Phase II trials of 5-fluorouracil and leucovorin in patients with metastatic gastric or pancreatic carcinoma

Abstract

BACKGROUND. Previous trials in patients with colorectal carcinoma have indicated that enhancement of 5-fluorouracil (5-FU) by leucovorin (LV) can result in an improved response rate and increased survival. METHODS. Phase II trials were performed with patients who had either gastric or pancreatic adenocarcinoma with metastases. Forty-one gastric carcinoma patients and 31 pancreatic carcinoma patients with measurable disease were treated with 5- FU, 425 mg/m2 intravenously (i.v.), on Days 1-5 plus LV, 20 mg/m2 i.v, on Days 1-5, repeated at 4 and 8 weeks, and then every 5 weeks thereafter. RESULTS. The patients with metastatic gastric carcinoma had a median survival of 4.8 months. There was a 22% objective response rate, including a 4.9% complete response rate and a 17.1% partial response rate. Among the 31 patients with pancreatic carcinoma, there was a median survival of 5.7 months. No patients in this group showed a response. CONCLUSIONS. The response rate for patients with metastatic gastric adenocarcinoma was modest and this regimen may provide temporary palliation for some patients. However, 5-Fu and LV treatment is ineffective against metastatic pancreatic carcinoma.