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Breast Density: Black, White and Shades of Gray Jen Rusiecki, MD VA Pittsburgh Health System Women’s Health Fellow AMWA Hot Topic 2016 Janice Janice is a 60 year old patient of yours who comes to your office to talk to you about a notification she received in the mail. She recently had her screening mammogram done and received a letter stating that she had “heterogeneously dense breasts” and recommending she discuss supplemental screening with you. She is confused about what this means… What is the next step for Janice’s breast cancer screening? A. B. C. D. E. Digital mammography with tomosynthesis Ultrasonography Magnetic resonance imaging Yearly screening mammography Further risk stratification Breast Density: Why Do We Care? • Breast density makes screening more complicated – Decreased sensitivity with mammography – Increased recall rates • Breast density is an independent risk factor for breast cancer • 40% of women 40 to 74 have dense breasts NOT DENSE A Machida. Breast Cancer. March 2015 B DENSE C Sprague, Ann Internal Med 2015 D BI-RADS 5th ed 2013 Breast Density: Timely but Controversial • Legislation enacted in 24 states – Requiring notification of women with dense breasts of their breast density – Additional state and federal legislation proposed – Notification also tells patients: discuss supplemental screening with physician • Unclear what “supplemental screening” should be BSCS Risk Score • Components: – – – – – – Prior cancer or DCIS history Age Race History in 1st degree relatives Prior biopsy Breast density • 5 yr risk: – – – – Low < 1% Average 1 – 1.66% Intermediate 1.67-2.49% High > 2.5% BSCS Score and Invasive Cancer Invasive Cancer Cases (95% CI) per 1000 Women BSCS Score Almost Entirely Scattered Fat Fibroglandular Densities Heterogeneously Dense Extremely Dense Low (00.99%) 0.14 (0.060.26) 0.21(0.14-0.31) 0.63 (0.46-0.84) 0.72 (0.331.37) Average (1.01.66%) 0.31 (0.130.65) 0.03 (0.270.52) 0.58 (0.44-0.76) 0.89 (0.541.37) Intermediate (1.67-2.49%) 0.48(0.13-1.22) 0.43 (0.290.61) 0.83(0.66-1.03) 1.17 (0.681.87) High (>2.5%) 0.90 (0.621.25) 1.48 (1.2-1.81) 1.62 (1.082.34) Kerlikowske, Annals of Inter Med, 2015 BCSC Score and Imaging Supplemental Imaging Discussion Interval cancer cases Discussion/Int erval Cancer All with heterogeneously or extremely dense 100,00 89 1124 All with extremely dense 16,956 19 892 50-74 y with extremely or 70-74 13,470 y with heterogeneously dense 16 842 Risk ≥1.67% and extremely dense or risk≥ 2.5% with heterogeneously 24,412 35 694 40-74y with extremely or 4049y with heterogeneously 46,412 41 1132 Risk ≥1.67% and heterogeneously or extremely dense breast 48,722 56 870 Strategy Kerlikowske, Annals of Inter Med, 2015 Supplemental Screening Options • Digital mammography with tomosynthesis • Ultrasonography • MRI Head to Head Comparison Breast cancer detection rates of supplemental screening Recall Rates: US 14% MRI 12-14% DBT 7-11% PPV: US 3% MRI 3-30% Melnikow, Annals Inter Med, 2016 Tomosynthesis Improved Mammography Performance: Friedewald et al Rates per 1000 cases Digital Digital Mammography Mammography Alone + Tomo Percent Change P value Recall 106 89 -17 <0.001 Biopsy 18 19 0.9 0.004 Cancer Detection 4.3 5.5 1.2 <0.001 Invasive Cancer 2.9 4.1 1.2 <0.001 DCIS 1.4 1.4 0 0.95 Supplemental Digital Mammography with Tomosynthesis • Advantages – Decreased recall rate – Increase in cancer detection rate – Improved positive predictive values for recall and biopsy – Cost effective Friedewald. JAMA. 2014 Lee. Radiology. 274(3) McCarthy JNCI. 2014 • Disadvantages – May increase radiation dosage patient receives – May require new equipment/training for techs and radiologists Supplemental Ultrasonography • Potential Advantages – Non-invasive – Low risk procedure for patients (no radiation) – Minimal improvement in screening with additional gains in cancer deaths and QALYs compared to mammography alone Sprague. Annals of Internal Medicine 2015 • Disadvantages – Cost effectiveness data: >$100,000 per QALY gained – High false positive rate – Low positive predictive value Supplemental MRI • In average risk women, no studies address MRI in women with dense breasts specifically – In contrast to women with increased risk (Gail score >20%) in which MRI is recommended • High false positive rate, low PPV • Expensive • Requires contrast which may be poorly tolerated by patients Freer, Breast Imaging, 35(2) Clinical Recommendations Breast density alone should not prompt the need for supplemental imaging Screening mammogram at age 40 (or 45) and calculate BSCS Score • Dense breast: – If score >1.65% and extremely or >2.5% and heterogeneously dense breast discuss supplemental screening with tomosynthesis • Normal breast density: – Engage in shared decision making about further screening frequency – Screening mammogram at age 50 and continue every other year Ultrasonography and MRI are not cost effective with high false positives and low PPV What is the next step for Janice’s breast cancer screening? A. B. C. D. E. Digital mammography with tomosynthesis Ultrasonography Magnetic resonance imaging Yearly screening mammography Further risk stratification What is the next step for Janice’s breast cancer screening? A. B. C. D. E. Digital mammography with tomosynthesis Ultrasonography Magnetic resonance imaging Yearly screening mammography Further risk stratification Acknowledgments • Dr. Rohr-Kirchgraber • Dr. McNeil • Drs. Karmo and Mieczkowski Breast Density: Prevalence and Risk BI-RADS BREAST DENSITY Almost entirely fat Scattered fibroglandular densities Heterogeneously dense PREVALENCE (PERCENT) RELATIVE RISK FOR BREAST CANCER Age <50 Age >50 Age <50 Age>50 4.3 10.2 0.49 0.59 34.3 49.0 1.00 (reference) 1.00 (reference) 47.0 35.5 1.55 1.46 14.4 5.3 2.00 1.77 Extremely dense Sprague, Ann Internal Med 2015 USPTSF Guidelines 2015 • Current evidence is insufficient to assess the benefits and harms of adding tomosynthesis to conventional screening mammography • For women with radiologically dense breast, current evidence is insufficient to assess the benefits and harms of adjunctive ultrasound, MRI or tomosynthesis States with Mandatory Notification Head to Head Comparison Supplemental Imaging Mode Sensitivity Specify PPV Cancer Detection (per 1000 women) Recall Rates Ultrasound 80-83% 86-94% 0.03 4.4 14% MRI 75-100% 78-94% 0.03-0.33 3.5-28.6 12-14% Tomosynthesis 93%* 70%* 0.35* 5.4-6.9 7-11% * G i l b e r Ultrasound vs MRI Sensitivity: US 80-83% MRI 75-100% Specificity: US 86-94% MRI 78-94% PPV: US 0.03 MRI 0.03-0.33 Tomosynthesis Improves Mammography Performance • European prospective studies (Skaane et al & Ciatto et al) – Improved invasive cancer detection – Reduced false positive rate – Reduced recall rate • Observational studies in United States (McDonald et al) – Reduced recall rate – Recalled patients were more likely to have invasive cancer