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. (COLONPREV)

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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