Gemcitabine in patients with advanced malignant melanoma or gastric cancer: Phase II studies of the EORTC Early Clinical Trials Group

BACKGROUND:Gemcitabine is a water-soluble analogue of deoxycytidine which has shown significant antitumour activity in a broad panel of slow-growing murine and human carcinomas. Objective responses have been reported in early clinical studies in breast, head and neck, non-small cell lung cancer patients. The weekly schedule was selected for disease-oriented phase II studies because of its better tolerability as compared to daily or twice-weekly schemes. PATIENTS AND METHODS:Gemcitabine (1000 mg/m2) was given as a 30 min. infusion, weekly for three consecutive weeks, followed by one-week rest, every 4 weeks. Twenty-nine patients with locally advanced/metastatic gastric cancer and 39 patients with metastatic malignant melanoma entered the study. No prior chemotherapy for advanced disease had been given in all cases. RESULTS:Among 26 evaluable patients with gastric cancer, 1 partial response (PR) of 9 months (4%), 11 no change (NC) and 14 tumour progression (PD) were observed. Of 33 evaluable patients with malignant melanoma, 1 patient achieved a PR for 10 months (3%), 2 had NC and 30 PD. Toxicity was similar in the two groups with moderate myelosuppression, mainly neutropenia, mild to moderate nausea and vomiting in 70% of patients and fatigue grade 1-2 in 50%. CONCLUSIONS:At the tested schedule gemcitabine has no relevant antitumour activity in previously untreated patients with advanced malignant melanoma or gastric cancer.