Durado Brooks, MD, MPH Director, Prostate and Colorectal Cancers American Cancer Society

1. Recommendations for Preventing Cancer and Finding It Early:Prostate and ColorectalUCAN Conference May 14, 2015 Durado Brooks, MD, MPH Director, Prostate and Colorectal Cancers American Cancer Society

2. Prostate Cancer

3. USPSTF Recommendation on PCA Screening with PSA (May 2012) “The U.S. Preventive Services Task Force (USPSTF) recommends against prostate-specific antigen (PSA)-based screening for prostate cancer... This recommendation applies to men in the U.S. population that do not have symptoms that are highly suspicious for prostate cancer, regardless of age, race, or family history. “

4. Guidelines from other organizations

5. What’s Different about Prostate Screening? Compared to other recommended cancer screenings: Less scientific evidence that prostate cancer screening saves lives Breast Cancer: 9 studies show mammograpy lowers deaths Prostate Cancer: 2 positive studies, and 1 in which screening did not lower the risk of dying from prostate cancer Studies did not include significant numbers of African American or other high risk men Available tests are less accurate False positives and false negatives very common More evidence of Overdiagnosis (~1 out of every 4 cases in African Americans) Major treatment side effects and complications Overtreatment (one-third to one-half of all treated men would likely do well without treatment)

6. Limitations/Harms . False negative results • PSA and DRE “normal”, but cancer is present • May lead to false reassurance and delayed diagnosis Research has shown that no PSA level can completely rule-out cancer • Prostate Cancer Prevention Trial found cancer in significant proportion of men with “normal” PSA level

7. False Negative Results Prostate Ca in Men with PSA < 4.0ng/ml in the Prostate Cancer Prevention Trial Adapted from Thompson I. N Engl J Med 2004;350:2239-46

8. False Negative PSA 4.0+ PSA 4+ 7.6% Positive biopsy 25% High grade 19% <4.0 “Normal” PSA 92.4% Positive biopsy 15% High grade 15% PSA Sources: SEER, PCAW, Prostate Cancer Prevention Trial Data

9. False Negative – Population Level 4.0+ PSA 4+ 7.6% Positive biopsy 25% High grade 19% <4.0 “Normal” PSA 92.4% Positive biopsy 15% High grade 15% PSA Screen 10,000 Men PSA 4+ 760 Cancer 190 High grade 36 PSA <4 9240 Cancer 1386 High grade 208 Sources: SEER, PCAW, Prostate Cancer Prevention Trial Data

10. False Positive Results If 100 men in each age group are tested: *Lowering the threshold PSA (e.g. to 2.5 ng/ml) will increase false positives and resulting biopsies

11. False Positive PSA False positive results may lead to: • Anxiety and fear of a cancer diagnosis • Additional tests, with associated costs and risk of complications • Insurance implications* • “pre-existing condition” exclusions for health insurance • Life insurance - high rates or uninsurable *A prostate cancer diagnosis carries similar implications

12. Overdiagnosis

13. Treatment Risks/Harms . • Estimates from USPSTF review: • 90% of diagnosed men choose active treatment • 195,000 men each year • 38% radiation • 40% prostatectomy • 5/1000 men die within 30 day of prostatectomy • 200-300/1000 treated men experience impotence, incontinence or both These complications may be a worthwhile trade-off for men whose lives are saved by treatment, but it is not clear how many men fall into this category.

14. False negatives and false positives are common. • Overdiagnosis and overtreatment are problems, but the magnitude is uncertain. • Treatment-related complications and side effects can be significant. Balance of Benefits and Harms PotentialHarms PotentialBenefits • PSA screening detects cancers earlier. • Treating PSA-detected cancers may be more effective, but this is uncertain. • PSA may contribute to the declining death rate, but the extent is unclear

15. ACS Guideline for the Early Detection of Prostate Cancer Source: Wolf, et al. CA, 2010 The American Cancer Society recommends that asymptomatic men who have at least a 10-year life expectancy have an opportunity to make an informed decision with their health care provider about whether to be screened for prostate cancer, after receiving information about the uncertainties, risks, and potential benefits associated with prostate cancer screening.

16. ACS Guideline *Men who have less than 10 year life expectancy (due to age or health problems) should not be screened Age to start the discussion depends on risk

17. ACS Guideline: Emphasis on Informed Decision Making African American and men with PCa family hx should be informed of their increased risk Core elements of IDM discussion: • Screening increases the chance of finding prostate cancer at an earlier stage • Screening might lower a man’s risk of dying from prostate cancer – but this is not entirely clear • Screening gives many false negative and false positive results • Overdiagnosis and overtreatment are common

18. ACS Decision Aids

19. Decision Aids: Values and Preferences

20. ACS Guideline:Supporting Materials and Information • Materials for clinicians and patients are available at www.cancer.org/prostatemd • Patient Decision Aid “Should I Be Tested for Prostate Cancer” • Brochure “What You Should Know About Prostate Cancer Testing” • Links to videos for patients and clinicians • Prostate Cancer Fact Sheet • Cancer Facts for Men • Links to decision aids from other organizations

21. Research Needs • New screening paradigms • Identifying higher risk men at earlier age • New screening and diagnostic tools • Detect men at risk of significant cancers • Detect cancers but not benign disease • Distinguish aggressive, dangerous prostate cancers from slow-growing, low risk forms • New Treatments • lower risk of complications, side effects

22. Research Needs • Optimal approaches to informed decision-making • Screening • Treatment • Appropriate use of active surveillance • Evaluation of AS factors and outcomes in African American men • High quality treatment for all who choose to be treated • Treatment disparities for African American men well-documented • Potential for improved access and outcomes through ACA, health system restructuring

23. Colorectal Cancer

24. Colorectal Cancer (CRC) • 3rd most common cancer and the 2nd deadliest in the U.S. • 132,700 new cases in US in 2015 • More than 49,000 deaths • Incidence and death rates falling steadily over the past 20 years • Treatment advances • Screening --> prevention and early detection

25. ColorectalCancer Incidence, 1980-2008 Incidence Rate per 100,000 Utah DOH

26. ColorectalCancer Mortality, 1980-2008 Age Adjusted Mortality Rate per 100,000 Utah DOH

27. ColorectalCancer Deaths by Race, Utah Utah DOH

28. Age: the most impactful risk factor CRC usually develops after age 50. The chances of getting it increases as you get older. http://science.education.nih.gov/supplements/nih1/cancer/guide/pdfs/ACT3M.PDF. CRC screening should begin at age 50 for most people, earlier for those with a family history.

29. Why Screen for CRC?There are two aims of screening: 2. Early Detection Find cancer in the early stages, when best chance for a cure 1. Prevention Find and remove polyps to prevent cancer

30. Risk factor - polyps Different types of polyps: • Hyperplastic • Low risk: very small chance they’ll grow into cancer • Adenomas • About 9 out of 10 colon and rectal cancers start as adenomas Usually takes 10 or more years for polyp to become cancer

31. Benefits of Screening *1996 - 2003

32. CRC mortality under 2 screening scenarios 80% screening rate by 2018 yields: • 43,000 averted cases and 21,000 averted cancer deaths/yr • 277,000 cases averted and 203,000 total averted deaths from 2013 through 2030

33. 80% Colon Cancer Screening Rate By 2018

34. http://nccrt.org/tools/80-percent-by-2018/

35. http://nccrt.org/tools/80-percent-by-2018/

36. Recommended Screening Tests ACS and USPSTF • Colonoscopy • High Sensitivity Fecal Occult Blood Testing • Guaiac • Immunochemical • Flexible Sigmoidoscopy (FSIG) • Recent studies support efficacy • Availability extremely limited in U.S.

37. CRC Screening: National Rates In 2012, 65.1% of US adults were up to date with screening. • The percentages of blacks and whites up-to-date with screening were equivalent. • Lower rates for Hispanics and Native Americans • Lowest rates among the uninsured

38. CRC Screening: Utah In 2012, 70.2%of Utah adults were up to date with screening. • Significant differences by race/ethnicity, as well as by education and income

39. CRC Screening by Race, Utah 2012-2013 Utah DOH

40. CRC Screening by Ethnicity, Utah 2012-2013 Utah DOH

41. CRC Screening by Education, Utah 2012-2013 Utah DOH

42. CRC Screening by Education, Utah 2012-2013 Utah DOH

43. What’s the Problem? • Medical practice is demand (patient) driven • Practice demands are numerous/diverse • Few practices currently have mechanisms to assure that every eligible patient gets an appropriate recommendation for screening. • Opportunistic vs organized screening

45. “Action Plan” Toolkit Version Eight page guide introduces clinicians and staff to concepts and tools provided in the full Toolkit Contains links to the full Toolkit, tools and resources Not colorectal-specific; practical, action-oriented assistance that can be used in the office to improve screening rates for multiple cancer sites (colorectal, breast and cervical) Available at http://nccrt.org/about/provider-education/crc-clinician-guide/

46. Staff Involvement • Key Point…..the clinicians cannot do it all! • Time that patients spend with non-clinician staff is underutilized • Standing orders can empower nurses, intake staff, etc. to distribute educational materials, schedule appointments, etc. • Involve staff in meetings to discuss progress in achieving office goals for improving the delivery of preventive services

47. Communication

48. http://nccrt.org/about/provider-education/manual-for-community-health-centers-2/http://nccrt.org/about/provider-education/manual-for-community-health-centers-2/

50. http://nccrt.org