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Annals of Oncology 4:333-336, 1993
© 1993 European Society for Medical Oncology

brief-report

Phase II study of cisplatin and 120-hour continuous infusion of 5-fluorouracil in patients with advanced pancreatic adenocarcinoma

P. Rougier, J. J. Zarba, M. Ducreux, M. Basile, J. P. Pignon, M. Mahjoubi, M. Benahmed, J. P. Droz, E. Cvitkovic and J. P. Armand

Department of Medicine, Institut Gustave Roussy Villejuif, France

correspondence to: Philippe Rougier, M.D., Institut Gustave-Roussy, 39, Rue Camille Desmoulins, 94805 Villejuif, Cedex, France

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 synergjstic 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.

pancreatic cancer, chemotherapy, 5-fluorouracilcisplatin combination


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