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Annals of Oncology 15:474-477, 2004
© 2004 European Society for Medical Oncology

Original Paper

Phase II study of cisplatin, gemcitabine and 5-fluorouracil in advanced pancreatic cancer

Received 4 August 2003; revised 7 November 2003; accepted 19 December 2003

Background:

The aim of this study was to determine the activity of the combination of cisplatin, gemcitabine and 5-fluorouracil (5-FU) as therapy for metastatic or locally advanced inoperable pancreatic adenocarcinoma.

Patients and methods:

Patients with histologically proven advanced or metastatic pancreatic adenocarcinoma received first-line chemotherapy comprising cisplatin (20 mg/m2 on days 1, 8, 15, 22, 29 and 36), gemcitabine (1000 mg/m2 on days 1, 8, 29 and 36) and 5-FU (200 mg/m2 as continuous infusion on days 1–42) every 56 days.

Results:

A total of 34 patients were studied. Eighty courses were administered (median two courses per patient). Among 32 patients evaluable for response, two patients had a complete response and four a partial response for an overall response rate of 19% (95% confidence interval 7% to 36%). Thirteen patients had stable disease (40%) and 13 progressed. Median progression-free survival was 4.7 months, median survival 9.0 months and 26% of patients achieved 1-year survival. Ten of 25 patients (40%) with pain at presentation had a sustained reduction of analgesic consumption. The principal grade 3/4 toxicities were neutropenia, thrombocytopenia, anaemia and mucositis, occurring in 24%, 21%, 9% and 3% of patients.

Conclusion:

This schedule seems well tolerated and active in pancreatic cancer and worthwhile of further evaluation.

A. Novarino1, I. Chiappino1,*, G. F. Bertelli2, A. Heouaine3, G. Ritorto1, A. Addeo1, G. Bellone4, M. Merlano3 and O. Bertetto1

1 Oncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino, Italy; 2 South West Wales Cancer Institute, Singleton Hospital, Swansea, UK; 3 Oncologia Medica, Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy; 4 Dipartimento di Fisiopatologia Clinica,Università di Torino, Torino, Italy

Key words: chemotherapy, cisplatin, 5-fluorouracil, gemcitabine, pancreatic cancer, phase II study


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