A phase II trial of docetaxel in advanced non-small cell lung cancer.

Twenty-nine patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) were treated with docetaxel. Ten patients had already received chemotherapy, the others had received no chemotherapy. Docetaxel was administrated i.v. over 60 min every 21 days at a dose of 100 mg/m2. Twenty-three patients were evaluable for response. There were no complete responses and eight partial responses. The overall response rate was 35% (28% in the intent to treat analysis). Median duration of response was 43 weeks and median time to progression 12 weeks. Neutropenic infections, neurotoxicity and asthenia were dose-limiting toxicities (6% of 118 cycles). The other main toxicities were asthenia in 48%, skin reactions in 31% and nail changes in 31% of the patients. Single-agent docetaxel appears to be active against both previously treated and untreated advanced NSCLC. Toxicity was acceptable but should be carefully monitored.