Breast Density Notification Law Information For Primary Care Providers

Breast Density Notification LawInformation For Primary Care ProvidersCaren M. Stalburg, MD MAAssistant Professor, Ob/Gyn and Learning Health SciencesChief, Division of Professional Education, Department of Learning Health Sciences

2016 Michigan Section ACOG Snow MeetingFebruary 5, 2016

DisclosuresPersonal: BioventusCheryl T. Lee, MD and Renee Pinsky, MDNothing to discloseCME video lecture series:Grant: Michigan Department of Health and Human ServicesFunding in part from the Centers for Disease Control and Prevention (CDC) Cooperative Agreement 3U58DP003921

Become familiar with the breast density notification legislationUnderstand what breast density is and how it affects interpretation of the mammogram and cancer riskUnderstand supplementary screening options Apply understanding of risk conferred from breast density to a personalized assessment of a womans breast cancer risk Intended Learning Outcomes

Enacted legislation

Introduced legislation

No action

Insurance coverage lawD.E.N.S.E. 2011 2015, areyoudenseadvocacy.org, All rights reserved. Accessed 9-18-2015U.S. Breast Density Legislation24917

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Michigan Law

Signed: January 2015

Effective: June 1, 2015

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MammographyDiffering X-ray absorption Fibrous & glandular (FG) tissueFatDensityRelative amountWhite (FG) vs black/gray (fat)What is Breast Density?

Extremely Dense

Fat Density

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BI-RADS (Breast Imaging Reporting and Data System)

Almost entirely fattyScattered areas of fibroglandular densityHeterogeneously denseExtremely denseAssessing Breast DensitySickles EA, DOrsi CJ, Bassett LW, et al. ACR BI-RADS Mammography. In: ACR BI-RADS Atlas, Breast Imaging Reporting and Data System, Breast Imaging Atlas. Reston, VA. American College of Radiology; 2013. Ciatto S, Bernardi D, Calabrese M, et al. A first evaluation of breast radiological density assessment by QUANTRA software as compared to visual classification.Breast2012; 21:503506.

How is breast density measured and reported?8

BI-RADS Almost entirely fattyScattered areas of fibroglandular densityHeterogeneously denseExtremely denseSickles EA, DOrsi CJ, Bassett LW, et al. ACR BI-RADS Mammography. In: ACR BI-RADS Atlas, Breast Imaging Reporting and Data System, Breast Imaging Atlas. Reston, VA. American College of Radiology; 2013.Ciatto S, Bernardi D, Calabrese M, et al. A first evaluation of breast radiological density assessment by QUANTRA software as compared to visual classification.Breast2012; 21:503506.

c and d = DENSE BREASTSAssessing Breast Density

How is breast density measured and reported?9

Decreases breast densityGetting olderGaining weight (dilutional)Tamoxifen/othersIncreases breast densityWeight lossExogenous hormonesLactation

Density can change in same woman

In SUMMARY10

Kerlikowske K. et al, J Clin Onc August 20, 2010 vol. 28 no. 24, p. 3830-3837.Distribution of Breast DensityBIRADS breast density # of women (~600,000 )%Fatty57,96110 Scattered259,01844Heterogeneous216,39537Extremely Dense53,9959

Heterogeneously DenseExtremely DenseScattered densitiesPredominantly fatty# of women Density

Carney PA et al Individual and combined effects of age, breast density, and hormone replacement therapy use on the accuracy of screening mammography Ann Intern Med. 2003 Feb 4;138(3):168-75Dense tissue hiding a cancer on a mammogramSensitivity: Extremely Dense 63%Fatty 87%

Clinical Relevance - Masking

2 fold relationship12

Clinical Relevance - Masking

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Diagnostic Performance of Digital versus Film Mammography for Breast-Cancer ScreeningPisano, E. et al for the Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group; N Engl J Med 2005; 353:1773-1783 October 27, 2005http://www.fda.gov.RadiationEmittingProductsDigital Imaging is more accurateUnder age 50Dense breasts (>50% dense)Pre or peri-menopausal

>95% of units in US are digital

Digital mammography vs film screen

Digital 2011

Film 1993

Digital Mammography Imaging Screening Trial DMIST 2005 43000 women comparing film and digital for accuracyPart of ACRIN (ACR imaging network)Digital detected more cancers in these women than film screenSO DIGITAL Mammography is a relatively recent advance helping diagnosis in dense breasts14

McCormack, VA Cancer Epidemiol Biomarkers Prev. 2006. 15(6);1159-1169.Clinical Relevance - RiskMeta analysis of 11 studies with >14,000 cases

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* Compared to average densityHeterogeneously dense- 1.2 xExtremely dense- 2.1 xClinical Relevance - Risk*Sickles EA The use of breast imaging to screen women at high risk for cancer Radiol Clin of NA 2010;48(5), 859-878

Predominantly fatty

Scattered densities

Heterogeneously denseExtremely dense

Tomosynthesis (DBT)UltrasoundMRIMolecular Breast Imaging (MBI)

ALL can increase cancer detectionNONE proven to decrease mortality or morbidityNone recommended by major organizations for density aloneNCCN Breast Cancer Screening and Diagnosis Version 1.2014; Friedewald, Berg, Hooley, Parris, Weigert, Rhodes- See referencesSupplemental Screening

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BenefitsIncreased invasive cancer detection in all densities (41%)Decreased recall rate (15%)Removes superimposition of tissue

Park J M et al. Radiographics 2007;27:S231-S240; Friedewald, SM JAMA 2014;311(24):2499-2507Tomosynthesis

Ciatto S. et al LancetOncol. 2013;14(7):583-589.RisksRadiation dose - 2x regular mammogramCan synthesize 2-D images from the 3-D images to decrease the doseIncreased interpretation timeTomosynthesis

*UM research

Slices overcome problem overlying tissues.

5.3 additional cancers/1000 women in year 13.7/1000 in years 2 and 3Screening UltrasoundBerg WA, et al, JAMA, 2008; 299, 2151-2163; Berg WA JAMA 2012 ; 307:1394-1404.

Image courtesy of R.W. Pinsky, MDUsed with permissionACRIN 6666False +PPV Mammo alone4.422.6 %US alone8.18.9 %Mammo + US10.411.2 %

High risk for breast CA and had >50% increased densityThen added screening USN

ACRIN showed increased pick up of 4.2 cancers /1000 women by adding screening US to dense breasts.

BUT at what cost?20

Hooley Weigert Parris # of patients 935 8647 5519# of Cat 4 or 5 5% 5% 3.3%# of incremental cancers 3.2/1000 3.25/1000 1.8/1000Size of cancer 0.5 - 0.9 cm 0.4 - 8 cm 0.4 - 1.5 cmPPV 6.5% 6.7% 5.5%

Connecticut Experience >50% denseAll risk levelsHand held whole breast ultrasoundHooley et al, Radiology, 2012; Weigert et al, Breast Journal 2012; Parris et al, Breast Journal 2013

Cancer detection rate is similar to Acrin 666 studyCAN THIS SLIDE BE OMITTED?SMALL study -We know supplemental screening will increase detection.21

Computer model study of cost/benefit of supplemental screening US Aged 50-74 yearsDense breastsPer 1000 women:0.36 additional deaths averted1.7 QALYs (Quality Adjusted Life Years) gained354 biopsy recommendationsCost effectiveness ratio: $325,000 per QALY gainedScreening Ultrasound

Sprague BL, Benefits, Harms, and Cost-Effectiveness of SupplementalUltrasonography Screening for Women With Dense Breasts Ann Intern Med. 2015;162:157-166

Automated high frequency linear transducer~1000 images acquiredCan scroll through imagesLimited outcome studies to dateMay become more widely used with further studyAutomated Ultrasoundhttp://rsna.org/NewsDetail.aspx?id=6336

U systems23

Powerful magnetic fieldNo radiationIV gadolinium requiredNot recommendedPregnancyPacemakerIncompatible implanted metalImpaired renal functionSevere claustrophobia

MRI

U systems24

Berg WA JAMA 2012 ; 307:1394-1404. Expanded ACRIN trial: Higher risk AND denseAdded MRI screening after 3 rounds of M/US

MRIDense, negative mammogram

Diagnosis: Invasive Ductal CA

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SensitivitySpecificityPPVRecall RateMammo alone56%89%29%11%Mammo + US94%74%11%16%MRI100% 70%19%31%

ACRIN +MRIBerg WA JAMA 2012 ; 307:1394-1404 58% accepted offer of study MRI612 women in MRI-added groupSupplemental cancer yield of MRI: 14.7/1000

CLICKS1-High sensitivity-lower specificity than mammo2-low PPV3- HIGH recall rate

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#1-Being femaleIncreasing ageGenetic: 5-10% of breast cancers are hereditary (gene mutations) BRCA 1 and 2 most commonRare genetic syndromes: Cowdens, Li Fraumeni, etcPrevious chest wall radiation age 10-30 Lobular carcinoma in situ: 7 to 11 x risk Personal history of breast cancer: Approximately 3-4 x risk of a second cancer.Proliferative lesions with atypia 3 to 5 x risk1st degree relative with breast cancer (mother, sister or daughter)Dense breasts 1.2 x (Hetereogeneously dense) 2.1x (Extremely dense)Race/Ethnicity: Caucasian incidence > African-AmericanAfrican-American mortality > caucasianAshkenazi jews Benign proliferative lesions: 1.5 to 2 x normalEarly menarche (before age 12) or late menopause (after age 55) longer lifetime exposure to hormonesLifestyle-related risk factors include: Combined HRT, >1 alcoholic drink/day, overweight or obese, physical inactivity

Breast Cancer Risk Factors

Highest to lowest risk listing on slide, most common are female and age27

Dense Breasts General Recommendations

Density is a relatively minor risk factor (1.2-2.1x)Supplemental screening Insufficient evidence to supportModest increased cancer detection in avg. risk women and finds generally small, invasive, and node negative cancersMR has not been studied in avg risk/dense breastsFalse positive studies leading to increased imaging and biopsiesNo proven reduction in death from breast cancer (US/MR/MBI)Modify risk factors that can be controlledBMI, exercise, alcohol intake

Dense Breast General RecommendationsSupplemental screening with USN or MRI is NOT supported in women with AVG. risk factorsNCCNACR/SBI (2015)ACOG (2014 Committee Consensus)ACS (2014)USPSTFCochrane Review

Estimate Patient Risk ProfileHigh RiskBRCA mutation/rare syndromes (Cowdens, LiFraumeni)>20% lifetime risk per risk modelsThoracic radiation age 10-301st degree untested relative of genetic high risk personYES = HIGH RISKAnnual screening with digital mammogram age 30Annual screening with MRI age 25**screening ultrasound if MRI cannot be performedConsider referral for genetic counselingConsider medications for breast cancer risk reductionNOCONTINUE

Estimate Patient Risk ProfileIs she at intermediate risk for breast cancer?Personal history of breast cancerPrior biopsy-LCIS or atypiaModerate BC risk (15-20%) per risk modelsYES = INTERMEDIATE RISKAnnual mammogram age 40 (with tomosynthesis if available) CBE 40 annual Supplementary screening-No current clear guidelines Discussion with patient re: benefits and risks Ultrasound, MRINONext SlideACR/SBI appropriateness criteria:MRI is usually appropriate US may be appropriate If dense breasts raise a womans risk to this level with other risk factors, supplementary screening should be considered

Estimate Patient Risk ProfileAverage/Low riskNo other risk factors besides increased densityReassure patient - density small riskAnnual mammogram > 40 (with tomosynthesis if available)CBE annually 40 Breast cancer risk reduction counseling**(BMI, exercise, alcohol)Supplemental screening is NOT supported in women with average risk by any major recommending group

Should I stop getting mammograms?NO! Multiple RCT trials show Mammo decreases BC mortalityShould I be worried?Density is a relatively minor risk factor Put in context of other BC risk factorsSupplemental screening is availableWhat should I do?Mammography per guidelinesReview BC risk factors Follow guidelines for risk levelsIf intermediate risk discuss tolerance for false positives and level of patient concern.

Patient Questions:

No perfect modelGail model NOT for supplementary screeningPittsburgh breast density website recommendation www.densebreast.info.orgUse models that estimate risk re: need for genetic screeningClaus, Tyrer Cusick, BOADICEA, BRCAPROPossibly Breast Cancer Surveillance Consortium Model (BCSC)Consult your Genetic counselorRisk Models

Low income patients - uninsured or underinsured Large deductibles or out of pocket expensesMay be eligible for funding of mammograms or supplemental screeningTo find out if your low-income patient is eligible for the program or to find a BCCCNP agency nearest you call:1-800-922-MAMM (6266) MDHHSBreast and Cervical Cancer Control Navigation Program (BCCCNP)

Clinical recommendationsImaging recommendationsHigh RiskCBE > 25 q 6-12 moAnnual mammo > 30Annual MRI >25Intermediate RiskCBE > 40 q 6-12 moor when risk diagnosedAnnual mammo > 40+/- Suppl. ScreeningLow/Average RiskCBE > 40 annualCBE 25-39 q 3 yearsAnnual mammo > 40*

Summary recommendations for women with dense breasts*MCCs Breast Cancer Advisory Committee still recommends yearly mammo at age 40 http://www.michigancancer.org/

http://screeningforbreastcancer.orgUSPSTF Final Mammography Screening GuidelinesJanuary 11, 2016Women ages 50-74

The USPSTF recommends screening mammography every 2 years for women ages 50 to 74 years.B recommendation Women ages 40-49

The decision to start screening mammography in women before age 50 years should be an individual one.Women who place a higher value on the potential benefit than the potential harms, may choose to begin screening every 2 years between the ages of 40 and 49 years.C recommendationSHARED DECISION MAKINGWomen 75+

The current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women age 75 years and older.I statement

www.MIdensebreasts.org

Didactic videosFree online AMA PRA Category I CME

www.MIdensebreasts.org

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Information for providers

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MCC provider resources and density worksheetwww.michigancancer.org/Resources/BreastPV.htmlNCCN Breast Cancer Screening Guidelineswww.NCCN.orgNCI BC risk assessment toolwww.cancer.gov/bcrisktoolAmerican College of Obstetrics and Gynecology 2015 Density Policy statementwww.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Management-of-Women-With-Dense-Breasts-Diagnosed-by-Mammography

US Preventive Services Task Forcehttp://screeningforbreastcancer.orgFor Providers: Go to web Links

ACR/SBI website www.acr.orgEnglish Brochure http://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Resources/Breast%20Imaging/Breast%20Density%20bro_ACR_SBI_F.pdfSpanish Brochurehttp://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Resources/Breast%20Imaging/Breast%20Density%20Bro_Spanish_F%20Hi%20Rez.pdfACS breast density fact sheethttp://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-039989.pdfCalifornia Breast density group website www.breastdensity.infoPittsburgh Breast density website www.densebreast-info.orgFor Providers: Go to web Links

ACS breast density fact sheethttp://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-039989.pdfNational Cancer Institute BC risk assessment toolhttp://www.cancer.gov/bcrisktoolACR/SBI website www.acr.orgwww.mammographysaveslives.orgEnglish Brochurehttp://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Resources/Breast%20Imaging/Breast%20Density%20bro_ACR_SBI_F.pdfSpanish Brochurehttp://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Resources/Breast%20Imaging/Breast%20Density%20Bro_Spanish_F%20Hi%20Rez.pdfCalifornia Breast density group websitewww.breastdensity.infoPittsburgh density websitewww.densebreast-info.org

For Patients: Go to web Links

D.E.N.S.E. 2011 2015, Are You Dense Advocacy, Inc.. All Rights Reserved. Accessed 2-2-2015.Http://Www.Legislature.Mi.Gov Accessed 2-2-2015.Sickles Ea, Dorsi Cj, Bassett Lw, Et Al. ACR BI-RADS Mammography. In: ACR BI-RADS Atlas, Breast Imaging Reporting And Data System, Breast Imaging Atlas. Reston, VA. American College Of Radiology; 2013. Kerlikowske K. Et Al, Adapted From Breast Cancer Risk By Breast Density, Menopause, And Postmenopausal Hormone Therapy Use, J Clin Onc August 20, 2010 Vol. 28 No. 24, P. 3830-3837. Carney Pa Et Al Individual And Combined Effects Of Age, Breast Density, And Hormone Replacement Therapy Use On The Accuracy Of Screening Mammography Ann Intern Med. 2003 Feb 4;138(3):168-75Pisano, E. Et Al For The Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group. Diagnostic Performance Of Digital Versus Film Mammography For Breast-cancer Screening N Engl J Med 2005; 353:1773-1783 October 27, 2005Mccormack, Va Breast Density And Parenchymal Patterns As Markers Of Breast Cancer Risk: A Meta-analysis Cancer Epidemiol Biomarkers Prev. 2006. 15(6);1159-1169.

Bibliography

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Sickles EA The Use Of Breast Imaging To Screen Women At High Risk For Cancer Radiol. Clin Of NA 2010;48(5), 859-878.http://www.Fda.Gov.Radiationemitting products Friedewald, SM Breast Cancer Screening Using Tomosynthesis In Combination With Digital Mammography, JAMA 2014;311(24):2499-2507.Park J M Et Al. Breast Tomosynthesis: Present Considerations And Future Applications Radiographics 2007;27:S231-S240Berg WA, Et Al, Combined Screening With Ultrasound And Mammography Vs. Mammography Alone In Women At Elevated Risk Of Breast Cancer JAMA, 2008; 299, 2151-2163Brem, RF, Assessing Improvement In Detection Of Breast Cancer With Three-dimensional Automated Breast USD In Women With Dense Breast Tissue : The Somoinsight Study. Radiology Vol.274: 3-March 2015Hooley Et Al, Screening US In Patients With Mammographically Dense Breasts: Initial Experience With Connecticut Public Act 09-41. Radiology 2012 Oct;265(1):59-69 Bibliography continued

Weigert Et Al, The Connecticut Experiment: The Role Of Ultrasound In The Screening Of Women With Dense Breasts. Breast J.2012 Nov-dec;18(6):517-22. Parris, T., Wakefield, D. And Frimmer, H. (2013), Real World Performance Of Screening Breast Ultrasound Following Enactment Of Connecticut Bill 458. The Breast Journal, 19:6470. Sprague Bl, Benefits, Harms, And Cost-effectiveness Of Supplemental Ultrasonography Screening For Women With Dense Breasts Ann Intern Med. 2015;162:157-166 Berg WA Detection of Breast Cancer with Addition of annual Screening Ultrasound or a Single Screening MRI to Mammography in Women with Elevated Breast Cancer Risk JAMA 2012 ; 307:1394-1404. Rhodes DR. Molecular Breast Imaging At Reduced Radiation Dose For Supplemental Screening In Mammographically Dense Breasts AJR 2015; 204:241251 National Comprehensive Cancer Network NCCN Guidelines V.1.2014 Breast Cancer Screening and DiagnosisBibliography continued

Thank YouCaren M. Stalburg, MD MAcarens@umich.edu