Single-agent activity of gemcitabine in advanced non-small cell lung cancer

Gemcitabine, a novel nucleoside analog, shows reproducible response rates of 20% and above in single-agent studies in non-small cell lung cancer. In the phase II studies reported, chemotherapy-naive patients received gemcitabine (starting doses, 800 to 1,250 mg/ m2) as a single agent on days 1, 8, and 15 of a 28-day cycle. In three large studies of 82, 84, and 161 patients, response rates were 22.5%, 20%, and 21.8%, respectively. The median duration of response in these studies was 8.1, 12.7, and 7.6 months, respectively. The median length of survival for all patients (responders and non-responders) was 8.1, 9.2, and 9.4 months, respectively. Three trials in Japan involving 206 patients produced response rates of 16.3%, 26.0%, and 20.9%. A US phase I/II study of gemcitabine at doses of 1,000 to 2,800 mg/ m2 recorded an overall response rate of 26% in a population of mainly stage IV (87%) patients. Responses were seen across disease stages and histologic subtypes in performance status 0, 1, and 2 patients and in the elderly. Gemcitabine produced marked benefit (lasting 2 to 5 months) in a number of disease-related symptoms, most notably cough, hemoptysis, and dyspnea. Improvements in performance status were seen in 52% of patients receiving gemcitabine. Gemcitabine was well tolerated with few of the side effects normally associated with cytotoxic drugs.