Phase II Study of Cisplatin and 120-hour Continuous Infusion of 5-fluorouracil in Patients with Advanced Pancreatic Adenocarcinoma

Background: Advanced pancreatic carcinoma (APC) is a rapidly fatal disease and an active chemotherapy with palliative effects and impact on patient survival is needed. 5 fluorouracil (5-FU) combined with cisplatin (CDDP) has a recognized synergistic activity, but its activity in APC has never been well established.

Methods: Forty eligible patients (pts) with measurable APC were treated in a phase II trial with 5-FU 1000 mg/m2/day from day 1 to day 5 by continuous intravenous infusion and CDDP 100 mg/m2 on day 2. Eighty percent of the pts (36/40) had metastatic disease, 32.5% (13/40) were previously treated and 65% (26/40) had performance states of 2 or 3.

Results: Of 38 evaluable pts, one had a complete response and 9 achieved partial responses; the overall response rate (RR) was 26.5% (95% CI: 12% to 40%). The median duration of responses was 10 months (range 4-18). The RR in non-pretreated pts was 32% A palliative effect was seen in 45% of pts (17/38). The median survival was 7 months and 12 pts (29%) were alive at 1 year. Leukopenia was the most important toxicity; 11 pts (27%) had a grade 4 leukopenia and 3 had neutropenic fever.

Conclusions: The combination of CDDP and 5-FU in continuous infusion seems an active and well tolerated treatment in APC and will be compared to standard therapy in a multicentric randomized trial.