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 diseaseand an active chemotherapy with palliative effects and impacton patient survival is needed. 5 fluorouracil (5-FU) combinedwith cisplatin (CDDP) has a recognized synergjstic activity,but its activity in APC has never been well established. METHODS:: Forty eligible patients (pts) with measurable APC were treatedin a phase II trial with 5-FU 1000 mg/m²/ day from day 1 today 5 by continuous intravenous infusion and CDDP 100 mg/m²on day 2. Eighty percent of the pts (36/40) had metastatic disease,32.5% (13/40) were previously treated and 65% (26/40) had performancestates of 2 or 3. RESULTS:: Of 38 evaluable pts, one had a complete response and 9 achievedpartial responses; the overall response rate (RR) was 26.5%(95% CI: 12% to 40%). The median duration of responses was 10months (range 4-18). The RR in non-pretreated pts was 32% Apalliative effect was seen in 45% of pts (17/38). The mediansurvival was 7 months and 12 pts (29%) were alive at 1 year.Leukopenia was the most important toxicity; 11 pts (27%) hada grade 4 leukopenia and 3 had neutropenic fever. CONCLUSIONS:: The combination of CDDP and 5-FU in continuous infusion seemsan active and well tolerated treatment in APC and will be comparedto standard therapy in a multicentric randomized trial. pancreatic cancer, chemotherapy, 5-fluorouracilcisplatin combination