PD-L1表达作为生物标志物预测PD-1/PD-L1抑制剂治疗三阴性乳腺癌疗效的Meta分析  

PD-L1 expression as a biomarker predicts the efficacy of PD-1/PD-L1 inhibitors in triple-negative breast cancer:A meta-analysis

作　　者：李晓雯 项荣武 梁建坤[1,2] LI Xiaowen;XIANG Rongwu;LIANG Jiankun(Department of Medical Device,Shenyang Pharmaceutical University,Shenyang 110016,China;Liaoning Medical Big Data and Artificial Intelligence Engineering Technology Research Center,Shenyang Pharmaceutical University,Shenyang 110016,China;Beijing Buchang New Drug Development Co.,Ltd.,Beijing 100176,China)

机构地区：[1]沈阳药科大学医疗器械学院,辽宁沈阳110016 [2]沈阳药科大学辽宁省医药大数据与人工智能工程技术研究中心,辽宁沈阳110016 [3]北京步长新药研发有限公司,北京100176

出　　处：《沈阳药科大学学报》2020年第11期1050-1056,共7页Journal of Shenyang Pharmaceutical University

基　　金：辽宁省社会科学规划基金项目(L16BJY032);辽宁省教育厅科学技术研究项目(201610163L31);辽宁省自然科学基金项目(20180550345);辽宁省自然科学基金项目(20180550823)。

摘　　要：目的采用Meta分析评价方法,探讨程序性死亡配体-1(programmed death ligand l,PD-L1)表达可否作为生物标志物预测程序性死亡受体-1(programmed death-1,PD-1)及其配体(PD-L1)抑制剂治疗三阴性乳腺癌(triple-negative breast cancer,TNBC)的疗效。方法检索PubMed、Embase、Cochrane Library、ScienceDirect、Web of Science数据库,收集2019年9月前发表的关于PD-L1表达与PD-1/PD-L1抑制剂治疗TNBC疗效相关的临床研究。根据纳入排除标准,筛选文献并提取研究数据信息,采用纽卡斯尔-渥太华量表(Newcastle-Ottawa scale,NOS)进行文献质量评价,采用Stata/SE 15.1软件的Egger法及Begg法评估发表偏倚,并采用Review Manager 5.3软件进行统计分析。对于二分类变量,如客观缓解率(objective response rate,ORR)采用相对危险度(relative risk,RR)及95%可信区间(CI)作为效应量进行评估;对于生存时间数据,如无进展生存期(progression free survival,PFS)、总生存期(overall survival,OS)采用风险比(hazard ratio,HR)及95%可信区间(CI)进行评估。结果共纳入6篇文献(共845例患者),分析结果显示,PD-L1表达阳性(≥1%)患者与PD-L1表达阴性(<1%)患者比较,PD-L1阳性患者可获得更长的PFS及OS;然而PD-L1阳性患者的ORR并未显著高于PD-L1阴性患者。结论 PD-L1表达可作为预测患者疗后无进展生存期及总生存期的生物标志物,但无法预测患者的疗后客观缓解率。Objective To investigate whether the expression of programmed death ligand l(PD-L1) can be used as a biomarker to predict the efficacy of programmed death-1(PD-1) and its ligand(PD-L1) inhibitor in the treatment of triple-negative breast cancer(TNBC) by using the Meta-analysis evaluation method.Methods PubMed,Embase,Cochrane Library,ScienceDirect,and Web of Science databases were searched to collect clinical studies published before September 2019 on the correlation between PD-L1 expression and the efficacy of PD-1/PD-L1 inhibitors in the treatment of TNBC.According to the inclusion and exclusion criteria,the literatures were screened;the research data were extracted;the literature quality was evaluated with the Newcastle-Ottawa scale(NOS);the publication bias was assessed by the Egger/SE 15.1 software Egger method and Begg method;and statistical analysis was performed using Review Manager 5.3 software.For binary variables,such as objective response rate(ORR),relative risk(RR) and 95% confidence interval(CI) were used as the effect size;survival time data,such as progression-free survival(PFS) and overall survival(OS),were assessed using hazard ratio(HR) and 95% confidence interval(CI).Results A total of 6 articles(a total of 845 patients) were included.The analysis results showed that patients with positive PD-L1 expression(≥1%) had significantly longer OS and PFS compared with patients with negative PD-L1 expression(<1%).However,the ORR of PD-L1 positive patients was not significantly higher than that of PD-L1 negative patients.Conclusion PD-L1 expression can be used as a biomarker to predict progression-free survival and overall survival,but cannot predict the objective response rate of patients after treatment.

关 键 词：程序性死亡受体-1 探讨程序性死亡配体-1 三阴性乳腺癌 免疫检查抑制剂 生物标志物 

分 类 号：R737.9[医药卫生—肿瘤]