Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial

Title: Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial
Authors: Atkin, WS
Edwards, R
Kralj-Hans, I
Wooldrage, K
Hart, AR
Northover, JM
Parkin, DM
Wardle, J
Duffy, SW
Cuzick, J
Item Type: Journal Article
Issue Date: 27-Apr-2010
Date of Acceptance: 27-Apr-2010
ISSN: 0140-6736
Publisher: Elsevier
Start Page: 1624
End Page: 1633
Journal / Book Title: Lancet
Volume: 375
Copyright Statement: Open Access funded by Cancer Research UK
Sponsor/Funder: Medical Research Council (MRC)
Funder's Grant Number: G9615910
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
Colorectal Neoplasms
Middle Aged
UK Flexible Sigmoidoscopy Trial Investigators
Colorectal Neoplasms/diagnosis/mortality/pathology/*prevention & control Female Humans Male Middle Aged *Sigmoidoscopy
11 Medical And Health Sciences
Notes: Atkin, Wendy S Edwards, Rob Kralj-Hans, Ines Wooldrage, Kate Hart, Andrew R Northover, John M A Parkin, D Max Wardle, Jane Duffy, Stephen W Cuzick, Jack UK Flexible Sigmoidoscopy Trial Investigators Cancer Research UK/United Kingdom Medical Research Council/United Kingdom Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't England Lancet Lancet. 2010 May 8;375(9726):1624-33. Epub 2010 Apr 27. BACKGROUND: Colorectal cancer is the third most common cancer worldwide and has a high mortality rate. We tested the hypothesis that only one flexible sigmoidoscopy screening between 55 and 64 years of age can substantially reduce colorectal cancer incidence and mortality. METHODS: This randomised controlled trial was undertaken in 14 UK centres. 170 432 eligible men and women, who had indicated on a previous questionnaire that they would accept an invitation for screening, were randomly allocated to the intervention group (offered flexible sigmoidoscopy screening) or the control group (not contacted). Randomisation by sequential number generation was done centrally in blocks of 12, with stratification by trial centre, general practice, and household type. The primary outcomes were the incidence of colorectal cancer, including prevalent cases detected at screening, and mortality from colorectal cancer. Analyses were intention to treat and per protocol. The trial is registered, number ISRCTN28352761. FINDINGS: 113 195 people were assigned to the control group and 57 237 to the intervention group, of whom 112 939 and 57 099, respectively, were included in the final analyses. 40 674 (71%) people underwent flexible sigmoidoscopy. During screening and median follow-up of 11.2 years (IQR 10.7-11.9), 2524 participants were diagnosed with colorectal cancer (1818 in control group vs 706 in intervention group) and 20 543 died (13 768 vs 6775; 727 certified from colorectal cancer [538 vs 189]). In intention-to-treat analyses, colorectal cancer incidence in the intervention group was reduced by 23% (hazard ratio 0.77, 95% CI 0.70-0.84) and mortality by 31% (0.69, 0.59-0.82). In per-protocol analyses, adjusting for self-selection bias in the intervention group, incidence of colorectal cancer in people attending screening was reduced by 33% (0.67, 0.60-0.76) and mortality by 43% (0.57, 0.45-0.72). Incidence of distal colorectal cancer (rectum and sigmoid colon) was reduced by 50% (0.50, 0.42-0.59; secondary outcome). The numbers needed to be screened to prevent one colorectal cancer diagnosis or death, by the end of the study period, were 191 (95% CI 145-277) and 489 (343-852), respectively. INTERPRETATION: Flexible sigmoidoscopy is a safe and practical test and, when offered only once between ages 55 and 64 years, confers a substantial and longlasting benefit. FUNDING: Medical Research Council, National Health Service R&D, Cancer Research UK, KeyMed.
Publication Status: Published
Open Access location:
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