Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel

Purpose A phase III study to determine whether a weekly docetaxel schedule improves the therapeutic index compared with the classic 3-weekly schedule. Patients and Methods Patients with stage IIIB-IV non-small-cell lung cancer (NSCLC) were randomly assigned to docetaxel 75 mg/m(2) on day 1 every 3 weeks (3-weekly) and 35 mg/m(2) on days 1, 8, and 15 (weekly) for <= eight cycles. End points included survival (primary), toxicity, and,response. Results 208 (103 in the 3-weekly arm and 105 in the weekly arm) were Of 215 patients enrolled, assessable for response. At baseline, 24.5% of patients (51 out of 208) had received prior paclitaxel therapy and 43.3% of patients (90 out of 208) had been progression-free for more than 3 months after first-line therapy. After 12 months' follow-up, median survival was 6.3 68 to 7.84 months) with 3-weekly docetaxel and 9.2 months (95% Cl, 4 months (95% Cl,. 5.83 to 12.59 months) with weekly docetaxel (P = .07) after a median of four (range, one to eight) and two (range, one to eight) treatment cycles, respectively. Overall, response rates were 12.6% v 10.5% with 3-weekly versus weekly docetaxel. Significantly fewer patients reported grade 3 to 4 toxicities with weekly docetaxel versus 3-weekly docetaxel (P <= .05). There were significantly lower rates of grade 3 to 4 anemia(P <= .05), leucopenia (P < .0001), and neutropenia (P <= .001) with weekly versus 3-weekly treatment. No grade 3 to 4 thrombocytopenia or mucositis was reported. Conclusion Weekly clocetaxel 35 mg/m(2) demonstrated similar efficacy and better tolerability than standard 3-weekly clocetaxel 75 mg/m(2) and can be recommended as a feasible alternative second-line treatment option for patients with advanced NSCLC.