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

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 > or = 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.