Colonoscopy Intervals and Colorectal Cancer Incidence after Adenoma Removal

BACKGROUND: More evidence is needed to inform recommendations for intervals of colonoscopy surveillance after polyp removal. METHODS: In this ongoing noninferiority trial conducted in eight European countries, we randomly assigned patients with high-risk adenomas (defined as ≥1 adenoma with a diameter of ≥10 mm, high-grade dysplasia, or villous growth or 3 to 10 adenomas of any kind) to undergo a first colonoscopy at 5 years after polyp removal or at 3 years; surveillance at 3 years is currently recommended in guidelines. The 3-year group also underwent colonoscopy at 5 years. The primary end point is the cumulative incidence of colorectal cancer at 10 years, with a prespecified noninferiority margin of 0.7 percentage points for the upper boundary of the confidence interval for the difference between the two groups. Here, we report the results of an interim analysis conducted after 5.5 years of follow-up. Inverse probability weighting was used to account for missing data owing to nonparticipation in surveillance colonoscopy at 5 years. In this analysis, the incidence of colorectal cancer is reported with a one-sided 99.12% confidence interval; for the final analysis at 10 years, the plan is to calculate a 95.33% confidence interval to maintain an overall type I error of 5%. RESULTS: A total of 10,799 patients underwent randomization: 5398 patients were assigned to the 5-year group and 5401 to the 3-year group. The 5-year cumulative incidence of colorectal cancer was 0.77% with less-frequent surveillance and 0.82% with more-frequent surveillance (difference, -0.05 percentage points); the upper boundary of the 99.12% confidence interval was 0.68, which met the criterion for noninferiority. The distribution of cancer stage at diagnosis did not appear to differ substantially between the two groups. A total of 5 patients died of colorectal cancer: 3 patients (0.06%) in the 5-year group and 2 (0.04%) in the 3-year group. CONCLUSIONS: In this interim analysis of a 10-year noninferiority trial, beginning surveillance colonoscopy at 5 years after polyp removal was noninferior to beginning at 3 years with respect to the cumulative incidence of colorectal cancer at 5 years among patients with high-risk adenomas. (Funded by the Research Council of Norway and others; EPoS II ClinicalTrials.gov number, NCT02319928.).

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Publication Details

Journal
New England Journal of Medicine
Published
2026-09-16
DOI
https://doi.org/10.1056/nejmoa2603816
Citations
2
Primary Topic
Colorectal Cancer Screening and Detection
Type
article
Field-Weighted Citation Impact
7.48

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article

Colonoscopy Intervals and Colorectal Cancer Incidence after Adenoma Removal

Alejandro Martínez‐Roca, Claudia Jaensch, Joaquín Cubiella, Manon C.W. Spaander et al.
2 citations
New England Journal of Medicine
Colorectal Cancer Screening and Detection
7.48
article

Colonoscopy Intervals and Colorectal Cancer Incidence after Adenoma Removal

Alejandro Martínez‐Roca, Claudia Jaensch, Joaquín Cubiella, Manon C.W. Spaander, Hans‐Olov Adami, Jorgen Tilma, Monika Ferlitsch, Øyvind Holme, Jarosław Reguła, Uffe S. Løve, Linn Bernklev, Evelien Dekker, Frank ter Borg, Sarah Barry, Michael Bretthauer, Mette Kalager, Rodrigo Jover, Miguel A. Hernán, Andrzej Białek, Luisa de–Castro, Mário Dinis-Ribeiro, Hong Dung Nguyen, Magnus Løberg, Nastazja D. Pilonis, Anna Macios, Mirosław Szura, Monique E. van Leerdam, Michal F. Kaminski, Pilar Díez-Redondo, Sandra Baile-Maxía, Jens Aksel Nordberg Nilsen, Rune Erichsen, Lauren Barnett, Maria Pellise, Joep Ijspeert, Luis Bujanda, Annemarie van Berkel
article en
2 citations

Abstract

BACKGROUND: More evidence is needed to inform recommendations for intervals of colonoscopy surveillance after polyp removal. METHODS: In this ongoing noninferiority trial conducted in eight European countries, we randomly assigned patients with high-risk adenomas (defined as ≥1 adenoma with a diameter of ≥10 mm, high-grade dysplasia, or villous growth or 3 to 10 adenomas of any kind) to undergo a first colonoscopy at 5 years after polyp removal or at 3 years; surveillance at 3 years is currently recommended in guidelines. The 3-year group also underwent colonoscopy at 5 years. The primary end point is the cumulative incidence of colorectal cancer at 10 years, with a prespecified noninferiority margin of 0.7 percentage points for the upper boundary of the confidence interval for the difference between the two groups. Here, we report the results of an interim analysis conducted after 5.5 years of follow-up. Inverse probability weighting was used to account for missing data owing to nonparticipation in surveillance colonoscopy at 5 years. In this analysis, the incidence of colorectal cancer is reported with a one-sided 99.12% confidence interval; for the final analysis at 10 years, the plan is to calculate a 95.33% confidence interval to maintain an overall type I error of 5%. RESULTS: A total of 10,799 patients underwent randomization: 5398 patients were assigned to the 5-year group and 5401 to the 3-year group. The 5-year cumulative incidence of colorectal cancer was 0.77% with less-frequent surveillance and 0.82% with more-frequent surveillance (difference, -0.05 percentage points); the upper boundary of the 99.12% confidence interval was 0.68, which met the criterion for noninferiority. The distribution of cancer stage at diagnosis did not appear to differ substantially between the two groups. A total of 5 patients died of colorectal cancer: 3 patients (0.06%) in the 5-year group and 2 (0.04%) in the 3-year group. CONCLUSIONS: In this interim analysis of a 10-year noninferiority trial, beginning surveillance colonoscopy at 5 years after polyp removal was noninferior to beginning at 3 years with respect to the cumulative incidence of colorectal cancer at 5 years among patients with high-risk adenomas. (Funded by the Research Council of Norway and others; EPoS II ClinicalTrials.gov number, NCT02319928.).

New England Journal of MedicineVol. 395(11)
Universitat de Miguel Hernández d'Elx (ES), Jagiellonian University (PL), Oslo University Hospital (NO), Harvard University (US), Universidade do Porto (PT), University of Oslo (NO), Aarhus University (DK), Leiden University Medical Center (NL), Akershus University Hospital (NO), Vestre Viken Hospital Trust (NO), Erasmus MC (NL), University Hospital Complex Of Vigo (ES), Karolinska Institutet (SE), Regionshospitalet Viborg (DK), Noordwest Ziekenhuisgroep (NL), Biogipuzkoa Health Research Institute (ES), Oncode Institute (NL), IPO Porto (PT), Regional Hospital Horsens (DK), Frontier Agriculture (United Kingdom) (GB), Postgraduate School of Molecular Medicine (PL), Hospital General Universitario de Alicante Doctor Balmis (ES), Capital Region of Denmark (DK), Barnes Hospital (GB), The Maria Sklodowska-Curie National Research Institute of Oncology (PL), Amsterdam University Medical Centers (NL), Regional Hospital Randers (DK), Deventer Ziekenhuis (NL), Hospital Universitario Río Hortega (ES), i3S - Instituto de Investigação e Inovação em Saúde, Universidade do Porto (PT), Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES), Sørlandet Sykehus (NO), Institut für Lungenforschung (DE), Complejo Hospitalario de Ourense (ES), Instituto de investigación sanitaria y biomédica de Alicante (ES), Gdańsk Medical University (PL), Medical University of Vienna (AT), Pomeranian Medical University (PL)
Stiftelsen Kristian Gerhard Jebsen, Kræftens Bekæmpelse, Narodowe Centrum Nauki, KWF Kankerbestrijding, Norges Forskningsråd, Instituto de Salud Carlos III
Good health and well-being
Openalex Percentile: Top 2%
Colorectal Cancer Screening and Detection
7.48
DOISourceOpenAlex
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