietitians, social workers, andphysical therapists. There are plans toincrease psychiatric services by hiringsomeone with a specific interest inpsycho-oncology. Although dedicatedpsychosocial onco l ogy personnel canbe difficult to staff in rural areas,Zuckerman is hoping to use fundingfrom the NCCCP for this purpose.This funding may also allow a support-ive oncology clinic to open in each of

the five sites. Rosales envisions a half-day clinic of survivorship and a half-day clinic of advanced diseasepatients, staffed by a multidisciplinaryteam. The clinics would offer a dieti-tian, a social worker, a psychiatrist, apharmacist, a nurse practitioner, andreferrals to financial counselors andphysical therapists.

The rural location of its patientsaffects survivorship services as well.With patients in remote areas, sur-vivorship services means “making surethat patients have the information, theresources, and the tools they need toempower themselves to lead healthylives. We have to take into accountthat all of them may not have theopportunity to participate in exerciseclasses. We have to give them theinformation about how they can do iton their own in their own geographicsetting,” said Rosales.

Patient education is a similar chal-lenge. In the Hispanic community, manybelieve that cancer cannot be cured. “Itis even harder when these groups ofworkers are spread over a large area, tobe able to reach out and have themunderstand that cancer can be cured. Agreat deal of time and effort will be need-ed to communicate that early diagnosisis important,” said Montgomery. “We arehoping that we can do more communityoutreach and interaction with the peo-ple in those communities to deal witha lot of those disparities and get therural and Hispanic population into thehealthcare system in a timely manner,”echoed Winschell. MSTI employsboth Hispanic and Spanish-speakingoncologists and nurses to help withthese efforts.

Clinical trials and biospecimenresearch

NCCCP sites are also tasked to

“increase participation in clinical trials,”and “participate in biospecimen re searchinitiatives to support personalized medi-cine.” Using funding from the contract,MSTI will be able to start a phase 1 clin-ical trial program within the next 2 years,“which will be a huge thing becausethere is no place in Idaho or in our sur-rounding area that offers phase 1 trials,”said Zuckerman. At current, MSTIaccrues only to phase 3 trials, usuallyfrom one of the cooperative groups—Southwest Oncology Group, RadiationTherapy Oncology Group, NationalSurgical Adjuvant Breast and BowelProject, Eastern Cooperative OncologyGroup, and Cancer and LeukemiaGroup B—as well as to a limited numberof industry-sponsored and investigator-initiated phase 2 trials.

Biospecimen processing is alreadyunder way. In conjunction with BoiseVeterans Affairs Medical Center andBoise State University, MSTI has bro-ken ground on the building wherebiospecimens will be stored. “I thinkone of the things nationally is the NCI[National Cancer Institute] is trying tostandardize how biospecimens arestored and to enable researchers fromanywhere in the country to accessthese biospecimens,” said Zuckerman.

Meeting the challenge“The challenge is not only to deliver

best standards of care, but also to imple-ment that across our multiple sites.Many of our patients cannot come intoour main center in Boise, so our goaland our responsibility is to provide carein their own communities,” explainedZuckerman. Along with fellow NCCCPsite Billings Clinic Cancer Center inBillings, Montana, MSTI hopes tomeet the NCI’s challenge of providingthe best evidence-based care to allAmericans. �

Reducing Disparities in Cancer Care ... Continued from cover

Members of St. Luke’s Mountain States Tumor Institute, from left: DanZuckerman, MD; Alicia Rosales, LMSW; Jill Winschell, RN; and Paul G.Montgomery, MD, FACP.

St. Luke’s Mobile Mammography Service brings mammography to the ruralareas of southwestern Idaho.



O N C O L O G Y D R U G C O D E S

Medications Used for the Treatment of Breast Cancer

Current MedicareFDA- code price allowableapproved Compendia listed (AWP-based (ASP + 6%), CPT ®

generic (Brand) HCPCS code: for breast off-label use for pricing), effective effective administrationname code description cancer breast cancera 10/1/10 10/1/10-12/31/10 codes

Breast cancer forms in tissues of the breast, usuallythe ducts (tubes that carry milk to the nipple) andlobules (glands that make milk). It occurs in bothmen and women, although male breast cancer israre. The following sections will assist healthcareprofessionals and payers by providing appropriatecoding, billing, and reimbursement informationassociated with the management of breast cancer.

The following sections include:• Associated ICD-9-CM codes used for theclassification of breast cancer

• Drugs that have been FDA-approved in thetreatment of breast cancer

• Drugs that are compendia listed for off-labeluse for breast cancer based on clinical stud-ies that suggest beneficial use in some cases.Please note: if a check mark appears in theFDA column it will NOT appear in thecompendia off-label use column

• Corresponding HCPCS/CPT® codes and code descriptions

• Current Code Price (AWP-based pricing)• Most recent ASP plus 6% (Medicare allow-able), if applicable

• Possible CPT® Administration Codes foreach medication

Associated ICD-9-CM Codes Used for Breast Cancer174 Malignant neoplasm of female breast

Includes: breast (female)connective tissuesoft partsPaget’s disease of:breastnipple

Use additional code to identify estrogen receptorstatus (V86.0, V86.1)

Excludes: skin of breast (172.5, 173.5)174.0 Nipple and areola174.1 Central portion174.2 Upper-inner quadrant174.3 Lower-inner quadrant174.4 Upper-outer quadrant174.5 Lower-outer quadrant174.6 Axillary tail174.8 Other specified sites of female breast

Ectopic sites

Inner breastLower breastMalignant neoplasm of contiguous oroverlapping sites of breast whosepoint of origin cannot be determinedMidline of breastOuter breastUpper breast

174.9 Breast (female), unspecified

175 Malignant neoplasm of male breastUse additional code to identify estrogen receptorstatus (V86.0, V86.1)

Excludes: skin of breast (172.5, 173.5)175.0 Nipple and areola175.9 Other and unspecified sites of male

breastEctopic breast tissue, male

PO BOX 290616, Wethersfield, CT 06109 T: (860) 563-1223 • F: (860) 563-1650

www.RJHealthSystems.com

This information was supplied by:

anastrozole J8999b: prescription drug, � NDC NDC N/A(Arimidex) oral, chemotherapeutic, level level

not otherwise specified pricing pricinganastrozole S0170: anastrozole, oral, �� $13.48 S0170: N/A(Arimidex) 1 mg not payable

by Medicarebacillus J9031: bCG (intravesical) �� $169.10 $114.93 96413, 96415Calmette-Guerin per installation(Tice BCG, TheraCys)bevacizumab J9035: injection, bevacizumab, �� $68.50 $58.44 96413, 96415(Avastin) 10 mgcapecitabine J8520: capecitabine, oral, �� $8.52 $6.85 N/A(Xeloda) 150 mgcapecitabine J8521: capecitabine, oral, �� $28.41 $22.58 N/A(Xeloda) 500 mgcarboplatin J9045: injection, carboplatin, �� $48.55 $3.70 96409, 96413, 96415(Paraplatin) 50 mgcisplatin J9060: cisplatin, powder �� $4.33 $1.50 96409, 96413, 96415(Platinol AQ) or solution, per 10 mgcisplatin J9062: cisplatin, �� $21.66 $7.49 96409, 96413, 96415(Platinol AQ) 50 mgcyclophosphamide J8530: cyclophosphamide, �� $2.09 $0.83 N/A(Cytoxan) oral, 25 mgcyclophosphamide J9070: cyclophosphamide, �� $10.57 $5.96 96409, 96413, 96415(Cytoxan) 100 mg (all 100-mg NDCs

inactive: 500-mg NDCs used to calculate code price)



O N C O L O G Y D R U G C O D E SSupplied by: RJ Health Systems




cyclophosphamide J9080: cyclophosphamide, �� $21.15 $11.92 96409, 96413, 96415(Cytoxan) 200 mg (all 100-mg NDCs

inactive: 500-mg NDCs used to calculate code price)

cyclophosphamide J9090: cyclophosphamide, �� $52.87 $29.79 96409, 96413, 96415(Cytoxan) 500 mgcyclophosphamide J9091: cyclophosphamide, �� $95.21 $59.59 96409, 96413, 96415(Cytoxan) 1 gramcyclophosphamide J9092: cyclophosphamide, �� $171.35 $119.18 96409, 96413, 96415(Cytoxan) 2 gramdaunorubicin citrate J9151: injection, daunorubicin �� $68.00 $57.66 96413liposome citrate, liposomal formulation, (DaunoXome) 10 mgdocetaxel J9171: injection, �� $24.29 $18.01 96413(Taxotere) docetaxel, 1 mgdoxorubicin J9000: injection, doxorubicin �� $13.20 $3.04 96409(Adriamycin) hydrochloride, 10 mgdoxourubicin HCl J9001: injection, doxorubicin �� $613.03 $486.80 96413liposome hydrochloride, all lipid (Doxil) formulations, 10 mg epirubicin J9178: injection, �� $5.38 $1.80 96409, 96413(Ellence) epirubicin HCl, 2 mg estradiol J8499b: prescription drug, �� NDC NDC N/A(Estrace) oral, non-chemotherapeutic, level level

not otherwise specified pricing pricingetoposide J8560: etoposide, oral, �� $57.33 $28.48 N/A(Vepesid) 50 mgexemestane J8999b: prescription drug, �� NDC NDC N/A(Aromasin) oral, chemotherapeutic, level level

not otherwise specified pricing pricingexemestane S0156: exemestane, �� $13.50 S0156: not N/A(Aromasin) 25 mg payable by

Medicarefluorouracil J9190: injection fluorouracil, �� $3.37 $1.74 96409(Adrucil) 500 mgfluoxymesterone J8499b: prescription drug, �� NDC NDC N/A(Androxy) oral, non-chemotherapeutic, level level

not otherwise specified pricing pricingfulvestrant J9395: injection, fulvestrant, �� $97.29 $83.02 96402(Faslodex) 25 mggemcitabine J9201: injection, �� $177.83 $148.35 96413(Gemzar) gemcitabine hydrochloride,

200 mggoserelin acetate J9202: goserelin acetate � $451.19 $194.29 96372, 96402(Zoladex 3.6 mg ONLY) implant, per 3.6 mghydroxyurea J8999b: prescription drug, �� NDC NDC N/A(Hydrea) oral, chemotherapeutic, level level

not otherwise specified pricing pricinghydroxyurea S0176: hydroxyurea, oral, �� $1.28 S0176: not N/A(Hydrea) 500 mg payable by

Medicareifosfamide J9208: injection, ifosfamide, �� $56.40 $34.15 96413, 96415(Ifex) 1 gram






Continued from page 23


irinotecan J9206: injection, irinotecan, �� $31.48 $6.12 96413, 96415(Camptosar) 20 mgixabepilone J9207: injection, ixabepilone, �� $73.76 $63.74 96413, 96415(Ixempra) 1 mglapatinib ditosylate J8999b: prescription drug, �� NDC NDC N/A(Tykerb) oral, chemotherapeutic, level level

not otherwise specified pricing pricingletrozole J8999b: prescription drug, �� NDC NDC N/A(Femara) oral, chemotherapeutic, level level

not otherwise specified pricing pricingleucovorin calcium J0640: injection, leucovorin �� $3.60 $1.05 96372, 96374, 96409(Wellcovorin) calcium, per 50 mgleuprolide J9217: leuprolide acetate �� $493.20 $208.22 96402(Eligard, (for depot suspension), Lupron Depot) 7.5 mgleuprolide J9218: leuprolide acetate, �� $27.52 $4.79 96402(Lupron) per 1 mglomustine J8999b: prescription drug, �� NDC NDC N/A(CeeNu) oral, chemotherapeutic, level level

not otherwise specified pricing pricinglomustine S0178: lomustine, oral, �� $10.59 S0178: not N/A(CeeNu) 10 mg payable by

Medicaremedroxyprogesterone J1051: injection, �� $9.67 $8.12 96402(Depo-Provera) medroxyprogesterone acetate,

50 mgmegestrol J8999b: prescription drug, � � NDC NDC N/A(Megace) oral, chemotherapeutic, level level

not otherwise specified pricing pricingmegestrol S0179: megestrol acetate, �� $0.66 S0179: not N/A(Megace) oral 20 mg payable by

Medicaremelphalan J8600: melphalan, oral, �� $5.68 $4.80 N/A(Alkeran) 2 mgmelphalan J9245: injection, �� $1,922.50 $1,401.83 96409, 96413(Alkeran) melphalan hydrochloride, 50 mgmethotrexate J8610: methotrexate, �� $3.61 $0.12 N/Asodium oral, 2.5 mgmethotrexate J9250: methotrexate sodium, �� $0.29 $0.19 96372, 96374, 96401,sodium 5 mg 96409, 96450methotrexate J9260: methotrexate sodium, �� $2.86 $1.89 96372, 96374, 96401,sodium 50 mg 96409, 96450mitomycin J9280: mitomycin, �� $67.20 $20.77 96409(Mutamycin) 5 mgmitomycin J9290: mitomycin, �� $218.40 $83.07 96409(Mutamycin) 20mgmitomycin J9291: mitomycin, �� $300.00 $166.15 96409(Mutamycin) 40 mgmitoxantrone J9293: injection, mitoxantrone �� $106.50 $40.83 96409, 96413(Novantrone) hydrochloride, per 5 mgoxaliplatin J9263: injection, �� $8.25 $4.71 96413, 96415(Eloxatin) oxaliplatin, 0.5 mg


For more information about GEMZAR, please see your Lilly sales professional or visit GEMZAR.com.

GEMZAR® is a registered trademark of Eli Lilly and Company. GC58323 0509 PRINTED IN USA © 2010, Lilly USA, LLC. ALL RIGHTS RESERVED.






Continued from page 24

paclitaxel J9265: injection, �� $15.54 $7.45 96413, 96415(Taxol) paclitaxel, 30 mgpaclitaxel J9264: injection, �� $11.20 $9.38 96413protein-bound paclitaxel protein-boundparticles (Abraxane) particles, 1 mgpemetrexed J9305: injection, � $61.65 $51.44 96409(Alimta) pemetrexed, 10 mgprednisone J7506: prednisone, �� $0.04 $0.04 N/A

oral, per 5 mgtamoxifen J8999b: prescription drug, �� NDC NDC N/A(Nolvadex) oral, chemotherapeutic, level level

not otherwise specified pricing pricingtamoxifen S0187: tamoxifen citrate, �� $1.89 S0187: not N/A(Nolvadex) oral, 10 mg payable by

Medicaretestolactone J8999b: prescription drug, �� NDC NDC N/A(Teslac) oral, chemotherapeutic, level level

not otherwise specified pricing pricingthiotepa J9340: injection, � $138.00 $114.09 51720, 96409(Thiotepa) thiotepa, 15 mgtoremifene citrate J8999b: prescription drug, �� NDC NDC N/A(Fareston) oral, chemotherapeutic, level level

not otherwise specified pricing pricingtrastuzumab J9355: injection, �� $78.26 $68.28 96413, 96415(Herceptin) trastuzumab, 10 mgtriptorelin J3315: injection, �� $870.00 $181.93 96372, 96402(Trelstar Depot, triptorelin pamoate, Trelstar LA) 3.75 mgtopotecan J8705: topotecan, � $89.73 $77.10 N/A(Hycamtin) oral, 0.25 mgtopotecan J9350: injection topotecan, �� $1,306.10 $1,090.84 96413(Hycamtin) 4 mgvinBLAStine J9360: injection, �� $3.18 $1.64 96409

vinblastine sulfate, 1 mgvinCRIStine J9370 : vincristine sulfate, �� $5.83 $3.98 96409(Vincasar) 1 mgvinCRIStine J9375: vincristine sulfate, �� $11.66 $7.96 96409(Vincasar) 2 mgvinCRIStine J9380: vincristine sulfate, �� $29.15 $19.90 96409(Vincasar) 5 mgvinorelbine J9390: injection, �� $42.60 $11.05 96409(Navelbine) vinorelbine tartrate, per 10 mgaCompendia references available upon request.bWhen billing a non-classified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J8999 for Nolvadex) in Column 24D and the drug name, strength, and National DrugCode (NDC) in Box 19 in order to ensure appropriate reimbursement.

ReferencesHCPCS Level II Expert 2010 • Current Procedural Terminology (CPT®) 2010 (CPT © copyright 2010 American Medical Association. All rights reserved. CPT® is a registered trademark of the AmericanMedical Association) • ICD-9-CM for Professionals Volumes 1 and 2, 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 4, 4thQuarter 2010 • FDA-approved indication (from the product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC,Wethersfield, Connecticut • CMS (Centers for Medicare & Medicaid Services), Medicare Allowable 4th Quarter 2010 (effective dates 10/1/10-12/31/10).

Prices listed herein are effective as of October 1, 2010.


Nomination forms are available atwww.TheOncologyNurse.com/award

Who Will Be theONE?The OncologyNurse ExcellenceAward Winner

The Oncology Nurse-APN/PA is pleased to

announce the inaugural Nurse Excellence

Award. The award will recognize an

oncology nurse nominated by his/her

peers for an outstanding contribution to

oncology nursing practice, patient care,

research, or education in 2010.

The four leading nominees will be profiled

in the February issue of The Oncology

Nurse-APN/PA. Readers will have an

opportunity to vote for the winner online

at www.TheOncologyNurse.com/award or

by visiting The Oncology Nurse-APN/PA

booth at the 2011 ONS Congress. The

winner will be announced in the June

issue of The Oncology Nurse-APN/PA .

�� TON_October 2010_v6_TON 10/15/10 3:01 PM Page 27


Lung Cancer

CHICAGO—Early initiation of pallia-tive care (PC) in the management ofmetastatic non–small-cell lung cancer(NSCLC) led to a longer survival timeand better quality of life (QOL) thanstandard treatment, in a randomizedphase 3 trial.The study compared QOL and clini-

cal outcomes for early PC versus stan-dard oncology care in 150 patients withnewly diagnosed metastatic NSCLC.“We found that compared with stan-

dard oncology care, integrated palliativecare led to improvements in quality oflife, lower rates of depression, less aggres-sive care at the end of life, greater docu-mentation of resuscitation preferences,and, in addition, higher survival rates,”said Jennifer S. Temel, MD, of Mass -achusetts General Hospital, Boston, dur-ing her presentation at the annual meet-ting of the American Society of ClinicalOncology.Patients were randomly assigned to

receive early PC integrated with standardoncology care (n = 77), which includedPC visits at least monthly from the timeof enrollment, or standard care (n = 74),which included meeting with PCproviders only when requested by thepatient, family, or oncologist. PC wasdelivered according to established guide-lines for symptom management, decisionmaking, and assistance with coping.There were no differences among the

arms in patient demographics, baselinemeasures of QOL, or psychological dis-tress, and no difference between thenumber of chemotherapy lines theyreceived during the study period. Al -though the design was randomized, thestudy was not assessed in blinded fashion.QOL was determined by measures of

symptoms and psychological distress.The FACT-Lung instrument assessedlung cancer–specific symptoms (LungCancer Symptom Index) and function-al/physical well-being (Trial OutcomeIndex), whereas psychological distresswas measured by the Hospital Anxietyand Depression Scale (HADS) and thePatient Health Questionnaire (PHQ)-9.Change in FACT-Lung Trial OutcomeIndex was the primary end point.The 12-week QOL assessment was

completed by 78% in the PC group(13% had died) and by 64% in the stan-dard care group (23% had died). At 12weeks, 100% of the PC group had expe-rienced a PC visit (by definition), whichincluded four or more visits for 65% ofpatients. In the standard care group, 4%of the patients had two visits and 9%had one visit; no patient in this arm hadmore than two PC visits.

Early PC superior in multipleoutcomes“At 12 weeks, patients assigned to

early PC experienced better QOL, as

measured by the FACT-Lung and TrialOutcome Index,” Temel reported.The effect of early PC on psychologi-

cal distress was also highly favorable, asthese patients experienced lower rates ofdepression according to both the HADS(15.8% vs 38.3%; P = .01) and thePHQ-9 (3.5% vs 17%; P = .02).

Interestingly, fewer patients random-ized to PC received aggressive care atthe end of life (33.3% vs 53.6%; P =.05), but despite this they lived signifi-cantly longer than the standard care arm(11.6 months vs 8.0 months; P = .02),Temel reported.Aggressive care was defined as no use

of hospice, use of hospice for 3 days orless, or chemotherapy administeredwithin 14 days of death. Patients in the

standard care arm averaged 4 days ofhospice care, compared with 11 days forthose in PC arm.Patients treated in the PC arm were

also more likely to have documentedtheir resuscitation preferences (53% vs28%; P = .05).Temel suggested that the improvement

in QOL and decreased rates of depressionmay be related to better symptom man-agement and patients’ acceptance of theirillness. Prolonged survival may be relatedto earlier recognition and management ofmedical issues, improved QOL andmood, the administration of less chemo -therapy at the end of life and longer hos-pice admission.The paper’s discussant, Raffit Hassan,

MD, of the National Cancer Institute,lauded the investigators. “This is thefirst randomized study of early palliativecare in newly diagnosed patients withadvanced NSCLC,” he noted. “It showsthat palliative care and active cancertherapy can go hand in hand, and thatinitiation of early palliative care at diag-nosis improves QOL, psychologicalwell-being, end-of-life care, and evenoverall survival.”He said future research should have

overall survival as the primary end point,and should include more diverse popula-tions and more patients with poor per-formance status in order to better definePC benefits in this subset. �

In Metastatic NSCLC, Early Palliative Care ImprovesSurvival as Well as QOLBy Caroline Helwick

“At 12 weeks, patientsassigned to early PCexperienced better QOL,as measured by theFACT-Lung and TrialOutcome Index.” —Jennifer S. Temel, MD

Aresearch-based educational pro-gram aimed at enhancing com-munication between non-

Hodgkin lymphoma patients and theirhealthcare providers has just beenlaunched and is available for healthcareproviders.Framing Life With Lymphoma was

developed by the Cancer SupportCommunity, which unites TheWellness Community and Gilda’sClub World wide, and was supportedby a grant from Cephalon.“Non-Hodgkin lymphoma is the

seventh most common cancer, yet themajority of people who are diagnosedhave very little information on thedisease and how it may impact their

lives,” said David Henry, MD, clinicalprofessor of medicine at PennsylvaniaHospital and the physician advisor forFraming Life With Lymphoma.The program contains simple tip

sheets outlining ways to approacheach conversation the patient is likelyto encounter from diagnosis throughtreatment. The information was creat-ed through input from an expert steer-ing committee and a national surveyof 150 hematologists/oncologists and133 patients with indolent lymphoma. The survey found that 96% of physi-

cians and 86% of patients felt theircommunication could be made moreefficient with informational aids. Thesurvey also revealed that about two in

five patients do not ask all theirintended questions during visits, usu-ally because they don’t remember. “This survey shows that it is critical

that patients have resources to helpthem understand their condition andtreatment options. This helps themcommunicate more effectively withtheir physicians,” Henry said. “In addition to providing informa-

tion, physicians need to work withtheir patients to create a team-basedapproach to treatment,” he added.“Working as a team creates an envi-ronment where informed patients aremore comfortable addressing theirconcerns and questions, and this canhave a positive impact on their overall

treatment experience.”Kim Thiboldeaux, president and

CEO of the Cancer Support Com -munity, also applauded the pro-gram.“We hope Framing Life WithLymphoma will become an importantresource for the lymphoma communi-ty,” she said. “A clear majority ofpatients and physicians reported thatdiscussion materials would improvetheir conversations. That is what thisprogram aims to do.”The patient tip sheets for newly

diagnosed patients and those undergo-ing treatment, along with the surveyresults and other program information,can be downloaded at www.FramingLifeWithLymphoma.org. �

HEMATOLOGIC CANCERS

New “Tip Sheets” Help NHL Patients Communicate withthe Oncology TeamBy Caroline Helwick


Hematologic Cancers


CHICAGO—Patients with myelodys-plastic syndromes (MDS) treated withhypomethylating agents (HMAs), espe-cially decitabine, are more likely toachieve hematologic responses whentreated with a greater number of cycles,investigators from Georgia CancerSpecialists in Marietta reported at the2010 annual meeting of the AmericanSociety of Clinical Oncology.“The likelihood of improvement in

anemia, thrombocytopenia, and neu-tropenia is associated with the number ofcycles. For every extra cycle, the chanceof improvement increases,” said RodolfoBordoni, MD. Responses increased by15% to 19% with each additional cyclebeyond the first.Although clinical trials of HMAs

have demonstrated a range of clinicalbenefits, concern exists about the appli-cability of trial results in the communi-ty practice setting where patients maydiffer in terms of demographics, risklevel, comorbidities, and treatment reg-imen, Bordoni noted.“We therefore examined hematologic

outcomes in MDS among patients treat-ed with the HMAs azacitidine anddecitabine in a large community hema-tology/oncology practice,” he said.This was a retrospective observation-

al study of patients through electronicmedical record data for 2006-2009. Thepopulation included 1070 patients withintermediate- or high-grade MDS, 137(13%) of whom received azacitidine (n= 53) or decitabine (n = 84). Thegroups were well-balanced except thatdecitabine recipients were somewhatsicker, he noted.The Charlson comorbidity index was

≥1 in the month preindex for 40/53 onazacitidine and 66/84 on decitabine.Mean Charlson index was 1.2 for theazacitidine group and 1.7 for thedecitabine group. Mean number ofcycles was five for azacitidine and fourfor decitabine.

Response increased per cycleThe total number of cycles signifi-

cantly predicted hemoglobin level(odds ratio [OR], 1.19; P = .029),platelet count (OR, 1.15; P = .031), andabsolute neutrophil count (ANC) (OR,1.16; P = .047), Bordoni reported. This improvement, however, was

largely driven by decitabine, which wasassociated with a 58% improvement inhemoglobin response per additionalcycle (P = .0035). There was also atrend toward a greater likelihood ofhemoglobin ≥11 g/dL for decitabineover azacitidine (OR, 2.70; P = .085)after controlling for the number ofcycles given. Although decitabine-

treated patients were also more likely tohave a platelet response, the differencewas not statistically significant aftercontrolling for the number of cycles.The drugs were equally likely to pro-

duce an ANC response. The use ofgrowth factors during treatment wasnegatively associated with ANCresponse (OR, 0.96; P = .046) as wellas hemoglobin response (OR, 0.85;

P = .007), he added.The findings suggest that “we should

not give up on slow responders,” Bordonisaid. “Continuing on treatment is thekey to hematologic response.” �

More Cycles of Decitabine Equals Better MDS OutcomesBy Caroline Helwick

Help reduce the risk of infection in patients receiving moderate-risk* chemotherapy regimens

Act before febrile neutropenia strikes

Potential consequences of febrile neutropenia may be serious and can impact patient care

First- and every-cycle Neulasta® achieved:

� 94% reduction in febrile neutropenia

(17% placebo vs 1% Neulasta®; P < 0.001).1,2

� 93% reduction in febrile neutropenia–

related hospitalization (14% placebo

vs 1% Neulasta®; P < 0.001).1,2

� 80% reduction in febrile neutropenia–

related IV anti-infective use (10% placebo

vs 2% Neulasta®; P < 0.001).1,2

Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety InformationDo not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of Neulasta®. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta®.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta® for ARDS. Discontinue Neulasta® in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® in patients with serious allergic reactions.

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

Bone pain and pain in extremity occurred at a higher incidence in Neulasta®-treated patients as compared with placebo-treated patients.

Please see brief summary of Neulasta® Prescribing Information on the adjacent page.

* Regimens associated with 17% risk of febrile neutropenia.

References: 1. Vogel C, et al. J Clin Oncol. 2005;23:1178-1184. 2. Neulasta® (pegfilgrastim) Prescribing Information. Thousand Oaks, Calif: Amgen.

© 2010 Amgen. All rights reserved. MC49047-A-1 04-10 www.neulasta.com



International News

Western Lifestyle Responsiblefor UK Breast Cancer SurgeLONDON—A Western lifestyle char-

acterized by an excess of food and alco-hol and a lack of exercise may explainincreasing breast cancer rates in the

United Kingdom, new data suggest.Findings from the World Cancer

Research Fund (WCRF) show that the

breast cancer rate in the UnitedKingdom is more than four times higherthan in eastern Africa, which has thelowest breast cancer rate worldwide.The organization recently reported

that 87.9 women per 100,000 in theUnited Kingdom were diagnosed withbreast cancer in 2008 versus only 19.3women per 100,000 women in easternAfrica, which includes Kenya andTanzania.Cancer experts have suggested that

the growing gap in breast cancer ratesbetween rich and poor countries may bepartly a function of better surveillanceand diagnosis in wealthier countries.They also emphasize, however, thatlifestyle is an important contributor.In fact, it is estimated that 40% of

breast cancer cases in the UnitedKingdom, or more than 18,000 cases peryear, could be avoided if women adopt-ed a healthier lifestyle involving a bet-ter diet, more exercise, and less alcohol.Women in eastern Africa consume

less alcohol than UK women and areless likely to be obese. They are alsomore likely to breastfeed, and breast-feeding has been associated with alower rate of breast cancer.Rachel Thompson, MD, with the

WCRF, said that breast cancer is notthe only cancer for which lifestyle maybe a contributor. In fact, roughly athird of the most common cancers inthe United Kingdom could be prevent-ed by lifestyle changes, she noted.

No Evidence that StatinsCause CancerSTOCKHOLM—Statins do not in -crease the risk of cancer, according tothe results of a large meta-analysisreleased at the European Society ofCardiology Congress 2010.Researchers from the University of

Oxford, United Kingdom, and theUniversity of Sydney, Australia, said ina news release that their results will“reassure the millions of people world-wide who are taking statins to lowercholesterol levels and clarify earlierresearch that had raised concerns of acausal link.”The data are from the Cholesterol

Treatment Trialists’ Collaboration,which reviewed data from 170,000patients enrolled in 26 trials. Overall,10,000 patients developed cancer andmore than 3500 died of cancer.“Statin therapy had no adverse

effect on cancer at any site or in anygroup of individuals, irrespective oftheir cholesterol levels,” said principal

BRIEF SUMMARY OF PRESCRIBING INFORMATIONNeulasta® (pegfilgrastim) injection, for subcutaneous use

INDICATIONS AND USAGENeulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

CONTRAINDICATIONSDo not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

WARNINGS AND PRECAUTIONSSplenic RuptureSplenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute Respiratory Distress SyndromeAcute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS.

Serious Allergic ReactionsSerious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions. Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Use in Patients With Sickle Cell DisordersSevere sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Potential for Tumor Growth Stimulatory Effects on Malignant CellsThe granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

ADVERSE REACTIONSThe following serious adverse reactions are discussed in greater detail in other sections of the Brief Summary:

Warnings and Precautions] Warnings

and Precautions] Warnings and Precautions]

Warnings and Precautions]

Warnings and Precautions]The most common adverse reactions occurring in 5% of patients and with a between-group difference of 5% higher in the pegfilgrastim arm in placebo controlled clinical trials are bone pain and pain in extremity.

Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer

pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. In animal reproduction studies, when pregnant rabbits received pegfilgrastim at cumulative doses approximately 4 times the recommended human dose (based on body surface area), increased embryolethality and spontaneous abortions occurred. Signs of maternal toxicity (reductions in body weight gain/food consumption) and decreased fetal weights occurred at maternal doses approximately equivalent to the recommended human dose (based on body surface area). There were no structural anomalies observed in rabbit offspring at any dose tested. No evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area).Women who become pregnant during Neulasta treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Nursing MothersIt is not known whether pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.

Pediatric UseSafety and effectiveness of Neulasta in pediatric patients have not been established. The adverse reaction profile and pharmacokinetics of pegfilgrastim were studied in 37 pediatric patients with sarcoma. The mean (± standard

0-inf) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 22.0 (± 13.1) mcg·hr/mL in the 6 to 11 years age group (n = 10), 29.3 (± 23.2) mcg·hr/mL in the 12 to 21 years age group (n = 13), and 47.9 (± 22.5) mcg·hr/mL in the youngest age group (0 to 5 years, n = 11). The terminal elimination half-lives of the corresponding age groups were 20.2 (± 11.3) hours, 21.2 (± 16.0) hours, and 30.1 (± 38.2) hours, respectively. The most common adverse reaction was bone pain.

Geriatric UseOf the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

Renal ImpairmentIn a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. Therefore, pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary.

DOSAGE AND ADMINISTRATIONThe recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed.NOTE: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex); persons with latex allergies should not administer this product.

This product, its production, and/or its use may be covered by one or more US Patents, including US Patent Nos. 5,824,784; 5,582,823; 5,580,755, as well as other patents or patents pending.

receiving docetaxel 100 mg/m2 every 21 days. (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and <1% Asian, Native American or other.Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients.

Table 1. Adverse Reactions With ≥ 5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3

System Organ Class Preferred Term

Placebo (N = 461)

Neulasta 6 mg SC on Day 2

(N = 467)

Musculoskeletal and connective tissue disorders

Bone pain 26% 31%

Pain in extremity 4% 9%

LeukocytosisIn clinical studies, leukocytosis (WBC counts > 100 x 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies.

ImmunogenicityAs with all therapeutic proteins, there is a potential for immunogenicity. Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Neulasta with the incidence of antibodies to other products may be misleading.

Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal relationship to Neulasta.Gastro-intestinal disorders: Warnings and Precautions]Blood and lymphatic system disorder: Sickle cell crisis

Warnings and Precautions]Respiratory, thoracic, and mediastinal disorder: ARDS

Warnings and Precautions]General disorders and administration site conditions: Injection site reactionsSkin and subcutaneous tissue disorders: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, Sweet’s syndrome, generalized erythema and

Warnings and Precautions]

DRUG INTERACTIONSNo formal drug interaction studies between Neulasta and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results.

USE IN SPECIFIC POPULATIONSPregnancyPregnancy Category CThere are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Neulasta should be used during

Neulasta® (pegfilgrastim)

Manufactured by:Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799

© 2010 Amgen Inc. All rights reserved.www.neulasta.com1-800-77-AMGEN (1-800-772-6436)

v 11.0

Reports from the European Society of Cardiology Congress and the JointAnnual Meeting of the International Continence Society and InternationalUrogynecological AssociationBy Jill Stein


International News


investigator Jonathan Emberson, MD,of the University of Oxford. “Therewas also no association of cancer withstatin dose or duration.”The study was funded by the UK

Medical Research Council, the BritishHeart Foundation, and the NationalHealth and Medical Research Council(Australia).

Overactive Bladder withoutHematuria May Be CancerSymptomTORONTO—Overactive bladder(OAB) symptoms without hematuriamay be a presenting symptom of bladdercancer, researchers reported at the jointannual meeting of the InternationalContinence Society and InternationalUrogynecological Association.Most patients with bladder cancer

present with hematuria.Jeffrey Weiss, MD, of State Uni versity

of New York Downstate College ofMedicine in Brooklyn, and colleaguessearched a database for the years 1998through 2008 to identify patients with-out hematuria who underwent cys-toscopy as part of an evaluation forrefractory OAB.Overall, 1420 patients underwent

cystoscopy, and eight were found tohave bladder cancer. The mean dura-tion of OAB symptoms was 3.3 years.In all cases, the initial biopsy in

patients with bladder cancer demon-strated low-grade Ta transitional carci-noma that, in most cases, resembled atypical papillary transitional cell tumoron cystoscopy. At a mean follow-up of5.2 years, four (50%) patients had expe-rienced one or two recurrences and twohad disease progression—in one case tocarcinoma in situ and in the other caseto high-grade T3 disease.The study also found that bladder

cancer was 10 times more common inwomen with OAB than men withOAB despite the fact that it is two tothree times more common in men thanin women in the general population.Because OAB symptoms without

hematuria may be an initial symptomof bladder cancer, patients with OABsymptoms even without hematuriashould be advised to undergo cys-toscopy to rule out underlying bladdercancer, the authors said.

Urinary Incontinence andErectile Dysfunction afterProstate Cancer SurgeryCommon and EnduringTORONTO—New data show thaturinary incontinence and erectile dys-function frequently occur after radicalprostatectomy for prostate cancer andpersist in more than 75% of men at fol-low-up 1 year after surgery.The new findings, based on a survey

by Scottish and Canadian researchers,

were reported at the joint annual meet-ing of the International ContinenceSociety and International Urogyne -cological Association.Of 764 men who completed a ques-

tionnaire roughly 6 weeks after radicalprostate surgery, 93% had urinaryincontinence. At 12 months, 76%remained incontinent. Results also

revealed that 80% of men had persist-ent erectile dysfunction at 12 months.Neither the route of operation (ab d-

ominal, perineal, or laparoscopic) northe nerve-sparing technique (onenerve bundle spared, both nerve bun-dles spared, neither spared, or un -known sparing) was associated withlong-term persistent urinary inconti-

nence. Erectile dysfunction was mostlikely to occur when nerve sparing wasnot possible.Principal investigator Suzanne

Hagen, MD, of Glasgow CaledonianUni versity, urged clinicians to providemen scheduled for prostate cancer sur-gery with a clear-cut assessment of out-comes they can expect afterward. �

Now Enrolling Subjects with

Advanced Hepatocellular Carcinoma

1056

78

07/1

0

CA182-033 BRISK-FL:A Randomized, Double-blind Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced HCC

CA182-034 BRISK-PS: A Randomized, Double-blind Phase III Study of Brivanib plus Best Supportive Care versus Placebo plus BSC in Patients with HCC Who Have Failed or are Intolerant to Sorafenib

Key Inclusion Criteria:

Men and women, at least 18 years of age

Histologic or cytologic confi rmed diagnosis of advanced HCC

Not eligible for surgery and loco-regional therapy

At least 1 measurable lesion

Key Exclusion Criteria:

Brain metastasis or evidence of leptomeningeal disease

Previous or concurrent cancer that is distinct from HCC

History of active cardiac disease

No prior use of any systemic anti-cancer chemotherapy for HCC (except sorafenib for CA182-034 ONLY)

For more information, please go to www.clinicaltrials.gov and search under NCT-00858871 and NCT-00825955. NOPQ


Approximately two-thirds of patients with myelodysplastic syndromes (MDS) have lower-risk disease, defined as Low- and Intermediate-1–risk per IPSS.* However, existing prognostic tools for MDS do not differentiate those patients with lower-risk disease who have a poor prognosis.1

The International Prognostic Scoring System (IPSS)The IPSS helps to estimate the overall survival of patients with MDS. Certain patients classified with lower-risk MDS by the IPSS system may benefit from the “wait and watch” approach currently used by many physicians. However, one limitation of the IPSS is that it does not identify patients with lower-risk MDS and poor prognosis who may be candidates for early therapeutic intervention.

A proposed prognostic scoring system for patients with lower-risk MDSThis scoring system stratified patients with lower-risk MDS into 3 risk categories and evaluated the characteristics associated with survival.1 Following a multivariate analysis, the parameters below were found to be associated with decreased survival1:

• Platelets (<50 x 109/L; 50–200 x 109/L)

• Age (≥60 years)

• Unfavorable cytogenetics†

• Hemoglobin (<10 g/dL)

• Percent of marrow blasts (≥4%–10%)

The authors recommend the validation of this model by confirming the results in another patient population. Until these results are validated, the main use of this model will be to assign patients with poor prognoses to investigational clinical trials.1

Utility of proposed scoring systemThis scoring system may help to identify those patients with lower-risk MDS who may benefit from early therapy. Using this system, the authors determined that of the 673 patients in Risk Categories 2 and 3, 80% had a poor prognosis if untreated. They believed that the need to treat this population was further supported by the number of patients who died (90%) before their disease transformed to acute myelogenous leukemia.1

Results from 856 patients showed 31% of patients with a median survival of 14.2 months (1.2 years) (Risk Category 3), 48% with a median survival of 26.6 months (2.2 years) (Risk Category 2), and 21% with a median survival of 80.3 months (6.7 years) (Risk Category 1).1‡

R

Clinical challenge: Identification of patients with lower-risk MDS* and a poor prognosis


0 12 24 36 48 60 72 84 960

0.2

0.4

0.6

0.8

1.0

Months from Referral

Cum

ulat

ive

Prop

ortio

n Al

ive

Assigned Score‡

0-23-4≥5

182 (21)408 (48)265 (31)

Total (%)

43212173

Dead (No.)

65337

4-yr (%)

Estimated Survival of Lower-risk MDS Patients by Risk Category1

802714

Median (mo)

Survival

Reprinted with permission from Garcia-Manero et al (2008).1

This study indicated that it is possible to identify those lower-risk MDS patients with a poor prognosis (those in Risk Categories 2 and 3) who may benefit from early therapeutic intervention. The proposed prognostic tool based on the IPSS classification of this specific patient type may have a significant impact on1:

• MDS treatment approaches

• When to treat lower-risk MDS

• Clinical trial development

©2010 Celgene Corporation 07/10 CELG10172T

This proposed model may have implications for clinical trial design and potentially for the treatment decision process for patients with lower-risk MDS.1

*MDS, myelodysplastic syndromes; lower-risk MDS, Low- and Intermediate-1–risk per International Prognostic Scoring System.†In this scoring system, only diploid and 5q were considered favorable cytogenetics; all others were considered unfavorable.1‡ Category scoring based on: Category 1 = score 0-2, Category 2 = score 3-4, Category 3 = ≥5. Assigned score: age (≥60 years) = 2; platelets (<50 x 109/L) = 2, platelets (50–200 x 109/L) = 1; hemoglobin (<10 g/dL) = 1; bone marrow blasts (≥4%–10%) = 1; unfavorable cytogenetics = 1.1

Reference: 1. Garcia-Manero G, Shan J, Faderl S, et al. A prognostic score for patients with lower risk myelodysplastic syndrome. Leukemia. 2008;22(3):538-543.



Genetics

Multiple professionaland societal guide-lines emphasize the

importance of genetic coun-seling and testing for indi-viduals at risk for heredit-ary breast cancer.1,2 For awoman newly diagnosedwith breast cancer, informa-tion gained from geneticcounseling and testing candirectly impact her surgicalmanagement and treatment plan. Ofthe syndromes known to have an ele-vated risk of breast cancer, hereditarybreast and ovarian cancer (HBOC) isthe most common. HBOC is associatedwith mutations in the BRCA1 andBRCA2 genes. Women with a BRCAmutation have up to a 65% chance ofdeveloping a new primary breast can-cer3 and often choose mastectomy withcontralateral risk-reducing mastectomyover breast-conservation surgery.4,5 Ac -cording to the American Society ofBreast Surgeons, in ideal circumstancespatients who are at significant risk forharboring a BRCA mutation mayundergo testing before de finitive sur-gery.6 However, for a woman and herhealthcare team to use genetic informa-tion, a woman has to be identified as atrisk and undergo appropriate services ina timely manner. One method for iden-tifying women at risk for BRCA muta-tions is an inexpensive, one-page flowchart.A chart review of patients seen

between May 1, 2007, and December31, 2008, at Sarasota Memorial HealthCare System’s (SMHCS) Genetic Ed -ucation Program revealed only twoindividuals were referred for geneticcounseling at the time of surgical deci-

sion: one before definitivesurgery and one after lump -ectomy and before radia-tion therapy. In addition,neither referral was inter-nal. To increase the numberof women offered geneticcounseling and testingbefore definitive surgery,SMHCS implemented aquality-im provement initia-tive. Identification fo cused

on women at risk for HBOC. Thegenetic counselor met with breasthealth (BH) clinicians, four oncologycertified nurses, to determine the pre-ferred medium for a risk assessment tool.A flow sheet, modeled off Medi care cri-teria for BRCA1/2 testing, was designedto capture women with personal andfamily histories suggestive of HBOC.BH clinicians used the tool duringintakes for all individuals presenting forbiopsy, and information was recorded.For individuals returning to the BHcenter with positive results, a BH clini-cian introduced genetics. Fact sheets forinterested clients were faxed to thegenetic counselor for an appointment.Between January 1, 2009, and De -

cember 31, 2009, 99.6% (229/230) ofnewly diagnosed individuals seen at theBH center were screened for features ofHBOC. Approximately one fourth(53/229) were identified as being at riskfor BRCA mutations. This is consistentwith data obtained at major academicmedical centers.7 BH clinicians wereinvolved in positive biopsy disclosurefor 23 (43.4%) at-risk individuals. Ofthe 19 (82.6%) individuals referred forgenetic counseling, the genetic coun-selor spoke with and offered services to15 individuals: seven proceeded with

genetic counseling before definitive sur-gery, one after treatment was complete,three were uninsured and could notafford the cost, and four were not inter-ested. Regarding the at-risk individualswho did not receive positive resultsfrom BH clinicians, as of July 1, 2010,23% (7/30) had been referred for genet-ic counseling. How ever, none werereferred before definitive surgery. Achart review is planned to determine ifany at-risk individuals underwent in-office genetic testing.

By creating a flow chart and providingminimal training to BH clinicians,SMHCS was able to increase the num-ber of women speaking to a geneticcounselor before definitive surgery fromone to 15. Although this is greater thana 1000% increase, it is less than ideal.The National Com prehensive CancerNetwork guidelines clearly state “agenetic counselor or medical geneticistshould be involved early in counselingpatients who potentially meet criteriafor an inherited syndrome.”8 The processfailed to account for the 30 at-risk indi-viduals who would not receive positive

biopsy results from BH clinicians. Inaddition, as of July 1, 2010, only 17 of 53at-risk individuals had undergone agenetic counseling consult at SMHCS.Identifying individuals at risk for hered-itary breast cancer requires a multidisci-plinary team approach. The mechanismused depends on the needs and resourcesof the institution. To ensure all at-riskindividuals are offered genetic services,hospitals need to evaluate their currentmethod of identification and considercollaboration with local genetic profes-sionals and/or companies providingphone genetic counseling. �

References1. Lu K, Kauff N, Powell B, et al; for American Collegeof Obstetricians and Gynecologists; ACOG Committeeon Practice Bulletins—Gynecology; ACOG Committeeon Genetics; and Society of Gynecologic Oncologists.ACOG practice bulletin No. 103: hereditary breast andovarian cancer syndrome. Obstet Gynecol. 2009;113:957-966.2. Khatcheressian JL, Wolff AC, Smith TJ, et al; for theAmerican Society of Clinical Oncology. AmericanSociety of Clinical Oncology 2006 update of the breastcancer follow-up and management guidelines in theadjuvant setting. J Clin Oncol. 2006;24:5091-5097.3. Antoniou A, Pharoah PDP, Narod S, et al. Averagerisks of breast and ovarian cancer associated withBRCA1 or BRCA2 mutations detected in case seriesunselected for family history: a combined analysis of 22studies. Am J Hum Genet. 2003;72:1117-1130.4. Stolier AJ, Fuhrman GM, Mauterer L, et al. Initialexperience with surgical treatment planning in the newlydiagnosed breast cancer patient at high risk for BRCA-1or BRCA-2 mutation. Breast J. 2004;10:475-480.5. Schwartz MD, Lerman C, Brogan B, et al. Impact ofBRCA1/BRCA2 counseling and testing on newly diag-nosed breast cancer patients. J Clin Oncol. 2004;22:1823-1829.6. American Society of Breast Surgeons OfficialStatement. BRCA genetic testing for patients with andwithout breast cancer. June 12, 2006. www.breastsurgeons.org/statements/PDF_Statements/BRCA_Testing.pdf. Accessed July 1, 2010. 7. Shannon KM, Lubratovich ML, Finkelstein DM, etal. Model-based predictions of BRCA1/2 mutation sta-tus in breast carcinoma patients treated at an academicmedical center. Cancer. 2002;94:305-313.8. National Comprehensive Cancer Network. ClinicalPractice Guidelines in Oncology: Genetic/Familial High-RiskAssessment: Breast and Ovarian. V.1.2010. www.nccn.org/professionals/physician_gls/PDF/genetics_screening.pdf.Accessed July 1, 2010.

Cristi Radford, MS, CGC

Identifying Newly Diagnosed Individuals with BreastCancer at Risk for Hereditary Breast CancerBy Cristi Radford, MS, CGCSarasota Memorial Health Care System, Sarasota, Florida

By creating a flow chartand providing minimaltraining to BH clinicians,SMHCS was able toincrease the number ofwomen speaking to agenetic counselor beforedefinitive surgery fromone to 15.

Genetic Profiling Changing Clinical Practice in SomeAreas of OncologyBy John Schieszer

CHICAGO—Gene-expression profil-ing, combined with a novel chemoradi-ation regimen, may predict pathologiccomplete response in patients withesophageal cancer, according to newdata presented at the 46th annual meet-ing of the American Society of ClinicalOncology. New studies presented at this meeting highlighted several new“genetic fingerprinting” techniques thatmay improve and guide chemo therapy

in specific cancer populations.Researchers looked at pathologic

complete response rate and toxicity in aphase 2 trial involving 36 patients withstage II to IVa esophageal cancer, 29(81%) of whom had undergone surgeryin the course of their treatment. Thetreatment consisted of three 85-mg/m2

doses of oxaliplatin over the course of amonth, a 625-mg/m2 twice-daily dose oforal capecitabine, and radiation thera-

py, followed by surgery 4 to 6 weekslater. Two cycles of oxaliplatin andcapecitabine were given postoperative-ly. Gene-expression profiling (usingmicroarrays by Agilent Technology)was conducted on primary tumor tissue.The researchers have found that

eight of the 29 patients who had theiresophagus removed following the oxali-platin regimen had no cancer in the sur-gical specimen (a 28% pathologic com-

plete response rate). “Another clearresult is that this regimen is very well-tolerated by patients without significantside effects,” said study investigatorNikhil Khushalani, MD, who is an assis-tant professor of medicine at RoswellPark Cancer Institute. “There appear tobe several gene pathways that areenriched when studying different sub-groups, the pathologic complete re sponse



THE 5-YEAR SURVIVAL RATEIS 17% FOR PATIENTS WITHMETASTATIC SOFT TISSUE SARCOMA,YET SIGNIFICANT THERAPEUTICADVANCEMENTS ARE LAGGING.1

NEW TREATMENTS ARE URGENTLY NEEDED.

Reference: 1. National Cancer Institute. Surveillance Epidemiology and End Results. seer.cancer.gov/statfacts/html/soft.html. Accessed March 19, 2010.

Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved. 21003100(5)-ARI

SARCOMA: THE ONLY THING PROGRESSING IS THE DISEASE



Nursing Practice

Split Scheduling for Chemotherapy IncreasesEfficiency, Reduces CostsBy Karen Rosenberg

With communitycancer centers fac- ing rising costs

and declining revenues,finding more efficient waysto run a practice is critical.In this interview, CathyMaxwell, RN, OCN, direc-tor of clinical operations atAdvanced Medical Spe -cialties in Miami, Florida,discusses how communitycancer centers can makethe most efficient use of chemotherapynurses by efficient scheduling and howthis not only increases nurse and patientsatisfaction but also reduces costs.

What efficiencies can be gainedwith proper scheduling in an infusioncenter?Because chemotherapy nurses are usu-

ally among the higher paid employees, itis important to use them efficiently. Youdon’t want to have them doing tasks andduties that do not require a registerednurse (RN), and you want to schedulethem in a way that you’re not wastingthem as resources. That all translatesinto dollars. There are different ways tostaff an infusion suite to make optimaluse of nurses’ time.The scheduling of the treatments is

crucial because you want to make surethat your schedule reflects what is actu-ally going to happen as much as youpossibly can predict. I’ve found that inmany cases, the schedule is already setup to fail before the first patient walksin the door because it doesn’t reflectwhat time the patient is actually going

to be sitting in the chair. Forexample, say a patient hasan 8:00 AM appointmentbut first the nurse has to geta blood count, the results ofthe blood count have to beinterpreted, and the nursehas to get a doctor’s orderbefore the infusion canbegin. So if you have thatpatient scheduled in thechemo chair at 8:00 AM,your schedule is already set

up incorrectly. One of the best ways touse your nurses’ time efficiently is whatwe call a “split schedule.” This meansthat the patient comes in the day beforethe infusion for their blood count, fortheir office visit with the doctor, and forassessment of their readiness for thetreatment; then he or she gets treat-ment the next day.Many people think their patients

won’t accept split scheduling, but we dothis in the three sites that I’m responsi-ble for and it is very successful. In thisday and age when you have to controlyour inventory of drugs, this is the bestway to predict what you’re going toneed for the next day, which is especial-ly important when you’re talking aboutexpensive drugs. We used to carry$800,000 to $1 million worth of drugsin our mixing room every day for threelocations. We are now at $400,000 withthe split schedule, and our goal is to geteven lower than that.

How would you achieve that?My goal by the end of the year is to

get the doctors’ orders 48 hours ahead of

time, because we would be able to tight-en up our inventory even more. In mostplaces around the country, you haveuntil about 6:00 PM to place your ordersfor delivery by 10:00 AM the next morn-ing. If you have that ability, you don’thave to house expensive drugs; you canorder them as you need them. If youhave same-day scheduling, you don’tknow for sure whether the patient isgoing to get their chemotherapy untilafter the office visit. Meanwhile, thepatient has an appointment in thechemotherapy infusion suite and thenurses are waiting for the patient. Ifthere is a delay in receiving the patientor the treatment is canceled, it wastesresources and costs the practice money.When the doctor orders a change intreatment, in our practice we need 5business days to run it through ourfinancial department to make sure thepatient’s out-of-pocket costs haven’tchanged, that it’s not an off-label regi-men, and that we don’t need priorapproval from the insurance company.

What changes have you seen in yourpractice as a result of the implementa-tion of split scheduling?With the split schedule, patients’

treatment begins as soon as they arriveat the infusion suite so you can stay onschedule and staff the suite for what youtruly need, not what you think youmight need. This way, you can use yournurses more efficiently, not wasteresources, and free up chair space.Another thing that we noticed whenwe started split scheduling was thatovertime was practically eliminated. Incenters where the nurses are paid hourlysalaries, eliminating overtime can resultin huge savings. Keeping on schedule increases both

nurse satisfaction and patient satisfac-tion. Studies of patient satisfactionshowed that patients most dislike wait-ing. So even though with split schedul-ing patients have to come in for two vis-its, their actual time in the office is less.They’re not wasting time waiting. Theygo in, see the doctor, and go home.Then when they come back for theirtreatment, they get in on time, knowhow long it’s going to take, and gohome. They’re much happier because of that.We had an independent group do a

patient satisfaction survey a few monthsafter we started split scheduling in anew satellite office. This satellite officewas opened in an effort to decompressour original office of 15 doctors. Wesplit the schedule at that time becauseall of the chemotherapy was prepared atthe remote site and we needed to be cer-tain the patients were going to get theirprescribed doses and drugs. We inter-viewed those patients who had experi-enced both same-day scheduling andsplit scheduling. We found that patientsatisfaction was higher for the splitschedule than the old schedule, andpatients believed the wait time was bet-ter at the new office. That made it easi-er when we decided to start split sched-uling in a larger practice. We basicallytold the patients that we had no choice,because with split scheduling we foundwe could lower inventory, cut costs, andreduce overtime.

Did you meet with any resistancefrom patients when you introducedsplit scheduling?We distributed a letter in our waiting

room about 2 months before startingthat explained the reasons for the

Cathy Maxwell, RN, OCN

Nurses and patients interact in the chemotherapy infusion suite at AdvancedMedical Specialties.

Tips for SchedulingChemotherapy Infusions• Develop and follow guidelines for scheduling• Consider time needed for intravenous access and premedication• Allow extra time for new patients• Schedule in 15-minute slots (ie, 2-hour treatment = 8 slots)• Stagger the infusion schedules (ie, recliner 1 at 8:15; recliner 2 at 8:30; …)• Assign four to five recliners per nurse, and arrange them close together in pods

• Make necessary adjustments to the nurses’ assignments the day before treatment to adjust to the census

• Have enough chairs and enough time to handle patients• Limit the number of exceptions to the scheduling guidelines



STARTS STRONG. LASTS LONG.

IndicationALOXI® (palonosetron HCl) injection 0.25 mg is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

Important Safety Information

of its components

include headache (9%) and constipation (5%)

Please see the brief summary of the Full Prescribing Information on the adjacent page.

References: 1. Gralla R, Lichinitser M, Van der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14:1570-1577. 2. Eisenberg P, Figueroa-Vadillo J, Zamora R, et al. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer. 2003;98:2473-2482. 3. Data on fi le. Eisai Inc., Woodcliff Lake, NJ. 4. Aapro MS, Grunberg SM, Manikhas GM, et al. A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol. 2006;17:1441-1449.

ALOXI®

Help support your patients’ chemotherapy treatment goals Powerful CINV prevention in the fi rst 24 hours and up to 5 days following

moderately emetogenic chemotherapy1,2

Lasts long against nausea following moderately emetogenic chemotherapy

Powerful acute CINV prevention following highly emetogenic chemotherapy4

ALOXI® provides powerful CINV prevention that can’t be ignored.


change, but we still had a lot of angrypatients and family members at first. Ihad to do a lot of damage control. Icalled every patient or caregiver whorequested to speak to someone andexplained to them that we were doingthis to stay in business. When we werehonest with them and explained why we

did it, they were extremely understand-ing and cooperated.

Anyone thinking of starting splitscheduling has to realize it’s going to berough at first, but after you get throughthat period, it’s a piece of cake. In addi-tion, within the next month, we sawthe change in inventory and change in

overtime, so you get instant financialgratification from making that change.

What are some other ways practicescan increase efficiency?

To run efficiently, you have to sched-ule your nursing staff so that you havethe bulk of your nurses there at the

busier times. I recommend having flexi-ble nursing schedules with staggeredstarting times and a per diem pool ofnurses to help you cover vacations andother time off.

Cancer treatments today are muchmore complicated than they used to be,and it takes more interactions from thenurse to take care of the patient. A

nurse who works 10 hours probablyshouldn’t take care of more than 10 or11 patients who are getting chemother-apy. In our practice, we separatepatients who are coming in for shotsand blood counts and other non–infu-sion-related services from those who aregetting infusions. They’re seen in therapid treatment area where a nurselooks at their blood count and a medicalassistant gives the injections. That waythe nurses who are in the infusion suiteare doing infusions. In most cases, youdon’t need an RN to give an injection.But you do need an RN (in some statesan LPN) to give chemotherapy.

Our challenge every day is to keepeverybody safe and happy. As thingschange in our field, we have to be flexi-ble, we have to change. We have to stayefficient, save money, but at the sametime we have a huge service to deliver. �


Nursing Practice

ALOXI® (palonosetron HCl) injection

BRIEF SUMMARY OF PRESCRIBING INFORMATION

INDICATIONS AND USAGE

Chemotherapy-Induced Nausea and VomitingALOXI is indicated for:

DOSAGE AND ADMINISTRATIONRecommended DosingChemotherapy-Induced Nausea and Vomiting

Instructions for I.V. Administration

CONTRAINDICATIONS

[see Adverse Reactions (6) ]

WARNINGS AND PRECAUTIONSHypersensitivity

ADVERSE REACTIONS

≥

Table 1: Adverse Reactions from Chemotherapy-Induced Nausea and Vomiting Studies ≥ 2% in any Treatment Group

Postmarketing Experience

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONSPregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

≥

≥ ≥

≥

Renal Impairment

Hepatic Impairment

Race

OVERDOSAGE

PATIENT COUNSELING INFORMATION FDA-Approved Patient Labeling (17.2) in

Instructions for Patients

see Adverse Reactions (6)

ALOXI®

EventALOXI

0.25 mg (N=633)

Ondansetron 32 mg I.V. (N=410)

Dolasetron 100 mg I.V.

(N=194)

Split Scheduling for Chemotherapy... Continued from page 36

FDA Approves DocetaxelInjection One-Vial Formulation

The US Food and Drug Ad -ministration (FDA) has approved anew one-vial formulation of doc-etaxel injection concentrate (Tax -otere, sanofi-aventis). This new for-mulation eliminates the initialdilution step, as well as the secondvial containing the diluent. Withthe one-vial formulation, the phar-maceutical ingredients and the 1-hour intravenous infusion adminis-tration remain unchanged.

Docetaxel is approved for use intreating patients at specific stages ofmetastatic and adjuvant breast can-cer, metastatic androgen-indepen-dent prostate cancer, advancednon–small-cell lung cancer, ad -vanced gastric adenocarcinoma,and locally advanced squamous cellcarcinoma of the head and neck.

Recent FDAApproval

I recommend havingflexible nursing scheduleswith staggered startingtimes.


A Friday Satellite Symposium preceding the 52nd ASH

Annual Meeting

December 3, 2010 Rosen Centre Hotel Ballrooms A & B, Orlando, Florida

Challenging Cases in Multiple Myeloma A Dialogue Between Community and Academic Clinicians to Improve Patient Care and Outcomes

This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

This activity is jointly sponsored by the University of Cincinnati, Medical Learning Institute, Inc., a nonprofit medical accreditation company, and Center of Excellence Media, LLC.

Register online today atwww.myelomacases.com/register

This continuing medical education symposium will serve as a forum for discussion of cur-rent questions and concerns regarding the treatment and management of patientsthrough the multiple myeloma (MM) life cycle. A panel of domestic and internationalmyeloma experts will be joined by representatives from community cancer care facili-ties and private oncology practices. By thoroughly engaging participants with interac-tive cases and physician point-counterpoint-style discussions, this symposium will provideevidence-based treatment and management recommendations and address newtreatment regimens and management strategies based on recent clinical trials andemerging data. In addition to considering differences in domestic and internationalcare, barriers and/or limitations faced by community cancer centers and private-prac-tice oncologists will be debated.

This activity has been developed for hematologists and medical oncologists, as well asnurses, pharmacists, and other allied health professionals who are interested in meetingthe challenges faced when treating patients with multiple myeloma in academic andcommunity settings.

TARGET AUDIENCE

ACKNOWLEDGMENT

At the end of this activity participants will be able to:• Apply early management strategies that consider new diagnostic and staging criteriafor SMM, MGUS, and MM and new imaging studies in order to improve prognosis foryour patients.

• Evaluate novel therapeutic regimens as induction therapy for your patients consider-ing an SCT in order to provide the most rapid response and allow the largest amountof stem cell collection, while maintaining safety and tolerance.

• Integrate novel agent-based regimens that provide optimal outcomes and a survivalbenefit into your management strategy for patients ineligible for SCT after appraisingemerging data from clinical trials.

• Identify patient- and disease-associated factors that impact choice of therapeuticagent and formulate management strategies using a risk-adapted approach to treatment of MM.

• Construct optimal treatment regimens based on novel combinations and make informed treatment decisions in order to improve the long-term outlook for myelomapatients across the life cycle of the disease.

LEARNING OBJECTIVES

PROGRAM DESCRIPTION

Leon Dragon, MD, FACPMedical DirectorKellogg Cancer CenterNorthshore University HealthSystemHighland Park, IL

Charles M. Farber, MD, PhDSection Chief of Hematology and OncologyDepartment of MedicineCarol G. Simon Cancer Center, Morristown, NJ

Shoba Kankipati, MDAssociate Physician EPIC Care East Bay Partners in Cancer CareSan Francisco Bay Area, CA

Jonathan L. Kaufman, MD Assistant Professor Blood and Marrow Transplantation Department of Hematology and Medical Oncology Emory University School of Medicine Member, Winship Cancer Institute Emory University, Atlanta, GA

Stefan Knop, MDUniversity Hospital WürzburgWürzburg, Germany

Noopur Raje, MDAssociate Professor of MedicineHarvard Medical SchoolDirector, Center for Multiple MyelomaMassachusetts General HospitalBoston, MA

G. David Roodman, MD, PhDProfessor of MedicineVice Chair for Research Department of MedicineDirector, Myeloma ProgramDirector, Bone Biology CenterUniversity of Pittsburgh Medical CenterPittsburgh, PA

Ari Umutyan, MDRedwood Regional Medical GroupHematology and Medical OncologyNapa, CA

ACCREDITATION INFORMATION Physician AccreditationThe University of Cincinnati designates this activity for a maximum of 3 AMA PRA Category1 Credits™. The University of Cincinnati is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.Physicians should only claim credit commensurate with the extent of their participationin the activity.

Registered Pharmacy DesignationMedical Learning Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 3.0 contact hours (0.3 CEUs)of continuing education credit.

The universal activity number for this activity is 0468-9999-10-058-L01-P.

Registered Nurse DesignationMedical Learning Institute, Inc. (MLI)

Provider approved by the California Board of Registered Nursing, Provider Number15106, for 3.0 contact hours.

12:30 - 1:00 PM Registration and Lunch Service

1:00 - 1:10 PM Welcome and Introduction Sundar Jagannath, MD - Chair

CASE PRESENTATIONSEach case will be presented by an expert faculty member and discussed by the international and community panel.

1:10 – 1:40 PM Case 1: Difficult diagnosis G. David Roodman, MD, PhD

1:40 – 2:10 PM Case 2: Newly diagnosed, stem cell transplant eligible patientSundar Jagannath, MD

2:10 – 2:40 PM Case 3: First-line therapy in a non-SCT eligible patient Stefan Knop, MD

2:40 – 3:10 PM Case 4: Multiple risk factors Jonathan L. Kaufman, MD

3:10 – 3:40 PM Case 5: Treatment of MM across the life cycle Noopur Raje, MD

3:40 - 3:50 PM Question & Answer Session

3:50 - 4:00 PM Closing Remarks Sundar Jagannath, MD

PROGRAM AGENDA

CHAIR: Sundar Jagannath, MDProfessor, Hematology and Medical OncologyMount Sinai School of Medicine’s Tisch Cancer Institute Director of the Multiple Myeloma Program, The Mount Sinai Medical CenterNew York, NY

FACULTY

�� TON_October 2010_v6_TON 10/15/10 3:01 PM Page 39


CONTINUING EDUCATION

Medication safety is an ongoingchallenge for hospitals, healthcare providers, and healthcare

delivery systems. Medication errors inhospitals are common1,2 and can lead topatient harm. A study by Leape and col-leagues found that serious medicationerrors occurred most often in physicianordering (39%) and nurse administration(38%). The remaining 23% occurredduring transcription (12%) and pharma-cy dispensing (11%).3Strategies are needed to reduce pre-

ventable adverse drug events (ADEs),and the implementation of healthcareinformation technology (HIT) has beentouted as a promising strategy for pre-venting medication errors. Com put -erized physician order entry (CPOE) hasbeen shown to decrease serious medica-tion errors by 55%.4 Bar code technolo-gy, which is widely adopted in industriesoutside of healthcare because of its ease

of use and reliability, has been shown toprevent errors in dispensing drugs fromthe pharmacy.5 At the bedside, the useof bar code technology to verify apatient’s identity and the medication tobe administered has been shown to bean effective strategy for preventingmedication errors, and its use has beenincreasing. The US Department ofVeterans Affairs, for example, pio-neered the way by instituting a nationalbar coding program in 1999 in its hospi-tal system.6,7Bar code medication verification at

the bedside is usually implemented inconjunction with an electronic medica-tion administration record (eMAR).This combination of technologiesallows nurses to automatically docu-ment the administration of drugs byscanning their bar codes6 to ensure thecorrect medication is administered inthe correct dose at the correct time tothe correct patient. Because the eMARimports drug orders electronically fromthe physician’s order entry or the phar-macy system, its implementation mayreduce transcription errors.6Bar code plus eMAR technology is

not without its drawbacks. One studyfound that although medication man-agement improved, the system studiedwas difficult to implement.8 Further -more, other studies have highlightedcertain unintended consequences ofeMAR implementation, such as hospitalstaff relying too heavily on the technol-ogy, bypassing some of the hospital’ssafety processes, or overriding the sys-tem’s alerts, thus increasing the risk fornew errors.9,10

Study examines efficacy and safetyof bar code technology in hospitalsettingGiven the uncertainties with bar

code plus eMAR technology, my col-leagues and I at Brigham and Women’sHospital evaluated its implementationin 35 adult medical, surgical, and inten-sive care units in our 735-bed tertiaryacademic medical center to assess itseffects on administration and transcrip-tion errors, as well as associated poten-tial ADEs.6During the 9-month study, we com-

pared 6723 medication administrationson patient units before the bar code pluseMAR technology was introduced with7318 medication administrations after

the technology was introduced. We alsoreviewed order transcriptions in bothtime frames.6

ResultsOf the 1272 nontiming errors ob -

served, 776 occurred in medicationadministration on units without the barcode plus eMAR system (an 11.5%error rate) compared with 495 sucherrors on units that used it (a 6.8% errorrate), corresponding to a 41.4% relativereduction in errors (P <.001). The rateof potential ADEs (associated withnontiming errors) fell from 3.1% with-out the use of the bar code plus eMARsystem to 1.6% with its use, represent-ing a 50.8% relative reduction (P<.001). A 27.3% (P <.001) reductionwas seen in the rate of timing errors inmedication administration, but the rateof potential ADEs associated with tim-ing errors did not differ significantly.6Transcription errors also were re -

duced with the bar code plus eMAR sys-tem. Of the 3082 transcription ordersreviewed, 1799 orders were on units

without the technology. We found 110transcription errors, of which 53 werepotential ADEs, corresponding to 6.1transcription errors and 2.9 potentialADEs per 100 medication orders tran-scribed. In the 1282 medication ordersreviewed on units with the bar codeplus eMAR system, transcription errorswere completely eliminated.6

Clinical implications of bar codetechnologyThis study demonstrates that bar

code plus eMAR technology can be animportant intervention to improvemedication safety. Because the studyhospital administers approximately 5.9million doses of medications per year,use of the bar code plus eMAR isexpected to prevent approximately95,000 potential ADEs at the point ofmedication administration every year inthis medical center. The electronicorder-entry system processed about 1.69million medication orders during thestudy period. As a result, the system isalso expected to prevent approximately

Bar Coding: An Effective Strategy for PreventingMedication ErrorsBy Eric G. Poon, MD, MPHDirector of Clinical Informatics, Brigham and Women’s Hospital; Assistant Professor of Medicine, Harvard Medical School, Boston

PROGRAM CNE002 • RELEASE DATE: OCTOBER 15, 2010 • EXPIRATION DATE: OCTOBER 15, 2011

ESTIMATED TIME TO COMPLETE: 1.0 HOUR

CONTINUING NURSING EDUCATION

ACCREDITATION AND CONTACT

HOURS STATEMENT

Science Care is approved by the CaliforniaBoard of Registered Nursing, Provider number15559, for 1.0 Contact hour.

METHOD OF PARTICIPATION

1. Read the article in its entirety2. Go to www.TheOncologyNurse.com3. Select “Continuing Education”4. Click on this article’s title from the listshown

5. Select “Click here to complete the posttestand obtain a CE certificate online”

6. Complete and submit the CE posttest andCE Activity Evaluation

7. Print your Certificate of Credit

This activity is provided free of charge to participants.

FACULTy DISCLOSURES

As a provider accredited by the California Boardof Registered Nursing, Science Care must ensurebalance, independence, objectivity, and scientificrigor in all its activities. All course directors, fac-ulty, planners, and any other individual in a posi-tion to control the content of this educationalactivity are required to disclose to the audienceany relevant financial relationships with anycommercial interest. Science Care must deter-mine if the faculty’s relationships may influencethe educational content with regard to expositionor conclusion and resolve any conflicts of inter-est prior to the commencement of the educa-tional activity.

Disclosures are as follows:• Joanne Abbotoy, BSN, RN, has nothing to disclose.

• Eileen Koutnik-Fotopoulos has nothing todisclose.

• Dawn Lagrosa has nothing to disclose.• Eric G. Poon, MD, MPH, has nothing to disclose.

• Karen Rosenberg has nothing to disclose.The staff of Science Care have nothing todisclose.

DISCLAIMER

The opinions and recommendations expressedby faculty, authors, and other experts whoseinput is included in this program are their ownand do not necessarily represent the viewpointof Science Care or Green Hill HealthcareCommunications, LLC.

COPyRIGHT STATEMENT

Copyright © 2010 Science Care. All rightsreserved.

EDITORIAL BOARD

Joanne Abbotoy, BSN, RNNurse AdministratorRoswell Park Cancer InstituteElm & Carlton StreetsBuffalo, NY 14263

Eric G. Poon, MD, MPHDirector of Clinical InformaticsBrigham and Women’s Hospital

Assistant Professor of MedicineHarvard Medical School75 Francis Street Boston, MA 02115

STATEMENT OF NEED

Medication safety is an ongoing challenge, andmedication errors can lead to patient harm.Serious medication errors can occur duringphysician ordering, nurse administration, tran-scription, and pharmacy dispensing. Bar codetechnology has been shown to prevent errors indispensing drugs from the pharmacy and veri-fying a patient’s identity and the medication tobe administered at the bedside. Strategies tohelp reduce preventable adverse drug eventsthrough the use of bar code technology areincreasingly being implemented in healthcaresystems, requiring nurses to be up to date onthe technology to ensure that medicationadministration is for the right patient, the rightroute, the right dose, the right time, and theright medication.

TARGET AUDIENCE

Advanced practice nurses, registered nurses,and other interested healthcare professionals,especially those caring for cancer patients

LEARNING OBJECTIVES

After completing this activity, the readershould be able to:• Explain how bar code verification technolo-gy combined with an electronic medicationadministration record can help reducemedication errors

• Describe technologic solutions to adminis-tration-stage and medication transcrip-tion–stage errors

• Discuss the importance of using the tech-nology properly to ensure that bar codetechnology is effective in reducing medica-tion errors


www.TheOncologyNurse.com


50,000 potential ADEs related to tran-scription errors.6Whereas nurses and pharmacists

often intercept errors made by physi-cians during the medication-orderingstage, errors made during the adminis-tration stage and, to a lesser extent, dur-ing the medication transcription stageoften go undetected.3 This findingunderscores the need for highly reliablestrategies, such as bar code technology,to act as an additional safety componentin medication administration and ordertranscription.6Pharmacists’ role in dispensing med-

ications is crucial in hospitals. The closeintegration of order-entry, pharmacy,and medication administration systemsensures that nurses administer medica-tions only after pharmacists havereviewed the orders, providing patientswith the added benefit of the pharma-cists’ clinical knowledge.6 Preventingtrans cription errors is also vital. Factoringin the high number of doses adminis-tered and orders transcribed in acutecare hospitals, implementation of a barcode plus eMAR system could signifi-cantly improve medication safety.6The results of this study were similar

to Bates and colleagues’ findings onCPOE, which reduced serious medica-tion errors at the ordering stage by more

than 50%.4 Decision support embeddedwithin CPOE systems is more likely toprevent errors that result from poorjudgment, lack of knowledge, or incom-plete clinical information when choos-ing a therapeutic plan. In contrast, a barcode plus eMAR system is more likely toprevent errors associated with memorylapses or mental slips in executing atherapeutic plan.6 My colleagues and Ihave suggested that these two technolo-gies could play complementary roles inimproving medication safety in acutecare. More research is needed to deter-mine which of these two technologiesshould be implemented first, if an organ-ization has to make that choice.6In the current study, the rate of med-

ication administration errors fell signifi-cantly, but not all the errors were elimi-nated. We offer two possible reasons.Patient safety technology is effective if itis used as intended. Whereas the studyhospital expended substantial resourcesin the training of end users, 20% of thedrugs administered on units with the barcode plus eMAR technology were ad -ministered without the bar code scan-ning step during the study period. Inaddition, the study hospital used anearly version of the software; severalimportant improvements have beenmade since this study was conducted. In

light of these issues, we recommend thatdeployment of HIT should be envi-sioned not as a single event in time butrather as an ongoing process thatrequires modifications and improve-ments.6Multiple limitations of this study,

however, warrant consideration. Thestudy findings reflect the experience ofone hospital that already has fully imple-mented CPOE for physicians and barcode verification for pharmacy staff.Hospitals considering implementationof a bar code plus eMAR technologywithout CPOE, pharmacy bar code ver-ification, or both may observe a differentoutcome on the effect on administrationerrors. The study also examined potentialADEs, not actual ADEs. Furthermore,the study hospital worked closely withusers and clinical leaders who were will-ing to support a significant change inworkflow to improve the overall med-ication process.6 Healthcare organiza-tions interested in using a bar code pluseMAR technology should take intoaccount these factors and find strategiesto implement the technology in themost cost-effective way.6Bar code plus eMAR technology, in

my opinion, improves medication safe-ty by reducing administration and tran-scription errors, providing support for

its inclusion as a 2013 criterion formeaningful use of HIT under theAmerican Recovery and ReinvestmentAct of 2009. �

References1. Brennan TA, Leape LL, Laird NM, et al. Incidence ofadverse events and negligence in hospitalized patients:results of the Harvard Medical Practice Study I. N Engl JMed. 1991;324:370-376.2. Bates DW, Cullen DJ, Laird N, et al. Incidence ofadverse drug events and potential adverse drug events.Implications for prevention. ADE Prevention StudyGroup. JAMA. 1995;274:29-34.3. Leape LL, Bates DW, Cullen CJ, et al. Systems analy-sis of adverse drug events. ADE Prevention StudyGroup. JAMA. 1995;274:35-43.4. Bates DW, Leape LL, Cullen DJ, et al. Effect of com-puterized physician order entry and a team interventionon prevention of serious medication errors. JAMA.1998;280:1311-1316.5. Poon EG, Cina JL, Churchill W, et al. Medication dis-pensing errors and potential adverse drug events beforeand after implementing bar code technology in the phar-macy. Ann Intern Med. 2006;145:426-434.6. Poon EG, Keohane CA, Yoon CS, et al. Effect of bar-code technology on the safety of medication administra-tion. N Engl J Med. 2010;362:1698-1707.7.Wright AA, Katz IT. Bar coding for patient safety. NEngl J Med. 2005;353:329-331.8. Puckett F. Medication-management component of apoint-of-care information system. Am J Health SystPharm. 1995;52:1305-1309.9.McDonald CJ. Computerization can create safety haz-ards: a bar-coding near miss. Ann Intern Med. 2006;144:510-516.10. Koppel R, Wetterneck T, Telles JL, Karsh BT.Workarounds to barcode medication administration sys-tems: their occurrences, causes, and threats to patientsafety. J Am Med Inform Assoc. 2008;15:408-423.

Eileen Koutnik-Fotopoulos contributed tothe preparation of this article.

COMMENTARY

Simply Implementing a Bar Coding System Is NotEnough: A Nurse’s PerspectiveBy Joanne Abbotoy, BSN, RNNurse Administrator, Roswell Park Cancer Institute, Buffalo, New York

Medication safety is a complexissue that needs to be ad -dressed from multiple points

throughout the patient care continu-um. The errors associated with hand-written orders, transcription practices,prescribing, dispensing, and adminis-tering medication can be re ducedwhen a bar coding system is imple-mented. This is especially true with theimplementation of electronic healthrecords (EHRs) and computerized phy -sician order-entry systems. For a bar coding system to be success-

ful, staff education and onsite supportduring implementation are of criticalimportance. Education of frontline usersshould include use of the system, prob-lem resolution, “warning” message man-agement, and accurate error reporting.The possibility of developing system“workarounds” is a realistic yet flawedmanner of addressing problems thatarise, making it very important to teachnurses why these workarounds should

not be used. The bar code plus electron-ic medication administration record(eMAR) system discussed is based onthe “Five Rights” of medication admin-istration: (1) right patient, (2) rightroute, (3) right dose, (4) right time, and(5) right medication. Workaroundsbypass the safety features built into thebar code plus eMAR system, which helpensure these “rights.”For many reasons, it can be difficult

and time-consuming to implementand operationalize a bar code system.Therefore, it is important to set realis-tic goals and to manage the expecta-tions for nurses who will be end usersas well as to elicit their buy-in early inthe process. One of the best ways toensure buy-in is to include the enduser in the decision-making processbefore implementation. At RoswellPark Cancer In stitute, staff nurseswere included in policy revision,workflow redesign, scanner selection,and trials of new computer carts.

Nursing time for medication adminis-tration may be increased during thetime that nurses are learning to use thebar code plus eMAR system. Nursesneed to understand that the system isdesigned to increase patient safety, notto decrease nursing time for administer-ing medications. In addition, processesand structures may need to change.• Policies and procedures may needto be updated.• Workflow must be reviewed andmay need to be changed.• Hardware needs must be evaluatedand addressed.• Work groups and committees mayneed to be created or changed.It is important that the information

technology department be involved inthe planning from the start. In thismanner, the EHR system can be evalu-ated to assess the impact of adding a barcode program.After a bar code system is imple-

mented for medication administra-

tion, its use will need to be monitoredto ensure that it continues to functionproperly. As noted by Koppel and col-leagues, this can be accomplished bydirect observation, user interviews,review of override data, and proactiveprocess change. Repeated examination,evaluation, and correction are necessaryon an ongoing basis.1The literature supports the imple-

mentation of bar code systems for med-ication administration to promote thesafe administration of medications. Theimplementation of such systems shouldnot be done hurriedly or without prepa-ration and evaluation. Bar code tech-nology should not be seen as a quick fixbut rather as a tool to be used andreevaluated as the dynamic nature oftechnology evolves. �

Reference1. Koppel R, Wetterneck T, Telles JL, Karsh BT.Workarounds to barcode medication administration sys-tems: their occurrences, causes, and threats to patientsafety. J Am Med Inform Assoc. 2008;15:408-423.


CHICAGO—Among patients withlung cancer on highly emetogenicchemo therapy, those receiving palo -nosetron throughout all cycles ofchemo therapy had a 31% lower risk ofchemo therapy-induced nausea andvomiting (CINV) associated with anemergency department or hospitalvisit, than patients receiving other 5-

hydroxytryptamine type 3 (5-HT3)receptor antagonists (RAs).The study was presented by Hind T.

Hatoum, PhD, of the Center of Pharma -coeconomic Research at the Universityof Illinois at Chicago during the 46thannual meeting of the AmericanSociety of Clinical Oncology.The study compared the risk of serious

CINV among 1692 lung cancer patientsinitiated on cisplatin-based chemothera-py who were started and maintained on a 5-HT3–based prophylactic strategy,including palo nosetron, dolasetron,granisetron, or ondansetron. Patientswere identified from claims data (Phar-Metrics) between 2005 and 2008 andstratified into one of two groups:

palonosetron throughout all cycles ofchemotherapy (n = 390) and any other5-HT3–based regimen (n = 1302).CINV events were identified from

emergency department and hospitalclaims with codes of nausea, vomiting,and/or dehydration. The two groupswere compared for the risk of CINV,controlling for age, sex, comorbidity,and chemotherapy treatment days.The two treatment groups had com-

parable comorbidities, with no signifi-cant differences in the CharlsonComorbidity Index.The most widely represented chemo -

therapy regimens were cisplatin/etopo-side (25%), cisplatin alone (7%) andcisplatin/docetaxel/etoposide (6%).In what Hatoum called a “real-

world practice,” the average patientreceiving palonosetron had signifi-cantly fewer claims of both 5-HT3RAs and all antiemetics, as comparedwith patients receiving all other 5-HT3 RAs: 6.4 versus 12.4 for other5-HT3 RA claims (P <.0001), and 8.5versus 14.7 in all antiemetic claims (P <.0001).This represents 42% fewer antiemet-

ic claims and 58% fewer 5-HT3 RAclaims for palonosetron compared withpatients who received other agents,Hatoum noted. With palonosetron, fewer patients

experienced CINV events leading toemergency department or hospital vis-its: 16.4% versus 22.6% (P <.01) in theunadjusted analysis, which remained asignificant 31% reduction (P <.05) inthe adjusted analysis.Palonosetron-treated patients also

had, on average, significantly fewer cis-platin treatment days: 4.9 versus 5.7days (P <.0001). “We cannot ascertainwith 100% certainty what this means,but we suspect these patients were ableto have the dose pushed higherbecause they had less nausea and vom-iting. They did not have to delay treat-ment; and therefore, there were fewertreatment days,” Hatoum suggested.In addition, 51.0% of patients used

palonosetron without combining itwith the neurokinin-1 (NK1) antago-nist aprepitant and/or dexametha-sone, compared with 45.6% of thealternate group. Palonosetron, in con-trast to other 5-HT3 RAs, differential-ly in hibits “crosstalk” between NK1re ceptors and 5-HT3 signaling path-ways, and exhibits prolonged inhibi-tion of receptor function, Hatoumexplained, suggesting that “it mayhave properties such that you don’tneed the NK1 antagonist.” �

Palonosetron Demonstrates Benefits over Other 5-HT3 Receptor Antagonists in Lung Cancer PatientsBy Caroline Helwick


Supportive Care

ENTER OUR iPad GIVEAWAY

Visit us at booth #327 during the 11th Annual Institutes of Learning, November 12-14, Orlando, Florida, for your chance to WIN!


A Newsletter Series for Cancer Care Professionals

Center of Excellence Media, along with Editor-in-ChiefSagar Lonial, MD, of Emory University, are pleased tooffer your multidisciplinary cancer team this series ofnewsletters focusing on the challenges of treatingpatients with multiple myeloma.

SAGAR LONIAL, MDAssociate Professor of

Hematology and Oncology Emory University School of Medicine

� Earn Continuing Education Credits �

Each newsletter will feature:

These activities are supported by an educational grant from Millennium Pharmaceuticals, Inc.

• Front-line Therapy• Maintenance Settings• Transplant Settings• Retreatment Settings

• Non-Transplant Patients• Cytogenetics• Side Effect Management• Bone Health

• Contributions from thought-leadingphysicians, nurses, and pharmacists

• Continuing Education credits availableto physicians, nurses, and pharmacists

Presents the Third Annual Curriculum for CONSIDERATIONS IN MULTIPLE MYELOMA

PARTICIPATE TODAY at www.COEXM.com

8-part newsletter series

CASE STUDY DISCUSSIONS:

For complete learning objectives and accreditation information, please refer to each activity.

Target AudienceThese activities were developed for physicians, nurses, and pharmacists.

These activities are jointly sponsored by


The Doctor of Nursing Practice(DNP) degree has been designat-ed by the American Association

of Colleges of Nursing (AACN) as thegraduate degree for advanced practicenurses (APNs). Currently, obtaining thisdegree remains an option; pursuit of adoctoral degree in nursing is a personaland professional decision made by someAPNs. The trend toward doctoral prepa-ration appears to be gaining momentum,however, and after the year 2015 it maybe difficult to find a nurse practitionerprogram that awards a Master of Sciencein Nursing (MSN). The DNP degree is a practice-focused

doctorate that has gained enthusiasticsupport from the nursing community.Currently, 127 universities nationwideare accepting students into DNP pro-grams, and another 100 programs are inthe planning stages. The curriculum isbuilt on the DNP Essentials developedby AACN (www.aacn.nche.edu).

My nursing journeyI completed my undergraduate nursing

degree in 1992 at Marymount Uni -versity, Arlington, Virginia. Soon aftergraduation I took a PRN (per diem) posi-tion at George Washington University

Medical Center, Washington, DC, inthe outpatient clinics. I rotated throughvarious clinics reporting to the Depart -ment of Medicine. This experience wasgreat for a new graduate as it allowed meto decide which specialty was the best fit.One afternoon in April of 1994, I

took a phone call from the nurse man-ager in the cancer center asking if therewas anyone who would be interested indoing some per diem work. It took meabout 15 seconds to say, “I would beinterested.” I was healing from my ownmother’s death from a brain tumor. Ibelieved that working with cancerpatients would help me continue toheal and allow me to provide great serv-ice to those with the disease. Theoncology nurses I worked with werewonderful mentors. They were generouswith their time and always willing toshare their knowledge. I learned quick-ly and soon took a full-time positionwith an oncologist. He guided andinspired me to be the best I could be. Iconstantly thought of continuing myeducation. I wanted to offer more tocancer patients than I was able to inthat position. In 2004, I began an MSN and

Family Nurse Practitioner (FNP) pro-

gram. In our comprehensive examina-tions, I argued in favor of the DNPdegree in a debate. I had done a fairamount of reading regarding this newdegree and felt strongly in favor of it.AACN had published their positionstatement, and I had read it thorough-ly. I knew from that point that obtain-ing the DNP was my next goal.Although my MSN/FNP educationwas excellent, I felt a need and desirefor more education to fulfill my intel-lectual appetite for knowledge thatwould enhance my clinical skills as anAPN. The DNP focus was on practiceand the application of evidence direct-ly to the bedside. This appealed to me.I would earn this degree.I graduated with my MSN/FNP degree

from Marymount University in May2007 and immediately was hired by asolo oncologist in a private practice. In asolo practice, I faced challenges such asexplaining the role of an NP to patients,who were often resistant to seeing a newprovider. With the full support of my col-laborating physician, great humility, andperseverance over the next year, theoncology patients accepted me as a fullprovider. Soon I was seeing a full load ofpatients and learning how to performbone marrow biopsies. Life as an oncolo-gy NP was good.Nonetheless, I could still hear that

little voice calling out to me to move for-ward with my doctoral degree. I beganresearching universities offering theDNP. In December that year, I wasaccepted into Chatham University,Pittsburgh, Pennsylvania. I would be partof the second cohort to graduate. Therewere 22 other APNs in my cohort—sev-eral NPs, numerous nurse anesthetists,and one chief nursing officer. The pro-gram curriculum was rigorous and chal-

lenging. My capstone project was aresearch study looking at cancer patients’perceptions of the oncology NP’s role incancer management. The new knowl-edge gained from my doctoral work pro-vided me with clinical leadership skills aswell as an increased awareness of evi-dence-based practice, which allowed meto bring research results directly topatients at bedside. In May 2009, Iwalked down the aisle at ChathamUniversity and was announced to thefaculty and student body as Dr CatherineBishop. I knew I had earned the titlethrough my uncompromising work. I amnow proud to meet new patients andintroduce myself as Dr Bishop, theoncology NP.

Implications for APNsThe DNP is the highest degree that

can be earned by APNs. It has been saidthat this practice-focused doctorate putsnursing on the same level as many otherhealthcare fields, such as pharmacy,medicine, and physical therapy. It isimportant to remember, however, thatthe DNP is a degree, not a role. I con-tinue to function within my scope ofpractice as a doctorally prepared NP. Iam better equipped to manage the com-plexities of my patient populationbecause of the breadth of knowledgegained within my doctoral program.The degree has led to professionalopportunities that may not have pre-sented themselves otherwise. My col-laborating physicians are proud of myachievements and my commitment tofurthering my education. My patientsbelieve that earning this degree showsthe commitment I have made to themto provide excellent, quality care. Theyfeel rewarded by my work and are happyto call me Dr Bishop. �


Nursing Education and Training

Doctor of Nursing Practice: An OncologyNurse Practitioner’s JourneyBy Catherine S. Bishop, DNP

Hematology-Oncology Associates of Fredericksburg, Virginia

Table AACN’s Doctor of Nursing Practice Essentials

• Scientific underpinnings for practice• Organizational and systems leadership for quality improvement and systems thinking• Clinical scholarship and analytical methods for evidence-based practice• Information systems/technology and patient care technology for theimprovement and transformation of healthcare• Healthcare policy for advocacy in healthcare• Interprofessional collaboration for improving patient and population health outcomes• Clinical prevention and population health for improving the nation’shealth • Advanced Nursing Practice

Source: www.aacn.nche.edu/DNP/pdf/Essentials.pdf.

Residency Programs forNurses Surging in PopularityBy John Schieszer

SEATTLE—New doctors have receivedon-the-job training in residency pro-grams for decades. Now, a growing num-ber of new nurses are doing the exactsame thing. Nurse residency programsare now rising in popularity and that, inpart, is due to hospitals trying to stave offa huge projected nursing shortage overthe next 10 to 15 years.Nurse residency programs were first

introduced in the United Statesapproximately 15 years ago, and pro-grams were established in Illinois andTexas. Until now, however, the ideareally did not take off. This summer, acomprehensive cancer care center wasthe first to implement a nurse residen-cy program, and other cancer centersmay soon be joining the trend.Because of an aging workforce, it is

expected that there will be a signifi-cant nursing shortage over the next

two decades. So, some hospitals aroundthe country are establishing specialnursing residency programs as a meansof retaining new graduates. Nationally,the average turnover rate of first-yearnurses is reported to be approximately27%. One study showed that 35% to60% of new graduates change employ-ers within the first year of employment(Beecroft P, et al. Nurs Econ. 2007;21:13-18, 39).“At 6 months, the nurses get hit hard,

and many places lose nurses. Some nurs-es leave the profession as well as the hos-pital. So, we wanted to find out how wecould better support nurses during thistime,” said Martha Kershaw, RN, MS,OCN, who is the nursing staff develop-ment instructor at Roswell Park CancerInstitute, Buffalo, New York.Roswell Park Cancer Institute is one



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Breast Cancer

group versus the nonpathologic com-plete response group.”The study continues to accrue pa -

tients, and Khushalani expects to havemature survival data by fall 2010. “Ibelieve this is an efficacious regimen, andit’s definitely well-tolerated,” he said.“We hope that the exploratory gene-expression profiling results will translateinto clinically meaningful hypothesesthat can be validated in a large, prefer-ably multicenter study.”

Genetic profiling to identifytrastuzumab resistance in breastcancer patientsOther researchers at Roswell Park

Cancer Institute are hoping to deter-mine whether genetic profiling mayeffectively identify which breast cancer

patients are most likely to respond tothe drug trastuzumab.Trastuzumab interferes with a protein,

known as the human epidermal growthfactor receptor type 2 (HER2), which islinked to breast cancer. However, a highnumber of breast cancer patients(approximately 50%) don’t respond tothe drug and experience recurrence.Currently, there is great interest inresearch that might elicit factors thatdrive responses.Over the past 2 years, researchers

looked at 41 breast carcinoma cases inwhich amplified HER2 levels were seenand for which fresh frozen tissue wasavailable. Of these patients, 12 weretreated with trastuzumab and three(25%) experienced recurrence. Amongthe 11 patients not treated with the drug,

six (55%) had recurrence. Gene microar-rays were used to identify differentiallyexpressed genes for trastuzumab (respon-sive vs resistant).The investigators found that the dif-

ferentially expressed genes for recurrenceor nonrecurrence were distinct betweenthe group treated with tras tuzumab andthe group that was not treated with thedrug. The researchers hope that differen-tial expression of key genes identified inthis study may offer insights intotrastuzumab resistance among breastcancer patients. It is hoped that this typeof technology fingerprinting can lead tonew potential biomarkers for diagnosis,prognosis, and treatment.“The group that was treated with

trastuzumab and developed recurrencehad a genetic makeup different from

those who were not treated and devel-oped recurrence,” said study investiga-tor Thaer Khoury, MD, who is an assis-tant professor of pathology andlaboratory medicine at Roswell ParkCancer Institute. “The idea from thebeginning was to know why thesepatients who are treated with tras -tuzumab develop recurrence and whythe others did not. There is definitelysomething going on, and we’re startingto understand these mechanisms.”Khoury, who presented the study

findings at the meeting, said theyshould be of particular interest to clini-cians working in this area of cancer.The message about treatment and howit should be guided is now changing, asmolecular markers are complementingclinical markers. �

GENETICS

Genetic Profiling Changing ... Continued from page 34

Targeted Intraoperative Radiotherapy May Be asGood as Whole Breast Radiotherapy at ReducingBreast Cancer RecurrenceBy John Schieszer

CHICAGO—Targeted intraoperativeradiotherapy (TIR) for breast cancer, inwhich radiotherapy is confined to thearea of the breast where the tumor hasbeen removed, has been found to be asgood as whole breast radiotherapy atreducing breast cancer recurrence. Mostimportant, the new data presented atthe 46th annual meeting of the Am -erican Society of Clinical Oncologyshowed TIR can be carried out in justone hospital visit.The researchers say TIR for breast

cancer could mean much more thanconvenient care for patients, as well asreduced waiting lists and substantialsavings for the healthcare systems.Oncologist Michael Baum, MB, ChB,FRCS, ChM, MD(hc), professor emeri-tus of surgery at the University CollegeLondon and chairman of the TARGIT-A trial, said the nurses will be the keypeople on this major shift in the use ofradiotherapy for breast cancer.“The oncology nurse has a pretty

tough job,” said Baum, who helped setup the first oncology nurse training pro-gram in England. “They have to explainto the women the benefits and theharms of treatments. I think the oncol-ogy nurse will have to get up to speedvery quickly. This trial has alreadyattracted worldwide interest.”After breast-conserving surgery, 90%

of local recurrences occur very close tothe removed tumor (index quadrant)

despite the presence of multicentriccancers elsewhere in the breast. Thus,restriction of radiation therapy to thesite of tumor removal (tumor bed) dur-ing surgery could be adequate forselected patients. In TARGIT-A, theresearchers compared TIR with theconventional policy of whole breastexternal beam radiotherapy (EBRT).The prospective, randomized trialincluded women aged 45 years and olderwith invasive ductal breast carcinomaundergoing breast-conserving surgery.

In this trial, 2232 women were includ-ed. The median age was 63 years and83% of the women were less than age 70.The median tumor size was 12 mm and17% were lymph-node positive.After 4 years of follow-up, there

were six local recurrences in the intra-operative radiotherapy group and fivein the EBRT group. This translated tovery similar recurrence rates in bothgroups. The frequency of any compli-

cations and major toxicities were simi-lar in the two groups. For major toxici-ty, the rates were 3.3% in the TIRgroup versus 3.9% in the EBRT group.“The side effects have been looked

at very carefully,” said Baum in aninterview with The Oncology Nurse.“The toxicity levels are good in botharms. However, there is significantlymore grade 3 radiation toxicity in theexternal beam compared with theintraoperative.”The investigators, however, found

that the intraoperative approach pro-duced a greater incidence of seromarequiring aspiration. The incidencerate was 2.1% for the TIR group com-pared with 0.8% in the EBRT group.The trial used the INTRABEAM

radio therapy system, a mobile radio-therapy platform with a miniature,electronic, high-dose rate (HDR), low-energy x-ray source. The use of low-energy x-ray radiation eliminates the

need for a specialized treatment room,in contrast to other high-energy radia-tion sources (linear accelerators andHDR/HDR brachy therapy systems)that require specially designed rooms.This system is set up to be used in theoperating room at the time of surgery.The intrabeam radiation is applied for20 to 30 minutes, exposing the affect-ed tissue in the tumor bed from insidethe tumor cavity.Baum said that this study was set up

to demonstrate that 25 minutes in theoperating room is equivalent to 6weeks of postoperative radiotherapy.He said that these study results willnow change how women with thistype of breast cancer (early invasivebreast cancer suitable for breast-con-serving surgery) receive their therapy.Once they are aware of this option, hethinks the demand will then be great.“I think personally the women willvote with their feet,” he told TheOncology Nurse.Besides the obvious benefits of

completing all the necessary radio-therapy in a single session at the timeof surgery, TIR almost completelyavoids irradiation of the intrathoracicstructures such as the heart, lung, andesophagus. Baum said he hoped thesetrial results influence a paradigm shiftfrom conventional radiation ap -proaches to single-dose treatment foreligible patients. �

“There is significantly more grade 3radiation toxicity in the external beamcompared with the intraoperative.”—Michael Baum, MB, ChB, FRCS, ChM, MD(hc)


��

Experts from various disciplineswill be featured in blog segments over the course of the year, allowing members tointeract with their colleagueson multiple subject areas.

Informational/educational resources to help you andyour patients navigate theircancer treatment and improve their quality of life.

Members receive subscriptions to the Journal of Oncology Navigation & Survivorship, The Oncology Nurse-APN/PA,and the bimonthly Journal of Multidisciplinary Cancer Care(a more than $150 value).

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� �� TON_October 2010_v6_TON 10/15/10 3:02 PM Page 47

of four healthcare centers collaboratingon the first nurse residency program(Western New York Nurse ResidencyProgram) in the Buffalo, New York, area.The program was kicked off on July 29,2010, with a program on skills reinforce-ment. Sixteeen new nurses working atRoswell Park Cancer Institute wereamong 96 nurses signed up for the resi-dency program from the four Buffalo areahealthcare centers.In many respects, a nursing residen-

cy program can be especially beneficialfor new oncology nurses. It can helpaddress many problems that new nursesare faced with and thus allow them tobetter focus on oncology treatments.“With oncology nurses, the treatmentschange every day, and the things thatour nurses have to know in addition towhat a regular new graduate has toknow are amazing. So we are able tofocus on the oncology aspects of nurs-ing that they need to know. The resi-dency program helps with the basicnursing skills as well as the basic assess-ment skills and also help them becomea member of the team on their floor,”said Kershaw in an interview with TheOncology Nurse.The residency program focuses on

how to be a member of the hospitalteam and be active in the hospital aswell as the nursing profession. Thenursing residency program in theBuffalo area is based on one inWisconsin, which was started severalyears ago and has been highly success-ful. In the program, each new graduatenurse is hired into a “home” unit wherethat nurse will be based. Each nurse isthen connected with a mentor, whoserole is not to evaluate the new gradu-ate, but to offer psychosocial and pro-fessional support throughout the firstyear of employment.Valerie Smith, who is 29 years old,

just finished nursing school last May.Eight weeks later, Smith started hernursing residency program. “I think itis a good program. It is nice to be ableto learn about things that you are notreally confident about,” Smith said inan interview with The Oncology Nurse.“This kind of program lets you knowthat everyone has the same fears. Itreally helps to talk to other nursesabout how their first year is going.”In the Western New York Nurse

Residency Program, all new graduatenurses have the opportunity to partici-pate in approximately 6 hours of inter-active professional education sessionseach month. The sessions are offeredoff-unit and allow new graduates toreview their knowledge and skills in an

encouraging and productive learningenvironment. The goals of the pro-gram are to help nurses develop clini-cal competence and to help expandtheir critical-thinking skills.Studies suggest that new nurses often

feel that they have grasped the require-ments of their job and how to be an effec-tive member of a nursing team. However,many new nurses may need assistance inmanaging competing priorities on theirunit, unexpected and abrupt changes in

patients’ conditions, and other teamworkchallenges.“New nurses need support the first

year,” Kershaw said. “They have a pre-ceptor, an experienced nurse who teach-es them their role as a nurse and evaluatesthem to make sure they are competent tobe on the floor. Our program provideseducation events each month, and thementors help nurses when they have abad day or help answer the questions theyare too embarrassed to ask.” �


Nursing Life

Martha Kershaw, RN, MS, OCN, nursing staff development instructor at RoswellPark Cancer Institute, left, with new graduate nurse Valerie Smith, RN

NURSING EDUCATION AND TRAINING

Residency Programs for Nurses Surging in PopularityContinued from page 44

“I had a good week at the clinic. Not one malpractice suit.”

Pasta fagioli

Following a diet high in fruits,vegetables, and whole grainscan reduce your risk of colorec-

tal cancer. Limit your intake of redmeat to less than 18 ounces per weekand avoid processed meats. Replaceanimal protein once or twice a weekwith a plant-based meal using leg -umes or tofu. Try to consume at least35 g of fiber per day. Look for high-fiber cereals and breads to help meetthis goal. This month’s recipe ispacked with high-fiber ingredientsand immune-boosting nutrients. En -joy this recipe of pasta fagioli as amain dish for a quick and easy, nutri-tious weeknight dinner.

Ingredients

⅛ cup olive oil

4 garlic cloves, chopped

1 small white onion, chopped

2 tablespoons basil, chiffonade

1 15-oz can white beans

1 15-oz can plum tomatoes

½ lb whole wheat ditalini

½ teaspoon oregano

Salt and pepper to taste

Grated Parmesan cheese to taste

Directions

• Cook pasta and set aside

• In a medium saucepan, heat olive oil

• Add onion and sauté for 5 minutes

• Add garlic, basil, and oregano andcook for 1 more minute

• Add white beans and plum tomatoes

• Cook for about 15 minutes

• Add salt and pepper to taste

• Mix in pasta

• Finish with grated Parmesancheese

Serves 4

Nutritional InformationEach serving provides:380 calories, 9 g total fat, 0 mg cholesterol, 150mg sodium, 63 g carbohydrate, 17 g dietary fiber,16 g protein

Recipe courtesy of Peter Pascale, CCCExecutive Chef, Somerville, New Jersey.

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Meetings

adverse reactions were defined by any of the following adverse events occurring during or within 24 hours of the start of infusion: nausea, pyrexia, chills, hypotension, vomiting,and dyspnea. In Study 9, the following Grade 3 and 4 adverse reactions occurred more frequently in R-FC–treated patients compared to FC-treated patients: infusion reactions (9% in R-FC arm), neutropenia (30% vs. 19%), febrile neutropenia (9% vs. 6%), leukopenia (23% vs. 12%), and pancytopenia (3% vs. 1%). In Study 10, the following Grade 3 or 4 adverse reactions occurred more frequently in R-FC–treated patients compared to FC-treated patients: infusion reactions (7% in R-FC arm), neutropenia (49% vs. 44%), febrile neutropenia (15% vs. 12%), thrombocytopenia (11% vs. 9%), hypotension (2% vs. 0%), and hepatitis B (2% vs. <1%). Fifty-nine percent of R-FC–treated patients experienced an infusion reaction of any severity. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The observed incidence of antibody (including neutralizing antibody) positivity in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Rituxan with the incidence of antibodies to other products may be misleading. Using an ELISA assay, anti-human anti-chimeric antibody (HACA) was detected in 4 of 356 (1.1%) patients with low-grade or follicular NHL receiving single-agent Rituxan. Three of the four patients had an objective clinical response. The clinical relevance of HACA formation in Rituxan-treated patients is unclear. Postmarketing Experience The following adverse reactions have beenidentified during post-approval use of Rituxan in hematologic malignancies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Rituxan. Hematologic: prolongedpancytopenia, marrow hypoplasia, and late-onset neutropenia, hyperviscosity syndrome in Waldenstrom’s macroglobulinemia. Cardiac: fatal cardiac failure.: Immune/Autoimmune Events: uveitis, optic neuritis, systemic vasculitis, pleuritis, lupus-like syndrome, serum sickness, polyarticular arthritis, and vasculitis with rash. Infection: viralinfections, including progressive multifocal leukoencephalopathy (PML), increase in fatal infections in HIV-associated lymphoma, and a reported increased incidence of Grade 3 and 4 infections in patients with previously treated lymphoma without known HIV infection. Neoplasia: disease progression of Kaposi’s sarcoma. Skin: severe mucocutaneousreactions. Gastrointestinal: bowel obstruction and perforation. Pulmonary: fatalbronchiolitis obliterans and pneumonitis (including interstitial pneumonitis). DRUGINTERACTIONS Formal drug interaction studies have not been performed with Rituxan. In patients with CLL, Rituxan did not alter systemic exposure to fludarabine or cyclophosphamide. USE IN SPECIFIC POPULATIONS Pregnancy Category C: There are no adequate and well-controlled studies of rituximab in pregnant women. Postmarketing data indicate that B-cell lymphocytopenia generally lasting less than six months can occur in infants exposed to rituximab in-utero. Rituximab was detected postnatally in the serum of infants exposed in-utero. Non-Hodgkin’s lymphoma is a serious condition that requires treatment. Rituximab should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Reproduction studies in cynomolgus monkeys at maternal exposures similar to human therapeutic exposures showed no evidence of teratogenic effects. However, B-cell lymphoid tissue was reduced in the offspring of treated dams. The B-cell counts returned to normal levels, and immunologic function was restored within 6 months of birth. Nursing Mothers It is not known whether Rituxan is secreted into human milk.However, Rituxan is secreted in the milk of lactating cynomolgus monkeys, and IgG is excreted in human milk. Published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. The unknown risks to the infant from oral ingestion of Rituxan should be weighed against the known benefits of breast-feeding. Pediatric Use The safety and effectiveness of Rituxan in pediatric patients have not been established. Geriatric Use Diffuse Large B-Cell NHL AmongLpatients with DLBCL evaluated in three randomized, active-controlled trials, 927 patients received Rituxan in combination with chemotherapy. Of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. No overall differences in effectiveness were observed between these patients and younger patients. Cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients. Serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis. Low-Grade or Follicular Non-Hodgkin’s Lymphoma Clinical studies of Rituxan in low-grade or follicular, CD20-positive, B-cell NHL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Chronic Lymphocytic LeukemiaAmong patients with CLL evaluated in two randomized active-controlled trials, 243 of 676 Rituxan-treated patients (36%) were 65 years of age or older; of these, 100 Rituxan-treated patients (15%) were 70 years of age or older. In exploratory analyses defined by age, there was no observed benefit from the addition of Rituxan to fludarabine and cyclophosphamide among patients 70 years of age or older in Study 9 or in Study 10; there was also no observed benefit from the addition of Rituxan to fludarabine and cyclophosphamide among patients 65 years of age or older in Study 10 [see Clinical Studies]. Patients 70 years or older received lower dose intensity of fludarabine andscyclophosphamide compared to younger patients, regardless of the addition of Rituxan. In Study 9, the dose intensity of Rituxan was similar in older and younger patients, however in Study 10 older patients received a lower dose intensity of Rituxan. The incidence of Grade 3 and 4 adverse reactions was higher among patients receiving R-FC who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (Study 9); 56% vs. 39% (Study 10)], febrile neutropenia [16% vs. 6% (Study 9)], anemia [5% vs. 2% (Study 9); 21% vs. 10% (Study 10)], thrombocytopenia [19% vs. 8% (Study 10)], pancytopenia [7% vs. 2% (Study 9); 7% vs. 2% (Study 10)] and infections [30% vs. 14% (Study 10)]. OVERDOSAGE There has been no experience with overdosage in human clinical trials. Single doses of up to 500 mg/m2 have been administered in clinical trials. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to establish the carcinogenicor mutagenic potential of Rituxan or to determine potential effects on fertility in males or females. PATIENT COUNSELING INFORMATION Patients should be provided theRituxan Medication Guide and provided an opportunity to read prior to each treatment session. It is important that the patient’s overall health be assessed at each visit and the risks of Rituxan therapy and any questions resulting from the patient’s reading of the Medication Guide be discussed. Rituxan is detectable in serum for up to six months following completion of therapy. Individuals of childbearing potential should use effective contraception during treatment and for 12 months after Rituxan therapy.

Revised 02/2010 (4851501)

Jointly Marketed by:Biogen Idec Inc. 5200 Research Place San Diego, CA 92122Genentech USA, Inc. 1 DNA Way South San Francisco, CA 94080-4990

©2010 Biogen Idec Inc. and Genentech, Inc. 7140919 February 2010

RITUXAN® (Rituximab) Brief summary—Please consult full prescribing information.

INDICATIONS AND USAGE Non-Hodgkin’s Lymphoma (NHL) Rituxan® (rituximab) isindicated for the treatment of patients with: Relapsed or refractory, low-grade orfollicular, CD20-positive, B-cell NHL as a single agent; Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy; Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, afterfirst-line CVP chemotherapy; Previously untreated diffuse large B-cell, CD20-positiveNHL in combination with CHOP or other anthracycline-based chemotherapy regimens.Chronic Lymphocytic Leukemia (CLL) Rituxan® (rituximab) is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patientswith previously untreated and previously treated CD20-positive CLL. Limitations of useRituxan is not recommended for use in patients with severe, active infections.WARNINGS AND PRECAUTIONS Infusion Reactions Rituxan can cause severe,including fatal, infusion reactions. Severe reactions typically occurred during the firstinfusion with time to onset of 30–120 minutes. Rituxan-induced infusion reactions andsequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm,pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction,ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death. Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medicalmanagement (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusionreactions as needed. Depending on the severity of the infusion reaction and the requiredinterventions, temporarily or permanently discontinue Rituxan. Resume infusion at aminimum 50% reduction in rate after symptoms have resolved. Closely monitor thefollowing patients: those with pre-existing cardiac or pulmonary conditions, those whoexperienced prior cardiopulmonary adverse reactions, and those with high numbers ofcirculating malignant cells (≥25,000/mm3). [See Boxed Warning, Warnings and Precautions, Adverse Reactions.] Tumor Lysis Syndrome (TLS) Acute renal failure,hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis,some fatal, can occur within 12–24 hours after the first infusion of Rituxan in patientswith NHL. A high number of circulating malignant cells (≥25,000/mm3) or high tumor burdenconfers a greater risk of TLS. Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated. [See Boxed Warning.] Severe Mucocutaneous Reactions Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with Rituxan. Thesereactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoiddermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has varied from 1–13 weeks following Rituxan exposure. Discontinue Rituxan in patients who experience a severe mucocutaneous reaction. The safety ofreadministration of Rituxan to patients with severe mucocutaneous reactions has notbeen determined. [See Boxed Warning, Adverse Reactions.] Progressive MultifocalLeukoencephalopathy (PML) JC virus infection resulting in PML and death can occur in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases.The majority of patients with hematologic malignancies diagnosed with PML receivedRituxan in combination with chemotherapy or as part of a hematopoietic stem celltransplant. The patients with autoimmune diseases had prior or concurrentimmunosuppressive therapy. Most cases of PML were diagnosed within 12 months oftheir last infusion of Rituxan. Consider the diagnosis of PML in any patient presentingwith new-onset neurologic manifestations. Evaluation of PML includes, but is not limitedto, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue Rituxanand consider discontinuation or reduction of any concomitant chemotherapy orimmunosuppressive therapy in patients who develop PML. [See Boxed Warning, Adverse Reactions.] Hepatitis B Virus (HBV) Reactivation Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death can occur in patients with hematologicmalignancies treated with Rituxan. The median time to the diagnosis of hepatitis wasapproximately 4 months after the initiation of Rituxan and approximately one month afterthe last dose. Screen patients at high risk of HBV infection before initiation of Rituxan.Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBVinfection for several months following Rituxan therapy. Discontinue Rituxan and anyconcomitant chemotherapy in patients who develop viral hepatitis, and instituteappropriate treatment including antiviral therapy. Insufficient data exist regarding thesafety of resuming Rituxan in patients who develop hepatitis subsequent to HBVreactivation. [See Adverse Reactions.] Infections Serious, including fatal, bacterial,fungal, and new or reactivated viral infections can occur during and up to one yearfollowing the completion of Rituxan-based therapy. New or reactivated viral infectionsincluded cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue Rituxan for serious infections and institute appropriate anti-infective therapy. [See Adverse Reactions.] CardiovascularDiscontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of Rituxan for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina. [See Adverse Reactions.] Renal Severe, including fatal, renal toxicity can occur after Rituxanadministration in patients with NHL. Renal toxicity has occurred in patients whoexperience tumor lysis syndrome and in patients with NHL administered concomitantcisplatin therapy during clinical trials. The combination of cisplatin and Rituxan is not anapproved treatment regimen. Monitor closely for signs of renal failure and discontinueRituxan in patients with a rising serum creatinine or oliguria. Bowel Obstruction and Perforation Abdominal pain, bowel obstruction and perforation, in some cases leadingto death, can occur in patients receiving Rituxan in combination with chemotherapy. Inpostmarketing reports, the mean time to documented gastrointestinal perforation was 6(range 1–77) days in patients with NHL. Perform a thorough diagnostic evaluation andinstitute appropriate treatment for complaints of abdominal pain. [See Adverse Reactions.] Immunization The safety of immunization with live viral vaccines followingRituxan therapy has not been studied and vaccination with live virus vaccines is notrecommended. Laboratory Monitoring In patients with lymphoid malignancies, duringtreatment with Rituxan monotherapy, obtain complete blood counts (CBC) and platelet

WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions [see Warnings and Precautions, Adverse Reactions]. s Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) patients with Rituxan [see Warnings and Precautions, Adverse Reactions].s Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan [see Warnings and Precautions, Adverse Reactions]. s Progressive Multifocal Leukoen cephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving Rituxan [see Warnings and Precautions, Adverse Reactions].s

counts prior to each Rituxan course. During treatment with Rituxan and chemotherapy,obtain CBC and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias. [See Adverse Reactions]. The duration of cytopeniasscaused by Rituxan can extend months beyond the treatment period. ADVERSEREACTIONS The most common adverse reactions of Rituxan (incidence ≥25%)observed in clinical trials of patients with NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The most common adverse reactions of Rituxan (incidence ≥25%) observed in clinical trials of patients with CLL were: infusion reactions and neutropenia. Clinical Trials Experience in Lymphoid MalignanciesBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Rituxan in 2282 patients, with exposures ranging from a single infusion up to 6–8 months. Rituxan was studied in both single-agent and active-controlled trials (n = 356 and n = 1926). The population included 679 patients with low-grade follicular lymphoma, 927 patients with DLBCL, and 676 patients with CLL. Most NHL patients received Rituxan as infusion of 375 mg/m2 per infusion, given as a single agent weekly for up to 8 doses, in combination with chemotherapy for up to 8 doses, or following chemotherapy for up to 16 doses. CLL patients received Rituxan 375 mg/m2 as an initial infusion followed by 500 mg/m2 for up to 5 doses, in combination withfludarabine and cyclophosphamide. Seventy-one percent of CLL patients received 6 cycles and 90% received at least 3 cycles of Rituxan-based therapy. Infusion Reactions In the majority of patients with NHL, infusion reactions consisting of fever,schills/rigors, nausea, pruritus, angioedema, hypotension, headache, bronchospasm, urticaria, rash, vomiting, myalgia, dizziness, or hypertension occurred during the first Rituxan infusion. Infusion reactions typically occurred within 30 to 120 minutes of beginning the first infusion and resolved with slowing or interruption of the Rituxan infusion and with supportive care (diphenhydramine, acetaminophen, and intravenous saline). The incidence of infusion reactions was highest during the first infusion (77%) and decreased with each subsequent infusion. [See Boxed Warning, Warnings and Precautions.] Infections Serious infections (NCI CTCAE Grade 3 or 4), including sepsis,occurred in less than 5% of patients with NHL in the single-arm studies. The overall incidence of infections was 31% (bacterial 19%, viral 10%, unknown 6%, and fungal 1%). [See Warnings and Precautions.] In randomized, controlled studies where Rituxanwas administered following chemotherapy for the treatment of follicular or low-grade NHL, the rate of infection was higher among patients who received Rituxan. In diffuse large B-cell lymphoma patients, viral infections occurred more frequently in those who received Rituxan. Cytopenias and hypogammaglobulinemia In patients with NHL areceiving rituximab monotherapy, NCI-CTC Grade 3 and 4 cytopenias were reported in 48% of patients. These included lymphopenia (40%), neutropenia (6%), leukopenia (4%), anemia (3%), and thrombocytopenia (2%). The median duration of lymphopenia was 14 days (range, 1–588 days) and of neutropenia was 13 days (range, 2–116 days). A single occurrence of transient aplastic anemia (pure red cell aplasia) and two occurrences of hemolytic anemia following Rituxan therapy occurred during the single-arm studies. In studies of monotherapy, Rituxan-induced B-cell depletion occurred in 70% to 80% of patients with NHL. Decreased IgM and IgG serum levels occurred in 14% of these patients. Relapsed or Refractory, Low-Grade NHL Adverse reactions in Table 1occurred in 356 patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL treated in single-arm studies of Rituxan administered as a single agent. [See Clinical Studies.] Most patients received Rituxan 375 mg/m2 weekly for 4 doses.Table 1Incidence of Adverse Reactions in ≥5% of Patients with Relapsed or Refractory, Low-Grade or Follicular NHL, Receiving Single-agent Rituxan (N = 356)a,b

aAdverse reactions observed up to 12 months following Rituxan. bAdverse reactions graded for severity by NCI-CTC criteria.

In these single-arm Rituxan studies, bronchiolitis obliterans occurred during and up to 6 months after Rituxan infusion. Previously Untreated Low-Grade NHL In Study 4,patients in the R-CVP arm experienced a higher incidence of infusional toxicity and neutropenia compared to patients in the CVP arm. The following adverse reactions occurred more frequently (≥5%) in patients receiving R-CVP compared to CVP alone: rash (17% vs. 5%), cough (15% vs. 6%), flushing (14% vs. 3%), rigors (10% vs. 2%), pruritus (10% vs. 1%), neutropenia (8% vs. 3%), and chest tightness (7% vs. 1%). In Study 5, the following adverse reactions were reported more frequently (≥5%) in patients receiving Rituxan following CVP compared to patients who received no furthertherapy: fatigue (39% vs. 14%), anemia (35% vs. 20%), peripheral sensory neuropathy (30% vs. 18%), infections (19% vs. 9%), pulmonary toxicity (18% vs. 10%), hepato-biliary toxicity (17% vs. 7%), rash and/or pruritus (17% vs. 5%), arthralgia (12% vs. 3%), and weight gain (11% vs. 4%). Neutropenia was the only Grade 3 or 4 adverse reaction that occurred more frequently (≥2%) in the Rituxan armcompared with those who received no further therapy (4% vs. 1%). [See Clinical Studies.] DLBCL In Studies 6 and 7, [L see Clinical Studies]s the following adverse reactions,regardless of severity, were reported more frequently (≥5%) in patients age ≥60 yearsreceiving R-CHOP as compared to CHOP alone: pyrexia (56% vs. 46%), lung disorder (31% vs. 24%), cardiac disorder (29% vs. 21%), and chills (13% vs. 4%). Detailed safety data collection in these studies was primarily limited to Grade 3 and 4 adverse reactions and serious adverse reactions. In Study 7, a review of cardiac toxicity determined that supraventricular arrhythmias or tachycardia accounted for most of the difference in cardiac disorders (4.5% for R-CHOP vs. 1.0% for CHOP). The following Grade 3 or 4 adverse reactions occurred more frequently among patients in the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs. 7%) and lung disorder (6% vs. 3%). Other Grade 3 or 4 adverse reactions occurring more frequently among patients receiving R-CHOP were viral infection (Study 7), neutropenia (Studies 7 and 8), and anemia (Study 8). CLL The data below reflectexposure to Rituxan in combination with fludarabine and cyclophosphamide in 676 patients with CLL in Study 9 or Study 10 [see Clinical Studies]. The age range was s30–83 years and 71% were men. Detailed safety data collection in Study 9 was limited to Grade 3 and 4 adverse reactions and serious adverse reactions. Infusion-related

All Grades (%) Grade 3 and 4 (%)

Any Adverse Events 99 57Body as a Wholey 86 10

Fever 53 1Chills 33 3Infection 31 4Asthenia 26 1Headache 19 1Abdominal Pain 14 1Pain 12 1Back Pain 10 1Throat Irritation 9 0Flushing 5 0

Heme and Lymphatic Systemy p y 67 48Lymphopenia 48 40Leukopenia 14 4Neutropenia 14 6Thrombocytopenia 12 2Anemia 8 3

Skin and Appendagespp g 44 2Night Sweats 15 1Rash 15 1Pruritus 14 1Urticaria 8 1

All Grades (%) Grade 3 and 4 (%)

Respiratory Systemp y y 38 4Increased Cough 13 1Rhinitis 12 1Bronchospasm 8 1Dyspnea 7 1Sinusitis 6 0

Metabolic and NutritionalDisorders 38 3

Angioedema 11 1Hyperglycemia 9 1Peripheral Edema 8 0LDH Increase 7 0

Digestive Systemg y 37 2Nausea 23 1Diarrhea 10 1Vomiting 10 1

Nervous Systemy 32 1Dizziness 10 1Anxiety 5 1

Musculoskeletal Systemy 26 3Myalgia 10 1Arthralgia 10 1

Cardiovascular Systemy 25 3Hypotension 10 1Hypertension 6 1

9-13 NEW YORK, NYChemotherapy Foundation Symposiumwww.chemotherapyfoundationsymposium.org

11-13 ORLANDO, FLOncology Nursing Society’s AdvancedPractice Nursing Conferencewww.ons.org

12-14 ORLANDO, FLOncology Nursing Society’s 11thAnnual Institutes of Learningwww.ons.org

4-7 ORLANDO, FLAmerican Society of HematologyAnnual Meetingwww.hematology.org

8-12 SAN ANTONIO, TXSan Antonio Breast Cancer Symposiumwww.sabcs.org

20-22 SAN FRANCISCO, CAGastrointestinal Cancers Symposiumwww.gicasymposium.com

17-19 ORLANDO, FLGenitourinary Cancers Symposiumwww.gucasymposium.org

NOVEMBER 2010

10-12LOS ANGELES, CANational Conference on CancerNursing Researchwww.ons.org

2-5 SAN ANTONIO, TXSociety of Surgical OncologyAnnual Cancer Symposiumwww.surgonc.org

9-13 HOLLYWOOD, FLNational Comprehensive CancerNetwork 16th Annual Conference:Clinical Practice Guidelines & QualityCancer Carewww.nccn.org

FEBRUARY 2011

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ACROSS APPROVED CLL AND NHL INDICATIONS

DRIVING PATIENT OUTCOMESSupporting your central role in patient care

Resources to support your patients with NHL and CLL

Patients can talk to a nurse educator about RITUXAN, CLL, and NHL 24 hours a day, 7 days a week. Call the RITUXAN Support Center at (888) 455-2220.

You, your patients, and their caregivers can turn to RITUXAN.com for additional resources and materials.

RITUXAN Access Solutions is committed to connecting your patients to RITUXAN, regardless of their ability to pay; for more information, please visit www.RituxanAccessSolutions.com.

Warnings and Precautions RITUXAN can also result in serious, including fatal, adverse

reactions. These include hepatitis B reactivation with fulminant hepatitis and hepatic failure resulting in death; other infections, including bacterial, fungal, new or reactivated viral infections; cardiovascular events; severe, including fatal, renal toxicity; and abdominal pain, bowel obstruction and perforation, in some cases leading to death

Additional Important Safety Information The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias, including lymphopenia

The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with CLL were infusion reactions and neutropenia. Most patients treated with R-FC experienced at least one Grade 3 or 4 adverse reaction. The most frequently reported Grade 3 or 4 adverse reaction was neutropenia

In clinical trials, CLL patients 70 years of age or older who received R-FC had more Grade 3 and 4 adverse reactions compared with younger CLL patients who received the same treatment

For additional safety information, please see following page for brief summary of full prescribing information, including BOXED WARNINGS.

Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.

IndicationsRITUXAN® (Rituximab) is indicated for the treatment of patients with:

Previously untreated and previously treated CD20-positive CLL in combination with fl udarabine and cyclophosphamide (FC)

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent

Weekly ×4 Weekly ×8 Bulky disease Retreatment

Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy

Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy

Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens

RITUXAN is not recommended for use in patients with severe, active infections.

BOXED WARNINGS RITUXAN administration can result in serious,

including fatal, adverse reactions. These include infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML)

©2010 Genentech USA, Inc., and Biogen Idec Inc. All rights reserved. 10026002 May 2010

Resources to support your patients pp y p


october 2010, vol 3, no 7

Documents

breast cancer atrisk

lung cancer navigator

patients withlung cancer

navigator role

hereditary breast cancerpage

journal of oncology

yorkcancer center

official journal