Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial

Author(s): Antoni Castells¹;Enrique Quintero²;Luis Bujanda³;Susana Castán-Cameo⁴;Joaquín Cubiella⁵;José Díaz-Tasende⁶;Ángel Lanas⁷;Akiko Ono⁸;Miquel Serra-Burriel⁹;Eladio Frías-Arrocha²;Cristina Hernández¹⁰;Rodrigo Jover¹¹;Montserrat Andreu¹²;Fernando Carballo⁸;Juan Diego Morillas¹³;Dolores Salas⁴;Raquel Almazán¹⁴;Inmaculada Alonso-Abreu²;Jesús M Banales^3,15;Vicent Hernández¹⁶;Isabel Portillo¹⁷;Mercedes Vanaclocha-Espí¹⁸;Mariola de la Vega¹⁹

Source: DOI: 10.1016/S0140-6736(25)00145-X

Dr. Maen Hussein's Thoughts

People prefer stool card over colonoscopy, and it is not inferior.

BACKGROUND

Colonoscopy and the faecal immunochemical test are accepted strategies for colorectal cancer screening in the average-risk population (ie, people aged ≥50 years without personal or family history of colorectal cancer). In this trial, we aimed to compare whether invitation to screening with faecal immunochemical test was non-inferior to colonoscopy in a screening programme.

METHODS

COLONPREV was a pragmatic, randomised, controlled, non-inferiority trial done at 15 tertiary hospitals across eight regions of Spain. Eligible participants were presumptively healthy and aged between 50 years and 69 years without a personal history of colorectal cancer, adenoma or inflammatory bowel disease, family history of hereditary or familial colorectal cancer (ie, two or more first-degree relatives with colorectal cancer or one diagnosed before age 60 years), severe comorbidities, or previous colectomy. Participants were randomly assigned (1:1) to one-time colonoscopy or biennial faecal immunochemical test before invitation to screening. The primary endpoint was colorectal cancer mortality at 10 years, assessed in the intention-to-screen population. An absolute difference of less than 0·16 percentage points was required to show non-inferiority. This trial was registered with ClinicalTrials.gov, NCT00906997.

FINDINGS

Between June 1, 2009, and Dec 31, 2021, 57 404 individuals were randomly assigned to receive an invitation for colonoscopy (n=28 708) or the faecal immunochemical test (n=28 696). The intention-to-screen population consisted of 26 332 individuals in the colonoscopy group and 26 719 in the faecal immunochemical test group. In the intention-to-screen population, participation in any form of screening was 31·8% in the colonoscopy group and 39·9% in the faecal immunochemical test group (risk ratio [RR] 0·79 [95% CI 0·77 to 0·82]). Faecal immunochemical testing was non-inferior to colonoscopy with regard to the risk of colorectal cancer mortality at 10 years: the risk was 0·22% (55 deaths) in the colonoscopy group and 0·24% (60 deaths) in the faecal immunochemical test group (risk difference –0·02 [95% CI –0·10 to 0·06; RR 젓

INTERPRETATION

Participation in screening was higher among individuals invited to faecal immunochemical test screening than colonoscopy screening. On the basis of participation observed in this study, a faecal immunochemical test-based programme was non-inferior to a colonoscopy-based programme for colorectal cancer-related mortality.

FUNDING

Fundación Científica de la Asociación Española contra el Cáncer and Instituto de Salud Carlos III.

Author Affiliations

¹Department of Gastroenterology, Hospital Clínic of Barcelona, IDIBAPS, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona, Spain;²Department of Gastroenterology, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas, Universidad de La Laguna, Tenerife, Spain;³Department of Hepatology and Gastroenterology, Biogipuzkoa Health Research Institute, Donostia University Hospital, University of the Basque Country, San Sebastián, Spain;⁴Colorectal Cancer Screening Programme, Dirección General de Salud Pública, Conselleria de Sanitat, Valencia, Spain;⁵Department of Gastroenterology, Hospital Universitario de Ourense, Grupo de Investigación en Oncología Digestiva-Ourense, Ourense, Spain;⁶Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain;⁷Department of Gastroenterology, University of Zaragoza, Zaragoza, Spain;⁸Department of Gastroenterology, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain;⁹Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland;¹⁰Department of Epidemiology and Evaluation, Hospital del Mar Research Institute, Barcelona, Spain;¹¹Gastroenterology Unit, Hospital General Universitario de Alicante, Alicante, Spain;¹²Department of Gastroenterology, Hospital del Mar Research Institute, Barcelona, Spain;¹³Department of Gastroenterology, Hospital Clínico San Carlos, Madrid, Spain;¹⁴Servicio de Programas de Cribados Poblacionales, Dirección Xeral de Saúde Pública, Conselleria de Sanidade, Santiago de Compostela, Spain;¹⁵Department of Biochemistry and Genetics, School of Sciences, University of Navarra, Pamplona, Spain;¹⁶Department of Gastroenterology, Xerencia Xestion Integrada de Vigo Research Group in Digestive Diseases, SERGAS, Galicia Sur Health Research Institute, Vigo, Spain;¹⁷Basque Country Colorectal Screening Programme, Osakidetza Basque Health Service, Biobizkaia Health Research Institute, Bilbao, Spain;¹⁸Foundation for the Promotion of Health and Biomedical Research, Valencia, Spain;¹⁹Colorectal Cancer Screening Programme of Comunidad de Canarias, Servicio Canario de la Salud, Tenerife, Spain

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