Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening
Enrique Quintero, Antoni Castells, Luis Bujanda, Joaquín Cubiella, Dolores Salas, Ángel Lanas, Montserrat Andreu, Fernando Carballo, Juan Diego Morillas, Cristina Hernández, Rodrigo Jover, Isabel Montalvo, Juan Arenas, Eva Laredo, Vicent Hernández, Felipe Iglesias, Estela Cid, Raquel Zubizarreta, Teresa Sala, Marta Ponce, Mercedes Andrés, Gloria Teruel, Antonio Peris, María-Pilar Roncales, Mónica Polo-Tomás, Xavier Bessa, Olga Ferrer-Armengou, Jaume Grau, Anna Serradesanferm, Akiko Ono, José Cruzado, Francisco Pérez-Riquelme, Inmaculada Alonso-Abreu, Mariola de la Vega-Prieto, Juana Maria Reyes-Melian, Guillermo Cacho, José Díaz-Tasende, Alberto Herreros-de-Tejada, Carmen Poves, Cecilio Santander, Andrés González-Navarro, COLONPREV Study Investigators, Angel Lanas, Francisca Gonzalez-Rubio, Alberto Moya-Calvo, Mónica Polo-Tomas, Maria Pilar Roncales, Pilar Sebastian-Martínez, María Ángeles Valencia-Doblas, Nieves Valero-Capilla, Luis Bujanda, María E Alkiza, Jone Altzibar, Pilar Amiano, Juan Arenas, Edurne Artiñano, Angel Cosme, Isabel Egitegi, Kepa Elorriaga, Jose L Elósegui, José M Enriquez-Navascués, Cristina Erce, Inés Gil, María A Gutiérrez-Stampa, Marta Herreros, Elizabeth Hijona, Mariluz Jaúregui, Eva Laredo, Roberto Martínez, Maria J Mitxelena, Isabel Montalvo, Carlos Placer, Isabel Portillo, Enrique Quintero, Onofre Alarcón, Inmaculada Alonso-Abreu, Marta Carrillo-Palau, Mariola de la Vega-Prieto, María Luisa Díez-Fuentes, Antonio Gimeno-García, Yanira González-Méndez, Manuel Hernández-Guerra, Renata Linertová, David Nicolás-Perez, Juana María Reyes-Melián, Montserrat Andreu, Cristina Álvarez, Josep M Augé, Francesc Balaguer, Mercè Barau, Xavier Bessa, Felipe Bory, Andrea Burón, Antoni Castells, Xavier Castells, Mercè Comas, Míriam Cuatrecasas, Maria Estrada, Olga Ferrer, Imma Garrell, Jaume Grau, Rafael Guayta, Cristina Hernández, María López-Cerón, Francesc Macià, Leticia Moreira, Teresa Ocaña, Maria Pellisé, Mercè Piracés, Sandra Polbach, Marc Puigvehí, Cristina Rodríguez, Maria Sala, Agustín Seoane, Anna Serradesanferm, Judith Sivilla, Antoni Trilla, Joaquín Cubiella, Ma Belén Aguado, Susana Aldecoa, Raquel Almazán, Ana Alonso, Inés Castro, Estela Cid, Lucía Cid, Joan Clofent, Ma Luisa de Castro, Pamela Estévez, Ana Belén Fernández, Ma Dolores González, Simoneta González, Ma Carmen González-Mao, Vicent Hernández, Begoña Iglesias, Felipe Iglesias, Pilar Iglesias, Ángeles López-Martínez, Ramiro Macenlle, Alfonso Martínez, David Martínez, Carlos Menéndez, Carmen Méndez, José Antonio Hermo, Isabel Pérez, Carmen Portasany, Mar Rionda, Concepción Rivera, Benito Rodríguez, Rosa Rodríguez, Manuel Rubio, María Isolina Santiago, Miriam Vázquez, José Ángel Vázquez, Pablo Vega, Ma Carmen Vidal, Raquel Zubizarreta, Juan Diego Morillas, Luís Abreu, Francisco Javier Amador, Manuel Arroyo, Fernando Bandrés, Margarita Barba, José Manuel Blanco, Guillermo Cacho, José Cantero, Juan Carrasco, Beatriz Carrascosa, Gregorio Castellano, Francisco Colina, María Chaparro, Manuel Díaz-Rubio, José Díaz-Tasende, José Miguel Esteban, Conrado Fernández, Servando Fernández-Díez, Marta Fernández-Gil, Juan Ferrándiz, Alejandro Franco, Gabriela García-Álvarez, Aurelio Garrido, Sofía Garrido, Javier P Gisbert, Mariano Gómez-Haba, Inés Gómez-Molíns, Andrés González-Navarro, María José González, Belén Herranz, Pilar Herránz, Alberto Herreros, Rosario Iglesias, Sonia Izquierdo, Carlos López, María Aranzazu López-Rubio, Alicia Marín, José Carlos Marín, María Carmen Martín, José Luis Martínez, Raquel Martínez, Carmen Moliner, José Manuel Moreno, Ricardo Moreno, Amelia Nogueiras, María Teresa Pérez, Rafael Píriz, Carmen Plaza, Elena Polentinos, Carmen Povés, Pedro Ruíz, Inmaculada Salces, Francisco Sánchez-Ceballos, Cecilio Santander, Rocío Sastre, Vicente Valentín, Fernando Carballo, Miriam Alajarín, Fernando Alberca, Juan Bermejo, Joaquín Carrillo, José Cruzado, Purificación López, Mariano Martínez, María Dolores Navarro, Akiko Ono, Soledad Parra, Francisco Pérez-Riquelme, Pedro Riquelme-Tenza, Dolores Salas, Mercedes Andrés, Consuelo Calvo, Montserrat Jimenez, Araceli Málaga, Elena Pérez, Antonio Peris, Marta Ponce, Rodrigo Jover, Teresa Sala, Gloria Teruel, Enrique Quintero, Antoni Castells, Luis Bujanda, Joaquín Cubiella, Dolores Salas, Ángel Lanas, Montserrat Andreu, Fernando Carballo, Juan Diego Morillas, Cristina Hernández, Rodrigo Jover, Isabel Montalvo, Juan Arenas, Eva Laredo, Vicent Hernández, Felipe Iglesias, Estela Cid, Raquel Zubizarreta, Teresa Sala, Marta Ponce, Mercedes Andrés, Gloria Teruel, Antonio Peris, María-Pilar Roncales, Mónica Polo-Tomás, Xavier Bessa, Olga Ferrer-Armengou, Jaume Grau, Anna Serradesanferm, Akiko Ono, José Cruzado, Francisco Pérez-Riquelme, Inmaculada Alonso-Abreu, Mariola de la Vega-Prieto, Juana Maria Reyes-Melian, Guillermo Cacho, José Díaz-Tasende, Alberto Herreros-de-Tejada, Carmen Poves, Cecilio Santander, Andrés González-Navarro, COLONPREV Study Investigators, Angel Lanas, Francisca Gonzalez-Rubio, Alberto Moya-Calvo, Mónica Polo-Tomas, Maria Pilar Roncales, Pilar Sebastian-Martínez, María Ángeles Valencia-Doblas, Nieves Valero-Capilla, Luis Bujanda, María E Alkiza, Jone Altzibar, Pilar Amiano, Juan Arenas, Edurne Artiñano, Angel Cosme, Isabel Egitegi, Kepa Elorriaga, Jose L Elósegui, José M Enriquez-Navascués, Cristina Erce, Inés Gil, María A Gutiérrez-Stampa, Marta Herreros, Elizabeth Hijona, Mariluz Jaúregui, Eva Laredo, Roberto Martínez, Maria J Mitxelena, Isabel Montalvo, Carlos Placer, Isabel Portillo, Enrique Quintero, Onofre Alarcón, Inmaculada Alonso-Abreu, Marta Carrillo-Palau, Mariola de la Vega-Prieto, María Luisa Díez-Fuentes, Antonio Gimeno-García, Yanira González-Méndez, Manuel Hernández-Guerra, Renata Linertová, David Nicolás-Perez, Juana María Reyes-Melián, Montserrat Andreu, Cristina Álvarez, Josep M Augé, Francesc Balaguer, Mercè Barau, Xavier Bessa, Felipe Bory, Andrea Burón, Antoni Castells, Xavier Castells, Mercè Comas, Míriam Cuatrecasas, Maria Estrada, Olga Ferrer, Imma Garrell, Jaume Grau, Rafael Guayta, Cristina Hernández, María López-Cerón, Francesc Macià, Leticia Moreira, Teresa Ocaña, Maria Pellisé, Mercè Piracés, Sandra Polbach, Marc Puigvehí, Cristina Rodríguez, Maria Sala, Agustín Seoane, Anna Serradesanferm, Judith Sivilla, Antoni Trilla, Joaquín Cubiella, Ma Belén Aguado, Susana Aldecoa, Raquel Almazán, Ana Alonso, Inés Castro, Estela Cid, Lucía Cid, Joan Clofent, Ma Luisa de Castro, Pamela Estévez, Ana Belén Fernández, Ma Dolores González, Simoneta González, Ma Carmen González-Mao, Vicent Hernández, Begoña Iglesias, Felipe Iglesias, Pilar Iglesias, Ángeles López-Martínez, Ramiro Macenlle, Alfonso Martínez, David Martínez, Carlos Menéndez, Carmen Méndez, José Antonio Hermo, Isabel Pérez, Carmen Portasany, Mar Rionda, Concepción Rivera, Benito Rodríguez, Rosa Rodríguez, Manuel Rubio, María Isolina Santiago, Miriam Vázquez, José Ángel Vázquez, Pablo Vega, Ma Carmen Vidal, Raquel Zubizarreta, Juan Diego Morillas, Luís Abreu, Francisco Javier Amador, Manuel Arroyo, Fernando Bandrés, Margarita Barba, José Manuel Blanco, Guillermo Cacho, José Cantero, Juan Carrasco, Beatriz Carrascosa, Gregorio Castellano, Francisco Colina, María Chaparro, Manuel Díaz-Rubio, José Díaz-Tasende, José Miguel Esteban, Conrado Fernández, Servando Fernández-Díez, Marta Fernández-Gil, Juan Ferrándiz, Alejandro Franco, Gabriela García-Álvarez, Aurelio Garrido, Sofía Garrido, Javier P Gisbert, Mariano Gómez-Haba, Inés Gómez-Molíns, Andrés González-Navarro, María José González, Belén Herranz, Pilar Herránz, Alberto Herreros, Rosario Iglesias, Sonia Izquierdo, Carlos López, María Aranzazu López-Rubio, Alicia Marín, José Carlos Marín, María Carmen Martín, José Luis Martínez, Raquel Martínez, Carmen Moliner, José Manuel Moreno, Ricardo Moreno, Amelia Nogueiras, María Teresa Pérez, Rafael Píriz, Carmen Plaza, Elena Polentinos, Carmen Povés, Pedro Ruíz, Inmaculada Salces, Francisco Sánchez-Ceballos, Cecilio Santander, Rocío Sastre, Vicente Valentín, Fernando Carballo, Miriam Alajarín, Fernando Alberca, Juan Bermejo, Joaquín Carrillo, José Cruzado, Purificación López, Mariano Martínez, María Dolores Navarro, Akiko Ono, Soledad Parra, Francisco Pérez-Riquelme, Pedro Riquelme-Tenza, Dolores Salas, Mercedes Andrés, Consuelo Calvo, Montserrat Jimenez, Araceli Málaga, Elena Pérez, Antonio Peris, Marta Ponce, Rodrigo Jover, Teresa Sala, Gloria Teruel
Abstract
Background: Colonoscopy and fecal immunochemical testing (FIT) are accepted strategies for colorectal-cancer screening in the average-risk population.
Methods: In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we compared one-time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects. The primary outcome was the rate of death from colorectal cancer at 10 years. This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening. Study outcomes were analyzed in both intention-to-screen and as-screened populations.
Results: The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001). Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99). Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001).
Conclusions: Subjects in the FIT group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT00906997.).
Source: PubMed