A pilot study of irinotecan combined with 5-fluorouracil and leucovorin for the treatment of Chinese patients with locally advanced and metastatic gastric cancer.

The FOLFIRI regimen was evaluated for its anti-tumor activity and toxicity in Chinese patients with locally advanced and metastatic gastric cancer.Treatment consisted ofirinotecan, 180 mg/m2 (90-min infusion), leucovorin, 200 mg/m2 (2-h infusion), followed by 5-fluorouracil, 400 mg/m2 (bolus), and then 5-fluorouracil, 600 mg/m2 (22-h continuous infusion) on days 1 and 2, every 14 days.Twenty-six patients, of whom 17 were pretreated, were included in the study. Partial response was observed in 9 patients (37.5%). The overall disease control rate was 83.3%. Median progression-free and overall survival was 6.8 and 11.2 months, respectively. Grade 3-4 neutropenia was observed in 6 patients (23.1%) and grade 2-3 diarrhea in 5 (19.2%). No treatment-related deaths occurred.The results demonstrate that the FOLFIRI regimen is an active regimen with acceptable toxicity for Chinese patients with advanced and metastatic gastric cancer that merits further investigation in comparative trials.