Enrique Quintero1, Marta Carrillo2, Antonio Z Gimeno-García2, Manuel Hernández-Guerra2, David Nicolás-Pérez2, Inmaculada Alonso-Abreu2, Maria Luisa Díez-Fuentes3, Víctor Abraira4. 1. Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain. Electronic address: equinter@gmail.com. 2. Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain. 3. Laboratorio Central, Hospital Universitario de Canarias, La Laguna, Tenerife, Spain. 4. Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
Abstract
BACKGROUND & AIMS:Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer (CRC), but few studies have compared its efficacy for CRC detection with that of other screening strategies. We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests (FITs) and colonoscopy in detecting advanced neoplasia (advanced adenoma or CRC) in family members of patients with CRC. METHODS: In a prospective study, 1918 first-degree relatives of patients with CRC were randomly assigned (1:1 ratio) to receive a single colonoscopy examination or 3 FITs (1/year for 3 years; OC-Sensor; cutoff ≥10 μg hemoglobin/g feces, corresponding to 50 ng hemoglobin/mL buffer). The strategies were considered to be equivalent if the 95% confidence interval of the difference for the detection of advanced neoplasia was ±3%. Follow-up analyses were performed to identify false-negative FIT results and interval CRCs. RESULTS:Of all eligible asymptomatic first-degree relatives, 782 were included in the colonoscopy group and 784 in the FIT group. In the intention-to-screen analysis, advanced neoplasia was detected in 33 (4.2%) and 44 (5.6%) first-degree relatives in the FIT and colonoscopy groups, respectively (odds ratio = 1.41; 95% confidence interval: 0.88-2.26; P = .14). In the per-protocol analysis, 28 first-degree relatives (3.9%) in the FIT group and 43 (5.8%) in the colonoscopy group had advanced neoplasia (odds ratio = 1.56; 95% confidence interval: 0.95-2.56; P = .08). FIT missed 16 of 41 advanced adenomas but no CRCs. The FIT strategy required endoscopic evaluation of 4-fold fewer individuals to detect 1 advanced neoplasia than the colonoscopy strategy. CONCLUSIONS: Repeated FIT screening (1/year for 3 years) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC. This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy. ClinicalTrials.gov number: NCT01075633 (COLONFAM Study).
RCT Entities:
BACKGROUND & AIMS: Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer (CRC), but few studies have compared its efficacy for CRC detection with that of other screening strategies. We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests (FITs) and colonoscopy in detecting advanced neoplasia (advanced adenoma or CRC) in family members of patients with CRC. METHODS: In a prospective study, 1918 first-degree relatives of patients with CRC were randomly assigned (1:1 ratio) to receive a single colonoscopy examination or 3 FITs (1/year for 3 years; OC-Sensor; cutoff ≥10 μg hemoglobin/g feces, corresponding to 50 ng hemoglobin/mL buffer). The strategies were considered to be equivalent if the 95% confidence interval of the difference for the detection of advanced neoplasia was ±3%. Follow-up analyses were performed to identify false-negative FIT results and interval CRCs. RESULTS: Of all eligible asymptomatic first-degree relatives, 782 were included in the colonoscopy group and 784 in the FIT group. In the intention-to-screen analysis, advanced neoplasia was detected in 33 (4.2%) and 44 (5.6%) first-degree relatives in the FIT and colonoscopy groups, respectively (odds ratio = 1.41; 95% confidence interval: 0.88-2.26; P = .14). In the per-protocol analysis, 28 first-degree relatives (3.9%) in the FIT group and 43 (5.8%) in the colonoscopy group had advanced neoplasia (odds ratio = 1.56; 95% confidence interval: 0.95-2.56; P = .08). FIT missed 16 of 41 advanced adenomas but no CRCs. The FIT strategy required endoscopic evaluation of 4-fold fewer individuals to detect 1 advanced neoplasia than the colonoscopy strategy. CONCLUSIONS: Repeated FIT screening (1/year for 3 years) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC. This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy. ClinicalTrials.gov number: NCT01075633 (COLONFAM Study).
Authors: Ethna McFerran; James F O'Mahony; Richard Fallis; Duncan McVicar; Ann G Zauber; Frank Kee Journal: Epidemiol Rev Date: 2017-01-01 Impact factor: 6.222
Authors: Adeyinka O Laiyemo; Otis Brawley; David Irabor; Adam Boutall; Rajkumar S Ramesar; Thandinkosi E Madiba Journal: Int J Cancer Date: 2015-10-05 Impact factor: 7.396
Authors: Douglas K Rex; C Richard Boland; Jason A Dominitz; Francis M Giardiello; David A Johnson; Tonya Kaltenbach; Theodore R Levin; David Lieberman; Douglas J Robertson Journal: Am J Gastroenterol Date: 2017-06-06 Impact factor: 10.864
Authors: Kathleen F Mittendorf; Sarah Knerr; Tia L Kauffman; Nangel M Lindberg; Katherine P Anderson; Heather Spencer Feigelson; Marian J Gilmore; Jessica Ezzell Hunter; Galen Joseph; Stephanie A Kraft; Jamilyn M Zepp; Sapna Syngal; Benjamin S Wilfond; Katrina A B Goddard Journal: JCO Precis Oncol Date: 2021-11-03
Authors: Peter S Liang; Chelle L Wheat; Anshu Abhat; Alison T Brenner; Angela Fagerlin; Rodney A Hayward; Jennifer P Thomas; Sandeep Vijan; John M Inadomi Journal: Am J Gastroenterol Date: 2015-11-03 Impact factor: 10.864