Docetaxel in the treatment of non-small cell lung cancer: review of single-agent trials.

Several phase II studies have evaluated docetaxel, administered as a 1-hour intravenous infusion at a dose of 100 mg/m2 every 3 weeks, for chemotherapy-naive patients with advanced non-small cell lung cancer. Results have been consistent across numerous trials, with an overall response rate in the range of 23% to 38% and a median survival of 9 months. Results of a multicenter phase III trial of docetaxel versus best supportive care for the first-line treatment of non-small cell lung cancer are pending. In the second-line setting, after failure of first-line platinum-based chemotherapy, four phase II studies of docetaxel 100 mg/m2 have achieved response rates ranging from 16% to 22%, with encouraging median survival times of 30 to 42 weeks. Preliminary results of a large, multicenter, randomized phase III trial also indicated an advantage for docetaxel over control with regard to response, time to progression, survival, and quality of life. Results of a multicenter phase III trial of docetaxel versus best supportive care as second-line treatment will be reported soon. Weekly docetaxel has been well tolerated in phase I studies, with dose-limiting toxicity being asthenia rather than myelosuppression. Phase II trials of a dosage of 36 mg/m2/wk in elderly patients with advanced non-small cell lung cancer are ongoing. Docetaxel is a potent radiosensitizer. The dose-limiting toxicity of docetaxel when administered weekly with concurrent chest radiation at 50 to 64 Gy is esophagitis. Phase II trials of weekly docetaxel plus concomitant chest radiotherapy are in progress at the recommended phase II dosage of 20 to 30 mg/m2/wk.

RCT Entities:   Population Interventions Outcomes