Controversies in Breast Cancer Screening Strategies. Breast Cancer Screening Guidelines

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Controversies in Breast Cancer Screening Strategies Facilitator: Mary Lou Smith, JD, MBA Research Advocacy Network Panel: Therese Bevers, MD, The University of Texas MD Anderson Cancer Center Representing: National Comprehensive Cancer Network Kirsten Bibbins-Domingo, MD, PhD, MAS, University of California, San Francisco Representing: U.S. Preventive Services Task Force Kevin Oeffinger, MD, Memorial Sloan Kettering Cancer Center Representing: American Cancer Society Breast Cancer Screening Guidelines The guidelines are similar in recognizing the benefit of screening mammography in breast cancer detection They differ in recommendations especially for younger women (40-49) The goal of this session is to understand the rationale behind each of these different recommendations

Audience Polling Results In your practice, when do you recommend initiating mammographic screening in women with average-risk of developing breast cancer? 1. Before 40 years old 2. Between 40-44 years old 3. Between 45-49 years old 4. At 50 years old 5. After 50 years old 65% 7% 11% 14% 2% 1 2 3 4 5 Audience Polling Results At what interval(s) do you screen women ages 40-49 with mammography? 1. Annually 2. Bi-annually (every two years) 3. Mix of annually and bi-annually 4. None of the above 68% 22% 7% 3% 1 2 3 4

Audience Polling Results When do you talk about stopping screening? 1. When patient is older than 75 years old 2. It depends on the patient s life expectancy 3. When the patient declines 4. It depends on all of the above factors 58% 12% 27% 3% 1 2 3 4 Audience Polling Results In your experience, how difficult is it to obtain coverage for breast cancer screening mammograms from insurance companies (i.e. payors)? 1. Not at all difficult 2. Not very difficult 3. Neutral/No comment 4. Somewhat difficult 5. Very difficult 46% 34% 5% 13% 1% 1 2 3 4 5

Audience Polling Results Have you seen payors deny coverage for breast cancer screening mammograms? 1. Yes 2. No 74% 26% Yes No Audience Polling Results If you answered YES: Did the payors indicate that their decisions were based on any of the various approaches (e.g. Guidelines recommendations from NCCN, ACS, USPSTF, or other organization)? 1. Yes 2. No 65% 35% Yes No

Introductions Mary Lou Smith, JD, MBA Research Advocacy Network Kirsten Bibbins-Domingo, MD, PhD, MAS University of California, San Francisco Representing: U.S. Preventive Services Task Force Kevin Oeffinger, MD Memorial Sloan Kettering Cancer Center Representing: American Cancer Society Therese Bevers, MD The University of Texas MD Anderson Cancer Center Representing: National Comprehensive Cancer Network Breast Cancer Screening: U.S. Preventive Services Task Force Recommendations Kirsten Bibbins-Domingo, PhD, MD Chair, US Preventive Services Task Force Professor of Medicine and of Epidemiology & Biostatistics University of California, San Francisco

The U.S. Preventive Services Task Force (USPSTF) Independent panel of volunteer, non-federal experts (N=16) Makes recommendations on clinical preventive services offered in the primary care setting (screening tests, preventive medications, counseling) Members with expertise in primary care and in evidence-based medicine/research Family Medicine, Obstetrics and Gynecology, Internal Medicine, Geriatrics, Nursing, Pediatrics, Behavioral Health, Health Systems Explicit process of evidence review with input from sub-specialists with content expertise and public throughout the recommendation development process Basic USPSTF Methods for Developing Recommendations: The Letter Grades Certainty of Net Benefit Magnitude of Net Benefit Substantial Moderate Small Zero/Negative High A B C D Moderate B B C D Low I

USPSTF Grades A B C I All three grades are recommendations in favor of screening They differ by the level of certainty of the evidence and the magnitude of potential net benefit Not enough evidence to make a recommendation NOT a recommendation against screening rather it s a call for more research USPSTF Breast Cancer Screening Recommendations for Women 50-74 years Certainty of Magnitude of Net Benefit Net Benefit Substantial Moderate Small Zero/Negative High A B C D Moderate B B C D Low I The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. B recommendation. The USPSTF concludes with moderate certainty that the net benefit of screening mammography in women aged 50 to 74 years is moderate.

USPSTF Breast Cancer Screening Recommendations for Women 40-49 years Certainty of Magnitude of Net Benefit Net Benefit Substantial Moderate Small Zero/Negative High A B C D Moderate B B C D Low I The decision to start screening mammography in women prior to age 50 years should be an individual one. Women who place a higher value on the potential benefit than the potential harms may choose to begin biennial screening between the ages of 40 and 49 years. C recommendation. The USPSTF concludes with moderate certainty that the net benefit of screening mammography in the general population of women aged 40 to 49 years, while positive, is small. This is a positive recommendation not a recommendation against screening USPSTF Breast Cancer Screening Recommendations for Women 75 years and older Certainty of Magnitude of Net Benefit Net Benefit Substantial Moderate Small Zero/Negative High A B C D Moderate B B C D Low I The current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women age 75 years and older. I statement. Not a recommendation for or against screening a call for more research In the absence of evidence, clinicians and patients must use clinical judgment to determine age to stop screening

American Cancer Society Breast Cancer Screening Guideline Kevin C. Oeffinger, MD Chair, Breast Cancer Screening Guideline Panel American Cancer Society NCCN 21 st Annual Conference April 2, 2016 Current ACS Guideline Development Process Oversight Group Staff Systematic Review Contractor External Expert Advisors (Reviews process and reports to MOC & Board) Guideline Development Group & GDG Breast Subgroup MOC ACS Board

Grading Recommendation Statements Adapted from the handbook for grading the quality of evidence and the strength of recommendations using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach [updated October 2013]. http://www.guidelinedevelopment.org/handbook/#h.33qgws879zw. Accessed September 25, 2015. JAMA October 20, 2015 Volume 314, Number 15 2015 ACS Breast Cancer Screening Guideline S= Strong Recommendation Q = Qualified Recommendation 1. Women with an average risk of breast cancer should undergo regular screening mammography starting at age 45 years (S) 1a: Women who are ages 45 to 54 years should be screened annually (Q) 1b: Women who are 55 years and older should transition to biennial screening or have the opportunity to continue screening annually (Q) 1c: Women should have the opportunity to begin annual screening between the ages of 40 and 44 years (Q) 2. Women should continue screening as long as their overall health is good and they have a life expectancy of 10 years or longer (Q) 3. The ACS does not recommend clinical breast examination for breast cancer screening among average risk women at any age (Q)

Therese Bevers, MD The University of Texas MD Anderson Cancer Center National Comprehensive Cancer Network The National Comprehensive Cancer Network (NCCN ) is an alliance of 26 of the leading academic cancer centers in the United States dedicated to improving the quality, effectiveness, and efficiency of cancer care provided to patients. Multidisciplinary panels that includes experts representing multiple specialties and centers NCCN panels address screening, diagnosis, treatment and management of benign and malignant breast disease

NCCN Categories of Evidence and Consensus Please visit NCCN.org for more information on the NCCN Guidelines Development Process. Mammographic Screening NCCN recognizes that the primary purpose of screening women with average-risk for developing breast cancer is to decrease mortality and morbidity. NCCN recommends annual screening beginning at age 40 after women are counseled regarding potential benefits, risks, and limitations of breast screening. NCCN recommends consideration of severe comorbid conditions limiting life expectancy and whether therapeutic interventions are planned. Upper age not established.

Breast Cancer Screening Consensus Conference Core Group: USPSTF, ACS, NCCN, the American College of Radiology, the American College of Surgeons, the American Academy of Family Physicians, the American College of Physicians, and American Congress of Obstetricians and Gynecologists Stakeholders: Representatives from 22+ other organizations representing women s health care providers, radiologists, patient advocate organizations, and allied women s health professional communities, and patients A recording of this session will be available at http://education.nccn.org by June 2016.