Multicenter randomized noninferiority trial of effect of invitation to colonoscopy versus FIT screening on colorectal cancer mortality

Colonoscopy and FIT are accepted strategies for colorectal cancer (CRC) screening in the average-risk population (people aged ≥ 50 years without personal or family history of CRC. The randomized noninferiority COLONPREV trial, at 15 centers in Spain, compared the effect of invitation for colonoscopy screening on CRC mortality with the effect of invitation for FIT screening among the average-risk population. The intention-to-screen population consisted of 25,332 individuals in the colonoscopy group and 26,719 in the FIT group. Participation in any form of screening was 31.8% in the coloscopy group and 39.9% in the FIT group (RR 0.79; 95% CI 0.77-0.82). FIT screening was noninferior to colonoscopy with regard to the risk of CRC mortality at 10 years: 0.22% (n=55) in the colonoscopy group and 0.24% (n=60) in the FIT group (p for noninferiority=0.0005). The authors conclude that participation in screening was higher in the FIT group, whereas FIT screening was noninferior to coloscopy for the endpoint CRC-mortality.