Abstract
Within the last 5 years, gemcitabine, a new nucleoside analogue, has been evaluated in several international phase II trials in patients with advanced non-small cell lung cancer (NSCLC). Five trials have evaluated 438 patients. Gemcitabine was administered intravenously in four trials on days 1, 8, and 15 at a dose of 800 to 1,700 mg/m2 every 4 weeks. In the fifth trial, gemcitabine was given at a dose of 90 mg/m2 twice weekly x 3 every 4 weeks. The overall response rate was 21% (95% confidence limits, 16% to 25%) with a median survival of 4 weeks (range, 26 to 46 weeks). The median duration of response varied from 26 to 49 weeks. The activity of gemcitabine in NSCLC, together with its modest toxicity and distinct mode of action, suggest the need for further trials of gemcitabine in combination with other chemotherapeutic agents in the treatment of NSCLC.