A randomized placebo-controlled clinical study of nab -paclitaxel as second-line chemotherapy for patients with advanced non-small cell lung cancer in China.

We performed a randomized and placebo-controlled clinical study to investigate whether nab -paclitaxel can improve survival in patients with advanced non-small cell lung cancer (NSCLC) after unsuccessful first-line chemotherapy. Patients with stages III to IV advanced NSCLC after first-line platinum-based chemotherapy failure were randomly assigned in a 1:1 ratio to receive second-line treatment of nab -paclitaxel or placebo. Ninety two eligible patients were enrolled in the study. The median progression-free survival (PFS) was 4.6 months (95% confidence interval (CI): 3.4-6.7 months) for nab -paclitaxel, compared with 2.0 months (95% CI: 0.9-4.3 months) for placebo, representing a 56% reduction in disease progression (hazard ratio: 0.62; 95% CI: 0.33-0.81; P <0.001). The median overall survival (OS) was 6.3 months (95% CI: 3.9-8.2 months) for nab -paclitaxel, compared with 4.9 months (95% CI: 2.1-5.9 months) for placebo, representing a 22% reduction in disease progression (hazard ratio: 0.71; 95% CI: 0.33-0.85; P <0.001). Adverse events (AEs) were also observed for nab -paclitaxel. Nab -paclitaxel can improve survival in patients with advanced NSCLC after unsuccessful first-line chemotherapy.