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

2 Prostate Cancer

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. “

Guidelines from other organizations OrganizationRecommendation American Cancer Society (2010) Shared Decision Making National Comprehensive Cancer Network (2010) Shared Decision Making American Society of Clinical Oncology (2012) Shared Decision Making American Urological Association (2013) Shared Decision Making

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)

. 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 Limitations/Harms

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

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

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

False Positive Results Age (in years) # With PSA > 4.0* # With Cancer # False Positives 50s51–23–4 60s153–510–12 70s27918 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

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 False Positive PSA *A prostate cancer diagnosis carries similar implications

Overdiagnosis Risk of Pca Diagnosis & Death during the next 15 years (per 1000 men ) Age 50 Age 65 Race/EthnicityDiagnosisDeathDiagnosisDeath All White African American

. 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 /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.

 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  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. Potential Benefits Balance of Benefits and Harms Potential Harms

ACS Guideline for the Early Detection of Prostate Cancer 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. Source: Wolf, et al. CA, 2010

ACS Guideline Age to start the discussion depends on risk Risk GroupAge Average (with life expectancy 10 years or more*)50 Increased (African American or family history)45 Highest (multiple family members) 40 *Men who have less than 10 year life expectancy (due to age or health problems) should not be screened

ACS Guideline: Emphasis on Informed Decision Making 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 African American and men with PCa family hx should be informed of their increased risk

ACS Decision Aids

Decision Aids: Values and Preferences

ACS Guideline: Supporting Materials and Information Materials for clinicians and patients are available at –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

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

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

Colorectal Cancer (CRC) 3 rd most common cancer and the 2 nd 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

Colorectal Cancer Incidence, Incidence Rate per 100,000 Utah DOH

Colorectal Cancer Mortality, Age Adjusted Mortality Rate per 100,000 Utah DOH

Colorectal Cancer Deaths by Race, Utah Utah DOH

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

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

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

Benefits of Screening *

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

80% Colon Cancer Screening Rate By 2018

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.

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

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

©2010 American Cancer Society, Inc. No CRC Screening by Race, Utah Utah DOH

©2010 American Cancer Society, Inc. No CRC Screening by Ethnicity, Utah Utah DOH

©2010 American Cancer Society, Inc. No CRC Screening by Education, Utah Utah DOH

©2010 American Cancer Society, Inc. No CRC Screening by Education, Utah Utah DOH

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

©2009 American Cancer Society, Inc. No

“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 education/crc-clinician-guide/

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

Communication

Step #1 Make A Plan Determine Baseline Screening Rates Identify your patients due for screening Identify patients who received screening Calculate the baseline screening rate Improve the accuracy of the baseline screening rate Design Your Practice's Screening Strategy Choose a screening method Use a high sensitivity stool- based test Understand insurance complexities. Calculate the clinic's need for colonoscopy Consider a direct endoscopy referral system Step #2 Assemble A Team Form An Internal CHC Leadership Team Identify an internal champion Define roles of internal champions Utilize patient navigators Define roles of patient navigators Agree on team tasks Partner with Colonoscopists Identify a physician champion Step #3 Get Patients Screened Prepare The Clinic Conduct a risk assessment Prepare The Patient Provide patient education materials Make A Recommendation Convince reluctant patients to get screened Ensure Quality Screening for Stool- Based Screening Program Track Return Rates and Follow-Up Measure and Improve Performance Step #4 Coordinate Care Across The Continuum Coordinate Follow-Up After Colonoscopy Establish a medical neighborhood 49

51 Who’s Not Screened?

Address Potential Barriers to Screening* “I do not have health insurance and would not be able to afford this test. I do not feel the need to have it done.” #1: Affordability “Doctors are seen when the symptoms are evidently presumed, not before.” #2: Lack of symptoms “Never had any problems and my family had no problems, so felt it wasn't really necessary.” #3: No family history of colon cancer #1 reason among year olds & Hispanics #1 reason among 65+ year olds Nearly ½ uninsured *Based on 2014 consumer surveys

53 Address Potential Barriers to Screening* “I do not think it is a good idea to stick something where the sun don’t shine. The yellow Gatorade I cannot stomach.” #4: Perceptions about the unpleasantness of the test “I fear it will be uncomfortable. My doctor has never mentioned it to me, so I just let it go.” #5: Doctor did not recommend it “I just turned 50 and I am dealing with another health issue, so it's on the back burner.” #6: Priority of other health issues #1 reason among Black/African Americans; #3 reason among Hispanics *Based on 2014 consumer surveys

Activating Messages that Motivate  Most successful communications campaigns relay 3 messages to allow consumers to comprehend what is being asked to motivate action.  We recommend utilizing these messages, or similar messaging, to educate your constituents around options to help achieve our goal. There are several screening options available, including simple take home options. Talk to your doctor about getting screened. Colon cancer is the second leading cause of cancer deaths in the U.S., when men and women are combined, yet it can be prevented or detected at an early stage. Preventing colon cancer, or finding it early, doesn’t have to be expensive. There are simple, affordable tests available. Get screened! Call your doctor today.

Clinicians Reference: FOBT One page document designed to educate clinicians about important elements of colorectal cancer screening using fecal occult blood tests (FOBT). Provides state-of-the-science information about guaiac and immunochemical FOBT, test performance and characteristics of high quality screening programs. Available at High Quality Stool Testing

New CDC Resource  A new CDC-sponsored program to provide guidance and tools for clinicians on the best ways to implement screening for colorectal cancer.  Two versions: one for primary care providers and one for clinicians who perform colonoscopy procedures.  Continuing education credits are available at no cost for physicians, nurses, and other health professionals.

Cancer Resource Network The American Cancer Society is available 24 hours a day, 7 days a week, to help guide you through every step of a cancer experience. Referral for day-to-day questions such as financial, insurance, transportation, and lodging. Connection to others who have been there for emotional support. Easy to understand information to help you make decisions about your care cancer.org