9/29/2014 Presentation Objectives: Attendees will: Nancy L. Gantt, MD FACS Co-Medical Director, JACBCC 2014 Primary Care Update Humility of Mary Health Partners Disclosures: 1) Become familiar with background of current controversies in breast screening 2) Understand considerations involved in the recommendation for breast screening and additional diagnostic imaging. 3) Become aware of the COC indicators for quality care of breast cancer patients. Breast Cancer Screening Guidelines BSE starting in their 20’s Female CBE every 3 years for woman in their 20’s and 30’s, yearly starting at age 40 Breast cancer survivor Mammograms: Yearly starting at age 40, continuing as long as women remain in good health Start 10 years prior to age of onset of any first degree relative if premenopausal Women at high risk (greater than 20% lifetime risk) should get an MRI and a mammogram every year. Breast Cancer Screening USPTF 2002 vs. 2009 Mortality Does screening reduce the mortality from breast cancer? Overall mortality reduction of 30% since peak in 1980’s. Why? Past understanding (Scandinavian studies) mortality reduction of 30-50% with screening Recent review: 15% reduction mortality ages 40-49 32% mortality reduction 60’s False + with 10 yrs. screening cumulative 61% Possibly 19% “overdiagnosis” Pace, et al. JAMA 2014 Apr 2;311(13):1327-35. 2002 Recommendations: For all women >39, mammograms every 1-2 years 2009 Recommendation Statement: For women ages 50-74, mammography every 2 years For women < 50, “against routine screening” No benefit for CBE Recommended against teaching women BSE Ann Intern Med 2002;137:344-6 and 2009;151:716-26 1 9/29/2014 Subsequent USPTF addendum Breast screening “harms” “the decision to begin regular biennial screening “ before age 50 “should be an individual one and should take into account a woman’s own situation and her values regarding specific benefits and harms” False positive results leading to biopsy Cost, discomfort, imaging challenges Ann Intern Med 2009;151:716-26 Patient anxiety Can lead to prolonged psychosocial distress Radiation exposure Minimized (Analog 2.4 mGy, Digital 1.9 mGy) Overdiagnosis Can only be inferred from long-term F/U of RCT Screening (subsequent) Physician adherence to recommendations Majority: Mammo at age 40 Annual imaging: 98% GYN, 77% IM, 74% FM Womens Health Issues. 2014 May-Jun;24(3):e313-9. National guidelines: ACS, ASBS: Annual mammograms after age 40 ASBD: Annual mammograms and CBE after 40 AAFP (2007): Biennial mammograms after 40, yearly after age 50 NAPBC represents 20 organizations, supports ACS Canadian National Study Canadian National Study Study Structure: Study Conclusions: Patients who had mammograms between 1980-1985 Two groups of volunteers, ages 40-59 Group #1: CBE “only” Ages 40-49 received single CBE followed by “usual care” Group #2: CBE and screening mammography Followed up to 25 years Outcomes sought: Detecting cancers Cancer-specific mortality “Annual mammography for ages 40-59 does NOT reduce mortality from breast cancer above that of CBE and usual care when access to adjuvant care is readily available.” “Overall, 22% (106/484) of screen-detected invasive breast cancers were overdiagnosed, representing one overdiagnosed cancer for every 464 women who received screening in the trial 2 9/29/2014 Canadian National Study Breast screening studies: Caveats Criticisms of Study: Earlier discovery, stage QOL benefit More conservative local and systemic therapy ** If caught regionally, newer therapy can increase survival Not population based-”opportunistic” Lack of randomization-CBE prior to group assignment placed 11 palpable cancers in mammogram arm Poor quality imaging Hologic-Selenia Dimensions Earlier discovery, stage survival benefit Lead-time bias (earlier diagnosis W/O altered outcome) Length bias (preferential Dx. of slow-growing tumors) “Invite to screen” vs. “Usual care” Noncompliance (invited to screen but didn’t) Contamination (not invited to screen but did) Digital vs Analog Mammography 3-D Digital Mammography Includes a 3-D tomosynthesis image in combination with a 2-D image. Radiation exposure about 2.7 mGy. 3-D scan results in a stack of thin, high resolution image slices that show the inner structure of the breast without distortion typically caused by tissue shadowing or density. The thin layers of tissue are shown separately, which helps to separate benign lesions from suspicious lesions, and avoid biopsies. 3 9/29/2014 Why Breast Tomosynthesis (3D mammography)? Tissue superimposition hides pathologies in 2D Tissue superimposition mimics pathologies in 2D MRI of the Breast MRI Indications-NCCN Evaluating extent of cancer including multifocality REQUIREMENTS: Dedicated breast MRI Specialized software, table, and coils to enhance imaging and facilitate MRI guided breast biopsy Images interpreted by trained radiologists in conjunction with all of the patient’s other imaging Evaluating contralateral breast in woman with breast cancer Evaluate response to neoadjuvant therapy, potential for conservative therapy. Detecting primary breast cancer in woman with axillary nodal adenocarcinoma or Paget’s disease and otherwise negative imaging Yearly screening for abnormal BRCA gene carriers and women whose lifetime risk is >20% Additional MRI Indications-ACR Evaluating the augmented breast (non-contrast) Invasion of cancer deep to pectoralis fascia Extent of residual cancer post-lumpectomy Evaluation of possible breast cancer recurrence CAUTION: False-positive imaging-high sensitivity/low specificity Do not order in lieu of biopsy of suspicious lesions. Consider patient’s menstrual cycle $$$$$-obtain precertification 4 9/29/2014 Gamma Medica-Luma Gem Molecular Breast Imaging Analog Mammography/MBI Target population- women with dense breast tissue and increased risk for breast cancer. High resolution functional study of the breast. Patient is injected IV with short lived radioactive agent that is absorbed by breast tissue. Cancer cells absorb more of the radioactive agent, MBI is available in a limited number of Centers- only 2 in Ohio. Breast Density-the new “hot topic”! Clinically: Dense breasts convey 4-5X increased cancer risk Increased difficulty in imaging-tumors hide. Grading: Bi-Rads 4 categories Breast Density Legislation History: Nancy M. Cappello, Ph.D. of CT diagnosed with Stage III breast cancer 2 months after a “normal” mammogram, attributed to dense breast tissue Are You Dense Advocacy, Inc. is a 501(c)(4) tax–exempt organization Ohio: SB 54 was originally introduced by John Eklund (R-Chardon) and Eric Kearney (D-Cincinnati) on February 25, 2013. Substitute bill adopted by the Senate MHHS committee expected to be passed. Places the requirement to notify a patient on the facility, not the physician and contains a broad immunity clause. 5 9/29/2014 Breast Density Legislation Breast density awareness Legislative & grass-roots activities – January 2014 Illinois 2009 – Insurance Coverage Law 2013 - Density-Inform LawPOOR Washington Breast Density-”Minimal language” Maine Utah Ohio Indiana Colorado Missouri Kentucky 8 Tennessee Arizon a Massachusetts 1 Connecticut 2006 – Insurance Coverage Law 2009 – Density-Inform Law New Jersey Delaware Maryland 7 10 2 Virginia No. Carolina 11 So. Carolina Breast Density and Mammography Reporting Act, October, 2011, Rosa DeLauro (CT) Steve Israel (NY) Georgia Alabama 9 Texas Effective Dates: Pennsylvania Tennessee Working on a Bill/ Organized Activity Has inform law but not mandatory/poor 3 Michiga 4 n Pennsylvania 13 Iowa California 6 Introduced inform or notify bill 7 New York Minnesota Nevada Hawaii 6 New Hampshire 12 Oregon 5 14 Mandatory Density-Inform 3 01-30-14 07-01-14 Has Insurance Coverage Florida Law "Your mammogram demonstrates that you have dense breast tissue, which could hide abnormalities. Dense breast tissue, in and of itself, is a relatively common condition. Therefore, this information is not provided to cause undue concern; rather, it is to raise your awareness and promote discussion with your health care provider regarding the presence of dense breast tissue in addition to other risk factors." Over 1/3 of U.S. screening population live in states enacting density-inform legislation Source data from Are You Dense, Advocacy, dated January, 2014 DOC1437277 GE Automated Breast Ultrasound (ABUS) Imaging Architecture Acquire images • Automated image acquisition • 15 cm field-of-view transducer • Image acquisition time less than 3 minutes each breast • Total exam time ~15 minutes Interpret images • Supports image interpretation • Review 3D image sets on workstation • Read entire case in ~3 minutes1 1. ARRS 2012 Breast Imaging: Screening/Emerging Technologies Oral Abstract; Radiologist Interpretation Time for 3D Automated Breast Ultrasound Screening, R. Brem Clinical Practice Recommendations Patient risk assessment Personal/family history Risk assessment tools Gail model Tyrer-Cuzick (IBIS) Referral to Genetic Counselor Baseline screening age based on risk, personal choice Subsequent screening based on results of baseline Biennial imaging effective at balancing benefits/risks Discuss ongoing CBE, BSE Stop screening based on performance status Breast Cancer Screening Guidelines BSE starting in their 20’s CBE every 3 years for woman in their 20’s and 30’s, yearly starting at age 40 Mammograms: Yearly starting at age 40, continuing as long as women remain in good health Start 10 years prior to age of onset of any first degree relative if premenopausal Women at high risk (greater than 20% lifetime risk) should get an MRI and a mammogram every year. 6 9/29/2014 Mission The Commission on Cancer (CoC) is a consortium of professional organizations dedicated to improving survival and quality of life for cancer patients through standard-setting, prevention, research, education, and the monitoring of comprehensive quality care. NCDB Cancer Program Practice Profile Reports 1. Breast Conservation rate 2. Needle biopsy utilized for diagnosis of cancer 3. RT after mastectomy if >3 +LN 4. RT after lumpectomy age <70 5. Combination chemotherapy considered age <70 6. Tamoxifen or AI considered +ERA/PRA Questions? [email protected] 7
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