Abstract
BACKGROUND: As an inhibitor of programmed death-1 (PD-1) protein, nivolumab has been shown to be effective in various cancers. We thus conducted this meta-analysis to compare the relative efficacy of nivolumab vs docetaxel-based chemotherapy as a second-line treatment for previously treated advanced non-small cell lung cancer (NSCLC). METHODS: Relevant studies were identified through searches of databases and conference proceedings. Progression-free survival (PFS), overall survival (OS), drug responses, and adverse effects (AEs) were assessed as the primary endpoints. RESULTS: After screening, we included six studies (949 patients) in the final analysis. Nivolumab showed better efficacy in terms of the PFS (hazard ratios [HR]: 0.70, P = 0.03), OS (HR: 0.70, P < 0.00001), objective response rate (ORR) (risk ratios [RR]: 1.73, P = 0.0008), total AEs (RR: 0.77, P = 0.006), and grade 3-5 AEs (RR: 0.18, P < 0.00001) than docetaxel. The anti-tumor efficacy of nivolumab for NSCLC in terms of both PFS and OS was positively correlated with the level of PD-L1 expression. In the nivolumab treatment arm, the 10 most-reported AEs were fatigue (15.7%), nausea (10.8%), decreased appetite (10.3%), asthenia (9.8%), diarrhea (7.5%), rash (7.5%), arthralgia (5.4%), vomiting (4.4%), constipation (3.5%), and pyrexia (3.3%). CONCLUSIONS: For advanced NSCLC, nivolumab is a better therapy in terms of both anti-tumor efficacy and safety than docetaxel-based chemotherapy. More high-quality randomized controlled trials are needed to confirm these results.