Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A Randomized Trial

Øyvind Holme, Magnus Løberg, Mette Kalager, Michael Bretthauer, Miguel A Hernán, Eline Aas, Tor J Eide, Eva Skovlund, Jon Lekven, Jörn Schneede, Kjell Magne Tveit, Morten Vatn, Giske Ursin, Geir Hoff, NORCCAP Study Group†, Per Efskind, Ghous Gondal, Gert Huppertz-Hauss, Miguel A Hernán, Bjørn Hofstad, Øyvind Holme, Solveig Thorp Holmsen, Mette Kalager, Inger Kristin Larsen, Magnus Løberg, Volker Moritz, Sverre Nyhus, Espen Thiis-Evensen, Tom Grotmol, Eline Aas, Giske Ursin, Geir Hoff, Eva Skovlund, Morten Vatn, Tor Iversen, Jörn Schneede, Michael Bretthauer, Kjell Magne Tveit, Jon Lekven, Tor J Eide, Øyvind Holme, Magnus Løberg, Mette Kalager, Michael Bretthauer, Miguel A Hernán, Eline Aas, Tor J Eide, Eva Skovlund, Jon Lekven, Jörn Schneede, Kjell Magne Tveit, Morten Vatn, Giske Ursin, Geir Hoff, NORCCAP Study Group†, Per Efskind, Ghous Gondal, Gert Huppertz-Hauss, Miguel A Hernán, Bjørn Hofstad, Øyvind Holme, Solveig Thorp Holmsen, Mette Kalager, Inger Kristin Larsen, Magnus Løberg, Volker Moritz, Sverre Nyhus, Espen Thiis-Evensen, Tom Grotmol, Eline Aas, Giske Ursin, Geir Hoff, Eva Skovlund, Morten Vatn, Tor Iversen, Jörn Schneede, Michael Bretthauer, Kjell Magne Tveit, Jon Lekven, Tor J Eide

Abstract

Background: The long-term effects of sigmoidoscopy screening on colorectal cancer (CRC) incidence and mortality in women and men are unclear.

Objective: To determine the effectiveness of flexible sigmoidoscopy screening after 15 years of follow-up in women and men.

Design: Randomized controlled trial. (ClinicalTrials.gov: NCT00119912).

Setting: Oslo and Telemark County, Norway.

Participants: Adults aged 50 to 64 years at baseline without prior CRC.

Intervention: Screening (between 1999 and 2001) with flexible sigmoidoscopy with and without additional fecal blood testing versus no screening. Participants with positive screening results were offered colonoscopy.

Measurements: Age-adjusted CRC incidence and mortality stratified by sex.

Results: Of 98 678 persons, 20 552 were randomly assigned to screening and 78 126 to no screening. Adherence rates were 64.7% in women and 61.4% in men. Median follow-up was 14.8 years. The absolute risks for CRC in women were 1.86% in the screening group and 2.05% in the control group (risk difference, -0.19 percentage point [95% CI, -0.49 to 0.11 percentage point]; HR, 0.92 [CI, 0.79 to 1.07]). In men, the corresponding risks were 1.72% and 2.50%, respectively (risk difference, -0.78 percentage point [CI, -1.08 to -0.48 percentage points]; hazard ratio [HR], 0.66 [CI, 0.57 to 0.78]) (P for heterogeneity = 0.004). The absolute risks for death from CRC in women were 0.60% in the screening group and 0.59% in the control group (risk difference, 0.01 percentage point [CI, -0.16 to 0.18 percentage point]; HR, 1.01 [CI, 0.77 to 1.33]). The corresponding risks for death from CRC in men were 0.49% and 0.81%, respectively (risk difference, -0.33 percentage point [CI, -0.49 to -0.16 percentage point]; HR, 0.63 [CI, 0.47 to 0.83]) (P for heterogeneity = 0.014).

Limitation: Follow-up through national registries.

Conclusion: Offering sigmoidoscopy screening in Norway reduced CRC incidence and mortality in men but had little or no effect in women.

Primary funding source: Norwegian government and Norwegian Cancer Society.