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Annals of Oncology 14:205-208, 2003
© 2003 European Society for Medical Oncology

Original Paper

Weekly gemcitabine and cisplatin chemotherapy: a well-tolerated but ineffective chemotherapeutic regimen in advanced pancreatic cancer patients. A report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD)

S. Cascinu+, R. Labianca, V. Catalano, S. Barni, F. Ferraù, G. D. Beretta, L. Frontini, P. Foa, G. Pancera, D. Priolo, F. Graziano, M. Mare and G. Catalano

Departments and Units of Medical Oncology, Parma, Bergamo, Pesaro, Treviglio (BG), Milan, Taormina (ME) and Urbino (PU), Italy

Received 13 May 2002; revised 5 August 2002; accepted 9 September 2002

Background:

This phase II study was initiated to determine the activity and toxicity of a combination of gemcitabine (GEM) and cisplatin (CDDP) in patients with pancreatic cancer.

Patients and methods:

CDDP 35 mg/m2 was given as a 30-min infusion and GEM 1000 mg/m2 as a 30-min infusion. Both drugs were administered once weekly for 2 consecutive weeks out of every 3 weeks to chemonaive patients with locally advanced or metastatic pancreatic cancer.

Results:

Forty-five advanced pancreatic cancer patients received this regimen for a total of 180 cycles of chemotherapy. One complete and four partial responses have been observed for an overall response rate of 9% (95% confidence interval 10% to 11%). Twenty-one patients (46%) had stable disease and 19 progressed on therapy. The median time to progression was 3.6 months, with a median survival of 5.6 months. A clinical benefit was obtained in nine of 37 patients (24%). Side-effects were mainly represented by hematological toxicity. Grade 3/4 WHO toxicities included neutropenia (6% of the patients) and thrombocytopenia (11%). The dose of GEM and CDDP was reduced in 14 patients (31%) and treatment was delayed in 10 patients (22%).

Conclusions:

Our results in terms of response rate, clinical benefit and survival do not support an advantage for the combination of GEM and CDDP given by this schedule.

Key words: intensive chemotherapy, palliation, pancreatic cancer


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