The efficacy and safety of immune checkpoint inhibitor plus chemotherapy in patients with advanced non-small-cell lung cancer: a meta-analysis

Objective: To evaluate the efficacy and safety of immune checkpoint inhibitor (ICI) and chemotherapy (CT) versus CT alone in advanced non-small-cell lung cancer (NSCLC). Methods: Databases (PubMed, Embase and Cochrane Library) were searched for relevant randomized controlled trials (RCTs). Clinical outcome measures including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and grade 3–5 treatment-related adverse events (AEs) were analyzed by Stata 15.0 software; significance level was 0.05. Results: Eight RCTs involving 4227 patients were included. The results showed ICI + CT significantly improved OS (hazard ratio [HR] = 0.74, 95% CI: 0.62–0.85, p < 0.001), PFS (HR = 0.66, 95% CI: 0.57 − 0.75, p < 0.001) and ORR (odds ratio [OR] = 1.89; 95% CI, 1.43–2.49, p < 0.001) compared with CT alone. Subgroup analysis indicated that significantly longer OS was also observed in subgroups including combination regimens (pembrolizumab + CT, atezolizumab + CT, ipilimumab + CT, and nivolumab + ipilimumab + CT) and PD-L1 status [negative (< 1%), positive (≥ 1%), low (1–49%) and high (≥ 50%)]. However, ICI + CT showed signifcantly higher grade 3–5 treatment-related AEs than CT (OR = 1.46, 95% CI: 1.19 − 1.79, p < 0.001). Conclusions: ICI + CT showed better clinical efficacy than CT alone in patients with advanced NSCLC, with increased treatment-related AEs.