Colonoscopy versus Fecal Immunochemical Testing in Colorectal-Cancer Screening

Enrique Quintero, M.D., Ph.D., Antoni Castells, M.D., Ph.D., Luis Bujanda, M.D., Ph.D., Joaquín Cubiella, M.D., Ph.D., Dolores Salas, M.D., Ángel Lanas, M.D., Ph.D., Montserrat Andreu, M.D., Ph.D., Fernando Carballo, M.D., Ph.D., Juan Diego Morillas, M.D., Ph.D., Cristina Hernández, B.Sc., Rodrigo Jover, M.D., Ph.D., Isabel Montalvo, M.D., Ph.D., Juan Arenas, M.D., Ph.D., Eva Laredo, R.N., Vicent Hernández, M.D., Ph.D., Felipe Iglesias, R.N., Estela Cid, R.N., Raquel Zubizarreta, M.D., Teresa Sala, M.D., Marta Ponce, M.D., Mercedes Andrés, M.D., Gloria Teruel, M.D., Antonio Peris, M.D., María-Pilar Roncales, R.N., Mónica Polo-Tomás, M.D., Ph.D., Xavier Bessa, M.D., Ph.D., Olga Ferrer-Armengou, R.N., Jaume Grau, M.D., Anna Serradesanferm, R.N., Akiko Ono, M.D., José Cruzado, M.D., Francisco Pérez-Riquelme, M.D., Inmaculada Alonso-Abreu, M.D., Mariola de la Vega-Prieto, M.D., Juana Maria Reyes-Melian, M.D., Guillermo Cacho, M.D., José Díaz-Tasende, M.D., Alberto Herreros-de-Tejada, M.D., Carmen Poves, M.D., Cecilio Santander, M.D., and Andrés González-Navarro, M.D. for the COLONPREV Study Investigators

N Engl J Med 2012; 366:697-706, February 23, 2012

Background: Colonoscopy and fecal immunochemical testing (FIT) are accepted strategies for colorectal-cancer screening in the average-risk population.

Methods:In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we 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).

Conclusions: Subjects in the 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. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT00906997.)