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Randomized Controlled Trial
. 2012 Jun 21;366(25):2345-57.
doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.

Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy

Robert E Schoen  1 , Paul F Pinsky, Joel L Weissfeld, Lance A Yokochi, Timothy Church, Adeyinka O Laiyemo, Robert Bresalier, Gerald L Andriole, Saundra S Buys, E David Crawford, Mona N Fouad, Claudine Isaacs, Christine C Johnson, Douglas J Reding, Barbara O'Brien, Danielle M Carrick, Patrick Wright, Thomas L Riley, Mark P Purdue, Grant Izmirlian, Barnett S Kramer, Anthony B Miller, John K Gohagan, Philip C Prorok, Christine D Berg; PLCO Project Team
Collaborators, Affiliations
Randomized Controlled Trial

Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy

Robert E Schoen et al. N Engl J Med. .

Abstract

Background: The benefits of endoscopic testing for colorectal-cancer screening are uncertain. We evaluated the effect of screening with flexible sigmoidoscopy on colorectal-cancer incidence and mortality.

Methods: From 1993 through 2001, we randomly assigned 154,900 men and women 55 to 74 years of age either to screening with flexible sigmoidoscopy, with a repeat screening at 3 or 5 years, or to usual care. Cases of colorectal cancer and deaths from the disease were ascertained.

Results: Of the 77,445 participants randomly assigned to screening (intervention group), 83.5% underwent baseline flexible sigmoidoscopy and 54.0% were screened at 3 or 5 years. The incidence of colorectal cancer after a median follow-up of 11.9 years was 11.9 cases per 10,000 person-years in the intervention group (1012 cases), as compared with 15.2 cases per 10,000 person-years in the usual-care group (1287 cases), which represents a 21% reduction (relative risk, 0.79; 95% confidence interval [CI], 0.72 to 0.85; P<0.001). Significant reductions were observed in the incidence of both distal colorectal cancer (479 cases in the intervention group vs. 669 cases in the usual-care group; relative risk, 0.71; 95% CI, 0.64 to 0.80; P<0.001) and proximal colorectal cancer (512 cases vs. 595 cases; relative risk, 0.86; 95% CI, 0.76 to 0.97; P=0.01). There were 2.9 deaths from colorectal cancer per 10,000 person-years in the intervention group (252 deaths), as compared with 3.9 per 10,000 person-years in the usual-care group (341 deaths), which represents a 26% reduction (relative risk, 0.74; 95% CI, 0.63 to 0.87; P<0.001). Mortality from distal colorectal cancer was reduced by 50% (87 deaths in the intervention group vs. 175 in the usual-care group; relative risk, 0.50; 95% CI, 0.38 to 0.64; P<0.001); mortality from proximal colorectal cancer was unaffected (143 and 147 deaths, respectively; relative risk, 0.97; 95% CI, 0.77 to 1.22; P=0.81).

Conclusions: Screening with flexible sigmoidoscopy was associated with a significant decrease in colorectal-cancer incidence (in both the distal and proximal colon) and mortality (distal colon only). (Funded by the National Cancer Institute; PLCO ClinicalTrials.gov number, NCT00002540.).

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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1
Overall, Distal, and Proximal Colorectal-Cancer Incidence and Mortality.
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