| Objective:To evaluate the safety and Subgroup effectiveness of anti-PD-1/PD-L1 inhibitors and chemotherapy in the non-first-line treatment of advanced non-small-cell lung cancer(NSCLC).Methods :The clinical trials meeting the inclusion criteria were searched by computer,and the methodological quality of the included trials was evaluated and the meta analysis was performed by Review manager 5.3.The hazard ratios for overall survival and progress-free survival,and relative risk for the object response rate and treatment related adverse events were calculated by Review manager software.Results :According to the inclusion and exclusion criteria,five randomized controlled trials were included,all of which were the comparison of the efficacy and safety of PD-1/PD-L1 inhibitors and docetaxel.The results showed that PD-1/PD-L1 inhibitors significantly improved OS(HR = 0.70,95% CI: 0.64-0.75,P < 0.00001),PFS(HR =0.87,95% CI: 0.81-0.94,P = 0.0004),and ORR(HR = 1.53,95% CI = 1.16-2.01,P =0.003).The results of OS subgroup analysis showed that the efficacy of PD-1 / PD-L1 inhibitors in men,women,age < 75 years old,ECOG 0 or 1,smoking history,second-line treatment,squamous cell carcinoma,KRAS gene mutation positive,EGFR gene wild type was better than that in docetaxel group,but for age > 75 years old,Three line treatment,no smoking history,KRAS wild type and EGFR mutation positive patients,there was no significant difference between the two groups.The adverse events of PD-1/PD-L1 inhibitors was significantly lower than that of docetaxel;And the main causes of death were pulmonary inflammation,pneumonia,encephalitis and myocardial infarction.The most common of immune related adverse reactions include lung inflammation,increased colitis,hyperthyroidism,hypothyroidis-m,increased serum creatinine,aminotrensferase,and rash.Conclusion :PD-1/PD-L1 inhibitors can significantly improve OS,PFS and ORR of patients with previous treated NSCLC,and most of the subgroups can benefit from PD-1/PD-L1 inhibitors treatment,and the incidence of adverse reactions is significantly lower than that of docetaxel. |