[Safety and efficacy of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) in Chinese patients with advanced colorectal cancer].

To establish the maximum tolerated dose (MTD) of 5-fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI), and to evaluate the safety and efficacy in Chinese patients with advanced colorectal cancer. Patients were treated with a regimen consisting of infusional 5-fluorouracil (2 400 mg/m(2) on day 1), leucovorin (200 mg/m(2) on day 1), oxaliplatin (85 mg/m(2) on day 1), and irinotecan (at doses from 150 to 180 mg/m(2) on day 8) according to the dose-escalation schema. Treatment was repeated every 14 days. The UDP-glucuronosyl transferase (UGT) 1A1 genotypes were analyzed in the patients with dose-limiting toxicity (DLT). A total of 12 patients with advanced colorectal cancer were included. The MTD of FOLFOXIRI in these patients was oxaliplatin 85 mg/m(2) day 1, leucovorin 200 mg/m(2) day 1, 5-fluorouracil 2 400 mg/m(2) day 1, and irinotecan 150 mg/m(2) day 8 every 2 weeks. The most common toxicities were nausea, diarrhea, leukopenia, neutropenia and fatigue. The DLTs were febrile neutropenia and diarrhea. The objective response rate was 66.7%. Our results indicate that FOLFOXIRI regimen is considered safe and effective in Chinese patients with advanced colorectal cancer, and the MTD of FOLFOXIRI regimen for Chinese patients with advanced colorectal cancer is recommended.