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Fecal immunochemical test accuracy in average-risk colorectal cancer screening
Vicent Hernandez, Joaquin Cubiella, M Carmen Gonzalez-Mao, Felipe Iglesias, Concepción Rivera, M Begoña Iglesias, Lucía Cid, Ines Castro, Luisa de Castro, Pablo Vega, Jose Antonio Hermo, Ramiro Macenlle, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, Estela Cid, M Carmen Vidal, Angeles López-Martínez, Elisabeth Hijona, Marta Herreros-Villanueva, Luis Bujanda, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators
Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain
Joaquin Cubiella, Concepción Rivera, Ines Castro, Pablo Vega, Ramiro Macenlle, Estela Cid, Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, 32005 Ourense, Spain
M Carmen Gonzalez-Mao, Angeles López-Martínez, Department of Clinical Analysis, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain
M Begoña Iglesias, Department of Pathology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain
Elisabeth Hijona, Marta Herreros-Villanueva, Luis Bujanda, Department of Gastroenterology, Donostia Hospital, Biodonostia Institute, University of the Basque Country UPV/EHU, CIBERehd, 20010 San Sebastian, Spain
Author contributions: Hernandez V is the guarantor of the article. Hernandez V, Cubiella J, Gonzalez-Mao MC and Iglesias F participated in the planning of the study; Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martínez-Turnes A, Martínez-Ares D, Estevez P, Cid E, Vidal MC, López-Martínez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI took part in the execution of the study; Hernandez V, Cubiella J analyzed the study; Finally, all authors read the manuscript, made comments and approved the final version submitted.
Supported by Grants from the Conselleria de Sanidade of Xunta de Galicia, No. PS09/74; Asociación Española contra el Cáncer (Fundación Científica), Instituto de Salud Carlos III, No. PI08/90717; Obra Social de Kutxa, Diputación Foral de Gipuzkoa, No. DFG 07/5; Departamento de Sanidad del Gobierno Vasco, EITB-Maratoia, No. BIO 07/CA/19; Acción Transversal contra el Cáncer del CIBERehd (2008); CIBERehd funded by the Instituto de Salud Carlos III; and Dirección Xeral de Innovación e Xestión da Saúde Pública, Conselleria de Sanidade, Xunta de Galicia
Correspondence to: Joaquín Cubiella, MD, PhD, Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, C/ Ramón Puga 52-54, 32005 Ourense, Spain.
joaquin.cubiella.fernandez@sergas.es
Telephone: +34-98-8385399 Fax: +34-98-8385399
Received: September 13, 2013
Revised: October 18, 2013
Accepted: November 12, 2013
Published online: January 28, 2014
Processing time: 125 Days and 19.4 Hours
AIM: To assess the fecal immunochemical test (FIT) accuracy for colorectal cancer (CRC) and advanced neoplasia (AN) detection in CRC screening.
METHODS: We performed a multicentric, prospective, double blind study of diagnostic tests on asymptomatic average-risk individuals submitted to screening colonoscopy. Two stool samples were collected and the fecal hemoglobin concentration was determined in the first sample (FIT1) and the highest level of both samples (FITmax) using the OC-sensor™. Areas under the curve (AUC) for CRC and AN were calculated. The best FIT1 and FITmax cut-off values for CRC were determined. At this threshold, number needed to scope (NNS) to detect a CRC and an AN and the cost per lesion detected were calculated.
RESULTS: About 779 individuals were included. An AN was found in 97 (12.5%) individuals: a CRC in 5 (0.6%) and an advanced adenoma (≥ 10 mm, villous histology or high grade dysplasia) in 92 (11.9%) subjects. For CRC diagnosis, FIT1 AUC was 0.96 (95%CI: 0.95-0.98) and FITmax AUC was 0.95 (95%CI: 0.93-0.97). For AN, FIT1 and FITmax AUC were similar (0.72, 95%CI: 0.66-0.78 vs 0.73, 95%CI: 0.68-0.79, respectively, P = 0.34). Depending on the number of determinations and the positivity threshold cut-off used sensitivity for AN detection ranged between 28% and 42% and specificity between 91% and 97%. At the best cut-off point for CRC detection (115 ng/mL), the NNS to detect a CRC were 10.2 and 15.8; and the cost per CRC was 1814€ and 2985€ on FIT1 and FITmax strategies respectively. At this threshold the sensitivity, NNS and cost per AN detected were 30%, 1.76, and 306€, in FIT1 strategy, and 36%, 2.26€ and 426€, in FITmax strategy, respectively.
CONCLUSION: Performing two tests does not improve diagnostic accuracy, but increases cost and NNS to detect a lesion.
Core tip: Our study has determined fecal immunochemical test (FIT) diagnostic accuracy, number needed to scope and cost per lesion detected in colorectal cancer (CRC) screening programs. FIT is highly sensitive for CRC detection, allowing a drastic reduction in the cost per lesion detected when compared with direct screening colonoscopy. These data are relevant to design CRC screening programs in this setting.
