The use of docetaxel (Taxotere) in patients with advanced non-small cell lung cancer previously treated with platinum-containing chemotherapy regimens.

Several phase II studies have evaluated docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) at a dose of 100 mg/m2 administered as a 1-hour intravenous infusion every 3 weeks in the second-line treatment of non-small cell lung cancer (NSCLC). Two early phase II studies conducted at the University of Texas M.D. Anderson Cancer Center enrolled NSCLC patients who had failed prior platinum-containing regimen, and response rates of 22% and 17%, respectively, were observed in evaluable patients. The estimated 1-year survival rate for both studies was 40%. In the later phase II studies, patients who had received prior NSCLC treatment were enrolled and response rates ranged from 15% to 22% in evaluable patients. A phase III randomized study was conducted based on these encouraging data. In this first randomized phase III trial of second-line chemotherapy for advanced NSCLC, patients who had been previously exposed to at least one course of platinum-containing chemotherapy received docetaxel at 100 mg/m2 or 75 mg/m2 versus a control regimen of vinorelbine or ifosfamide. This is the first phase III study that has compared the benefits of different chemotherapies in the second-line treatment of NSCLC. Data from this phase III study are forthcoming. These results may provide important objective indications of the quality of life benefits that can be achieved in patients with NSCLC in the second-line setting with an active agent such as docetaxel.

RCT Entities:   Population Interventions Outcomes