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

Adult Male Lung Neoplasms Paclitaxel Middle Aged Disease-Free Survival 3. Good health Survival Rate 03 medical and health sciences 0302 clinical medicine Albumins Carcinoma, Non-Small-Cell Lung Humans Female Research Articles Aged
DOI: 10.1042/bsr20170020 Publication Date: 2017-03-30T00:25:27Z
ABSTRACT
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.
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