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

Abstract

4164 Background: Because of insufficient activity and high toxicity of current chemotherapy regimens in advanced gastric cancer (AGC), there is need for newer regimens. Methods: Twenty-five chemo-naive patients (pts) with stage IV AGC have been treated with FOLFIRI regimen consisting of irinotecan 180 mg/m2 over 30 minutes on day (d) 1 combined with leucovorin 200 mg/m2 over 2 h followed by 5-FU 400 mg/m2 bolus and 600 mg/m2 as 22 h infusion on d 1 and 2. The treatment was administered every 14 day until progression or intolerable toxicity. Results: Twenty-five pts (17 male/8 female); median age 54 (range 25–77), 22 pts with PS 0–1 and 3 pts with PS 2), received a total of 230 courses of chemotherapy (median 9; range 1–18). Objective response was observed in 9 pts (36%), all being partial. Median progression-free survival (PFS), 1 and 2 year PFS rates were respectively 9.3 months (mo), 28.4% and 15.3%. Median overall survival (OS), 1 and 2 year OS rates were respectively 12.6 mo, 48.0% and 17.8%. As serious adverse events, grade 3–4 neutropenia was observed in 5 pts (20.0%), grade 3 diarrhea in 4 (16.0%) pts. No treatment-related death occurred. Conclusions: FOLFIRI regimen is an active regimen with acceptable toxicity for the treatment of AGC. No significant financial relationships to disclose.