The French experience with infusional 5-FU in gastric and pancreatic cancer.

Abstract

Ninety-five patients with metastatic pancreatic (n = 38) or gastric (n = 57) carcinomas were treated by 5-day continuous infusion of 5-fluorouracil (5-FU) plus cisplatin in two parallel phase II trials. 5-fluorouracil was given at a dose of 1000 mg/m2 for 5 consecutive days and cisplatin was given on day 2 at a dose of 100 mg/m2. The total number of cycles administered was 425, and each patient received a median number of four cycles. Severe toxicities were observed in around 20% of the patients and 2 toxic deaths occurred. Response rate assessed in 92 evaluable patients was 34%. The overall median survival was 8 months. There were no clinical or biological factors predictive of response, but a better survival was observed in patients with objective response and CA 19-9 blood levels lower than 100 UI/I. These two predictive factors are independent when tested in a multivariate model. The combination of infusion 5-FU plus cisplatin can be considered as a standard for the treatment of gastric metastatic carcinomas and as a promising schedule for pancreatic carcinomas.