目的 评价在含铂双药治疗基础上联合程序性死亡受体1/程序性死亡受体配体1(PD-1/PD-L1)抑制剂和贝伐珠单抗治疗晚期非小细胞肺癌的疗效与安全性.方法 检索中国知网、万方、维普、Web of Science、PubMed等中英文数据库,检索时间为建库至2024年4月25日.收集含铂双药联合PD-1/PD-L1抑制剂及贝伐珠单抗(试验组)对比含铂双药联合或不联合PD-1/PD-L1抑制剂或贝伐珠单抗(对照组)治疗晚期非小细胞肺癌的队列研究或随机对照试验.筛选文献、提取数据并进行文献质量评价后,采用RevMan 5.4.1软件进行Meta分析和敏感性分析.结果 共纳入15篇文献,涉及13项研究,共计3282例患者.与对照组比较,试验组有更高的部分缓解率[RR=0.75,95%CI(0.68,0.82),P<0.00001]、完全缓解率[RR=0.47,95%CI(0.29,0.76),P=0.002]、疾病进展率[RR=1.23,95%CI(1.11,1.37),P<0.0001]、客观缓解率[RR=0.72,95%CI(0.67,0.79),P<0.00001]和疾病控制率[RR=0.85,95%CI(0.77,0.95),P=0.003],两组患者的疾病稳定率[RR=1.25,95%CI(0.86,1.83),P=0.25]和总体不良反应发生率[RR=0.95,95%CI(0.90,1.00),P=0.07]差异均无统计学意义.敏感性分析表明,所有结局指标的分析结果均稳健可靠.结论 在含铂双药治疗基础上,PD-1/PD-L1抑制剂联合贝伐珠单抗治疗晚期非小细胞肺癌具有提高患者客观缓解率和疾病控制率等临床获益,且不增加不良反应发生风险.
Meta-analysis of the efficacy and safety of PD-1/PD-L1 inhibitors combined with bevacizumab in the treatment of advanced non-small cell lung cancer
OBJECTIVE To evaluate the efficacy and safety of programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors combined with bevacizumab in the treatment of advanced non-small cell lung cancer (NSCLC) based on platinum-containing dual therapy. METHODS Retrieved from CNKI,Wanfang,VIP,Web of Science,PubMed and other Chinese and English databases,cohort studies or randomized controlled trial studies on the treatment of advanced NSCLC with platinum-containing double agents in combination with PD-1/PD-L1 inhibitors and bevacizumab (trial group) versus platinum-containing double agents with or without PD-1/PD-L1 inhibitor or bevacizumab (control group) were collected from the inception to April 25,2024. After screening literature,extracting data and evaluating quality,meta-analysis and sensitivity analysis were performed by using RevMan 5.4.1 software. RESULTS A total of 15 pieces of literature were included,involving 13 clinical studies with a total of 3282 patients. Compared with the control group,partial response rate[RR=0.75,95%CI(0.68,0.82),P<0.00001],complete response rate[RR=0.47,95%CI(0.29,0.76),P=0.002],progressive disease rate[RR=1.23,95%CI(1.11,1.37),P<0.0001],objective response rate (ORR)[RR=0.72,95%CI(0.67,0.79),P<0.00001]and disease control rate (DCR)[RR=0.85,95%CI (0.77,0.95),P=0.003]were higher in the trial group. There was no statistically significant difference in the stable disease rate[RR=1.25,95%CI (0.86,1.83),P=0.25]or overall adverse drug reaction incidence rate[RR=0.95,95%CI (0.90,1.00),P=0.07]between the two groups of patients. Sensitivity analyses showed robust and reliable results for all outcome indicators. CONCLUSIONS PD-1/PD-L1 inhibitors combined with bevacizumab based on platinum-containing dual therapy in the treatment of advanced NSCLC can improve patients' clinical benefits,such as ORR and DCR,without increasing the risk of adverse drug reaction.