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Beyond the Guidelines: Clinical Investigators Provide Their Perspectives on Current Strategies and Ongoing Research in
the Management of Breast Cancer
Wednesday, December 11, 20137:30 PM – 9:30 PMSan Antonio, Texas
Faculty Lisa A Carey, MDClifford Hudis, MDHope S Rugo, MD
George W Sledge Jr, MDSunil Verma, MD, MSEd
ModeratorNeil Love, MD
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Survey Faculty
Kathy S Albain, MD
Kimberly L Blackwell, MD
Howard A Burris III, MD
Harold J Burstein, MD, PhD
Lisa A Carey, MD
Rowan T Chlebowski, MD, PhD
Javier Cortes, MD, PhD
Kevin R Fox, MD
Julie R Gralow, MD
Daniel F Hayes, MD
Clifford Hudis, MD
Sara A Hurvitz, MD
Ian E Krop, MD, PhD
Hannah M Linden, MD
John Mackey, MD
Kathy D Miller, MD
Hyman B Muss, MD
Ruth O’Regan, MD
Joyce O’Shaughnessy, MD
Hope S Rugo, MD
Andrew D Seidman, MD
George W Sledge Jr, MD
Ian E Smith, MD
Joseph A Sparano, MD
Sunil Verma, MD, MSEd
Eric P Winer, MD
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Module 1
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Adjuvant Rx: ER-neg, HER2+Age: 40T: 1.5 cmN: 1+
AC-TH AC-TH 1616
99
11
TCH TCH
OtherOther
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Adjuvant Rx: ER-neg, HER2+Age: 40T: 1.5 cmN: 0
TCH TCH 1212
77
66
11
Pac/TrasPac/Tras
AC-TH AC-TH
Other Other
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Rx: ER-neg, HER2+Age: 40T: 0.8 cmN: 0
Pac/TrasPac/Tras 1212
99
33
22
TCH TCH
AC-TH AC-TH
Doc/Cyc/TrasDoc/Cyc/Tras
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Neoadjuvant Rx: ER-neg, HER2+Age: 40T: 4 cmTumor shrinkage needed for BCS
Trastuzumab/pertuzumab
Trastuzumab/pertuzumab
2424
22TrastuzumabTrastuzumab
Anti-HER2 Treatment (with Chemo)Anti-HER2 Treatment (with Chemo)
Choice of ChemotherapyChoice of Chemotherapy
Taxane and anthracycline
Taxane and anthracycline
1616
1010TaxaneTaxane
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Neoadjuvant Rx: ER-neg, HER2+Age: 40T: 2 cm
Trastuzumab/pertuzumab/
chemo
Trastuzumab/pertuzumab/
chemo
2121
55Trastuzumab/
chemo Trastuzumab/
chemo
Anti-HER2 TreatmentAnti-HER2 Treatment
Choice of ChemotherapyChoice of Chemotherapy
Taxane Taxane 1515
1010
11
Taxane and anthracycline
Taxane and anthracycline
Other* Other*
* N-: taxane-based or N+: taxane + anthracycline-based* N-: taxane-based or N+: taxane + anthracycline-based
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Adjuvant Rx: ER-neg, HER2+Age: 75T: 1.5 cmN: 1+
TCH TCH 1313
66
44
22
Pac/TrasPac/Tras
AC-TH AC-TH
Doc/Cyc/TrasDoc/Cyc/Tras
OtherOther 11
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Adjuvant Rx: ER-neg, HER2+Age: 75T: 1.5 cmN: 0
Pac/TrasPac/Tras 1313
99
22
22
TCH TCH
Doc/Cyc/TrasDoc/Cyc/Tras
Other* Other*
*Dose-dense AC-TH; no systemic therapy*Dose-dense AC-TH; no systemic therapy
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Adjuvant Rx: ER-neg, HER2+Age: 75T: 0.8 cmN: 0
Pac/TrasPac/Tras1818
33
22
NoneNone
33Other Other
TCH TCH
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Module 2
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Would you order 21-gene Recurrence Score® (RS)? (ER+, HER2-neg)Age: 40T: 1.5 cm N: 0
YesYes 2323
33NoNo
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Would you order 21-gene RS? (ER+, HER2-neg)Age: 40T: 1.5 cm N: 1+
YesYes 99
1717NoNo
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Would you order 21-gene RS? (ER+, HER2-neg)Age: 75T: 1.5 cm N: 0
YesYes 1111
1515NoNo
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Would you order 21-gene RS? (ER+, HER2-neg)Age: 75T: 1.5 cm N: 1+
YesYes 1414
1212NoNo
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Do the following assays predict benefit from adjuvant chemotherapy?
Oncotype DX®Oncotype DX® 2525
99
55
44
11
MammaPrint®MammaPrint®
IHC4IHC4
PAM50 PAM50
EPclinEPclin
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60 yo patient4.0-cm, ER+++, HER2-neg IDC requiring tumor shrinkage for BCS
21-gene RS?
It’s a good idea It’s a good idea 1111
99
66
It’s not a good ideaIt’s not a
good idea
OtherOther
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Continuation of endocrine treatment at 5 yearsAge: 40 Original tumor: 1.5 cm, node-negRx: Tamoxifen
Continue tamoxifen
Continue tamoxifen
1717
66
33
Stop tamoxifen (no further ET) Stop tamoxifen (no further ET)
OtherOther
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Continuation of endocrine treatment at 5 yearsAge: 40 Original tumor T: 1.5 cm; N: 2+Rx: Tamoxifen
Continue tamoxifen
Continue tamoxifen
2323
22
11
Switch to OS/A + AI Switch to OS/A + AI
Stop tamoxifen (no further ET) Stop tamoxifen (no further ET)
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Continuation of endocrine treatment at 5 yearsAge: 75Original tumor T: 1.5 cm; N: 0Rx: AI
Stop anastrozole (no further ET)
Stop anastrozole (no further ET)
2424
22Continue
anastrozole Continue
anastrozole
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Continuation of endocrine treatment at 5 yearsAge: 75Original tumor T: 1.5 cm; N: 2+Rx: AI
Continue anastrozole
Continue anastrozole
1515
1111Stop anastrozole (no further ET)
Stop anastrozole (no further ET)
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Module 3
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ER-neg, HER2+ mBC (no prior systemic Rx)Usual 1st-line Rx
Trastuzumab/pertuzumab/
taxane
Trastuzumab/pertuzumab/
taxane
2525
11Trastuzumab/
taxane Trastuzumab/
taxane
Choice of TaxaneChoice of Taxane
Paclitaxel Paclitaxel 1717
88Docetaxel Docetaxel
11Nab paclitaxel Nab paclitaxel
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ER-neg, HER2+ mBC (adj TCH 12 mo ago)Usual 1st-line Rx
Trastuzumab/pertuzumab/
taxane
Trastuzumab/pertuzumab/
taxane
2121
Choice of TaxaneChoice of Taxane
Paclitaxel Paclitaxel 1414
55Docetaxel Docetaxel
22Nab paclitaxel Nab paclitaxel
* Trastuzumab/pertuzumab/eribulin * Trastuzumab/pertuzumab/eribulin
44
11
T-DM1 T-DM1
Other* Other*
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ER-neg, HER2+ mBCUsual 2nd-line Rx
T-DM1 T-DM1 2222
11
11
Trastuzumab/lapatinib
Trastuzumab/lapatinib
Capecitabine/lapatinib
Capecitabine/lapatinib
22OtherOther
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ER+, HER2+ mBCAge 45, premenopausalMinimally symptomatic, liver mets
Trastuzumab + pertuzumab +
taxane
Trastuzumab + pertuzumab +
taxane
2424
22Other* Other*
* ET + trastuzumab; trastuzumab + pertuzumab + ET* ET + trastuzumab; trastuzumab + pertuzumab + ET
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ER+, HER2+ mBCAge 45, premenopausalAsymptomaticLow disease burden bone mets
ET + TrasET + Tras 1010
55
77
44
ET ET
Tras/Pert/taxane
Tras/Pert/taxane
Other* Other*
* Trastuzumab/pertuzumab/ET x 2; trastuzumab + taxane; ET + lapatinib + trastuzumab* Trastuzumab/pertuzumab/ET x 2; trastuzumab + taxane; ET + lapatinib + trastuzumab
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ER+, HER2+Age 75, postmenopausalAsymptomaticLow disease burden bone mets
ET + TrasET + Tras 1414
66
33
33
ET ET
Tras + Pert + ET Tras + Pert + ET
Other* Other*
* Nab paclitaxel + trastuzumab + pertuzumab; ET + trastuzumab + lapatinib; letrozole + lapatinib * Nab paclitaxel + trastuzumab + pertuzumab; ET + trastuzumab + lapatinib; letrozole + lapatinib
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ER+, HER2+Age 75, postmenopausalSomewhat symptomatic, liver mets
Tras+ Pert + taxane
Tras+ Pert + taxane
66
33
ET + TrasET + Tras
Other* Other*
*ET; nab paclitaxel + trastuzumab + pertuzumab; letrozole + lapatinib
*ET; nab paclitaxel + trastuzumab + pertuzumab; letrozole + lapatinib
1717
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T-DM1 with pertuzumab outside of a trial?
NoNo 2525
11YesYes
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Module 4
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60 yo womanER-neg, HER2-neg IDCPostlumpectomy local recurrence 2 years after AC T
None None 44
1313
33
22
44
TC or CMF TC or CMF
Gemcitabine + platinum
Gemcitabine + platinum
CapecitabineCapecitabine
Other chemoOther chemo
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60 yo womanER+, HER2+ IDCPostlumpectomy local recurrence while on anastrozole 2 years after AC TH
ET + anti-HER2 ET + anti-HER2 88
88
66
44
ET alone ET alone
Chemo + anti-HER2 plus or
followed by ET
Chemo + anti-HER2 plus or
followed by ET
Chemo + anti-HER2
Chemo + anti-HER2
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60 yo womanER-neg, HER2+ IDCPostlumpectomy local recurrence 2 years after AC TH
None None 55
66
66
33
22
TCH TCH
THPTHP
Other chemo + trastuzumab
Other chemo + trastuzumab
Trastuzumab ± lapatinib
Trastuzumab ± lapatinib
44Other Other
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ER/PR/HER2-neg mBC (BRCA+) Do PARP inhibitors demonstrate efficacy?
Yes, both w and w/o chemo
Yes, both w and w/o chemo 1414
77
55
Yes, without chemo
Yes, without chemo
I don’t know I don’t know
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ER/PR/HER2-neg mBC (BRCA-neg) Do PARP inhibitors demonstrate efficacy?
NoNo 1313
1212
11
I don’t know I don’t know
Yes, with chemo Yes, with chemo
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ER/PR/HER2-neg mBCRelative efficacy of capecitabine versus eribulin?
Eribulin is more efficacious
Eribulin is more efficacious 1111
1010
44
11
About the same About the same
I don’t know I don’t know
Capecitabine is more efficacious
Capecitabine is more efficacious
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ER+, HER2-neg mBC resistant to ETEfficacy of capecitabine versus eribulin?
About the sameAbout the same 1818
33
22
33
Capecitabine more efficacious
Capecitabine more efficacious
Eribulin more efficacious
Eribulin more efficacious
I don’t knowI don’t know
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Consider the last patient in your practice who died of breast cancerHow long did the patient live with (triple-negative) mBC?
<12 months<12 months 55
1919
22
12-24 months 12-24 months
>24 months >24 months
Median = 17 monthsMedian = 17 months
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Was she referred for hospice care?
Median duration was 4 weeks.Median duration was 4 weeks.
Wee
ksW
eeks
1515
1010
55
11 55 1010 1515 2020
Patient #Patient #
2525
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Time between last dose of chemotherapy for triple-negative mBC and patient’s death?
2525
Patient #Patient #Median = 8 weeksMedian = 8 weeks
Wee
ksW
eeks
2020
1515
1010
55
11 55 1010 1515 2020 2525
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Most common systemic agents administered
Eribulin Eribulin 2121
2121
1919
1818
1717
Platinum Platinum
Capecitabine Capecitabine
Gemcitabine Gemcitabine
Taxane Taxane
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Module 5
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ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone metsAfter 4 years adjuvant anastrozole
Fulvestrant Fulvestrant 1414
88
44
Exemestane/everolimus
Exemestane/everolimus
Other*Other*
*Tamoxifen x 2; exemestane; fulvestrant + AI*Tamoxifen x 2; exemestane; fulvestrant + AI
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ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone and liver metsAfter 4 years adjuvant anastrozole
FulvestrantFulvestrant 1212
1111
22
11
Exemestane/everolimus
Exemestane/everolimus
TamoxifenTamoxifen
OtherOther
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Preemptive antimucositis measures in patients receiving everolimus?
YesYes 1515
1111NoNo
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ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone metsAfter 1 year adjuvant anastrozole
*Exemestane; fulvestrant + AI*Exemestane; fulvestrant + AI
Fulvestrant Fulvestrant 1313
99
22
22
Exemestane/everolimus
Exemestane/everolimus
TamoxifenTamoxifen
Other*Other*
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ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone and liver metsAfter 1 year adjuvant anastrozole
Exemestane/everolimus
Exemestane/everolimus 1212
1111
33
Fulvestrant Fulvestrant
Other*Other*
*Fulvestrant + AI; capecitabine; tamoxifen*Fulvestrant + AI; capecitabine; tamoxifen
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ER+, HER2-neg mBCRelapse after 4 years of nonsteroidal AIEfficacy of high-dose fulvestrant versus everolimus/exemestane?
I don’t knowI don’t know 1111
1010
55
Exemestane/everolimus more
efficacious
Exemestane/everolimus more
efficacious
About the same About the same