Docetaxel: meeting the challenge of non-small cell lung cancer management.

The combined results of four phase II studies of docetaxel in non-small-cell lung cancer (NSCLC) are presented. All patients had either locally advanced (stage IIIb) or metastatic (stage IV) disease. Results are given for the 248 patients included in the trials who received docetaxel at a dose of 100 mg/m2 given by intravenous infusion every 21 days on an outpatient basis. Among 200 patients evaluable for response, the overall response rate was 31.3% in 128 previously untreated patients and 19.4% in 72 previously treated patients. A subgroup of 30 previously treated patients who were platinum-refractory achieved a response rate of 13.5%. In previously untreated and previously treated patients, median duration of response was 24.6 weeks and 28.7 weeks, respectively, with median times to progression of 14.4 weeks and 13.6 weeks and median survival durations of 9.0 months and 8.1 months. Similar response rates were achieved in patients with stage IIIb and stage IV disease (32% and 25%, respectively) and in patients with visceral metastases (28%) although patients with single-organ involvement did better than those with two or more organs involved. Response rates were comparable to or better than those seen with previous single-agent chemotherapeutic regimens for advanced NSCLC and even with some combination treatments, with a tolerable adverse event profile.