Abstract
Albumin-bound paclitaxel (nab-paclitaxel) has been demonstrated to improve outcomes with lesser neuropathy compared to that with paclitaxel in patients with advanced non-small cell lung cancer (NSCLC). However, the feasibility of adjuvant chemotherapy setting is still uncertain. This phase II trial assessed the feasibility of adjuvant chemotherapy with nab-paclitaxel and carboplatin in patients who underwent complete resection of pathological stage IB/II/IIIA NSCLC (UMIN000011225). Patients with completely resected pathological stage IB/II/IIIA NSCLC were recruited from July, 2013. Patients were administered adjuvant chemotherapy with 4 cycles of carboplatin (AUC 5) on day 1 and nab-paclitaxel (100 mg/m2) on days 1 and 8 every 3 weeks. The primary endpoint was the completion of 3 cycles of chemotherapy. The sample size was set at 30 patients, and the treatment was considered feasible if the 80% CI of the completion rate of 3 cycles of chemotherapy was ≥60%, α=0.05 and β=0.2. The study enrolled 30 patients including 2 pilot patients. The median relative dose intensities of modified weekly carboplatin and nab-paclitaxel were 80% and 70%, respectively. First two pilot patients were required dose reduction in conventional weekly carboplatin (AUC5) on day1 and nab-paclitaxel (100 mg/m2) on days 1, 8 and 15 every 3 weeks, therefore we modified this setting. Among the treated patients, grade 3 adverse event listed neutropenia (60%) and thrombocytopenia (10%). Dose delays were observed in 20% of patients owing to neutropenia (85%). In this interim result analysis, all 10 patients completed 3 cycles of chemotherapy. Conversely, neuropathy did not develop in any patients. Neither febrile neutropenia nor treatment-related mortality was observed in this study. Based on the results, modified adjuvant chemotherapy with weekly nab-paclitaxel and carboplatin is feasible, with acceptable hematologic and non-hematologic toxicity, in patients who underwent complete resection of pathological stage IB/II/IIIA NSCLC.
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