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Annals of Oncology 15:230-235, 2004
© 2004 European Society for Medical Oncology

Original Paper

Phase II study of cisplatin preceding gemcitabine in patients with advanced oesophageal cancer

Received 5 July 2003; revised 28 September 2003; accepted 6 October 2003;

Background:

For oesophageal cancer there is no effective standard therapy. We studied the feasibility and efficacy of the cisplatin–gemcitabine combination chemotherapy in patients with unresectable oesophageal cancer.

Patients and methods:

Thirty-six chemonaïve patients with unresectable or metastatic oesophageal adenocarcinoma (24) or squamous-cell-carcinoma (12) were treated with cisplatin (50 mg/m2, days 1 and 8), followed by gemcitabine (800 mg/m2, days 2, 9 and 16), every 28 days. Feasibility and efficacy were studied.

Results:

Toxicity was substantial but manageable. A median number of four therapy cycles was given. The most frequent grade ≥3 toxicities were leukopenia (75%) and neutropenia (83%). Three patients developed neutropenic fever. Grade 3/4 thrombocytopenia occurred in 24 out of 36 patients (67%), but did not result in serious bleeding disorders. Myelotoxicity was cumulative and required omission of gemcitabine on day 16 in 63% of cycles. Anaemia required treatment with erythropoietin, red blood cells or both in 81% of patients. Non-haematological toxicity consisted mainly of grade 1/2 nausea/vomiting or fatigue. Fourteen out of 34 evaluable patients had a major objective response (41%; two complete and 12 partial responses). The median actuarial survival was 9.8 months.

Conclusion:

This cisplatin–gemcitabine regimen was feasible, with myelosupression being the main toxicity, and had significant activity in patients with advanced oesophageal cancer.

J. R. Kroep1,*, H. M. Pinedo1, G. Giaccone1, A. Van Bochove2, G. J. Peters1 and C. J. Van Groeningen1

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

Key words: adenocarcinoma, advanced oesophageal cancer, cisplatin, gemcitabine, phase II, squamous cell carcinoma


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