A randomized phase II trial comparing every 3-weeks carboplatin/paclitaxel with every 3-weeks carboplatin and weekly paclitaxel in advanced non-small cell lung cancer

Background: The optimal schedule of taxane administration has been an area of active interest in several recent clinical trials. Methods: To address a pure schedule question, we randomized 161 patients with advanced stage IIIB or IV non-small-cell lung cancer (NSCLC) to either paclitaxel 225 mg/m 2 every 3 weeks x 4 cycles or 75 mg/m 2 /week x 12 (cumulative dose on each arm = 900 mg/m 2 ). Both arms received concurrent carboplatin AUC 6 every 3 weeks x 4 cycles. Results: The two arms were well-balanced in terms of known prognostic factors. The overall response rate and survival outcomes were similar on the two arms. There was significantly more grade 3/4 thrombocytopenia and grade 2-4 anemia on the weekly arm but less severe myalgias/arthralgias and alopecia. No difference in the rates of peripheral neuropathy was observed; however, patients on the every 3 weeks arm reported significantly more taxane therapy-related side-effects on the functional assessment of cancer therapy taxane subscale. Conclusions: This randomized trial exploring schedule-related issues with carboplatin/paclitaxel confirms the versatility of this regimen.