Preliminary report of a randomized trial of different docetaxel schedules in non-small cell lung cancer patients failing previous chemotherapy

[[abstract]]Background: To evaluate and compare the efficacy of different docetaxel schedules in NSCLC patients who failed previous chemotherapy. Methods: Treatment consisted of (A) docetaxel 35 mg/m2 intravenous infusion (IV) on days 1, 8, and 15 of every 4 weeks; (B) docetaxel 40 mg/m2 IV on days 1 and 8 of every 3 weeks; and (C) docetaxel 75 mg/m2 IV on day 1 of every 3 weeks. Patients were randomised at a ratio of 2:2:1, with (C) arm as a control arm. Between January 2002 and October 2003, 113 patients were enrolled into the study, and 101 patients were already off-study during that period. Results: Analysis of these 101 patients showed a patient number of 41:38:22, mean age: 67:67:64.5, median cycles received: 4:3:3, and objective response rates of 22%:10.5%:0%. Grade 3/4 neutropenia was significantly higher in the (C) arm. The majority of (C) arm patients needed a decrease in the treatment dose due to grade 4 or febrile neutropenia. Median survival was 7.1, 6.6, and 4.6 months, respectively. Conclusions: Weekly docetaxel chemotherapy produces a relatively lower toxicity profile, and better compliance and response rate than the conventional 3-week schedule