Aim: To evaluate the efficacy and safety of nivolumab for advanced/recurrent non-small-cell lung cancer (NSCLC). Methods: Electronic databases were searched, and a systematic evaluation was performed. Results: Seven phase III randomized controlled trials and 4705 patients were included. Nivolumab improved overall survival, progression-free survival and overall response rate for advanced/recurrent NSCLC. The efficacy of nivolumab was not correlated with PD-L1 expression levels. Nivolumab combination therapy was superior to nivolumab monotherapy. NSCLC patients may benefit from nivolumab in both first-line and second-line treatment. Nivolumab did not enhance the risk of commonly reported adverse events such as fatigue, hepatotoxicity and gastrointestinal events, but enhanced the risk of immune-related adverse events. Nivolumab-associated pneumonitis is a concern. Conclusion: Nivolumab showed improved efficacy for advanced/recurrent NSCLC but increased the risk of immune-related adverse events.
Keywords: advanced/recurrent non-small-cell lung cancer; efficacy; meta-analysis; nivolumab; safety.