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U.S. Preventive Services Task Force Screening Guidelines for Breast Cancer: Does it make sense? Does it help the PCP? Melanie Royce, MD, PhD Associate Professor, Department of Internal Medicine Chief of the Section of Breast Oncology, Division of Hematology-Oncology The University of New Mexico Cancer Center Objectives • What has changed in the new guidelines? Compare previous guidelines to the newly issued breast cancer guidelines • What is the rationale/reasoning behind the changes? Evaluate the science behind the recent guidelines • How does the change in guidelines impact current clinical practice? Consider additional implications Screening as a Public Health Prevention Tool: Classic Criteria • Natural history of disease is there a detectable preclinical phase? • Treatment: • Is effective treatment available? • Is treatment more effective if initiated at a pre-symptomatic stage? Does shift to earlier stage decrease mortality? • Screening Test: • Is it safe, inexpensive, acceptable? • Does it offer good discrimination between diseased and non-diseased? U.S. Preventive Services Task Force Grading of Recommendations Grade Certainty Net Benefit USPSTF Recommendation A High Substantial Yes, routinely offer B High Moderate Yes, offer C Moderate/High Small Not routinely offered D Moderate/High None No, discourage I Insufficient evidence Unknown No recommendation 2002 Breast Cancer Screening Recommendations • Screening mammography every 1-2 years for all women starting at age 40 (Grade B) • Emphasized that doctors should inform women about risks and benefits • Benefits of mammography increased with age • Breast self-exam (BSE) insufficient evidence, no recommendation (Grade I) • Clinical breast exam (CBE) insufficient evidence, no recommendation (Grade I) 2009 Breast Cancer Screening Recommendations Ann Intern Med 2009;151:716-726 2009 Breast Cancer Screening Recommendations Ann Intern Med 2009;151:716-726 2009 Recommendations: Key changes • Women age 40-49 (Grade C): • Should not receive routine mammography • Decision to start screening should take into account patient’s values re: benefits and harms • Applies only to women of average risk • Women age 50-74 (Grade B) Should be screened biannually • Women age > 75 (Grade I) • Breast self-exam (Grade D) Should not be taught Rationale for age recommendations •For most women, increasing age is the most important risk factor for breast cancer •Benefit for screening seems equivalent for women 40 to 49 yrs and 50 to 59 yrs, but… • Incidence and consequences differ between age groups Rationale for age recommendations Number of women needed to invite for screening for a 10-yr period to extend one woman’s life, by age group(decade) NNI= Number of Women Needed to Invite Rationale for age recommendations •Based on data selected and using number needed to screen to save 1 life as its metric, the USPTFS concluded that there is: • Moderate evidence that net benefit is small for women aged 40-49 • Moderate certainty of moderate benefit for women aged 50-74 • Lacking evidence for women aged >75 and balance of benefit/harms cannot be determined Choices Involve Value Judgments “The ages at which … tradeoff becomes acceptable to individuals and society are not clearly resolved by the available evidence” Heidi Nelson, M.D. University of Oregon, Evidence-Based Practice Center, USPSTF meta-analysis first author U.S. Preventive Services Task Force Panel and Data Sources • Panel involved well-respected scientists and institutions for meta-analysis and modeling • Panel membership was critiqued for not including radiologists • Data selected were best available Screening as a Public Health Prevention Tool: Breast Cancer as an Example • Natural History: Detectable preclinical phase Yes, for some tumors, but not all • Treatment: • Effective treatment available Yes, for majority of tumors • Treatment more at pre-symptomatic stage Early treatment prevents metastases • Screening Test (mammography): • Safe, inexpensive, acceptable Yes • Discriminates clinically relevant disease vs. not criteria where mammography is weak – Why? Screening as a Public Health Prevention Tool: Breast Cancer as an example • Tumor biology limits mammography as a screening test, particularly for younger women • Breast density, highest < 50 or pre-menopause, may obscure a tumor on imaging Screening as a Public Health Prevention Tool: Breast Cancer as an Example • Most aggressive tumors will not be caught by screening (interval cancers, Tumor D) • Mammography cannot identify tumors most likely to result in mortality Overdiagnosis (Tumor B) Esserman JAMA 2009. Unfortunately, None of these nuances, some of which disproportionately affect women aged 40 to 49, were clearly communicated Media Attention to Guidelines Mammograms Provide Preview of ObamaCare Access To Mammograms Decreased Following New Breast Cancer Screening Guidelines. New Breast-Cancer Screening Guidelines: Confusion, Dismay or Relief? New breast cancer screening guidelines confuse women Public Reaction to the Guidelines • Large perception that women under age 50 should not receive a mammogram • Related fear that health insurance companies will stop covering mammograms for women aged 40-49 • Breast cancer advocacy organizations apprehensive that it would undermine their prevention efforts Emphasis Leads to Misconception • “USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening before age 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms”. • “USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening before age 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms”. • “USPSTF recommends against screening mammography in women aged 40 to 49 years”. Scientifically, USPSTF recommendations • Appear sound in terms of methodology and data used for guideline development • Biological reasons for differences in efficacy of mammography for women age 40 to 49 exist • Choice of optimal ratio for benefit/harm can be critiqued, but that is beyond the science We can all agree that… • Scientific panels need assurance that guidelines can be issued free of undue influence or pressure • Politicized response to scientific process creates uncomfortable tension and precedent • Guidelines that are set under fear of reprisal is unlikely to serve the common good • Need to encourage thoughtful public debate about the science and about the value judgments they entail Future Direction, Shift in Strategy: Focus on Addressing Tumor Biology • Identify markers that differentiate clinically significant from minimal-risk breast tumors • Identify the patients at highest risk for breast cancer mortality before they develop cancer, and direct prevention efforts to them • Reduce or eliminate treatment for minimal-risk tumors • Develop patient communication tools to support informed decision-making about screening and treatment Thank you