Colonoscopy versus Fecal Immunochemical Testing in Colorectal-Cancer Screening

New England Journal of Medicine, 02/24/2012

Subjects in the fecal immunochemical testing (FIT) group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group.

Methods

  • In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, the authors compared one–time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects.
  • The primary outcome was the rate of death from colorectal cancer at 10 years.
  • This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening.
  • Study outcomes were analyzed in both intention–to–screen and as–screened populations.

Results

  • The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001).
  • Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99).
  • Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001).

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