Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomised controlled trial

Geir Hoff, Tom Grotmol, Eva Skovlund, Michael Bretthauer, Norwegian Colorectal Cancer Prevention Study Group, Michael Bretthauer, Erik Carlsen, Tor Jac Eide, Tom Grotmol, Geir Hoff, Tor Iversen, Stener Kvinnsland, Frøydis Langmark, Jon Lekven, Jørn Schneede, Eva Skovlund, Kjell Magne Tveit, Morten Vatn, Knut Bjerke, Per Efskind, Ghous Gondal, Kai Brynjar Hagen, Gert Huppertz-Hauss, Yngve Haugstvedt, Bjørn Hofstad, Solveig Thorp Holmsen, Anita Jørgensen, Inger Kristin Larsen, Per G Lund-Larsen, Idar Lygren, Volker Moritz, Sverre Nyhus, Odd Søreide, Espen Thiis-Evensen, Lisbeth Tranebjaerg, Aage Tverdal, Per Wium, Lars Ødegård, Hans-Olov Adami, Sandra J Lee, Douglas K Rex, Geir Hoff, Tom Grotmol, Eva Skovlund, Michael Bretthauer, Norwegian Colorectal Cancer Prevention Study Group, Michael Bretthauer, Erik Carlsen, Tor Jac Eide, Tom Grotmol, Geir Hoff, Tor Iversen, Stener Kvinnsland, Frøydis Langmark, Jon Lekven, Jørn Schneede, Eva Skovlund, Kjell Magne Tveit, Morten Vatn, Knut Bjerke, Per Efskind, Ghous Gondal, Kai Brynjar Hagen, Gert Huppertz-Hauss, Yngve Haugstvedt, Bjørn Hofstad, Solveig Thorp Holmsen, Anita Jørgensen, Inger Kristin Larsen, Per G Lund-Larsen, Idar Lygren, Volker Moritz, Sverre Nyhus, Odd Søreide, Espen Thiis-Evensen, Lisbeth Tranebjaerg, Aage Tverdal, Per Wium, Lars Ødegård, Hans-Olov Adami, Sandra J Lee, Douglas K Rex

Abstract

Objective: To determine the risk of colorectal cancer after screening with flexible sigmoidoscopy.

Design: Randomised controlled trial.

Setting: Population based screening in two areas in Norway-city of Oslo and Telemark county (urban and mixed urban and rural populations).

Participants: 55 736 men and women aged 55-64 years.

Intervention: Once only flexible sigmoidoscopy screening with or without a single round of faecal occult blood testing (n=13 823) compared with no screening (n=41 913).

Main outcome measures: Planned end points were cumulative incidence and mortality of colorectal cancer after 5, 10, and 15 years. This first report from the study presents cumulative incidence after 7 years of follow-up and hazard ratio for mortality after 6 years.

Results: No difference was found in the 7 year cumulative incidence of colorectal cancer between the screening and control groups (134.5 v 131.9 cases per 100 000 person years). In intention to screen analysis, a trend towards reduced colorectal cancer mortality was found (hazard ratio 0.73, 95% confidence interval 0.47 to 1.13, P=0.16). For attenders compared with controls, a statistically significant reduction in mortality was apparent for both total colorectal cancer (hazard ratio 0.41, 0.21 to 0.82, P=0.011) and rectosigmoidal cancer (0.24, 0.08 to 0.76, P=0.016).

Conclusions: A reduction in incidence of colorectal cancer with flexible sigmoidoscopy screening could not be shown after 7 years' follow-up. Mortality from colorectal cancer was not significantly reduced in the screening group but seemed to be lower for attenders, with a reduction of 59% for any location of colorectal cancer and 76% for rectosigmoidal cancer in per protocol analysis, an analysis prone to selection bias.

Trial registration: Clinical trials NCT00119912.

Conflict of interest statement

Competing interests: None declared.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787552/bin/hofg624825.f1_default.jpg
Fig 1 Flow chart for Norwegian Colorectal Cancer Prevention trial 1 cohort screened January 1999 to December 2001
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787552/bin/hofg624825.f2_default.jpg
Fig 2 Cumulative hazard for colorectal cancer in screening and control groups
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787552/bin/hofg624825.f3_default.jpg
Fig 3 Cumulative hazard for rectosigmoidal cancer among attenders compared with control group

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Source: PubMed

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