PHASE-II TRIAL OF 5-FLUOROURACIL, LEUCOVORIN AND CISPLATIN FOR TREATMENT OF ADVANCED PANCREATIC ADENOCARCINOMA

Background. Advanced pancreatic adenocarcinoma is a rapidly fatal dise ase for which an active chemotherapy regimen is sought. Here we report the outcome of a phase II trial to assess the toxicity and efficacy o f a combination of 5-fluorouracil (5-FU), leucovorin and cisplatin (CD DP). Methods. A regimen combining leucovorin (200 mg/m(2)/d x 5d), 5-F U (375 mg/m(2)/d x 5d in a 2-hour infusion) and CDDP (15 mg/m(2)/d x 5 d) was given to 52 patients with histologically-proven, previously unt reated, locally advanced (n = 13) and/or metastatic (n = 39) pancreati c adenocarcinoma. Results. Of 48 patients evaluable for response, 10 a chieved partial responses, for an overall response rate of 21% (95% CI 9.5%-32.5%), and a palliative effect was observed in 52%. The median survival was 9.5 months (18 months for locally-advanced and 5 months f or metastatic disease) with a 1-year survival of 34.6% and a median pr ogression-free survival of 4.5 months. Chemotherapy was well tolerated with grades 3 or 4 nausea/vomiting in 12%, diarrhea in 6%, anaemia in 17%, neutropenia in 12%, and thrombocytopenia in 10%. Eleven patients (21%) had Grade 2 peripheral neuropathy. Conclusion. The combination of leucovorin, 5-FU and CDDP seems to be an effective palliative treat ment, with moderate toxic effects,, in advanced pancreatic adenocarcin oma.