PURPOSE: We prospectively conducted a non-randomized phase II trial to evaluate the efficacy and safety of combination irinotecan, leucovorin (LV) and 5-fluorouracil (FU) as a first-line regimen for treating patients with previously untreated advanced colorectal cancer (CRC). MATERIALS AND METHODS: Twenty-six previously untreated patients with advanced, recurrent or metastatic CRC were enrolled in this study. The patients received either irinotecan 180 mg/m(2) on day 1 with LV bolus of 200 mg/m(2) and FU bolus of 400 mg/m(2), and this was followed by FU continuous infusion of 600 mg/m(2) on day 1 and day 2 (the FOLFIRI regimen), or they were treated with LV bolus of 400 mg/m(2) and FU bolus of 400 mg/m(2) followed by FU continuous infusion of 2,400 mg/m(2) for 46 hours (the simplified FOLFIRI regimen), and these treatments were repeated every 2 weeks until disease progression. RESULTS: The objective response rate was 23.1% (6/26) respectively, for both treatments. The median time to progression was 5.3 months (range: 0.4 approximately 19.9), and the overall survival was 11.2 months (range: 0.5 approximately 52.3). The prognostic factor for longer survival was the Eastern Cooperative Oncology Group (ECOG) performance status (PS). The non-hematological toxicities were similar for both treatment groups, with more frequent grade >or=3 neutropenia being noted for the simplified FOLFIRI regimen. CONCLUSION: The biweekly irinotecan based regimen was demonstrated to have a moderate antitumor activity with acceptable toxicity profiles, and the ECOG PS was the independent prognostic factor.
PURPOSE: We prospectively conducted a non-randomized phase II trial to evaluate the efficacy and safety of combination irinotecan, leucovorin (LV) and 5-fluorouracil (FU) as a first-line regimen for treating patients with previously untreated advanced colorectal cancer (CRC). MATERIALS AND METHODS: Twenty-six previously untreated patients with advanced, recurrent or metastatic CRC were enrolled in this study. The patients received either irinotecan 180 mg/m(2) on day 1 with LV bolus of 200 mg/m(2) and FU bolus of 400 mg/m(2), and this was followed by FU continuous infusion of 600 mg/m(2) on day 1 and day 2 (the FOLFIRI regimen), or they were treated with LV bolus of 400 mg/m(2) and FU bolus of 400 mg/m(2) followed by FU continuous infusion of 2,400 mg/m(2) for 46 hours (the simplified FOLFIRI regimen), and these treatments were repeated every 2 weeks until disease progression. RESULTS: The objective response rate was 23.1% (6/26) respectively, for both treatments. The median time to progression was 5.3 months (range: 0.4 approximately 19.9), and the overall survival was 11.2 months (range: 0.5 approximately 52.3). The prognostic factor for longer survival was the Eastern Cooperative Oncology Group (ECOG) performance status (PS). The non-hematological toxicities were similar for both treatment groups, with more frequent grade >or=3 neutropenia being noted for the simplified FOLFIRI regimen. CONCLUSION: The biweekly irinotecan based regimen was demonstrated to have a moderate antitumor activity with acceptable toxicity profiles, and the ECOG PS was the independent prognostic factor.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: J Y Douillard; D Cunningham; A D Roth; M Navarro; R D James; P Karasek; P Jandik; T Iveson; J Carmichael; M Alakl; G Gruia; L Awad; P Rougier Journal: Lancet Date: 2000-03-25 Impact factor: 79.321
Authors: A de Gramont; A Figer; M Seymour; M Homerin; A Hmissi; J Cassidy; C Boni; H Cortes-Funes; A Cervantes; G Freyer; D Papamichael; N Le Bail; C Louvet; D Hendler; F de Braud; C Wilson; F Morvan; A Bonetti Journal: J Clin Oncol Date: 2000-08 Impact factor: 44.544
Authors: Richard M Goldberg; Daniel J Sargent; Roscoe F Morton; Charles S Fuchs; Ramesh K Ramanathan; Stephen K Williamson; Brian P Findlay; Henry C Pitot; Steven R Alberts Journal: J Clin Oncol Date: 2003-12-09 Impact factor: 44.544