PHASE-II TRIALS OF 5-FLUOROURACIL AND LEUCOVORIN IN PATIENTS WITH METASTATIC GASTRIC OR PANCREATIC-CARCINOMA

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. METH ODS. Phase II trials were performed with patients who had either gastr ic or pancreatic adenocarcinoma with metastases. Forty-one gastric car cinoma patients and 31 pancreatic carcinoma patients with measurable d isease were treated with 5-FU, 425 mg/m(2) intravenously (i.v.), on Da ys 1-5 plus LV, 20 mg/m(2) i.v., on Days 1-5, repeated at 4 and 8 week s, and then every 5 weeks thereafter. RESULTS. The patients with metas tatic gastric carcinoma had a median survival of 4.8 months. There was a 22% objective response rate, including a 4.9% complete response rat e and a 17.1% partial response rate. Among the 31 patients with pancre atic carcinoma, there was a median survival of 5.7 months. No patients in this group showed a response. CONCLUSIONS. The response rate for p atients with metastatic gastric adenocarcinoma was modest and this reg imen may provide temporary palliation for some patients. However, 5-FU and LV treatment is ineffective against metastatic pancreatic carcino ma. (C) 1996 American Cancer Society.