潜在生物标志物预测PD-1/PD-L1抑制剂治疗恶性肿瘤临床疗效的Meta分析  

Meta-analysis of potential biomarkers for predicting clinical efficacy of PD-1/PD-L1 inhibitors in malignancies

作　　者：林雨虹 林志冰 王晓贤 刘洁[1] 方跃华[1] 周晓燕 LIN Yuhong;LIN Zhibing;WANG Xiaoxian;LIU Jie;FANG Yuehua;ZHOU Xiaoyan(Laboratory Department,Hospital Affiliated to Fujian Medical University,Fuzhou 350009,China)

机构地区：[1]福建医科大学附属福州第一医院检验科,福州350009

出　　处：《中国免疫学杂志》2024年第5期931-938,共8页Chinese Journal of Immunology

基　　金：福建医科大学启航基金项目(2020QH1259);福建省卫生健康青年科研课题(2018QH1241);福州市科技计划项目(2021-S-171)。

摘　　要：目的:研究可预测PD-1/PD-L1抑制剂治疗恶性肿瘤临床疗效的潜在生物标志物。方法:检索PubMed、Web of Science、CNKI、万方和维普数据库,检索时限为各数据库建库至2022年9月20日。由2名评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.4和STATA16.0软件进行Meta分析。结果:共纳入18项研究,共计4018例患者。在随访的1年和2年内,发现高水平肿瘤突变负担(TMB)的肿瘤患者使用PD-1/PD-L1抑制剂的总生存率(OS)(P=0.003,P=0.01)和无进展生存率(PFS)(P=0.0002,P=0.04)更高。在不同的随访时间内,以1%为临界值,PD-L1表达高低作为预测PD-1/PD-L1抑制剂OS和PFS的生物标志物差异无统计学意义(P>0.05)。结论:TMB可以作为预测PD-1/PD-L1抑制剂治疗恶性肿瘤患者后2年内临床疗效的生物学指标,但其效用能否持续更长时间有待进一步研究;PD-L1单项检测目前不能成为预测应用PD-1/PD-L1抑制剂受益与否的生物学标志物。Objective:To explore potential biomarkers that can predict the clinical efficacy of PD-1/PD-L1 inhibitors in malignancies.Methods:The PubMed,Web of Science,CNKI,Wanfang and VIP databases were searched from the establishment of the database to September 20,2022.After literature screening,data extraction and the risk of bias were evaluated independently by two evaluators,the Meta-analysis was performed using RevMan5.4 and STATA16.0 software.Results:This paper included 18 studies with a total of 4018 patients.Tumor patients with a high tumor mutational burden(TMB)were found to have higher overall survival(OS)(P=0.003,P=0.01)and progression-free survival(PFS)(P=0.0002,P=0.04)with PD-1/PD-L1 inhibitors within 1 year and 2 years of follow-up.At different follow-up times,with 1%as the critical value,there was no statistical significance in the level of PD-L1 expression as a biomarker for predicting OS and PFS of PD-1/PD-L1 inhibitors(P>0.05).Conclusion:TMB can be used as a biological indicator to predict the clinical efficacy of PD-1/PD-L1 inhibitors in patients with malignant tumors within 2 years after treatment,but whether its efficacy can last longer remains to be further studied.PD-L1 single test is not currently a biomarker for predicting the benefit of PD-1/PD-L1 inhibitors.

关 键 词：恶性肿瘤 肿瘤突变负担 PD-L1 生物标志物 

分 类 号：R739.5[医药卫生—肿瘤]