PHASE-II TRIAL OF TOPOTECAN ADMINISTERED AS A 21-DAY CONTINUOUS-INFUSION IN PREVIOUSLY UNTREATED PATIENTS WITH STAGE IIIB AND IV NON-SMALL-CELL LUNG-CANCER

Topotecan (9-dimethylaminoethyl-10-hydroxycamptothecin) is a topoisome rase I inhibitor. Twenty-six patients with stage IIIB or IV non-small- cell lung cancer (NSCLC) who had received no prior chemotherapy were t reated in a multicenter study with topotecan 0.6 mg/m(2)/day for 21 da ys by continuous intravenous infusion every 28 days; this starting dos e was decreased to 0.5 mg/m(2)/day in the last 23 patients because of myelosuppression. There was one partial response, for a response rate of 4% (95% confidence interval, 0.1%-19.6%). Median survival was 9 mon ths. One-year survival was 39%. Of the 58 lung cancer symptoms at base line, 40% were resolved by the end of best response (all in the partia l response patient, 62% in stable disease patients, 26% in progressive disease patients). Catheter-related infections complicated 19% of cou rses. Red-cell transfusions were given in 50% of courses. Toxicity inc luded grade 4 neutropenia (4%), grade 3-4 anemia (19%), grade 4 thromb ocytopenia (8%), and catheter-related infections (19% courses). Althou gh the major objective response rate was only 4%, patients treated wit h topotecan given as a 21-day continuous intravenous infusion experien ced a decrease in cancer-related symptoms and a 1-year survival of 39% .