Disclosures. Breast Cancer. Breast Imaging Modalities. Breast Cancer Screening. Breast Cancer 6/4/2014

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: Information for the Primary Care Physician Disclosures No financial relationships with commercial entities producing health care products/services. Roxsann Roberts, MD Section Chief, MRI Erlanger/EmCare Radiology Breast Imaging Modalities Mammography Screening and Diagnostic Ultrasound Tomosynthesis MRI Breast Specific Gamma Imaging (BSGI) Breast PET/PEM Breast Cancer Steady increase ages 40 through 75 Note no abrupt change age 50 10 year risk of breast cancer based on age: Age 30: 0.44% (1 in 227) Age 40: 1.47% (1 in 68) Age 50: 2.38% (1 in 42) Age 60: 3.56% (1 in 28) Age 70: 3.82 % (1 in 26) breastdensity.info 2/3 women diagnosed with breast cancer have no significant risk factors Breast Cancer Annual breast cancer incidence rates per 100,000 women, function of age for invasive + in-situ cancers (orange) and invasive breast cancer only (maroon) Mammographic screening: the only proven method to reduce number of deaths from breast cancer Approximately 30% reduction in number since late 20 th century Goal: Reduce mortality by detecting cancers at earliest stage Stage 1 disease, >98% 5 year survival 1

Screening Recommendations Breast cancer detection rate from a single mammography exam (per 1,000 examinations) in the Breast Cancer Surveillance Consortium (BCSC) 1996-2007. Age (years) 40s: avg 2.18/1000 or 1/459 Cancer detection rate 40-44 1.69 45-49 2.60 50-54 3.23 55-59 4.20 60-64 4.70 65-69 5.25 70-74 5.95 75-89 6.96 Any age 4.00 ACR Recommendations: Annually for asymptomatic women age 40 and older who are at average risk for breast cancer. Asymptomatic women under age 40 who are at increased risk for breast cancer. Woman with known mutation or genetic syndrome with increased breast cancer risk: yearly starting by age 30, but not before age 25. Untested woman with a first-degree relative with known BRCA mutation: yearly starting by age 30, but not before age 25. Woman with a 20% or greater lifetime risk for breast cancer based on breast cancer risk models: yearly starting by age 30, but not before age 25, or 10 years earlier than the age at which the youngest first-degree relative was diagnosed, whichever is later. Woman with a history of chest (mantle) radiation received between the ages of 10 and 30: yearly starting 8 years after the radiation therapy, but not before age 25. Woman with biopsy-proven lobular neoplasia, atypical ductal hyperplasia (ADH), ductal carcinoma in-situ (DCIS), invasive breast cancer, or ovarian cancer: yearly from time of diagnosis, regardless of age. Screening Recommendations Age at which annual mammography screening should end: there is no defined upper age limit at which mammography may not be beneficial Good health (5-10 year life expectancy?) Will the patient undergo additional testing or treatment? Benefit: since the onset of regular screening mammograms in 1990, mortality rate from breast cancer (unchanged in the previous 50 years) has declined 30% For 1000 screened, approximately 100 recalled 85 of these 100 extra views or US will resolve 20 will be followed BI-RADS 3: less than 2% chance of cancer 15 of 100 will be recommended for biopsy 4-6 will have breast cancer Early detection lumpectomy vs mastectomy/chemoradiation? Yearly evaluation? Ages 40-49 and early 50s More aggressive, faster growing cancers Increased likelihood for nodal spread Pre-clinical node-negative cancer prediction of spread Age 40-49: 16% Age 50-59: 7% Age 60-69: 5% Yearly screening older population? Mammography radiation dose 0.4 msv 7 weeks background radiation Background radiation for one year: 3 msv Denver add 1.5 msv Radon add 2.0 msv Computed Tomography (CT)-Abdomen and Pelvis: 10 msv - 3 years background radiation Computed Tomography (CT)-Head: 2 msv - 8 months background radiation 2

W oman's age is 44 years. Age at menarche was 13 years. Age at first birth was 24 years. Person is perimenopausal. Height is 5 ft 5 ins. W eight is 0 st 180 lb. Woman has never used HRT. 12.0% 9.6% 7.2% 4.8% 2.4% 0.0% Risk after 10 years is 2.384%. 10 year population risk is 2.145%. Lifetime risk is 10.41%. Lifetime population risk is 9.325%. Probability of a BRCA1 gene is 0.013%. Probability of a BRCA2 gene is 0.052%. 44 54 64 74 84 Personal risk Population risk 6/4/2014 No current breast issues Risk assessment? Comparisons or baseline? Digital mammography versus film screen Breast Cancer Risk Assessment?? 64 70 68 65 45 44 20 17 Film-Screen vs Digital Mmg Film-Screen vs Digital Mmg cancer.osu.edu 3

giottousa.com Craniocaudal and MLO views with XCCL as needed Implants: Additional views needed BI-RADS mammographic lexicon Density of breasts (newest lexicon changes): The breasts are almost entirely fatty There are scattered areas of fibroglandular density The breasts are heterogeneously dense, which may obscure small masses The breasts are extremely dense, which lowers the sensitivity of mammography Note: With increasing age, there is a general decrease in density, with improved sensitivity Evaluation: Screening BIRADS codes 1: Negative 2: Benign Findings 0: Incomplete, Need additional imaging evaluation and/or prior mammograms for comparison. MQSA: Written report to referring physician ASAP but no later than 30 days form the date of mammography exam MQSA: Must send or give directly to all patients a written summary, in lay terms, of the results of the study no later than 30 days from the date of the mammographic examination acr.org 4

Diagnostic Mammography Diagnostic Mammography Possible radiographic abnormality detected on screening mammography Patients with a current breast issue: With a specific focus of clinical concern including, but not limited to, mass, induration, axillary lymphadenopathy, some types of nipple discharge, skin changes, or persistent focal areas of pain or tenderness Patients following up for a probably benign exam Patients following up after treatment for known cancer or negative post biopsy Examination requires direct involvement of the radiologist for special views, physical breast examination, or consultation BI-RADS codes for diagnostic mammogram: 1 or 2: Negative or benign findings 3: Probably benign findings 4 or 5: Suspicious or highly suspicious 6: Known cancer Abnormal screening mammogram: Diagnostic Mammography BIRADS 0: What next? Diagnostic Ultrasound Breast MRI 5

MQSA: BI-RADS category 4 or 5 reasonable attempt to communicate directly with the health care provider ASAP. Should occur within 3 working days from the date of interpretation, using either documented verbal communication or a written report. If unavailable, a report should be given to the responsible designee of the health care provider. The actual or attempted direct communication should be documented in the mammogram report. MQSA: BI-RADS category 4 or 5 - reasonable attempt to communicate the results to the patient as soon as possible. This should occur within 5 working days from the date of interpretation. The actual or attempted communication should be documented. BI-RADS 3 Short-term follow-up for probably benign findings Diagnostic mammogram or ultrasound follow up Usually 6 month, can be shorter interval 3-4 month BI-RADS 4 or 5 Percutaneous biopsy Ultrasound-guided Stereotactic biopsy Ultrasound-Guided Breast Biopsy Stereotactic Breast Biopsy imagenorth.org radiologyinfo.org elourdes.com iame.com Dense Breasts Legislated information to mammography patients in Tennessee Breast Densities: 10% Almost entirely fatty 40% Scattered areas of fibroglandular density 40% Heterogeneously dense breasts 10% Extremely dense breasts Risk: When risk is expressed relative to average breast density (between scattered areas of fibroglandular density and heterogeneously dense), the risk for the 40% of women with heterogeneously dense breasts is only about 1.2 times greater and the risk for the 10% of women with extremely dense breasts is only about 2 times greater. Therefore, breast density is not a major cancer risk factor. breastdensity.info **Per enactment of the Tennessee legislature, patients with dense glandular tissue will now be informed by letter of their breast density. The decision to pursue additional screening modalities should not be based on breast density alone. Rather it should come from a discussion between the patient and her breast health physicians, which includes all factors which may influence her decision to undergo additional imaging. Please note that other modalities of breast imaging including ultrasound, tomosynthesis and MRI are considered adjunctive tools and not replacements for mammography. For scientifically accurate information, please refer to the American College of Radiology website (acr.org) or www.breastdensity.info** 6

Dense breasts: Increased superimposed tissues Can decrease sensitivity 10-20% What is the proper screening modality? Mammography Only screening tool that has been demonstrated through large randomized trials to lower breast cancer mortality. Those trials included all breast densities. While mammography sensitivity is somewhat lower in women with extremely dense breasts, it is still the best modality for population-based screening. Mammography is the only test that can reliably detect suspicious calcifications. Such calcifications are often the first sign of in-situ cancers, which (in 20% of cases) coexist with otherwise invisible invasive cancers. breastdensity.info Additional Screening? Risk assessment may be helpful Family history, personal history of atypia, other risk factors Tyrer-Cuzick, BRCAPRO, Claus, BOADICEA, Gail (less recommended) ACS Guidelines: High Risk (20-25% or greater): Consider screening breast MRI adjunctively to mammography Intermediate risk (15-20%): Consider screening MRI on individual basis Low risk: Screening MRI not recommended Screening Ultrasound ACRIN (ACR Imaging Network) findings: Increase in detection of invasive cancers in conjunction with mammography (and better with MRI) Cons: Increased rates of biopsy and false-positive exams Improvement after the initial screening US but persistently increased recall rates, rates of biopsy and false-positive exams Consider breast cancer risk factors, insurance coverage, tolerance for additional testing, including possibility of false positive biopsy Emerging, promising Digital mammography 2D Tomosynthesis commonly referred to as 3D fujifilm.com Observed 30% decrease in recall rates Larger observational study Decrease in recall rates Increase in cancer detection (including invasive cancers) No significant increase in biopsy rates Increase in PPV for recalls Increase in PPV for biopsies Diagnostic use One-view DBT shows better sensitivity and NPV in patients with fatty and dense breasts 7

Invasive ductal carcinoma Rose, SL et al. healthcare.siemens.com Summary Invasive ductal carcinoma Lipsit, ER. Hologic.com There is a steady increase in breast cancer risk ages 40-75 10 year risk of breast cancer based on age: Age 30: 0.44% (1 in 227) Age 40: 1.47% (1 in 68) Age 50: 2.38% (1 in 42) Age 60: 3.56% (1 in 28) Age 70: 3.82 % (1 in 26) Note no abrupt change at age 50 2/3 women diagnosed with breast cancer have no significant risk factors Mammographic screening: the only proven method to reduce number of deaths from breast cancer Approximately 30% reduction in number since late 20 th century Goal: Reduce mortality by detecting cancers at earliest stage Thank you! Mahalo and Aloha! 8

References American College of Radiology. Breast Imaging Reporting and Data System (BI-RADS) 5. Reston, Va: American College of Radiology; 2014 Berg WA, Blume JD, Cormack JB, et al. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA : the journal of the American Medical Association 2008;299:2151-63. Berg W, Hendrick E, Kopans D, Smith R. Frequently asked questions about mammography and the USPSTF Recommendations: a guide for practitioners.www.sbi-online.org. Accessed 5/1/2012. Berg WA, Zhang Z, Lehrer D, et al. 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 : the Journal of the American Medical Association 2012;307:1394-404. http://seer.cancer.gov/statfacts/html/breast.html Lipsit, Edward R. Clinical Case Review. May 2012. Hologic.com Lipson, JA, Hargreaves, J, Price ER on behalf of the California Breast Density Information Group (CBDIG). Frequently Asked Questions About Breast Density, Breast Cancer Risk, and the Breast Density Notification Law in California: A Consensus Document. March 2013 Mahoney, Mary, Newell, Mary S., et al. ACR Practice Guideline For The Performance Of Screening And Diagnostic Mammography, Revised 2013 Rose, SL, Tidwell, AL, et al. Implementation of in a Routine Screening Practice: An Observational Study.. American Journal of Roentgenology 2013 200:6, 1401-1408 Smith, Andrew. Fundamentals of, Improving the Performance of Mammography. Hologic.com Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20- year follow-up before and after introduction of screening. Lancet 2003;361:1405-1410 Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA: a cancer journal for clinicians. 2007;57(2):75-89. Waldherr, C, Cerny, P, et al. Value of One-View Versus Two-View Mammography in Diagnostic Workup of Women With Clinical Signs and Symptoms and in Women Recalled From Screening. American Journal of Roentgenology 2013 200:1, 226-231 9