Phase II trial of 5-fluorouracil, leucovorin and cisplatin for treatment of advanced pancreatic adenocarcinoma

Background. Advanced pancreatic adenocarcinoma is a rapidlyfatal disease for which an active chemotherapy regimen is sought.Here we report the outcome of a phase II trial to assess thetoxicity and efficacy of a combination of 5-flu-orouracil (5-FU),leucovorin and cisplatin (CDDP). Methods. A regimen combining leucovorin (200 mg/m²/d x 5d),5-FU (375 mg/m²/d x 5d in a 2-hour infusion) and CDDP (15 mg/m²/dx 5d) was given to 52 patients with histologically-proven, previouslyuntreated, locally advanced (n = 13) and/or metastatic (n =39) pancreatic adenocarcinoma. Results. Of 48 patients evaluable for response, 10 achievedpartial responses, for an overall response rate of 21% (95%CI 9.5%–32.5%), and a palliative effect was observed in52%. The median survival was 9.5 months (18 months for locally-advancedand 5 months for metastatic disease) with a 1-year survivalof 34.6% and a median progression-free survival of 4.5 months.Chemotherapy was well tolerated with grades 3 or 4 nausea/vomitingin 12%, diarrhea in 6%, anaemia in 17%, neutropenia in 12%,and thrombocytopenia in 10%. Eleven patients (21%) had Grade2 peripheral neuropathy. Conclusion. The combination of leucovorin, 5-FU and CDDP seemsto be an effective palliative treatment, with moderate toxiceffects, in advanced pancreatic adenocarcinoma. advanced pancreatic adenocarcinoma, cisplatin, 5-fluorouracil, leucovorin