Irinotecan combined with infusional 5-fluorouracil and high-dose leucovorin for the treatment of advanced gastric carcinoma as the first-line chemotherapy

BACKGROUND: Because of insufficient activity and high toxicity of current chemotherapy regimens in advanced gastric cancer (AGC), there is a need for newer regimens. METHODS: Twenty-five chemonaive patients with AGC have been treated with FOLFIRI regimen consisting of irinotecan 180 mg/m(2) over 30 min on day 1 combined with leucovorin 200 mg/m(2) over 2 h followed by 5-fluorouracil 400 mg/m(2) as bolus and 600 mg/m(2) as a 22-hour infusion on day 1 and 2. The treatment was administered every 14th day until progression or intolerable toxicity. RESULTS: Twenty-five patients (17 male, 8 female; 22 patients with PS 0-1 and 3 patients with PS 2), median age 54 (range 25-77), received a total of 230 courses of chemotherapy (median 9; range 1-18). Objective responses were observed in 9 patients (36%), all being partial. Median progression-free survival, 1- and 2-year progression-free survival rates were 8.6 months, 28.4% and 15.3%, respectively. Median overall survival, 1- and 2-year overall survival rates were 11.6 months, 48.0% and 17.8%, respectively. As serious adverse events, grade 3-4 neutropenia was observed in 5 patients (20.0%), grade 3 diarrhea in 4 patients (16.0%). No treatment-related death occurred. CONCLUSION: FOLFIRI regimen is an active regimen with acceptable toxicity for the treatment of AGC.