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Colonoscopy Screening for Colorectal Cancer: A Randomized Trial
No large randomized, controlled trials have been conducted to examine mortality outcomes from colonoscopy screening for colorectal cancer (CRC) — until now. In this study, 85,000 previously unscreened people (age range, 55–64) in Norway, Poland, and Sweden were randomized in a 1:2 ratio to receive an invitation to undergo colonoscopy screening, or to receive no invitation.
Only 42% of people in the invited group accepted their invitations and underwent colonoscopy; those with polyps had subsequent surveillance at standard intervals. The primary intent-to-screen analysis (which includes all invited people, whether or not they followed through with colonoscopy) revealed the following outcomes at 10 years:
- Cumulative incidence of CRC was significantly lower in the invited group (0.98% vs. 1.20%), likely due to removal of precancerous polyps.
- CRC-related mortality at 10 years was not significantly different in the two groups (0.28% vs. 0.31%).
- All-cause mortality at 10 years was identical in the two groups (11.0%).
- Among nearly 12,000 screening colonoscopies, no perforations and 15 cases of major bleeding were reported.
In a secondary adjusted per-protocol analysis — a comparison of people who actually underwent screening versus controls — a difference in CRC-related mortality reached significance (0.15% vs. 0.30%). This “best-case” outcome would translate to roughly 1 fewer CRC death per 700 screened people.
These results are not straightforward; hence, they probably won't change the general U.S. preference for colonoscopy to screen for CRC. Editorialists consider the primary findings — a small relative reduction in CRC risk and no reduction in CRC-related mortality — as “surprising and disappointing.” Results of the per-protocol analysis, which includes only the minority of invited people who actually underwent colonoscopy but introduces bias that randomization was designed to eliminate, are somewhat more compelling. Moreover, longer follow-up might yield a larger survival benefit. Additional randomized trials to compare colonoscopy and no screening probably won't be done, but large trials comparing colonoscopy and fecal immunochemical testing are in progress.
Bretthauer M et al.
Title: Effect of colonoscopy screening on risks of colorectal cancer and related death.
Source: N Engl J Med 2022 Oct 9; [e-pub]. (Abstract/FREE Full Text)