Message Breast Density Notification Legislation, The majority of states have enacted breast density notification legislation. Supplemental Screening and Controversies A basic understanding of the implications of Amie Y. Lee, MD dense breast tissue and supplemental screening Assistant Professor, Breast Imaging options will allow you to better communicate University of California, San Francisco with your patients. 1 2 Outline Outline • Origins of breast density legislation and • Origins of breast density legislation and current status. current status. • What is breast density? • What is breast density? • Why is it important? • Why is it important? • What to do about it? • What to do about it? 3 4 Page 1 1
Origins of Breast Density Legislation Origins of Breast Density Legislation • In 2003, Nancy Capello had a • She believed her cancer would have been diagnosed negative screening mammogram earlier had she been informed of her breast density and undergone supplemental screening http://areyoudense.org • 6 weeks later, a palpable lump was detected on CBE – A 2.5 cm mass was found on US • Capello lobbied for state legislation to inform women of dense breasts – Stage IIIC cancer with metastasis to 13 axillary lymph nodes – In 2009, the first breast density notification law passed in her state of CT • She learned for the first time that she had dense breast tissue Image use with permission by Dr. Nancy Capello 5 6 Origins of Breast Density Legislation Origins of Breast Density Legislation • She founded ‘Are You Dense Advocacy, Inc to advance Her story and the issue of breast density has received legislation in other states widespread national attention Image use with permission by Dr. Nancy Capello (http://areyoudense.org) 7 8 Page 2 2
2009: CT is the 1 st state to pass breast density 2012: CA becomes the 5 th state to pass breast density notification legislation notification legislation 9 10 2018: 35 states require breast density notification Federal Efforts: An additional 3 states recommend it densebreast-info.org 11 12 Page 3 3
California Breast Density Legislation California Breast Density Legislation “Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it • Effective as of April 1, 2013 harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast • Exact wording specified by law cancer. • This 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.” 13 14 Outline Breast Density Assessment • Origins of breast density legislation and • Density = Relative amount of fibroglandular current status in the U.S. tissue is within the breast • What is breast density? • Based on qualitative visual assessment of mammogram by the radiologist • Why is it important? – Indicate the relative possibility that a lesion could • What to do about it? be obscured by normal tissue 15 16 Page 4 4
Breast Density Categories Four Breast Composition Categories ACR BI-RADS 5 th ed. 2013 A. The breasts are almost entirely fatty B. There are scattered areas of fibroglandular density C. The breasts are heterogeneously dense, which may obscure small masses D. The breasts are extremely dense, which lowers the sensitivity of mammography (A) Fatty (B) Scattered (C) Heterogeneous (D) Extreme 17 18 Distribution of patients by density Outline ~50% have dense breast tissue • Origins of breast density legislation and current status in the U.S. Breast density policies impact approximately half the screening • What is breast density? population à Wide ranging consequences • Why is it important? • What to do about it? (A) Fatty (B) Scattered (C) Heterogeneous (D) Extreme 19 20 Page 5 5
What is the Clinical Significance of Masking Mammographic Breast Density? • Masking – Dense tissue can mask cancers on mammography • Risk – Presence of dense tissue is a risk factor for the development of breast cancer 21 22 23 24 Page 6 6
25 26 Masking Associated with Breast Density How much does dense breast tissue reduce the sensitivity of mammography? • Overall ~ 10% decreased sensitivity 27 28 Page 7 7
• Breast density is an independent risk factor but not a Risk Associated with Breast Density major one. • Risk of breast cancer increases with increasing breast density • Average density at screening is between B & C RR for density C vs. “average”: 1.2 – RR for density D vs. “average”: 2.1 – • Women with density D have a 4-6 x increased risk of breast cancer compared to women with density A densebreast-info.org 29 30 Outline Key Point • Origins of breast density legislation and current status in the U.S. Mammography is the only screening tool • What is breast density? shown to reduce breast cancer mortality in randomized controlled trials • Why is it important? • What to do about it? 31 32 Page 8 8
Imaging Options for Suppl Screening Imaging Options for Suppl Screening • Breast MRI • Whole Breast Ultrasound Any supplementary screening is in addition to − Hand-held (HHUS) (not instead of) screening mammography − Automated (ABUS) Decision to pursue supplemental screening is • Breast Tomosynthesis an informed personal decision, including discussion of other risk factors 33 34 Breast MRI Breast MRI • Not limited by dense breast tissue Limitations: • Limited specificity (increased false positives) • Most sensitive modality for detecting breast cancer • Requires IV contrast • Recommended for screening high risk • Length of exam women (>20-25% lifetime risk) • Expensive 35 36 Page 9 9
Breast MRI Breast MRI Invasive Ductal Carcinoma Small mass in dense breast tissue Spiculated enhancing mass 37 38 Breast Ultrasound Screening Whole Breast Ultrasound Limitations: • Finds additional cancers not seen at mammography • Very poor specificity • Well tolerated by patients • Very high false positive recall and biopsy rate • Less expensive, less invasive than MRI • >90% of biopsies are not malignant 39 40 Page 10 10
Breast Tomosynthesis (DBT) Tomosynthesis (DBT) Limitations • Studies to date are promising • Limited availability − Cancer detection similar to US, lower than MRI • Added time (but less than MRI and US) − Fewer false positives than US • Additional radiation (but within FDA limits) − Most studies: improved sensitivity + specificity Due to promising initial results, DBT is slowly being incorporated into the standard annual screening mammogram 41 42 Tomosynthesis (DBT) Screening 43 44 Page 11 11
Breast Density Legislation: Problems • Insurance coverage for supplemental screening not guaranteed − < 10 states mandate insurance coverage Additional guidance? • US and MRI increase false positives • No evidence of mortality benefit…yet 45 46 DenseBreast-info.org What do we offer at UCSF? • Screening mammography • Supplemental screening based on risk • If high risk (>20% lifetime risk), add MRI • US screening not offered at UCSF • DBT- Women may opt for this as part of routine screening mammography exam • Educational resource providing information on breast • Supplemental screening: Insurance coverage is not density to patients and health care providers guaranteed 47 48 Page 12 12
Summary Summary • ~ 50% of women undergoing screening • No consensus for supplemental screening mammography have dense breast tissue • Screening US improves cancer detection • MRI has the highest cancer detection • Dense breast tissue decreases the sensitivity of mammography by masking • Both US and MRI have limited specificity • Initial data on the performance of DBT is • Dense breast tissue is an independent cancer risk encouraging factor Mammography is the only screening tool shown to reduce breast cancer mortality in randomized controlled trials 49 50 Thank you! Amie.Lee2@ucsf.edu 51 Page 13 13
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