Randomized Phase II Study of Weekly Paclitaxel plus Carboplatin Versus Biweekly Paclitaxel plus Carboplatin for Patients with Previously Untreated Advanced Non‐Small Cell Lung Cancer

LESSONS LEARNED. This clinical trial, evaluating the efficacy and safety of a carboplatin plus paclitaxel regimen in a biweekly or weekly schedule instead of the more toxic 3‐weekly administration, showed that the weekly regimen was better in efficacy than the biweekly regimen, with mild toxicities, for patients with non‐small cell lung cancer (NSCLC). The weekly carboplatin plus paclitaxel regimen could be considered as an alternative to the 3‐weekly regimen in Japanese patients with NSCLC. BACKGROUND. Combination therapy comprising carboplatin (C) and paclitaxel (P) is the most commonly used regimen for the treatment of advanced non‐small cell lung cancer (NSCLC). Common toxicities associated with the regimen, such as neuropathy and myelosuppression, cause its discontinuation. In the present study, we conducted a clinical trial evaluating the efficacy of biweekly (B) and weekly (W) PC therapy to identify the appropriate chemotherapy schedule for Asian patients. METHODS. Chemonaive patients with IIIB/IV NSCLC and a performance status of 0–1 were randomly assigned to a biweekly regimen (paclitaxel 135 mg/m(2) with carboplatin area under the curve [AUC] 3 on days 1 and 15 of every 4 weeks) or to a weekly regimen (paclitaxel 90 mg/m(2) on days 1, 8, and 15 with carboplatin AUC 6 on day 1 of every 4 weeks). RESULTS. A total of 140 patients were enrolled in the study. The objective response rates (ORRs) were 28.1% (B) and 38.0% (W). The most common toxicity was neutropenia, with incidence rates of 62.0% (B) and 57.8% (W). Progression‐free survivals (PFSs) were 4.3 months (B) and 5.1 months (W), and overall survival durations were 14.2 months (B) and 13.3 months (W). CONCLUSION. The ORR and PFS in the weekly regimen were better than those in the biweekly schedule, although a statistical difference was not observed. The toxicity profile was generally mild for both regimens. The weekly CP regimen was suitable to be considered as an alternative to the current 3‐weekly regimen in NSCLC treatment.