Abstract
BACKGROUND: Non-small-cell lung cancer (NSCLC) is often associated with rapid progression following standard chemotherapy. Nivolumab, an inhibitor of PD-1/PD-L1, is reported to have potential efficacy for the treatment NSCLC. OBJECTIVE: The purpose of this meta-analysis was to systematically evaluate the efficacy and safety of nivolumab in patients with advanced NSCLC. METHODS: Online electronic databases were searched in June 2017, including: PubMed, Embase, and the Cochrane Library. Randomized controlled trials were included that compared nivolumab to chemotherapy in NSCLC patients with regard to oncological outcome profiles. Review Manager Version 5.3 software was used. RESULTS: Three studies were included in this analysis, comprising 1,395 patients with NSCLC, of whom 698 received nivolumab and 697 received chemotherapy without nivolumab. The pooled hazard ratios for overall survival (OS) and prolonged progression-free survival (PFS) were 0.77 (95% CI: 0.57-1.03; P=0.08) and 0.88 (95% CI: 0.64-1.20; P=0.41), respectively. The pooled odds ratio for overall response rate was 1.40 (95% CI: 0.66-2.96; P=0.39), indicating that no benefit with nivolumab was found for OS, PFS, or overall response rate. However, the odds ratio for treatment-related adverse events, grades 3 or 4, between the patients who received nivolumab and chemotherapy was 0.13 (95% CI: 0.09-0.17; P<0.00001). For patients with a PD-L1 expression level of 5% or more, no difference was observed in PFS (95% CI: 0.70-1.00; P=0.05) and OS benefit (95% CI: 0.34-1.15; P=0.13) between the groups. CONCLUSION: These data demonstrate no clinical survival benefit with nivolumab for NSCLC patients, even in a subpopulation of patients with levels of PD-L1>5%. However, nivolumab had a more favorable safety profile than chemotherapy. Future investigations are needed to determine whether the efficacy of nivolumab can be improved.