to screen or not to screen: update on screening mammography guidelines and dense breast legislation

To Screen or Not To Screen:Update on Screening

Mammography Guidelines

Deanna J. Attai, MD FACSAssistant Clinical Professor of Surgery

David Geffen School of Medicine at UCLA

@DrAttai

No Disclosures

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Ideal Screening Test

•Find cancer before clinically evident• Improve survival due to early detection•Low false negative (sensitivity)•Low false positive (specificity)•Reasonable cost•Widely available

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“Early Detection Saves Lives”

•Mammograms may lead to improved survival from breast cancer by detecting some cancers at an earlier, more treatable stage

•Some breast cancers are so aggressive that early detection does not lead to improved survival

•Deadlier cancers not readily detected by screening (interval cancers)

Screening Mammography Limitations

•Sensitivity varies depending on:•Age, menopausal status•Use of HRT•Breast density•BMI•Other factors

Overdiagnosis / Overtreatment

• Increased DCIS (60K/year)•No significant change in mortality rate (40K/year)

•We are finding things that don’t need to be found

•However… once found – obligated to treat

Parameter USPSTF ACS ASBrS ACOG NCCN ACR

When to Start

50 45 45 40 40 40

Frequency Biennial Annual to age 54, then biennial. Should have opportunity for annual

Annual to age 54, then annual or biennial based on SDM

Annual Annual Annual

When to Stop

75 Biennial after age 75 if life expect >10 years

Biennial after age 75 if life expect >10 years

Ind. Ind. Life expect <5-7 years

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If you torture the data long enough it will

confess to anything

Darrell Huff 1954How to Lie With Statistics

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Evidence Based Guidelines

• Not all evidence is created equal• Guideline tries to answer the

question:“How certain can you be that the stated evidence is a true measure of the benefits and harms of treatment?”

http://guides.lib.uw.edu/hsl/ebptoolsAccessed 24 April 2016

Age 40’s

• BC uncommon, need to screen more women to prevent one death

• Higher cumulative rates of false-positive results, associated potential harms (biopsies, anxiety)

• Meta-analysis supports screening at age 40

• Early detection -> less aggressive treatment and a wide range of treatment options

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Biennial Screening

• Benefit of screening mammography maintained by biennial screening

• Biennial screening likely to reduce harms of screening by nearly half

• Benefit of annual screening outweigh risks as breast cancer mortality lower with annual screening

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When To Stop

• No women > 75 years included in randomized trials

• Benefits of screening occur several years after test, % of women who survive long enough to benefit decreases with age

• Older women at greater risk for dying of other conditions

• Most breast cancer detected in this age group is ER+

• Acknowledge limited data• High incidence of breast

cancer in elderly women• Clinicians should use

judgment when applying screening guidelines

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Insurance Coverage

• Affordable Care Act mandates insurance coverage for screening consistent with USPSTF guidelines

• Amendment requires use of 2002 guidelines for mammography

• Insurers required to cover [screening] mammography, with no cost-sharing, every 1-2 years for women starting at age 40

•Medicare fully pays for [screening] mammograms once every 12 months with no upper age limit

Pace et al., 2013; Factcheck.org, 2013

Breast Cancer Risk Factors

• Age, menarche / menopause / reproductive history• Family history, genetics• Chest wall irradiation• Breast density• BMI• Lifestyle: alcohol, saturated fat, activity / exercise• Unknown factors

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Courtesy Dr. Amy DegnimMayo Clinic Rochester

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Gail Model: cancer.gov/bcrisktool/

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Only considers 1° maternal relatives

International Breast Intervention Study (IBIS)Tyrer-Cuzick

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http://breasthealth.northshorelij.com/

George Edward Pelham Box 1919 –2013

Mathematician/Professor of Statistics University of Wisconsin

All models are wrong, but some are useful

Courtesy Dr. Kevin HughesMassachusetts General Hospital

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Hereditary Breast and Ovarian Cancer (HBOC)Red Flags

• Personal breast cancer ≤ age 50, ≤ age 60 if TNBC• 1° / 2° relative with breast cancer ≤ age 45• Any personal / family history ovarian cancer• Any family history male breast cancer• Ashkenazi Jewish with breast / ovarian / pancreatic cancer

at any age • Breast, ovarian, pancreatic in same person or on same side

of family

http://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf

Screening Mammography• Full field digital mammography• Same facility / compare

images

• 10-20% cancers not seen on mammogram

• 40-50% with dense breast

Breast Cancer ScreeningUltrasound

• Used to characterize mammographic abnormality

• May be helpful in women with dense breast tissue

• NOT FDA-approved for cancer screening; ABUS approved as adjunct to mammogram

Breast Cancer Screening – MRI

• High risk screening• Newly diagnosed, surgical

planning (controversial)

• Evaluates metabolic activity• IV contrast - gadolinium• Will not show calcifications,

non-invasive cancer • Up to 20% false positive

• FAST MRIKuhl et al J Clin Oncol 2014;32:2304-2310

Breast Cancer DetectionOther Imaging Studies

• Tomosynthesis / 3D mammography• Contrast-enhanced mammography• PEM scanning – injection of FDG followed by breast imaging

– primarily for diagnosed breast cancer patients• BSGI – Tc-Sestamibi – diagnostic adjunct to mammography• Automated whole-breast ultrasound

• Thermography

BI-RADS Breast Imaging-Reporting and Data System

Assessment Categories:•Category 0 – Additional imaging needed•Category 1 – Normal•Category 2 – Benign findings•Category 3 – Probably benign (98%)•Category 4 – Suspicious (a, b, c)•Category 5 – Highly suspicious (>95%)•Category 6 – Known malignancy

BIRADS 3 Mammogram“Probably Benign”•MQSA – Mammography Quality Standards Act

• Mammography regulated by the FDA / lay letter mandated

•98% chance of being benign•Follow up appropriate•Q6 months x 2 years•Core biopsy may be an option

BI-RADS Breast Composition Categories

Level 1Fatty Breast

10%

Level 2Average Density

40%

Level 3Heterogeneous

40%

Level 4Extremely Dense

10%

Density grading is SUBJECTIVE

States with Dense Breast Notification Laws

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www.AreYouDense.org Accessed 04/24/2016

Breast Density• CA SB1538, Approved September 2012

Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of cancer. The information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician.

• 23 State Laws evaluated• Readability of most at HS level or above• Poor understandability• Discontinuity with states’ average literacy

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Breast Density• 50% of patients are considered to have dense breast

tissue (80% < age 40)• Risk factor for breast cancer

• Heterogeneously dense RR 1.2 versus average density• Extremely dense RR 2.1 versus average density

• No increased breast cancer mortality based on density• Other breast cancer risk factors may be more important

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Factors Affecting Breast Density

•Age•Menstrual and reproductive history•Family history, genetics•BMI•Race•Unknown factors

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Density and BMI

BMI DensityBMI Density


Mammographic density can change

Menopause

Weight Gain

8 years


Gastric Bypass

Weight Loss

1 year

Mammographic density can change


Density RiskAsian High Low

Young High Low

Older, High BMI Low High

Counterintuitive

Harvey SABCS, 2015Breast Cancer Res. 2014 Oct 8;16(5):451


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Courtesy Dr. Alyssa ThrockmortonBaptist Medical Center

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Courtesy Dr. Alyssa ThrockmortonBaptist Medical Center

Density is Only One Risk Factor

•Remember•Women with dense breasts may be at low risk

•Women with fatty replaced breasts may be a high risk


Dense Breast Management•Start with risk assessment (All Patients)

•Density not taken as stand-alone high risk marker•No survival benefit to additional imaging in average risk patient

•Not everyone needs supplemental imaging – HOWEVER - emotional, patient-driven factors

Ultrasound

Dense Breast Resources

• densebreast-info.org/• Breastdensity.info• breast.massrad.org/• drattai.com/areas-of-

focus/dense-breast-tissue

BreastScreeningDecisions.com

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Conclusions• Women and their breasts are

not one size fits all• Risk assessment essential

• Acknowledge uncertainties regarding risks and benefits of screening mammography

• Focus on shared decision making approach

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Society Guidelines• ACS

www.cancer.org/cancer/breastcancer/moreinformation/breastcancerearlydetection/breast-cancer-early-detection-acs-recs

• ACOGhttp://www.acog.org/About-ACOG/News-Room/Statements/2016/ACOG-Statement-on-Breast-Cancer-Screening-Guidelines

• USPSTF (draft)www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementDraft/breast-cancer-screening1

• ASBrSwww.breastsurgeons.org/new_layout/about/statements/PDF_Statements/Screening_Mammography.pdf

“I have yet to see any problem, however complicated, which, when

you looked at it in the right way, could not be made still more

complicated.”Poul Anderson


to screen or not to screen: update on screening mammography guidelines and dense breast legislation

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