5-Fluorouracil continuous infusion combined with cisplatin for advanced pancreatic cancer: A Japanese Cooperative Study

BACKGROUND/AIMS: The prognosis of patients with advanced pancreatic cancer is extremely poor. To improve their prognosis, providing effective chemothe rapy is necessary. The aim of this study was to evaluate the anti-tumor act ivity and toxicity of combined chemotherapy (FP therapy) using 5-fluorourac il and cisplatin in Japanese chemo-naive patients with advanced pancreatic cancer. METHODOLOGY: Thirty-seven previously untreated patients with histologically proven pancreatic adenocarcinoma were treated with FP therapy. 5-fluoroura cil was administered at 500mg/m(2)/day by continuous intravenous infusion f or 5 days and cisplatin was administered at 80mg/m(2) intravenously on the 1st day. Therapy was repeated every 4 weeks until there was evidence of dis ease progression or unacceptable toxicity. RESULTS: Three patients achieved partial responses, whereas none exhibited a complete response. The overall response rate was 8% (95% confidence inter val, 2-22%) and the response durations were 6, 9 and 12 months, respectivel y. The median survival time of patients was 5 months. Toxicities were gener ally mild and acceptable, although nausea/vomiting was the most commonly ob served toxicity. CONCLUSIONS: FP therapy on this schedule had limited anti-tumor activity fo r pancreatic cancer, indicating that, practically, it should not be perform ed in Japanese patients with advanced pancreatic cancer.