PD-1抑制剂联合化疗一线治疗晚期食管鳞状细胞癌的Meta分析  

Efficacy and safety of PD-1 inhibitors plus chemotherapy versus chemotherapy in first-line treatment of advanced esophageal squamous cell carcinoma:a Meta-analysis

作　　者：魏瑜[1] 高艳 努尔斯曼古丽·买买提明 马晓丽[1] 曹雷雨[1] 刘娟[1] 张莉[1] WEI Yu;GAO Yan;Nuersimanguli Maimaitiming;MA Xiaoli;CAO Leiyu;LIU Juan;ZHANG Li(4th Department of Internal Medicine,First Affiliated Hospital,Xinjiang Medical University,Urumqi 830054,China)

机构地区：[1]新疆医科大学第一附属医院综合内四科,乌鲁木齐830054

出　　处：《浙江医学》2022年第23期2545-2551,共7页Zhejiang Medical Journal

基　　金：新疆维吾尔自治区自然科学基金资助项目(2021D01C352)。

摘　　要：目的 系统评价程序性死亡受体1(PD-1)抑制剂联合化疗一线治疗晚期食管鳞状细胞癌(ESCC)患者的疗效及安全性。方法 检索The Cochrane Library、Web of Science、PubMed、EMbase、中国知网(CNKI)和万方等数据库,同时检索Journal of Clinical Oncology、The New England Oncology、The Lancet Oncology等杂志以及ASCO、EMSO会议摘要,筛选并提取PD-1抑制剂联合化疗(试验组)对比单独化疗(对照组)一线治疗晚期ESCC患者临床随机对照试验(RCT)的文献资料,采用RevMan5.3进行Meta分析。结果 共纳入5项RCT研究(2 962例)。系统评价显示,与对照组相比,试验组可显著延长晚期ESCC患者的总生存期(HR=0.68,95%CI:0.62~0.75,P<0.01)和无进展生存期(HR=0.62,95%CI:0.56~0.68,P<0.01),有效提高客观有效率(RR=1.42,95%CI:1.23~1.63,P<0.01)。亚组分析显示,与PD-1抑制剂联合5-氟尿嘧啶+顺铂方案化疗相比,PD-1抑制剂联合紫杉醇+顺铂方案化疗临床获益更显著;程序性死亡配体1的综合阳性评分(CPS)≥10时,试验组在延长总生存期方面相比对照组优势更显著,但两组患者3~5级不良反应发生率比较,差异无统计学意义(RR=1.13,95%CI:0.98~1.30,P>0.05)。结论 PD-1抑制剂联合化疗一线治疗晚期ESCC可为患者带来显著生存获益,总体安全性良好。Objective To analyze the efficacy and safety of PD-1 inhibitors plus chemotherapy versus chemotherapy in the first-line treatment of advanced esophageal squamous cell carcinoma(ESCC). Methods Relevant literature about randomized controlled trails(RCT) of PD-1 inhibitors plus chemotherapy versus chemotherapy in the first-line treatment of advanced ESCC patients was retrieved through The Cochrane Library, Web of Science, PubMed, EMbase, CNKI and Wanfang data, Journal of Clinical Oncology, The New England Oncology, The Lancet Oncology as well as ASCO and ESMO meeting abstracts. The bias of data was analyzed by using RevMan5.3 software. Results Totally 5 RCTs including 2 962 patients were analyzed. The Meta-analysis showed that compared with the chemotherapy(control group), PD-1 inhibitors plus chemotherapy(study group) significantly prolonged the overall survival(HR=0.68, 95%CI: 0.62-0.75, P<0.01), progression free survival(HR=0.62, 95%CI: 0.56-0.68, P<0.01), improved the overall response rate(RR=1.42, 95%CI: 1.23-1.63, P<0.01). In subgroup analysis, compared with PD-1 inhibitor plus 5-fluorouracil + cisplatin regimen, PD-1 inhibitor plus paclitaxel+cisplatin regimen had more significant clinical benefits. When the comprehensive positive score of PD-L1 was ≥10,the study group significantly prolonged the overall survival. In terms of safety, there was no significant difference in the incidence of grade 3-5 adverse reactions between the study group and the control group.(RR=1.13, 95%CI: 0.98-1.30, P>0.05). Conclusion Compared with chemotherapy, PD-1 inhibitor combined with chemotherapy in the first-line treatment for advanced ESCC patients is more effective, with good safety.

关 键 词：程序性死亡受体1抑制剂 化疗 一线治疗 晚期食管鳞状细胞癌 META分析 

分 类 号：R735.1[医药卫生—肿瘤]