A phase II clinical study of using nab-paclitaxel as second-line chemotherapy for Chinese patients with advanced non-small cell lung cancer.

The aim of this clinical study was to evaluate the efficacy and safety of nab-paclitaxel to treat patients with advanced non-small cell lung cancer (NSCLC) who failed first-line chemotherapy. Eligible patients had advanced NSCLC and had been treated with first-line platinum-based chemotherapy but still had disease progression. Patients received nab-paclitaxel 100 mg/m(2) (i.v.) on days 1, 8 and 15 of a 28-day cycle. Primary endpoint is 6-month progression-free survival (PFS). Fifty-six patients with advanced NSCLC were enrolled in the study (55.4 % male patients, 44.6 % female patients; median age 59.6 years; ranging from 32 to 83 years). Six-month PFS rate was 18 % (95 % CI 7.8-28.7 %). Median PFS was 3.5 months (95 % CI 1.9-5.8 months). Median overall survival was 6.8 months (95 % CI 4.7-9.3 months). No complete responses were achieved. Overall response rate was 16.1 % (95 % CI 8.9-24.7 %). Grade 3 or 4 adverse events (AEs) were observed in patients receiving nab-paclitaxel. The most common grade 3 or 4 AEs were dizziness, pulmonary embolism and fatigue. Nab-paclitaxel showed clinically equivalent efficacy on patients' survivals and response rates, as compared with other FDA-approved second-line chemotherapy agents. Given the tolerability on grade 3 or 4 adverse events, nab-paclitaxel may be considered an alternative second-line treatment option for NSCLC.