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The Evolution of Colorectal Cancer Screening

Learn about the FIT-Test, a new screening test for colorectal cancer. Examine the evidence supporting the use of FIT instead of colonoscopy for average-risk individuals. Explore the expected outcomes of a positive FIT test and the changes to the ColonCancerCheck program. Discover the role of primary care providers in FIT implementation in Ontario.

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The Evolution of Colorectal Cancer Screening

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  1. The Evolution of Colorectal Cancer Screening Survival with the FIT-Test Dr. Jan Owen & Dr. Brian YanMay 9, 2018

  2. Faculty/Presenter Disclosure • Faculty: Dr. Jan Owen and Dr. Brian Yan • Relationships with commercial interests: • Grants/Research Support: None • Speakers Bureau/Honoraria: None • Consulting Fees: None • Other: Employees of Cancer Care Ontario • Potential for conflict(s) of interest: • None • All information provided in presentation has been provided by Cancer Care Ontario.

  3. Learning Objectives • Introduce a new test for colorectal cancer screening: the Fecal Immunochemical Test (FIT) • Examine evidence to support FIT (instead of colonoscopy) for screening in persons at average risk for colorectal cancer • Discuss the expected outcomes of a positive FIT colonoscopy • Describe changes to the ColonCancerCheckprogram • Discuss primary care providers’ role in FIT implementation in Ontario

  4. Colorectal Cancer in Ontario • In 2018, it is estimated that approximately 6,376 men will be diagnosed with colorectal cancer and approximately 1,811 will die from it • Second leading cause of cancer deaths. • In 2018, it is estimated that approximately 5,219 women will be diagnosed with colorectal cancer and approximately1,548 will die from it • Third leading cause of cancer deaths. Colorectal cancer is the 2nd most commonly diagnosed cancer in Ontario

  5. gFOBT vs. No Screening 13% reduction in death Tinmouth et al. Program in Evidence-based Care (PEBC) Evidence Summary 2015; 15-14

  6. Organized CRC Screening in Canada FIT in 8 provinces, 1 territory

  7. CCC is planning to implement FIT as the recommended test for people at average risk of CRC

  8. What is FIT? • Fecal immunochemical test • At-home CRC screening test • One sample • Tube designed for easy sampling • Automated test processing at laboratory • Quantitative result

  9. FIT vs. gFOBT- Lab Parameters Detects lower levels of blood in stool No dietary restrictions Tinmouth J, et. al. Gut. 2015 Aug;64(8):1327-37.

  10. FIT vs. gFOBT- Lab Parameters Tinmouth J, et. al. Gut. 2015 Aug;64(8):1327-37.

  11. Accuracy for CRC: One Time Test FIT is comparable to mammography & Pap smear 1Lee J, et al. Ann Intern Med 2014;160:171-181. 2Canadian Task Force on Preventive Health Care. Screening for Colorectal Cancer. 2014.

  12. FIT vs. gFOBT – Clinical Implications 16% improvement 2X more accurate Tinmouth et al. Program in Evidence-based Care Evidence Summary 2015; 15-14

  13. Adenoma to Cancer Cancer Advanced adenoma FIT has potential to reduce the incidence of CRC FIT detects gFOBTdetects

  14. FIT vs. Colonoscopy for Average Risk Screening:The Evidence

  15. FIT vs. Colonoscopy Large RCT in Spain Mailed invitation to participate Primary outcome: CRC- death at 10 years Ages 50-69 years old Biennial FIT vs. one-time colonoscopy Reflects only the first round results • Quintero E., et. al., NEJM 2012;366:697-706

  16. Diagnostic Yield- Intention to Screen Quintero E., et. al., NEJM 2012;366:697-706

  17. Colonoscopy-Associated Complications Colonoscopy is not a benign procedure Rabeneck L., et. al., Gastroenterology 2008; 1899-1906.

  18. Screening with Colonoscopy vs FIT • 1.3 million screened • 100,000 screened 100,000 scoped 100,000 scoped yield with FIT 20x 4.5x FIT+ colonoscopy Average risk colonoscopy FIT: more people screened • same number of colonoscopies • more cancers detected

  19. FIT vs. Colonoscopy for Average Risk Screening: FIT Experience in Alberta

  20. Alberta FIT Roll Out: Impact on Colonoscopy Introduction of FIT CCSC 2015; courtesy of Dr Bob Hilsden

  21. Alberta: Lesions Detected at Colonoscopy Normal Normal Low risk adenoma Low risk adenoma Advanced adenoma Cancer Advanced adenoma CCSC 2015; courtesy of Dr Bob Hilsden

  22. FIT vs. Colonoscopy – Take Home • FIT is preferred by patients • FIT is as good as colonoscopy for detecting CRC in average risk patients • FIT is safer than colonoscopy • FIT-positive colonoscopy is high yield → colonoscopy used in persons most likely to benefit FIT  Better risk – benefit ratio of screening • The CCC program does not recommend screening with colonoscopy for average risk patients

  23. Transition to FIT

  24. Who Should be Screened with FIT? The ColonCancerCheck eligibility criteria for individuals: • Ages 50-74 at average risk • No first degree relative diagnosed with colorectal cancer • Asymptomatic • No screening with gFOBT or FIT in the past two years • No screening with colonoscopy or flexible sigmoidoscopy in the past 10 years • Valid Ontario Health Insurance Plan number Eligibility criteria have not changed

  25. How to Order FITfor Your Patients • Submit completed FIT requisition to central lab* • Lab will mail pre-labelled FIT kit to patient Step 3 Step 4 Step 2 Step 1 • * Participants may also request FIT through a mobile coach or Telehealth Ontario; patients who live on a First Nation reserve can request a FIT at a health centre or nursing station

  26. Requisition Changes Regular lab requisition cannot be used to request CCC program FIT (or gFOBT)

  27. New FIT Requisition New FIT requisition

  28. Ensure Your Patients Get Their FIT • Confirm that patient address information is up-to-date: • to obtain a FIT kit • to receive results Alternate FIT kit delivery option

  29. Why Centralized Distribution? • 11.1% of program gFOBTrequire re-testing • Majority of rejected tests due to mislabeling • Pre-labeled kits with patient identifiers • Inventory management at central site • gFOBTshelf-life: 3 years • FIT shelf life: 12-18 months

  30. Completing FIT: 3 Steps for Patients Step 1 Step 2 Step 3 *Ideally within 2 days, to ensure it arrives to the lab within 14 days of specimen collection *CCO is working on confirming options for completed FIT return for individuals living on a First Nation reserve.

  31. Multiple Options for FIT Return • Mail • Regular mail • Xpresspostincluded for some areas • Drop off at lab specimen collection centres • CCO is working on confirming options for completed FIT return for individuals living on a First Nation reserve

  32. Supporting Patients • User tested, patient-friendly FIT materials are being developed, including FIT instructions that use more visuals than words • Patients will continue to receive CCC correspondence DRAFT

  33. How to Manage Patients with an Abnormal FIT

  34. Case study #1 Anna is a 64 year old woman who has recently completed a Fecal Immunochemical Test (FIT). When her FIT result comes back as abnormal (positive), Anna calls you and mentions that she completed her FIT just one day after having a tooth removed by her dentist. Anna would like to repeat the FIT. What should you do and why?

  35. Case study #1 What should you do and why? a) Complete another FIT requisition for Anna b) Refer Anna for flexible sigmoidoscopy c) Have Anna come for an in-office gFOBT d) Counsel Anna on the importance of a follow-up colonoscopy and refer her promptly for colonoscopy e) None of the above

  36. FIT Results and Follow-Up by PCP • Results • Repeat FIT in 2 years* • Lab(s) will send FIT result to PCP • Cancer Care Ontario will send FIT result letter to patient • Normal Result • PCP to arrange for follow-up colonoscopy to be performed within 8 weeks • Abnormal Result Do NOT repeat FIT * For those aged 50-74

  37. Follow-Up of Abnormal FIT Results 50% of individuals receive a colonoscopy within 8 weeks of a gFOBT+ result • Approximately 25% of individuals are lost to follow-up at 6 months Time to colonoscopy after gFOBT+ result 6 months 4 months 2 months

  38. Importance of Follow-Up No follow-up Follow-up FIT+ who do not undergo colonoscopy are more likely to die from CRC Lee et al. JNCI 2017

  39. Importance of Timely Follow-Up Impact of diagnostic delay is seen within months - Significantly higher risk of CRC after 6 months Corley et al. JAMA 2017; 317(16): 1631-1641.

  40. Follow-Up of Abnormal FIT Results 50% of individuals receive a colonoscopy within 8 weeks of a gFOBT+ result • Approximately 25% of individuals are lost to follow-up at 6 months Time to colonoscopy after gFOBT+ result 6 months 4 months 2 months • Timely follow-up is a critical issue in Ontario  particularly important to address for FIT

  41. Case Study #2 Your 53 year old patient is due for gFOBT screening in June 2018. John, who has no family history of colorectal cancer, has heard about the Fecal Immunochemical Test (FIT) and would like to either wait for the introduction of FIT or complete both the gFOBT and FIT in 2018. What would be the appropriate response to John?

  42. Case Study #2 What would be the appropriate response to John? a) Tell John he can delay screening until FIT is available later in the year b) Tell John he can complete both screening tests c) Tell John he should not delay screening and should complete the gFOBT d) Tell John that the FIT is not as good as the gFOBT at detecting colorectal cancer e) Both c and d

  43. gFOBT vs. No Screening 13% reduction in death Tinmouth et al. Program in Evidence-based Care (PEBC) Evidence Summary 2015; 15-14

  44. When will FIT be Available in Ontario? • Until further notice: gFOBT remains the recommended CRC screening test in Ontario • We are actively working towards FIT: coming soon! Laboratories Communications Funding STAY TUNED Program design Quality assurance IT

  45. Clinical Pearls Use FIT, not colonoscopy • Centralized FIT kit distribution will minimize errors • FIT+ colonoscopy needed within 8 weeks • Screen with gFOBT until FIT is available

  46. Appendix

  47. Considerations • Post polypectomy surveillance recommendations are primarily intended for endoscopists to ensure appropriateness of colonoscopy • When referring for endoscopist surveillance, include prior scope & path report if available • How should PCPs manage cases where endoscopist recommendation does not align with surveillance guidelines? • Endoscopist recommendation may be influenced by other factors not accounted for in the surveillance guidelines, such as quality of colonoscopy: • Adequate bowel preparation, complete procedure to cecum, careful examination of colonic mucosa • Guidelines can be used to assist discussion with endoscopists

  48. CRC Mortality in Low Risk Adenoma vs. General Population • CRC Mortality in LRA vsGeneral Population • 25% significant relative risk reduction in CRC mortality of LRA vs. general population • Standardized mortality ratio = 0.75 (95% CI: 0.63–0.88) Loberg et al. N Engl J Med 2014

  49. Switching to FIT After Average Risk Colonoscopy • Systematic Review: Risk of advanced neoplasia and death with low risk adenomas • No evidence to support surveillance in people with LRA • Lower risk of CRC and CRC mortality compared to the general population • Small increase in relative risk for high risk adenoma at 4-10 years compared to those with normal colonoscopy

  50. Patient Attachment • PCPs can still register to accept and roster new patients who require follow-up • Code Q043A or Q053A

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