西班牙大肠癌普查计划Pilar Iglesias小组的最新研究报道了结肠镜检查与粪便免疫化学检查筛查对结直肠癌癌症死亡率的影响。2025年3月27日出版的《柳叶刀》杂志发表了这项成果。

背景:结肠镜检查和粪便免疫化学检查是平均风险人群（即年龄≥50岁，无个人或家族结直肠癌病史的人群）接受的结直肠癌筛查策略。在这项试验中，研究团队的目的是比较在筛查方案中，邀请用粪便免疫化学试验进行筛查是否优于结肠镜检查。

方法:COLONPREV是一项实用、随机、对照、非劣效性试验，在西班牙8个地区的15家三级医院进行。符合条件的参与者假定健康，年龄在50至69岁之间，无个人结直肠癌、腺瘤或炎症性肠病病史，家族史或家族性结直肠癌（即两个或两个以上一级亲属患有结直肠癌或一个在60岁之前被诊断出患有结直肠癌），严重的合并症，或既往结肠切除术。在邀请参与者进行筛查之前，参与者被随机分配（1:1）进行一次结肠镜检查或两年一次粪便免疫化学检查。主要终点是在意向筛查人群中评估的10年结直肠癌死亡率。绝对差异小于0.16个百分点为非劣效性。

发现:从2009年6月1日到2021年12月31日，57404人被随机分配接受结肠镜检查（n= 28708）或粪便免疫化学测试（n= 28696）的邀请。意向筛查人群包括26结肠镜检查组332人，26粪便免疫化学试验组719例。在有意筛查的人群中，结肠镜检查组和粪便免疫化学检查组参加任何形式筛查的比例分别为31.8%和39.9%（风险比[RR] 0.79）。在10年结直肠癌死亡风险方面，粪便免疫化学检查不低于结肠镜检查：结肠镜检查组的风险为0.22%（55例死亡），粪便免疫化学检查组的风险为0.24%（60例死亡）(风险差异为- 0.02 [95% CI - 0.10 ~ 0.06；Rr 0·92；pnon-inferiority = 0·0005)。

研究结果表明，应邀参加粪便免疫化学试验筛查的个体比参加结肠镜筛查的个体参与率更高。根据本研究中观察到的参与情况，基于粪便免疫化学测试的方案在结直肠癌相关死亡率方面并不亚于基于结肠镜检查的方案。

附：英文原文

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

Author: Antoni Castells, Enrique Quintero, Luis Bujanda, Susana Castán-Cameo, Joaquín Cubiella, José Díaz-Tasende, ángel Lanas, Akiko Ono, Miquel Serra-Burriel, Eladio Frías-Arrocha, Cristina Hernández, Rodrigo Jover, Montserrat Andreu, Fernando Carballo, Juan Diego Morillas, Dolores Salas, Raquel Almazán, Inmaculada Alonso-Abreu, Jesús M Banales, Vicent Hernández, Isabel Portillo, Mercedes Vanaclocha-Espí, Mariola de la Vega, ángel Lanas, Marta Jiménez, María Pilar Roncales, Francisca González-Rubio, Alberto Moya-Calvo, Pilar Sebastián-Martínez, Gonzalo Hijos, Federico Sopea, ángel Ferrández, Trinidad Serrano, Luis Bujanda, Juan Arenas, Patricia Aspichueta, Jesús M. Banales, Francisco J. Caballero-Camino, Ander Ezcurra, Inés Gil, María A. Gutiérrez-Stampa, Marta Herreros-Villanueva, Elizabeth Hijona, Arantza Izaguirre, Laura Izquierdo-Sánchez, Oihana Jardón, Ainhoa Lapitz, Eva Laredo, Isabel Montalvo, Beatriz Nafría, Irene Olaizola, Paula Olaizola, Maria J. Perugorria, Isabel Portillo, Pedro M. Rodrigues, Cristina Sarasqueta, Nerea Segues, Maite Solís, Enrique Quintero, Eladio Frías, Inmaculada Alonso-Abreu, Begoa Bellas-Beceiro, Marta Carrillo-Palau, Mariola de la Vega-Prieto, María Luisa Díez-Fuentes, Antonio Gimeno-García, Goretti Hernández-Mesa, David Nicolás-Pérez, Antoni Castells, Montserrat Andreu, Cristina Hernández, Alba Ortega, Cristina álvarez, Josep M. Augé, Francesc Balaguer, Mercè Barau, Xavier Bessa, Andrea Burón, Xavier Castells, Mercè Comas, Míriam Cuatrecasas, Mireia Díaz, Josep Alfons Espinàs, Maria Estrada, Olga Ferrer, Rebeca Font, Imma Garrell, Jaume Grau, Rafael Guayta, María López-Cerón, Francesc Macià, Leticia Moreira, Teresa Ocaa, Maria Pellisé, Mercè Piracés, Sandra Polbach, àngels Pozo, Cristina Rodríguez, Maria Sala, Agustín Seoane, Anna Serradesanferm, Judith Sivilla, Joaquín Cubiella, Pedro Davila-Pión, Jorge Hernández-Camoiras, Ma Belén Aguado, Susana Aldecoa, Raquel Almazán, Ana Alonso, Inés Castro, Estela Cid, Lucía Cid, Joan Clofent, Ma Luisa de Castro, Astrid Díez-Martín, Pamela Estévez, Ana Belén Fernández, Carme García-Benito, Ma Dolores González, Simoneta González, Ma Carmen González-Mao, Vicent Hernández, Begoa Iglesias, Felipe Iglesias, Pilar Iglesias

Issue&Volume: 2025-03-27

Abstract: 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, 57404 individuals were randomly assigned to receive an invitation for colonoscopy (n=28708) or the faecal immunochemical test (n=28696). The intention-to-screen population consisted of 26332 individuals in the colonoscopy group and 26719 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 0·92 [95% CI 0·64 to 1·32]; pnon-inferiority=0·0005).

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.

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

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00145-X/abstract