PD-1/PD-L1抑制剂联合化疗对比免疫单药治疗晚期NSCLC疗效及安全性的Meta分析

A Meta-analysis of the Efficacy and Safety of PD-1/PD-L1 Inhibitor Combined with Chemotherapy Compared with Immune Monotherapy in the Treatment of Advanced NSCLC

目的系统评价PD-1/PD-L1抑制剂单药(I)或联合化疗(I+C)作为晚期非小细胞肺癌一线治疗的疗效和安全性。方法对PubMed、Embase、CNKI等数据库进行检索,纳入符合标准的随机对照试验,采用RevMan 5.3软件和R语言进行统计分析。结果共纳入13项研究,涉及7281名患者。Meta分析结果显示,PD-1/PD-L1抑制剂单药(I)或联合化疗(I+C)与化疗相比在总生存期OS和无进展生存期PFS方面均明显改善了临床疗效。间接分析(I+C vs I)中,联合治疗(I+C)较单药(I)相比可显著延长PFS,OS没有显著差异。亚组分析显示,“I+C”治疗方案在PD-L1表达阳性(≥1%)和阴性(<1%)人群中均比单药“I”和化疗具有更好的PFS。而3~5级治疗相关不良反应事件发生率在“I+C”联合治疗中更常见。结论在PD-L1表达阴性或阳性情况下,PD-1/PD-L1抑制剂联合化疗在一线治疗晚期NSCLC中均可取得较好的疗效,但不良反应发生率也较高。

Objective To systematically evaluate the efficacy and safety of PD-1/PD-L1 inhibitors alone(I)or combined chemotherapy(I+C)as the first-line treatment of advanced non-small-cell lung cancer.Methods The PubMed,Embase,CNKI and other databases were searched,randomized controlled trials that met the standards were included,and RevMan 5.3 software and R language were used for statistical analysis.Results A total of 13 studies were included,involving 7281 patients.Meta-analysis results showed that PD-1/PD-L1 inhibitor single agent(I)or combination chemotherapy(I+C)compared with chemotherapy in OS and PFS significantly improved the clinical efficacy.In the indirect analysis(I+C vs I),the combination therapy(I+C)can significantly prolong the PFS compared with the single agent(I),and there is no significant difference in OS.Subgroup analysis showed that the"I+C"treatment regimen had better PFS than single-agent"I"and chemotherapy in both PD-L1 positive(≥1%)and negative(<1%)populations.The incidence of grade 3~5 treatment-related adverse events is more common in"I+C"combination therapy.Conclusion In the case of negative or positive PD-L1 expression,PD-1/PD-L1 inhibitor combined with chemotherapy can achieve better efficacy in the firstline treatment of advanced NSCLC,but the incidence of adverse reactions is also higher.