晚期胆道癌吉西他滨为基础化疗方案临床疗效Meta分析  

Efficacy and safety of gemcitabine-based chemotherapies in patients with biliary tract cancer:A systematic review and Meta-analysis

作　　者：宋华春 赵贤宝[1] 马云[1] 何娇波 何芳[1] 季倩青 陈亮 傅超 陈阳 SONG Hua-chun;ZHAO Xian-bao;MA Yun;HE J iao-bo;HE Fang;JI Qian-qing;CHEN Liang;FU Chao;CHEN Yang(Department of Oncology,Central Hospital of Yizvu City ,Yiwu 322000,P.R.China)

机构地区：[1]义乌市中心医院肿瘤科,浙江义乌322000

出　　处：《中华肿瘤防治杂志》2019年第4期264-271,共8页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的以吉西他滨(gemcitabine,GEM)为基础化疗方案治疗晚期胆道癌临床疗效尚不确定,本研究通过Meta分析综合评估以GEM为基础化疗方案治疗晚期胆道癌临床疗效,探讨其作为晚期胆道癌一线治疗方案可行性。方法检索PubMed、EMbase、MEDLINE、Ovid、EBSCO和Cochrane数据库自建库至2016-10发表的GEM为基础化疗方案治疗晚期胆道癌的前瞻性随机对照试验和文献,并进行文献筛选和提取资料。评估指标包括总生存期(overall survival,OS)、无进展生存期(progression-free survival,PFS)、完全缓解(complete remission,CR)、部分缓解(partial remission,PR)、疾病稳定(stability of the disease,SD)、客观缓解率(objective response rate,ORR)、临床受益率(clinical benefit rate,CBR)和不良反应。纳入研究的结果采用Review Manager 5.3软件进行Meta分析。结果共纳入9篇研究,包括906例病例。按照化疗方案进行分组,即GEM为基础的化疗方案(GC组)和不联合GEM为基础的化疗方案(包括GEM组和单独GEM组2个亚组)。总分析结果显示,GC组OS(HR=0.75,95%CI=0.65～0.87,P<0.001)、PFS(HR=0.75,95%CI=0.57～0.99,P=0.04)和ORR(OR=1.55,95%CI=1.07～2.25,P=0.02)优于不联合GEM为基础的化疗方案。亚组分析结果显示,GC组OS(HR=0.76,95%CI=0.64～0.90,P=0.002)和ORR(OR=1.70,95%CI=1.02～2.83,P=0.04)优于单独GEM组;GC组OS(HR=0.74,95%CI=0.57～0.95,P=0.02)和PFS(HR=0.58,95%CI=0.43～0.78,P<0.001)优于GEM组。总分析结果显示,GC组和不联合GEM为基础的化疗方案3或4级血液学不良反应发生率比较,包括白细胞减少症(OR=2.74,95%CI=1.86～4.03,P<0.001)、中性粒细胞减少症(OR=2.37,95%CI=1.21～4.66,P=0.01)、贫血(OR=3.61,95%CI=2.12～6.16,P<0.001)和血小板减少症(OR=1.92,95%CI=1.25～2.95,P=0.003),差异有统计学意义。结论 GEM为基础的联合化疗是一种潜在的一线治疗晚期胆道癌的有效方案,但不良反应增加。OBJECTIVE The clinical efficacy of gemcitabine-based chemotherapy for advanced biliary tract cancer(BTC)remains uncertain.This study assessed the clinical efficacy of gemcitab in e-based chemotherapy for adva need BTC by meta-analysis and explored its feasibility as a first-line treatment for advanced BTC.METHODS PubMed,EMbase,MEDLINE,Ovid,EBSCO and Cochrane databases were searched until 2016-10,and literature screening and data extraction were carried out.Overall survival(OS),progression-free survival(PFS),complete remission(CR),partial remission(PR),stability of the disease(SD),objective response rate(ORR),clinical benefit rate(CBR)and adverse reactions were assessed.The results of the study were carried out by Review Manager 5.3 software for Meta analysis.RESULTS Nine tri als including 906 patients were analyzed.The studies were divided into subgroups based on the chemotherapy regimen,including Gem based(GC group)and non-Gem-based chemotherapy(including two subgroups of GEM and GEM alone).In overall analyses,patients treated with Gem-based combination chemotherapy had significantly improvement of overall survival(HR=0.75,95%CI=0.65-0.87,P<0.001),progression-free survival(HR=0.75,95%CI=0.57-0.99,P=0.04),overall response rate(OR=1.55,95%CI=1.07-2.25,P=0.02).In subgroup analysis,Gem-based combination chemotherapy,comparing Gem monotherapy,can significantly improve overall survival,overall response rate(HR=0.76,95%CI=0.64-0.90,P=0.002;OR=1.70,95%CI=1.02-2.83,P=0.04),in addition,Gem-based combination chemotherapy,comparing to non-Genrbased chemotherapy,had significantly improvement of overall survival,progression free survival(HR=0.74,95%CI=0.57-0.95,P=0.02;HR=0.58,95%CI=0.43-0.78,P<0.001).A higher incidence of Grade 3 or 4 hematological toxicities,including leukopenia(OR=2.74,95%CI=1.86-4.03,P<0.001),neutro penia(OR=2.37,95%CI=1.21-4.66,P=0.01),anemia(OR=3.61,95%CI=2.12-6.16,P<0.001)and thrombocytopenia(OR=1.92,95%CI=1.25-2.95,P=0.003)was found in the Gem-based combination chemotherapy group compared with no Gem-b

关 键 词：胆道癌 吉西他滨 顺铂 化疗 META分析 

分 类 号：R735.8[医药卫生—肿瘤]