New US CRC Guidelines: Prevention vs. Early Detection

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New US CRC Guidelines: Prevention vs. Early Detection

  1. 1. New US CRC Guidelines:New US CRC Guidelines: Prevention vs. EarlyPrevention vs. Early DetectionDetection C5 Summit: New YorkC5 Summit: New York June 5, 2008June 5, 2008 David Lieberman MD Chief, Division of Gastroenterology Oregon Health Sciences University Portland VAMC
  2. 2. Risk Factors for CRC Sporadic/Sporadic/ Average RiskAverage Risk 75%75% IBD-1% Colitis Family History 15-20% HNPCC 3% FAP-1%
  3. 3. Colorectal Cancer Normal ColonNormal Colon AdvancedAdvanced AdenomaAdenoma 10-20% Lifetime Risk Genetic Environmental Lifestyle 5-6% Lifetime RiskNational Polyp Study:National Polyp Study: 76-90% reduction in76-90% reduction in Cancer incidenceCancer incidence after polypectomyafter polypectomy
  4. 4. Guideline Process • Prior guidelines from multiple organizations • Consensus guideline included: – American Cancer Society – Multi-Society Task Force on Colorectal Cancer • GI organizations and American College of Physicians – American College of Radiology • U.S. Preventive Services Task Force Legislation (and making consensus guidelines) is like making sausage; You do not want to know the details
  5. 5. Guideline Process • Rules of evidence • Where evidence was lacking: – Expert opinion – Areas for research noted • Emphasis on Quality in each program
  6. 6. Lifestyle and Diet Smoking Alcohol Obesity BMI Little Physical Activity Dietary Fat Fiber Micro-nutrients Folate Calcium Vitamin D Selenium Lieberman; JAMA 2003; Vogelaar, Cancer 2006; 107:1624 ScreeningScreening NSAIDS/ Aspirin
  7. 7. New CRC Guideline: Key Principles • Distinguish between –Early cancer detection tests –Cancer prevention tests • Establish minimum standard for early cancer detection tests • Emphasis on quality
  8. 8. Raising the bar MD Colon CancerColon Cancer PreventionPrevention Early ColonEarly Colon CancerCancer DetectionDetection
  9. 9. Average-Risk CRC Screening Tests which primarilyTests which primarily detect early cancerdetect early cancer Tests which detect bothTests which detect both cancer and adenomascancer and adenomas gFOBT FIT -Advantage:Advantage: Home test, non-invasiveHome test, non-invasive -LimitationsLimitations Repeat test every 1-2 yrsRepeat test every 1-2 yrs Low cancer preventionLow cancer prevention Program effectiveness ??Program effectiveness ?? Structural Exam -Advantage:-Advantage: Potential for cancer preventionPotential for cancer prevention Infrequent: 5-10 yrsInfrequent: 5-10 yrs -Limitations:-Limitations: Bowel prepBowel prep Office/hospital visitOffice/hospital visit Levin B, Lieberman D, McFarland B et al: 2008 CRC Guideline New Guideline: Tests which detect both early cancer and adenomas are preferred
  10. 10. Fecal Occult Blood Test: FOBTFOBT
  11. 11. FOBT- One-time testing Imperiale et al; NEJM 2004;351:2704-14 Young et al; Am J Med 2002; 97: 2499-2507 Morikawa et al; Gastroenterology 2005; 129: 422-8 Levi et al; Ann Intern Med 2007; 146:244-55 Lieberman et al;NEJM 2001;345:555-60 Imperiale et al; NEJM 2004;351:2704-14 Collins, Lieberman et al; Ann Intern Med 2005; 142:81-5 % of patients with cancer% of patients with cancer who have (+) testwho have (+) test % of patients with serious% of patients with serious Polyps who have (+) testPolyps who have (+) test 33-60%33-60% 11-50%11-50% More than 50% ofMore than 50% of patients with seriouspatients with serious polyps will not bepolyps will not be detected with one test !!!detected with one test !!! New Guideline: Any recommended test must detect >50% of cancers with one test
  12. 12. Stool Genetic Tests - Issues • One-time test can detect more than 50% of cancers • Evolving • Costly Imperiale et al; NEJM 2004;351:2704-14 Itzkowitz et al; Clin Gastro Hep 2007; 5: 111-7
  13. 13. FOBT: Mortality Reduction Adherence atAdherence at Every level: 100%Every level: 100% 40%40% PotentialPotential MortalityMortality ReductionReduction IF adherence toIF adherence to initial test: 75%initial test: 75% IF adherenceIF adherence to repeat testto repeat test after (-) test: 67%after (-) test: 67% IF rate ofIF rate of colonoscopycolonoscopy after (+) test: 75%after (+) test: 75% < 20%< 20% Effective – but only in aEffective – but only in a program of repeat testingprogram of repeat testing
  14. 14. Early Cancer Detection Tests • Requires programmatic adherence with (+) and (-) tests • Programmatic performance: • Unlikely to result in much cancer prevention gFOBT FIT UNKNOWNUNKNOWN
  15. 15. Adenoma and Cancer Detection Tests SigmoidoscopySigmoidoscopy:: Evidence: Case-Control Studies Efficacy: Mortality reduction left colon No benefit right colon Program performance: under study PLCO, UK, Italy
  16. 16. CT Colonography NEJM 2003; 349: 2191; JAMA 2004; 291:1713-9; Rockey: Lancet 2005;365: 305- 11 ACRIN,2007 90 86ACRIN,2007 90 86 SensitivitySensitivity SpecificitySpecificity Pickhardt 94% 96% Cotton 55 96 Rockey 59 96 Lesions > 10mm
  17. 17. CT Colonography: Who should be referred for Colonoscopy ? > 9mm> 9mm 5-10%5-10% >5mm>5mm 15-25%15-25% ALL with polypsALL with polyps 50%50% NEJM 2003; 349: 2191; JAMA 2004; 291:1713-9; Lancet 2005;365: 305-11 Levin B, Lieberman D, McFarland B et al; 2008 CRC Screening Guideline YES YES If largest polyp is 1-5mm: ??????
  18. 18. CT Colonography: Issues • Inter-observer variability • Detection of flat polyps • Bowel Prep • Radiation • Extracolonic findings • Intervals uncertain: – After negative exam – After exam with small polyps Low Resolution CTCLow Resolution CTC
  19. 19. Adenoma and Cancer Detection Tests ColonoscopyColonoscopy Evidence: Cohort Studies Efficacy: Uncertain, but extrapolated from FOBT and Sig studies Quality in practice: unknown Program performance: unknown National colonoscopy study (Winawer)
  20. 20. Colonoscopy Screening Studies (n > 1000) • Studies: 2000-20042000-2004 – VA Cooperative Study ;NEJM: 2000; 343: 162-8 (n = 3121) – Indiana Study; NEJM 2000; 343: 169-74 (n = 1994) – CT Colonography studies (n = 2447) (Pickhardt, Rockey, Cotton) – Fecal DNA Study; NEJM 2004; 351: 2704-14 (n = 4404) – Spain, Am J Gastroenterol 2003; 98: 2648-54 (n = 2210) • Studies: 2005-20062005-2006 – Women: (Schoenfeld) NEJM 2005; 352: 2061-8 (n = 1463) – Taiwan; Gastrointest Endosc 2005; 61: 547-53 (n = 1708) – Japan, Gastroenterology 2005; 129: 422-8 (n = 21,805 with iFOBT) – Seattle, JAMA 2006; 295: 2357-65 (N = 1244) – Poland, NEJM 2006; 355: 1863-72 (n = 50,148) – Germany (n = 1.14M)
  21. 21. gFOBT FIT Genetic/Genetic/ ProteomicsProteomics ImagingImaging ColonoscopyColonoscopy SurveillanceSurveillance
  22. 22. Colonoscopy • Appropriate utilization • High-quality exam to cecum • Low rate of missed lesions • Low rate of incompletely removed lesions • Low rate of adverse events QUALITYQUALITY Depends on:Depends on:
  23. 23. Colonoscopy Issues • Bowel Prep • Quality Issues – Missed lesions – Safety
  24. 24. Obstacles to Screening: Perceptions • Patient education: Screening works !!!
  25. 25. Obstacles to Screening: Perceptions • It is not fun • It is not effective • It is not clear what test to use • It costs too muchIt costs too much FOBT Flex-Sig Colon BaE $$
  26. 26. Cost of not screening Cost of Cancer CareCost of Cancer Care Emotional CostsEmotional Costs Missed opportunity for preventionMissed opportunity for prevention $50-100,000 per case
  27. 27. Overcoming Obstacles • Patient Education • Provider Education • Understanding obstacles to compliance
  28. 28. Colon Screening in USA 0 10 20 30 40 50 60 70 80 1975 1980 1985 1990 1995 2000 2005 2007 Rate of - FOBT, - Flexible Sigmoidoscopy - Colonoscopy %% MammographyMammography for Breast Cancerfor Breast Cancer
  29. 29. CRC Age-adjusted incidence rates/100,000 210,452 white Americans >21 yrs 0 5 10 15 20 25 30 35 78-80 81-83 84-86 87-89 90-92 93-95 96-98 2000 2010 Left Colon Right Colon SEER data; Rabeneck et al. Am J Gastroenterol 2003; 98: 1400 Lieberman et al; NEJM: 2000; 343: 162-8 Imperiale et al; NEJM: 2000: 343: 169-74 AmericanAmerican CancerCancer SocietySociety Ronald Reagan 1985 Colonoscopy ScreeningColonoscopy ScreeningFOBT/Flex sig Right Colon: No Change
  30. 30. Summary of 2008 CRC Screening Guideline • Distinguishes: – Tests which detect early cancer vs – Tests which detect both adenomas and cancer • Adherence to programmatic testing is a problem – Therefore any one-time test should detect more than 50% of cancers • Emphasis on Quality Clear preference for tests which may prevent cancerStool-Based Tests Colonoscopy or CT Colonography
  31. 31. Raising the bar MD ColonColon CancerCancer DetectionDetection 1970’s1970’s Colon CancerColon Cancer PreventionPrevention 1990’s1990’s Colon ScreeningColon Screening QualityQuality 20082008

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