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COLONPREV

  1. 1. COLONPREV HTTP://TRIALGURU.ORG Quintero E, et al. "Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening". The New England Journal of Medicine. 2012. 366(8):697-706.
  2. 2. (COLONPREV)
  3. 3. BACKGROUND  Colorectal cancer (CRC) is the 3rd most common cancer world wide and 2nd most common cause of cancer deaths  Colonoscopy in the USA is favored over FIT testing, which is more often used in Europe and Australia  Colonoscopy is considered more accurate for early detection and prevention of CRC  While considered to be less effective in neoplastic detection, FIT testing is better accepted and lower associated cost  No conclusive evidence assist regarding reduced mortality
  4. 4. CLINICAL QUESTION For asymptomatic patients between ages 50-69, what is the efficacy of fecal immunochemical testing (FIT) every 2 years compared to one-time-colonoscopy for reducing rate of death from colorectal cancer at 10 years?
  5. 5. DESIGN  Analysis: Intention-to-screen  Trial Design: Multicenter randomized, controlled noninferiority trial  N=53,302 (power of 80%)  FIT, every 2 years (n=26,703)  Colonoscopy, one time (n=26,599)  Setting: 15 centers in Spain  Follow-up: Ten-year follow-up will be complete in June 2021  Primary Outcome: reduction in the rate of death from colorectal cancer at 10 years
  6. 6. POPULATION Inclusion Criteria  Adult men and women ages 50-69  Asymptomatic Exclusion Criteria  Personal history of colorectal cancer, adenoma, or IBD  Family history of hereditary or familiar colorectal cancer  Severe coexisting illness  Recently screened for colorectal cancer (FOBT within 2 years or sigmoid/colonoscopy within 5 years)
  7. 7. INTERVENTIONS  Randomized to a group:  FIT testing q2 years  One-time colonoscopy  Subjects could accept the invited screening method or crossover between groups  Any positive FIT test was to be followed up with colonoscopy  Reduction in CRC death would be assessed 10 years after onset of screening modality
  8. 8. RESULTS - Cancer was detect 0.1% in colonoscopy group, and also 0.1% in the FIT group, with a P- value 0.99. This showed a non-significant difference between the two groups. - However, other adenomas/neoplasias, there were significant differences (shown by P<0.001) between the two groups
  9. 9. RESULTS There was no statistically significant difference between diagnostic yield of Colonoscopy over FIT test in terms of detection proximal/distal cancers There was a statistically significant difference in diagnostic yield between colonoscopy and FIT testing for detecting advanced and non- advanced adenomas and neoplasias
  10. 10. RESULTS - Among subjects who were screened by means of colonoscopy (5059), 27 (0.5%) were found to have colorectal cancer - Among patients screened by means of FIT, 767 (7.2%) tested positive, and 663 of these subjects further underwent colonoscopy. Out of the 663, 36 were found to have cancer. - (Odds ratio, 1.56; 95% CI, 0.93 to 2.56; P=0.09) - Hence, no statistically significant difference between colonoscopy and FIT in detecting cancer
  11. 11. BOTTOM LINE COLONPREV STUDY to be completed in 2021 In the 2012 interim analysis, fecal immunochemical testing (FIT) is non-inferior to baseline colonoscopy in terms of detecting colorectal cancer. HOWEVER, more adenomas were identified in colonoscopy group. FIT subjects were more adherent to colorectal-cancer screening methods than colonoscopy group.
  12. 12. CRITICISMS  Collection period is still underway so mortality data is not finalized (to be completed in 2021)  Mail-based invitation system  Colonoscopies can identify adenomas (which depending on the type impact recommendations for further screening and CRC)—FIT cannot identify adenomas
  13. 13. DISCUSSION QUESTIONS/ANSWERS  What is the main criticism of the COLONPREV trial?  For colon cancer screening in the COLONPREV trial, were patients with IBD studied?  What did the interim analysis of the COLONPREV trial show?  What is a limitation of FIT testing?
  14. 14. DISCUSSION QUESTIONS  What is the main criticism of the COLONPREV trial?  ANSWER: The study is not yet completed (to be completed in 2021)  For colon cancer screening in the COLONPREV trial, were patients with IBD studied?  ANSWER: No, patients with IBD were not study because may have positive FIT  What did the interim analysis of the COLONPREV trial show?  ANSWER: FIT was non-inferior to colonoscopy for detecting colon cancer screening  What is a limitation of FIT testing?  ANSWER: FIT testing cannot identify adenomas
  15. 15. BOARD-LIKE QUESTION A 50-year-old woman presents to PMD. She feels well without any symptoms. She has an uncle who experienced respiratory arrest with sedation during a screening colonoscopy, so refuses to under procedures for colon cancer screening. There is no family history of colon cancer or colon polyps. Physical examination: HR 78, BP 121, 72. BMI 22. Lungs clear Heart: RRR, normal S1/S2, no S3/S4/gallops/murmurs Abdomen: non-tender GU: no abnormalities Which of the following is the most appropriate strategy for colon cancer screening in this patient? A. Colonoscopy now, repeat q10 years B. FIT testing q1 year C. Flexible sigmoidoscopy every 5 years with FOBT q3 years D. Stool DNA testing q1 year
  16. 16. BOARD-LIKE QUESTION Educational Objective: Colorectal cancer screening Key Point: - This patient refuses procedures so FIT testing would be best - Adults aged 50 to 75 years should be screened for colorectal cancer using - high-sensitivity fecal occult blood testing every year - flexible sigmoidoscopy every 5 years, combined with high-sensitivity fecal occult blood testing every 3 years - colonoscopy every 10 years. ANSWER Which of the following is the most appropriate strategy for colon cancer screening in this patient? A. Colonoscopy now, repeat q10 years B. FIT testing q1 year C. Flexible sigmoidoscopy every 5 years with FOBT q3 years D. Stool DNA testing q1 year
  17. 17. COLONOSCOPY SCREENING RECOMMENDATIONS US Preventive ServicesTask Force (2013) Screening Average Risk Asymptomatic Patients,Age 50- 75:  FIT every 1 to 2 years is recommended, with follow-up for any positive FIT with colonoscopy.  Colonoscopy every 10 years is an acceptable alternative for screening. American Cancer Society,US Multi SocietyTask Force, and American College of Radiology, 2008  Screening Average Risk Asymptomatic Patients,Age 50+:  Flexible sigmoidoscopy every 5 years, or  Colonoscopy every 10 years, or  Double-contrast barium enema every 5 years, or  CT colonography (virtual colonoscopy) every 5 years, or  Yearly guaiac-based fecal occult blood test (gFOBT), or  Yearly fecal immunochemical test (FIT), or  Stool DNA test (sDNA) every 3 years
  18. 18. REFERENCES  Quintero E, et al. "Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening". The New England Journal of Medicine. 2012. 366(8):697-706.  Brain, P. COLONPREV. https://www.wikijournalclub.org/wiki/COLONPREV

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