Annals of Oncology 7:173-178, 1996
© 1996 European Society for Medical Oncology
research-article |
Phase II trial of 5-fluorouracil, leucovorin and cisplatin for treatment of advanced pancreatic adenocarcinoma
1Departments of Medical Oncology, Saint-Antoine Hospital Paris, France
2Departments ofGastroenterology, Saint-Antoine Hospital Paris, France
3Departments of Surgery, Tenon Hospital Paris, France
4Department of Surgery, Saint-Antoine Hospital Paris, France
Thierry André, M.D. Service d'Oncologie Medicale Professeur V. Izrael Hopital Tenon 4, rue de la Chine 75020 Paris, France
Background. Advanced pancreatic adenocarcinoma is a rapidly fatal disease for which an active chemotherapy regimen is sought. Here we report the outcome of a phase II trial to assess the toxicity 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/d x 5d) was given to 52 patients with histologically-proven, previously untreated, locally advanced (n = 13) and/or metastatic (n = 39) pancreatic adenocarcinoma.
Results. Of 48 patients evaluable for response, 10 achieved 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 for metastatic disease) with a 1-year survival of 34.6% and a median progression-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 treatment, with moderate toxic effects, in advanced pancreatic adenocarcinoma.
advanced pancreatic adenocarcinoma, cisplatin, 5-fluorouracil, leucovorin
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