Breast Cancer Screening Guidelines: Do They All Say the Same Thing?

1. Breast Cancer Screening Guidelines: Do They All Say the Same Thing? Marilyn Kile MSN, APRN-NP, ANP-BC, AOCNP Good Samaritan Hospital Cancer Center Every Woman Matters August 14, 2014

2. What Makes a Good Screening Test? Screening Tests Are Helpful When They: • Find cancer before symptoms occur • Screen for a cancer that is easier to treat and cure when found early • Has few false-negative test results (sensitivity) and few false-positive test results (specificity) • Decreases the chance of dying from cancer • Cost is reasonable National Cancer Institute, 2014

3. Who Publishes Cancer Screening Guidelines • American Cancer Society (ACS) • National Comprehensive Cancer Network (NCCN) • United States Preventive Services Task Force (USPSTF) • Professional Organizations (not inclusive list) • American College of Obstetricians and Gynecologists • The American Gastroenterology Association • American Family Physician

4. Guidelines Should be Evidence Based: Levels of Evidence • Not all evidence is created equal • It tries to answer the question: • “How certain can you be that the stated evidence is a true measure of the benefits and harms of treatment?” Cochrane Consumer Network: Retrieved on 6/9/2014

5. ACS: Levels of Evidence • Exact breakdown of evidence not found on website or in journal • ACS revised its process for creating cancer screening guidelines • More consistent with the new Institute of Medicine (IOM) standards for trustworthy clinical guideline development • Created a Guideline Development Group for writing the guidelines, using independent systematic review of evidence, and requires clear articulation of the benefits, limitations, and harms associated with each screening test • Ongoing process for reviewing evidence, commitment to update guidelines every 5 years or sooner if evidence warrants Smith et al., 2014

6. NCCN: Levels of Evidence • Levels of Evidence • Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. • Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. • Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate. • Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate. • All recommendations are category 2A unless otherwise noted National Comprehensive Cancer Network, Retrieved on 6/9/214

7. USPSTF: Level of Certainty USPSTF, 2012

8. USPSTF: Grading System for Recommendations USPSTF, 2012

9. Breast Cancer Screening GuidelinesAverage Risk

10. ACS: Average Risk Breast Cancer Screening Smith et al., 2014

11. NCCN: Average Risk Breast Cancer Screening NCCN, 2014

12. USPSTF: Breast Cancer Screening Recommendations • Recommends biennial screening mammography for women aged 50 to 74 years. Grade: B recommendation • The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. Grade: C recommendation • Concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. Grade: I Statement USPSTF, 2009

13. USPSTF: Breast Cancer Screening Recommendations • Recommends against teaching BSE. Grade: D recommendation • Concludes that the current evidence is insufficient to assess the additional benefits and harms of CBE beyond screening mammography in women 40 years or older. Grade: I Statement • Concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer. Grade: I Statement USPSTF, 2009

14. What are the differences?

15. Difference in Recommendations • Minimal difference between ACS and NCCN • Variation between USPSTF & ACS / NCCN • Mammography for women 40 to <50 years • Biennial versus annual screening • Screening women after the age of 75 • CBE

16. Screening Women in 40s USPSTF ACS / NCCN Meta – analysis supports screening at age 40 Benefit of early detection includes less aggressive treatment and a wide range of treatment options Benefits versus risk strongly supports the value of screening and the importance of adhering to a schedule of regular mammograms • Lower breast cancer incidence in younger women – have to screen more women to prevent one death • Initiation of screening younger women leads to higher cumulative rates of false-positive results and associated potential harms (biopsies) and this alters the risk/ benefit ratio of screening this age group Pace et al., 2013; NCCN, 2014; Smith et al., 2014

17. Biennial Screening USPSTF ACS / NCCN Acknowledges the controversy Believes evidence supports the benefit of annual mammogram outweighs the risk of the procedure as breast cancer mortality is lower with annual screening • A large proportion of the benefit of screening mammography is maintained by biennial screening • Changing from annual to biennial screening is likely to reduce the harms of mammography screening by nearly half • At the same time, benefit may be reduced when extending the interval beyond 24 months USPSTF, 2009; NCCN, 2014; Smith, 2014

18. Screening After Age 75 USPSTF ACS / NCCN Acknowledge there is limited data High incidence of breast cancer in elderly women Clinicians should use judgment when applying screening guidelines • No women > 75 years have been included in the randomized clinical trials • The benefits of screening occur only several years after the actual screening test, whereas the percentage of women who survive long enough to benefit decreases with age • Most breast cancer detected in this age group is estrogen receptor-positive type • Women of this age are at greater risk for dying of other conditions USPSTF, 2009; NCCN, 2014; Smith, 2014

19. CBE • USPSTF: Insufficient evidence to assess the additional benefits and harms of CBE beyond screening mammography; ACS / NCCN Recommend • Variation in how providers conduct a CBE • NCCN defines adequate breast exam as including “upright and supine position during exam, appearance of breast and palpation of all components of the breast” • No disagreement that mammography can detect breast cancer up to two years before it could be detected by CBE USPSTF, 2009; NCCN, 2014

20. Trends in Average RiskBreast Cancer Screening • The Affordable Care Act requires insurers to cover mammography, with no cost-sharing, every one to two years for women starting at age 40; Medicare fully pays for mammograms once every 12 months with no upper age limit • One study observed no decrease in mammography rates for women age >40 (in any age group) following publication of the USPSTF recommendations • There are programs that utilize USPSTF recommendations Pace et al., 2013; Factcheck.org, 2013

21. Future Needs in Breast Cancer Screening • Stratify risk • Calls for more research • Calls for objectivity when evaluating the evidence • A need to have better communication of the risks and benefits

22. Do we have guidelines that stratify risk for breast cancer screening?

23. Increased Risk Screening for Breast Cancer NCCN, 2014

24. Increased Risk Screening for Breast Cancer NCCN, 2014

25. High Risk Screening for Breast Cancer • NCCN Guidelines address the following situations • Individuals who test positive for deleterious mutation • Individuals where there is a known mutation in the family but have not tested for the mutation • Individuals where there is a known mutation in the family but have tested negative • Individuals with strong family history suggestive of hereditary syndrome not undergoing genetic testing or when no mutation is found • Individuals with strong family history undergoing genetic testing with finding of variant of unknown significance NCCN, 2014

26. High Risk Screening for Breast Cancer • Breast cancer awareness starting at age 18 • CBE every 6 to 12 months starting at age 25 • Breast screening • Age 25 to 29, annual breast MRI screening (preferred) or mammogram if MRI is unavailable or individualized based on the earliest age of onset in the family • Age >30 to 75, annual mammogram and breast MRI screening • Age >75 years, management should be considered on an individual basis • Risk reducing measures • Investigative imaging and screening studies NCCN, 2014