Randomized Phase III Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non–Small-Cell Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens

摘要: PURPOSE: To confirm the promising phase II results of docetaxel monotherapy, this III trial was conducted chemotherapy for patients with advanced non–small-cell lung cancer (NSCLC) who had previously failed platinum-containing chemotherapy. PATIENTS AND METHODS: A total 373 were randomized to receive either 100 mg/m2 (D100) or 75 (D75) versus a control regimen vinorelbine ifosfamide (V/I). The three treatment groups well-balanced key patient characteristics. RESULTS: Overall response rates 10.8% D100 and 6.7% D75, each significantly higher than 0.8% V/I (P = .001 P .036, respectively). Patients received longer time progression .046, by log-rank test) greater progression-free survival at 26 weeks .005, χ2 test). Although overall not different between groups, 1-year D75 treat...