目的 系统评价新辅助程序性死亡受体1(PD-1)/程序性死亡受体配体1(PD-L1)抑制剂联合化疗治疗可切除非小细胞肺癌(non-small cell lung cancer,NSCLC)的有效性和安全性.方法 计算机检索PubMed、EMbase、The Cochrane Library、中国知网和万方数据库从建库至2023年3月,关于PD-1/PD-L1抑制剂联合化疗治疗可切除NSCLC的相关研究,由两位评价员独立筛选文献、提取数据、评价纳入研究的偏倚风险.单臂研究采用非随机对照试验方法学评价指标(methodological index for non-randomized studies,MINORS)进行质量评价.采用RevMan 5.4进行Meta分析.结果 共纳入26篇文献,涉及965例患者.单臂研究MINORS评分均≥12分.Meta分析结果显示:新辅助PD-1/PD-L1抑制剂联合化疗治疗可切除NSCLC患者的病理完全缓解率、主要病理缓解率、客观缓解率、部分缓解率、手术率和R0切除率分别为39％[RD=0.39,95％CI(0.31,0.47)]、59％[RD=0.59,95％CI(0.53,0.65)]、72％[RD=0.72,95％CI(0.65,0.80)]、62％[RD=0.62,95％CI(0.56,0.69)]、86％[RD=0.86,95％CI(0.81,0.92)]和 94％[RD=0.94,95％CI(0.92,0.97)].安全性方面:新辅助免疫治疗联合化疗期间不良反应发生率为65％[RD=0.65,95％CI(0.52,0.78)],其中,3～5级不良反应发生率为16％[RD=0.16,95％CI(0.10,0.23)].结论 新辅助PD-1/PD-L1抑制剂联合化疗治疗可切除NSCLC患者具有显著的有效性,并且安全性较好.
Effect and safety of PD-1/PD-L1 inhibitors combined with chemotherapy in the neoadjuvant therapy of resectable non-small cell lung cancer:A systematic review and meta-analysis of single-group rate
Objective To systematically evaluate the effect and safety of neoadjuvant PD-1/PD-L1 inhibitors combined with chemotherapy for resectable non-small cell lung cancer(NSCLC).Methods The PubMed,EMbase,The Cochrane Library,CNKI,and Wanfang data were searched by computer to identify relevant studies on anti PD-1/PD-L1 combined with chemotherapy for resectable NSCLC from inception to March 2023.Two authors independently screened the literature,extracted the data,and evaluated the risk of bias in the included studies.The single-arm study was evaluated for quality using the methodological index for non-randomized studies(MINORS).Meta-analysis was conducted by RevMan 5.4 software.Results Twenty-six studies with 965 patients were included in this meta-analysis.MINORS scores of single-arm studies were ≥12 points.The meta-analysis results showed that the pooled pathologic complete response,major pathologic response,and objective response rates as well as partial response,surgical rate and R0 surgical resection rate of neoadjuvant PD-1/PD-L1 inhibitors combined with chemotherapy were 39％[RD=0.39,95％CI(0.31,0.47)],59％[RD=0.59,95％CI(0.53,0.65)],72％[RD=0.72,95％CI(0.65,0.80)],62％[RD=0.62,95％CI(0.56,0.69)],86％[RD=0.86,95％CI(0.81,0.92)],and 94％[RD=0.94,95％CI(0.92,0.97)],respectively.In terms of safety,the rate of adverse events(AEs)was 65％[RD=0.65,95％CI(0.52,0.78)],and the rate of grade 3 to 5 AEs was 16％[RD=0.16,95％CI(0.10,0.23)].Conclusion The combination of neoadjuvant PD-1/PD-L1 inhibitors with chemotherapy has good efficacy and safety in the treatment of patients with resectable NSCLC.
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