| Purpose: This meta-analysis and systematic review were conducted to evaluate the efficacy and safety of PD-1 inhibitors monotherapy versus chemotherapy in secondline treatment of AEC.Methods: Eligible randomized controlled trials were searched in Pub Med,Embase,and the Cochrane Library and abstracts presented at the American Society of Clinical Oncology or European Society of Medical Oncology to assess the efficacy and safety of PD-1inhibitors relative to chemotherapy for AEC from January 2015 to January 2021.Patients diagnosed with AEC and progressing after first-line therapy were included in this study.STATA12.0 software was used to calculate the hazard ratio（HR）of progression-free survival（PFS）and overall survival（OS）,the risk ratio（RR）of objective response rate（ORR）,and the odds ratio（OR）of adverse events（AEs）.Findings: Our study included four randomized controlled trials with 1,683 patients.The results indicated that PD-1 inhibitors prolonged the OS（HR=0.79,95% CI 0.71–0.88,P<0.01）and improved the ORR（RR=3.00,95% CI 2.36–3.82,P=0.01）,but did not improve the PFS（HR=0.96,95% CI 0.76–1.20,P=0.692）compared with chemotherapy in the second-line treatment of AEC.PD-1 inhibitors alone were associated with a lower incidence of all treatment-related AEs（TRAEs）（OR=0.29,95%CI 0.09–0.89,P=0.03）and grade 3–5 TRAEs（OR=0.26,95% CI 0.16–0.44,P<0.01） versus chemotherapy.PD-1 inhibitors prolonged OS mainly in the patient groups: male,age < 65-years-old,Eastern Cooperative Oncology Group（ECOG）performance status（PS）of 1,or PD-L1 tumor proportion score（TPS）≥ 10%.Asian patients have a longer OS than non-Asian patients（P=0.01）.Implications: The available evidence demonstrates that the efficacy and safety of PD-1 inhibitors were better than chemotherapy in the second-line treatment of AEC,and the benefiting population of these patients was limited to males,aged <65 years,ECOG PS = 1 or PD-L1 TPS ≥ 10%.Notably,Asian patients receiving immune monotherapy acquire longer OS than non-Asian patients. |
PDF Full Text Request