Randomized trial of 5-fluorouracil, leucovorin and cisplatin in advanced pancreatic cancer

Background/Aims: Phase II trials of combined 5 fluorouracil, leucovorin and cisplatin have demonstrated an 18-28% response rate in advanced pancreatic carcinomas. We investigated the effect of this chemotherapy regime on pati ents' survival. Methodology: Patients included gave informed consent. They had an advanced and proven pancreatic adenocarcinoma. The trial was multicentric, prospecti ve and randomized. It compared a 5-day course of leucovorin (200mg/m(2)/day ), 5-fluorouracil (375mg/m(2)/day) and cisplatin (15mg/m(2)/day) repeated e very 21 days (23 patients) with a control group (22 patients). The main end points were survival time (Kaplan-Meier and log-rank methods) and side eff ects of chemotherapy. Results: Association of leucovorin, 5-fluorouracil and cisplatin failed to demonstrate any advantage of this regimen compared with suported care alone . Median survival times were 8.6 months (SD +/-1.8) and 7.0 months (SD +/-0 .6), respectively. The modulation of 5-fluorouracil by leucovorin and cispl atin was well tolerated with moderate toxic effects. Conclusions: This multicentric trial failed to demonstrate any advantage of the evaluated chemotherapy regime in the palliative treatment of cancer of the exocrine pancreas. Other trials including gemcitabin and/or radiothera py are needed in advanced pancreatic adenocarcinoma.