Randomized study of weekly irinotecan plus high-dose 5-fluorouracil (FUIRI) versus biweekly irinotecan plus 5-fluorouracil/leucovorin (FOLFIRI) as first-line chemotherapy for patients with metastatic colorectal cancer: a Spanish Cooperative Group for the Treatment of Digestive Tumors Study

Annals of Oncology : Official Journal of the European Society for Medical Oncology
E ArandaEduardo Díaz-Rubio

Abstract

Irinotecan plus infusional 5-fluorouracil/leucovorin (FOLFIRI) is accepted as a reference treatment for the first-line treatment of patients with metastatic colorectal cancer (MCRC). The aim of this study was to demonstrate that a regimen without leucovorin (LV) (FUIRI) is not inferior to the standard FOLFIRI (response rate). Chemotherapy-naive patients with MCRC were randomized to receive either irinotecan (180 mg/m(2) on day 1) + 5-fluorouracil (5-FU) (400 mg/m(2) bolus and 600 mg/m(2) 22-h infusion) + LV (200 mg/m(2) on days 1-2) (FOLFIRI) every 2 weeks or irinotecan (80 mg/m(2)) + 5-FU (2.250 mg/m(2) 48-h infusion) (FUIRI) weekly. In all, 346 patients were included, 173 in each arm. In the intention-to-treat analysis, the response rates for FOLFIRI and FUIRI were 57% [95% confidence interval (CI) 49% to 64%] and 51% (95% CI 43% to 59%), respectively (P = 0.2809). No statistically significant differences were observed between FOLFIRI and FUIRI regarding median progression-free survival (8.3 versus 8.4 months; P = 0.4339) nor median overall survival (21.6 versus 19.2 months; log-rank test P = 0.2941). Grade 3/4 neutropenia was significantly more frequent on FOLFIRI arm (27% versus 9%), while the proportion of diarrhea was hig...Continue Reading

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Citations

Nov 30, 2013·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Renata KontekKsenia Matlawska-Wasowska
Jun 25, 2013·Maturitas·Antonio González-SarríasJuan Carlos Espín
Dec 14, 2018·Journal of Cancer Education : the Official Journal of the American Association for Cancer Education·Krzysztof Adamowicz, Zuzanna Baczkowska-Waliszewska
Jan 20, 2019·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Yujie LiuJianru Xiao
Nov 14, 2018·Journal of Cancer Education : the Official Journal of the American Association for Cancer Education·Krzysztof AdamowiczMonika Lichodziejewska-Niemierko
Jan 11, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Roger SidhuSteve Dahlberg
Nov 15, 2012·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Clemens GiessenVolker Heinemann

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