PD-1/PD-L1 antibodies efficacy and safety versus docetaxel monotherapy in advanced NSCLC patients after first-line treatment option: systems assessment.

Meta-analysis was conducted to systematically assess the effectiveness and safety of programmed cell death protein-1 or ligand-1 (PD-1 or PD-L1) antibodies versus docetaxel alone in advanced non small cell lung cancer (NSCLC). In addition, the prognostic significance of PD-L1 expression in advanced NSCLC was also investigated. 5 eligible studies including 3579 patients were identified through comprehensive search of multiple databases. The results showed that pooled hazard ratios (HR) for overall survival (OS) and progression free survival (PFS) were 0.69 (95% CI: 0.63-0.75; p < 0.001) and 0.87 (95% CI: 0.80-0.94; p < 0.001), between PD-1/PD-L1 antibodies and docetaxel treatment arms, respectively. The pooled relative risk (RR) value for objective response rate (ORR) was 1.53, (95% CI: 1.16-2.01, p = 0.003). Further, subgroup analysis based on PD-L1 expression indicated that pooled HR for OS was significant with 0.66(95% CI: 0.59-0.74, p < 0.001) for PD-L1≥1%. However, PD-L1 < 1% had HR value of 0.79 (95% CI: 0.67-0.93, p = 0.006). Our study concluded that advanced NSCLC patients benefited more with PD-1/PD-L1 antibodies than docetaxel in the second line treatment. PD-L1≥10% in tumor tissues is sufficient to show significant improvement in patient's outcome with PD-1/PD-L1 antibodies compared to docetaxel. Moreover, PD-1/PD-L1 antibodies treatment showed significant decrease in conventional chemotherapy adverse events, but increased immune-associated adverse effects.