GEMCITABINE - A PHASE-II STUDY IN PATIENTS WITH ADVANCED RENAL-CANCER

Gemcitabine is a fluorine-substituted cytarabine analog with broad exp erimental antitumor activity. It's activity was explored in chemothera py-naive patients with advanced progressive renal-cell carcinoma. A to tal of 39 patients were included in the study, of whom 37 were fully e valuable. In five patients the primary tumor remained in situ. Gemcita bine at 800 mg/m(2) was given as a weekly 30-min infusion for 3 consec utive weeks followed by 1 week of rest. One complete response and two partial responses were observed giving a response rate of 8.1% [95% co nfidence interval (CI), 2-22%). The duration of the responses is curre ntly 32, 15, and 19 months, respectively. The median survival for all patients was 12.3 months. Gemcitabine was generally well tolerated, wi th nausea and vomiting (20.5% grade III) and neutropenia (5.3% grade I II) being the most significant side effects. Gemcitabine given at this dose level and on this schedule has only limited activity in advanced renal-cell carcinoma.