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Cologuard vs Colonoscopy Options for Colon Cancer Screening

Cologuard vs Colonoscopy Options for Colon Cancer Screening. Eric Poulin, MD. 2017 AAPCE CME Conference November 3, 2017. Disclosures. Employer Mayo Clinic Health System Mayo has financial relationship to Cologuard Personal No financial relationships. Cologuard vs Colonoscopy.

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Cologuard vs Colonoscopy Options for Colon Cancer Screening

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  1. Cologuard vs ColonoscopyOptions for Colon Cancer Screening Eric Poulin, MD 2017 AAPCE CME Conference November 3, 2017 San Antonio, TX

  2. Disclosures • Employer • Mayo Clinic Health System • Mayo has financial relationship to Cologuard • Personal • No financial relationships

  3. Cologuard vs Colonoscopy • Definitions • Colon Cancer Screening • medical examination or test • asymptomatic persons • purpose: prevent colon cancer • common and aggressive cancer • generally ends life quickly once metastatic • usually asymptomatic until advanced stages

  4. Cologuard vs ColonoscopyOptions for Colon Cancer Screening • Colonoscopy • insertion of flexible video scope to cecum • purpose: removing “benign” adenomatous polyps or sessile serrated polyps (SSPs) • can grow into cancer over time • done at regular intervals: 5-10 yrs. • expected to prevent colon cancer by removing these precursor lesions

  5. Cologuard vs Colonoscopy • Colonoscopy variation in USA • Sedation • Versed + Fentanyl by RN • Propofol by CRNA • None • Health System Management • Scheduling • Preps • Communication with patients • Appropriate screening intervals

  6. Cologuard vs ColonoscopyOptions for Colon Cancer Screening • Colonoscopy variation in USA • Technique • CO2 vs Water during insertion • Right colon retroflexion • Polyp removal: forceps/snare, hot/cold • Endoscopist • Complication rate • To-the-Cecum rate • Adenoma detection rate

  7. Cologuard vs ColonoscopyOptions for Colon Cancer Screening • Cologuard • DNA and FIT test of stool • approved by FDA in 2014 • only for average-risk adults ≥ 50 years old • cancer biomarkers • mutant KRAS • NDRG4/B • FIT portion is identical to standard FIT

  8. Cologuard vs Colonoscopy • Cologuard • includes total human DNA control • results are combined and scored • cut-off value • reported as positive or negative

  9. Cologuard vs ColonoscopyOptions for Colon Cancer Screening Completed Studies • 2014 NEJM, Imperiale TF, et al. • 9989 patients. • average risk screening age 50 – 84 • 65 cancer, 757 advanced adenomas • colonoscopy was reference standard

  10. Cologuard vs Colonoscopy • 2014 NEJM, Imperiale TF, et al. • Sensitivity for cancer • FIT-- 74% Cologuard-- 92% • Sensitivity for advanced adenomas (≥ 1 cm; HG dysplasia; villous; including SSPs) • FIT– 5 to 46% Cologuard-- 42%

  11. Cologuard vs Colonoscopy • 2014 NEJM, Imperiale TF, et al. • Sensitivity for cancer • FIT-- 74% Cologuard-- 92% • Sensitivity for advanced adenomas (≥ 1 cm; HG dysplasia; villous; including SSPs) • FIT– 5 to 46% Cologuard-- 42%

  12. Figure 1Sensitivity by Size of Largest Precancerous Lesion Cologuard FIT 42% Imperiale TF, et al. NEJM 2014.

  13. Figure 2Sensitivity by Pathology of Precancerous Lesion Cologuard FIT Imperiale TF, et al. NEJM 2014.

  14. Figure 3Sensitivity by Location of Precancerous Lesions Cologuard FIT Imperiale TF, et al. NEJM 2014.

  15. Cologuard vs ColonoscopyOptions for Colon Cancer Screening Studies in Progress • the “Gold Standard” – colonoscopy • 2016 JAMA Intern Med, Bretthauer M, et al. • randomized European trial. • 94,959 patients. ages 55 to 64. • entry 2009 - 2014. • 31,420 randomly assigned to colonoscopy screening. 40% completed test. • plan to monitor patients for 15 years • ADRs of endoscopists monitored

  16. Cologuard vs Colonoscopy Studies in Progress • 2016 JAMA Intern Med, Bretthauer M, et al. • initial findings in over 12,000 patients: • to-the-cecum rate 97% • one perforation 0.01% • post-polypectomy bleeding 0.14% • colon cancer 0.5% • any adenomas 30% • high risk adenomas 10% • goal: prove lower colon cancer mortality

  17. Cologuard vs ColonoscopyOptions for Colon Cancer Screening Studies in Progress • 2017 BMC Cancer, van Lanschot, et al. • "MOCCAS“ • planned 4000 patients • ages 50-75. Netherlands. • scheduled high risk surveillance • excluding IBD and genetic syndromes • colonoscopy is reference standard • goal: sensitivities for FIT and Cologuard

  18. Cologuard vs Colonoscopy • USPSTF • 2016 updated evidence report--colonoscopy • reduced colon cancer mortality • 1-2x flex sig, incidence ratio 0.73 • multiple rounds of biennial guaiac testing, at 30 yrs, incidence ratio 0.78 • serious complications (screening) • perforations -- 4 in 10,000 • major bleeds -- 8 in 10,000

  19. Cologuard vs ColonoscopyOptions for Colon Cancer Screening • USPSTF-- current screening recommendations • Grade A • age 50 – 75 • Grade C • age 76 - 85, individualize • priority to: • no prior screen-- they benefit most • healthy enough to tolerate surgery

  20. Cologuard vs Colonoscopy • Potential Problems • What are we communicating to patients about this decision? • What do patients walk away remembering and understanding?

  21. Cologuard vs ColonoscopyOptions for Colon Cancer Screening • Example Problem • 2014 Mayo Rochester CME for primary care providers. Many hundreds in attendance. • Disclosures • “Minor equity investor” • “May receive royalties” ?

  22. Cologuard vs Colonoscopy • 2014 Mayo Rochester CME for primary care • Slide 7 • “major killer worldwide, #2 in USA.” • “shift toward right side. 50% in US.” • Is Cologuard sensitive enough for detecting advanced pre-cancer? • “Long dwell time with pre-cancers permits detection by repeated testing” • “Sensitivity may be higher if endoscopist knows Cologuard result”

  23. Cologuard vs ColonoscopyOptions for Colon Cancer Screening • 2014 Mayo Rochester CME for primary care • All the elements for effective detection • “High sensitivity for CRC & greatest-risk precancer” • Cologuard risk • “False negative could potentially delay diagnosis of disease (lacks sensitivity for polyps < 2 cm size)”

  24. Cologuard vs ColonoscopyOptions for Colon Cancer Screening • 2014 Mayo Rochester CME for primary care • All the elements for effective detection • “High sensitivity for CRC & greatest-risk precancer” • Cologuard risk • “False negative could potentially delay diagnosis of disease (lacks sensitivity for polyps < 2 cm size)”

  25. Cologuard vs Colonoscopy • Bottom Line • This is what I tell my patients: Cologuard is 50/50 at detecting pre-cancers that should be removed now

  26. Questions & Discussion

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