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

Randomized Controlled Trial

. 2018 Jun 5;168(11):775-782. doi: 10.7326/M17-1441. Epub 2018 Apr 24. Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A Randomized Trial Magnus Løberg  1 Mette Kalager  2 Michael Bretthauer  1 Miguel A Hernán  2 Eline Aas  3 Tor J Eide  1 Eva Skovlund  4 Jon Lekven  5 Jörn Schneede  6 Kjell Magne Tveit  7 Morten Vatn  7 Giske Ursin  8 Geir Hoff  9 NORCCAP Study Group†

Collaborators, Affiliations

Collaborators Affiliations

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Randomized Controlled Trial

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

Øyvind Holme et al. Ann Intern Med. 2018.

. 2018 Jun 5;168(11):775-782. doi: 10.7326/M17-1441. Epub 2018 Apr 24. Authors Øyvind Holme  1 Magnus Løberg  1 Mette Kalager  2 Michael Bretthauer  1 Miguel A Hernán  2 Eline Aas  3 Tor J Eide  1 Eva Skovlund  4 Jon Lekven  5 Jörn Schneede  6 Kjell Magne Tveit  7 Morten Vatn  7 Giske Ursin  8 Geir Hoff  9 NORCCAP Study Group† Collaborators Affiliations

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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.

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Conflict of interest statement

Disclosures: All authors report no conflicts of interest.

Figures

Appendix Figure 1

Study flow chart. CRC…

Appendix Figure 1

Study flow chart. CRC = colorectal cancer; FOBT = fecal occult blood…

Appendix Figure 1

Study flow chart. CRC = colorectal cancer; FOBT = fecal occult blood testing.

Appendix Figure 2

Risks for CRC, rectosigmoid…

Appendix Figure 2

Risks for CRC, rectosigmoid cancer, and death from CRC for women and…

Appendix Figure 2

Risks for CRC, rectosigmoid cancer, and death from CRC for women and men in the screening and control groups. CRC = colorectal cancer.

Appendix Figure 3

Fifteen-year risks for CRC…

Appendix Figure 3

Fifteen-year risks for CRC and death from CRC with and without screening…

Appendix Figure 3

Fifteen-year risks for CRC and death from CRC with and without screening for women and men. CRC = colorectal cancer.

Figure 1:. Risk of colorectal cancer, rectosigmoid…

Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and…

Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and women in the screening and control groups.

Panel A: colorectal cancer risk in women; Panel B: colorectal cancer risk in men; Panel C: rectosigmoid cancer risk in women; Panel D: rectosigmoid cancer risk in men; Panel E: colorectal cancer mortality risk in women; Panel F: colorectal cancer mortality risk in men

Figure 1:. Risk of colorectal cancer, rectosigmoid…

Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and…

Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and women in the screening and control groups.

Panel A: colorectal cancer risk in women; Panel B: colorectal cancer risk in men; Panel C: rectosigmoid cancer risk in women; Panel D: rectosigmoid cancer risk in men; Panel E: colorectal cancer mortality risk in women; Panel F: colorectal cancer mortality risk in men

Figure 1:. Risk of colorectal cancer, rectosigmoid…

Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and…

Figure 1:. Risk of colorectal cancer, rectosigmoid cancer, and colorectal cancer mortality for men and women in the screening and control groups.

Panel A: colorectal cancer risk in women; Panel B: colorectal cancer risk in men; Panel C: rectosigmoid cancer risk in women; Panel D: rectosigmoid cancer risk in men; Panel E: colorectal cancer mortality risk in women; Panel F: colorectal cancer mortality risk in men

Figure 2:

15-year risks of colorectal cancer…

Figure 2:

15-year risks of colorectal cancer (light-blue) and colorectal cancer mortality (dark blue) with…

Figure 2:

15-year risks of colorectal cancer (light-blue) and colorectal cancer mortality (dark blue) with and without screening for men and women

Comment in Similar articles Cited by References
    1. USPSTF, Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr., et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(23):2564–75. - PubMed
    1. Atkin W, Wooldrage K, Parkin DM, Kralj-Hans I, MacRae E, Shah U, et al. Long term effects of once-only flexible sigmoidoscopy screening after 17 years of follow-up: the UK Flexible Sigmoidoscopy Screening randomised controlled trial. Lancet. 2017. - PMC - PubMed
    1. Holme O, Loberg M, Kalager M, Bretthauer M, Hernan MA, Aas E, et al. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA. 2014;312(6):606–15. - PMC - PubMed
    1. Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, et al. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. New England Journal of Medicine. 2012;366(25):2345–57. - PMC - PubMed
    1. Segnan N, Armaroli P, Bonelli L, Risio M, Sciallero S, Zappa M, et al. Once-only sigmoidoscopy in colorectal cancer screening: follow-up findings of the Italian Randomized Controlled Trial--SCORE. J Natl Cancer Inst. 2011;103(17):1310–22. - PubMed

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