卡瑞利珠单抗联合化疗治疗晚期NSCLC的疗效及安全性Meta分析

Efficacy and safety of Camrelizumab combined with chemotherapy in the treatment of advanced NSCLC:a Meta analysis

目的Meta分析卡瑞利珠单抗在晚期非小细胞肺癌(NSCLC)治疗中的疗效及安全性。方法检索Web of science、PubMed、EMBASE、Cochrane Library、clinicaltrials.gov、中国知网、中国生物医学文献服务系统、维普、万方和中国临床试验注册中心等数据库,筛选卡瑞利珠单抗联合化疗治疗晚期NSCLC的随机对照研究;用RevMan 5.3软件评价纳入文献的质量,并提取资料进行统计学分析。结果共5项文献被纳入,有408例患者参与研究,所有研究数据完整无缺失,所有纳入患者对治疗方案耐受性良好。卡瑞利珠单抗联合化疗对比单纯化疗的统计分析显示:近期疗效中客观缓解率ORR(RR=1.60,95%CI:1.23-2.08,P=0.0005<0.05)、疾病控制率DCR(RR=1.16,95%CI:1.02-1.31,P=0.02<0.05)。远期疗效中无进展生存时间PFS(WMD=2.12,95%CI:1.64-2.60,P=0.00001<0.05)、总生存时间OS(WMD=1.38,95%CI:-0.17-2.93,P=0.08>0.05)。免疫因子CD4^(+)(WMD=5.22,95%CI:4.07-6.37,P<0.05)、CD8^(+)(WMD=-3.67,95%CI:-4.79-2.54,P<0.05)、CD4^(+)/CD8^(+)(WMD=0.25,95%CI:0.08-0.42,P<0.05)。毒副反应指标皮疹(RR=1.43,95%CI:0.74-2.75,P=0.29>0.05)、胃肠道反应(RR=1.18,95%CI:0.81-1.70,P=0.39>0.05)。结论卡瑞利珠单抗在晚期NSCLC治疗中可以显著提高近期疗效、改善患者免疫功能、延长无进展生存时间及具有良好的安全性,但不能延长总生存时间。

Objective Meta analysis of the efficacy and safety of Camrelizumab in the treatment of advanced non-small cell lung cancer(NSCLC).Methods Retrieve database such as Web of science,PubMed,EMBASE,Cochrane Library,clinicaltrials.gov,CNKI,China Biomedical Literature Service System,VIP,Wanfang and Chinese Clinical trials Registry to screen randomized controlled studies of the combination of Camrelizumaband chemotherapy for advanced NSCLC.RevMan 5.3 software was used to evaluate the quality of the included literatures,and the data were extracted for statistical analysis.Results A total of 5 articles were included,and 408 patients were enrolled in the study,all studies with complete and no missing data,and all included patients tolerated the treatment regimen well.The statistical analysis of the comparison of Camrelizumab plus chemotherapy versus chemotherapy alone showed that:The objective response rate ORR(RR=1.60,95%CI:1.23-2.08,P=0.0005<0.05)and disease control rate DCR(RR=1.16,95%CI:1.02-1.31,P=0.02<0.05)in the near-term efficacy.Long term outcomes included progression free survival time PFS(WMD=2.12,95%CI:1.64-2.60,P=0.00001<0.05)and overall survival time OS(WMD=1.38,95%CI:-0.17-2.93,P=0.08>0.05).The immune factors CD4^(+)(WMD=5.22,95%CI:4.07-6.37,P<0.05),CD8^(+)(WMD=-3.67,95%CI:-4.79--2.54,P<0.05),and CD4^(+)/CD8^(+)(WMD=0.25,95%CI:0.08-0.42,P<0.05)were significantly increased.The indicators of toxicities were rash(RR=1.43,95%CI:0.74-2.75,P=0.29>0.05),gastrointestinal reactions(RR=1.18,95%CI:0.81-1.70,P=0.39>0.05).Conclusions In the treatment of advanced NSCLC,Camrelizumab could significantly improve the short-term efficacy,improve the immune function of patients,prolong the progression free survival time and a good safety profile,but not the overall survival time.