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Annals of Oncology 15:484-488, 2004
© 2004 European Society for Medical Oncology

Original Paper

Phase II trial of cisplatin and gemcitabine in patients with advanced gastric cancer

Received 20 August 2003; revised 14 November 2003; accepted 19 December 2003

Background:

This phase II study was performed to determine the efficacy and toxicity of cisplatin and gemcitabine in patients with advanced gastric cancer.

Patients and methods:

Forty chemo-naïve patients with measurable locoregionally advanced or metastatic gastric cancer were included; the median patient age was 53 years (range 35–71). Cisplatin was administered at a dose of 50 mg/m2, given in 1 h intravenously (i.v.) on days 1 and 8, followed after 24 h by gemcitabine at a dose of 800 mg/m2 given in 30 min i.v. on days 2, 9 and 16, every 28 days.

Results:

A median number of four therapy cycles were given (range 2–8). Myelosuppresion was the most important toxicity. Grade 3–4 thrombopenia was observed in 19 patients (48%) and grade 3–4 leukopenia was observed in 23 (58%). Myelotoxicity was cumulative and caused omission of gemcitabine on day 16 in 55% of cycles. Non-haematological toxicity consisted mainly of grade 1–2 nausea and vomiting. Objective responses were observed in 30% of patients including two complete remissions and 10 partial remissions. Median survival was 11 months (range 3–27+).

Conclusions:

This cisplatin–gemcitabine regimen had moderate efficacy in patients with advanced gastric cancer, with manageable toxicity. Further studies with this combination may be warranted.

S. M. De Lange1, C. J. van Groeningen1, J. R. Kroep1, A. Van Bochove2, J. F. Snijders1, G. J. Peters1, H. M. Pinedo1 and G. Giaccone1,*

1 Department of Medical Oncology, VU University Medical Centre, Amsterdam; 2 Department of Internal Medicine, De Heel-Zaans Medisch Centrum, Zaandam, The Netherlands

Key words: advanced gastric cancer, cisplatin, gemcitabine


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