1. Breast Cancer Screening What’s New to Know? The Issue of Breast Density Catherine Babcook MD Partner, Mountain Medical Physician Specialists Medical Director of Breast Imaging McKay Dee Hospital Center

2. Disclosure This presentation has no commercial content, promotes no commercial vendor and is not supported financially by any commercial vendor. I receive no financial remuneration from any commercial vendor related to this presentation.

3. Screening Recommendations ACS, ACR, ACOBGYN, Intermountain HC – Annual mammographic screening beginning at age 40 – Continue screening if a woman is in good health and has a life expectancy of 5 years or more

4. Mammography Facts < Screening 1980’s, the death rate for breast cancer in the U.S. was unchanged for 50 years Since 1990 the death rate from breast cancer has decreased by 30% In women ages 50-74, 15- 20% more lives saved by screening every year instead of every two years When analyze appropriately performed RCTs and service screening data - 30 to 40% decrease in mortality in the 40-49 year-old group.

5. More Facts Update of the Swedish Trials by Lazlo Tabar, when “no shows” were placed in the control group, there was a 63% decrease in the death rate of the screened group. Anxiety of a false positive mammogram or invasive procedure - Recent study of 1171 women, 97% indicated a false positive result would not deter them from screening.

6. Many Components of Cancer detection Woman has to get a screening mammogram Radiologist factors: Interpretation variability Woman factors: Breast density, implants

7. Radiologist Factors Recall RatePPV1PPV2Cancer Detection Rate ACR Guidelines< 12%5-10%25-40%2-10/1000 Interpretive Ability:

8. Woman Factors Clinically “dense” = Mammographically Dense Breast Tissue – Pattern and Density:

9. Breast Density on Mammography Density = How much White tissue White tissue - glandular Dark tissue – fat

10. Breast Density Fatty BreastExtremely Dense Breast

11. 4 Categories of Density Mammography Report – Parenchymal Density: Almost Entirely Fatty (< 25% Glandular ) Scattered Fibroglandular Densities (25-50% Glandular) Heterogeneously Dense (51-75% Glandular) Extremely Dense (> 75% Glandular)

12. Almost Entirely Fat (< 25% Glandular

13. Scattered Fibroglandular Densities (25-50% Glandular)

14. Heterogeneously Dense (51-75% Glandular

15. Extremely Dense (>75% Glandular

16. Why Does it Matter? Cancer is WHITE on mammograms Amount of WHITE glandular tissue impacts visibility of WHITE cancer

17. Mass visibility on Mammo

18. Dense Tissue – White Cancer

20. Cancer Can be Hidden by Glandular Tissue on Mammo ‘Snowflakes in a snowball’, ‘polar bear in a snowstorm’ What do we do: – Wait until it’s big enough to feel – Add a test that improves cancer detection in white glandular tissue

21. White on White Mammo Cancer Problem Mammographic Sensitivity Varies with Breast Density – Fatty – 85% – Dense – 70% with Digital Mammo NOT USELESS BY A LONG WAY

22. Density Issue Not New Awareness of Density Issue Is New – Nancy Cappello PhD – Dx with advanced stage breast cancer after years of normal annual screening mammography from age 40 – 34 yrs as an educator, administrator and state dept. consultant in Connecticut – “Nancy’s Law” 2009; Areyoudense.org

23. Magnitude of Density Issue 40% of Women have dense breasts – 65% of premenopausal women – 25% of postmenopausal women

24. Adjunctive Screening Tests Tomosynthesis – Oslo,N=13000,27% CA,15% FP Longer compression, increased dose, exp. capital, no reimbursement, doubled interpretation time Whole Breast Ultrasound: handheld, automated MRI – not indicated for density alone, cost, annual gadolinium risk, FP BSGI – expensive capital, space, sig additional dose, no reimburse PEM – expensive capital, space, sig additional dose, no reimburse

25. Breast Ultrasound

26. Cancer on Ultrasound Not visible in dense tissue on mammo Visible dark cancer on ultrasound

27. Cancer on Ultrasound Not visible in dense tissue on mammo Visible dark cancer on ultrasound

28. Screening Breast Ultrasound – Kolb et al Radiol 2002;225(1):165-175 – Crystal et al AJR 2003;1818(1):177-182 – Gordon et al Cancer 1995:76(4):626-630 – Kaplan Radiology 2001;221 (3):641-649 – All criticized: Single center studies Retrospective studies Not blinded to mammo findings etc.

29. Screening Breast US Studies ACRIN 6666: N= 2600, Berg et al 2008 JAMA, Vol 299(18)2151-2163 – 60 % increase in cancer detection over mammo alone – Low PPV for biopsy: 11%, mammo 25-40%, – radiologist handheld scanning, too much time to be practical – No documentation to allow for future comparison

30. Automated Whole Breast US Efficient – rad not scanning, tech not interpreting Large Volume of patients Standardized, reproducible Comparison capability

31. AWBU Studies Kelly et al 2010 Eur Radiology 20:734-742 N= 4500 23 additional Cancers found on US 100% Increase in cancer detection 22/23 invasive cancers, ave size 0.9 cm

32. AWBU Studies: Kelly et al 2010 Eur Radiology 20:734-742 Mammography alone found 23 AWBU found 38 23 mammographically occult Recall Rate: ACR < 10% for Mammo – Mammo 4.2% – AWBU 6.5% Positive Predictive Value Bx (PPV) ACR 25-40% – Mammo 39% – AWBU 38.4% – AWBU + Mammo 62.5%

33. AWBU Studies USys FDA study submission: – 30% increase in cancer detection over mammography alone – RSNA presentation: 25% increase in CA detection

34. AWBU: Our Experience 15,000 Screening Mammograms/yr – 5 cancers/1000 women screened 600 AWBU/yr – 4/600 ~ 6/1000 additional cancers

35. Cases – 51 year old

37. Cases – 53 year old MammoAWBU

38. Dense Breast Tissue 40% of Women 40% x 15,000 scr mammos = 6000 eligible women seen at McKay Dee Breast Center 600 AWBU exams/yr.

39. Breast Density and AWBU Women don’t have to get it Not covered by insurance – $275, $200 – Flex spending acct etc. Women do need to be informed – our job Women need the opportunity to make the choice