摘要
目的:通过Meta分析,评价帕博利珠单抗治疗晚期非小细胞肺癌(NSCLC)在真实世界的有效性与安全性。方法:检索Cochrane Library、PubMed、EMBase、中国知网数据库、维普中文科技期刊数据库和万方医学数据库自建库到2021年6月11日,帕博利珠单抗治疗晚期NSCLC的真实世界研究文献,采用MINORS量表进行文献质量评估,收集文献的有效性和安全性数据进行Meta分析。结果:本研究最终纳入16篇真实世界研究,其中英文文献14篇,中文文献2篇,共有病人例数3699例。经Meta分析合并后得出客观缓解率(ORR)为47%(95%CI:45%,49%)、疾病控制率(DCR)为75%(95%CI:71%,79%)、不良反应发生率为37%(95%CI:32%,42%)、3~5级不良反应发生率为12%(95%CI:8%,15%)、因为不良反应而终止治疗的发生率为8%(95%CI:6%,11%),亚组分析结果发现程序性死亡受体1(PD-L1)≥90%、美国东部肿瘤协作组(ECOG)评分=0-1可能与临床受益良好有关。结论:帕博利珠单抗治疗晚期NSCLC的有效性和安全性良好,但纳入的研究样本量偏小,需继续开展多中心真实世界研究。
Objective:To evaluate the real-world efficacy and safety of pembrolizumab in the treatment of advanced non-small cell lung cancer(NSCLC) by Meta-analysis. Methods: The Cochrane Library, PubMed, EMBase, CNKI database, VIP Chinese scientific journal database and Wanfang Medical Database were searched for real-world research literature on pembrolizumab in advanced NSCLC until June 11, 2021. The MINORS scale was used to evaluate the quality of the literature, and the efficacy and safety data of the literature were collected for Meta-analysis. Results: This study finally included 16 real-world studies, including 14 in English and 2 in Chinese, with a total of 3699 patients. The objective response rate(ORR) was 47%(95%CI: 45%, 49%), and the disease control rate(DCR) was 75%(95%CI: 71%, 79%), the incidence of adverse reactions was 37%(95% CI: 32%, 42%), the incidence of grade 3-5 adverse reactions was 12%(95% CI: 8%, 15%), the incidence of treatment discontinuation due to adverse reactions was 8%(95% CI: 6%, 11%). Subgroup analysis found that PD-L1≥90% and ECOG PS=0-1 may be associated with better clinical benefit. Conclusion:Pembrolizumab has good efficacy and safety in the treatment of advanced NSCLC, but the sample size of the included studies is too small, so it is necessary to conduct multi-center real-world studies in the future.
作者
何梓健
万宁
梁蔚婷
杨蓓蓓
张建萍
季波
HE Zijian;WAN Ning;LIANG Weiting;YANG Beibei;ZHANG Jianping;JI Bo(College of Pharmacy,Jinan University,Guangzhou 510632,Guangdong,China;Department of Clinical Pharmacy,General Hospital of Southern Theater Command,Guangzhou 510010,Guangdong,China;Guangdong Branch Center,National Clinical Research Center for Geriatric Diseases(Chinese PLA General Hospital),Guangzhou 510010,Guangdong,China;Department of Pharmacy,Center for Prevention and Treatment of Tumor of Sun Yat-sen University,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Guangzhou 510060,Guangdong,China;Department of Clinical Pharmacy,Baoji Central Hospital,Baoji 721008,Shanxi,China)
出处
《暨南大学学报（自然科学与医学版）》
CAS
CSCD
北大核心
2022年第4期393-405,共13页
Journal of Jinan University(Natural Science & Medicine Edition)
基金
广东省自然科学基金(2021 A1515012251)。
