CDK4/6抑制剂联合氟维司群二线治疗Luminal型晚期乳腺癌的Meta分析  

Combinatorial CDK4/6 inhibitors and fulvestrant in second⁃line therapy for luminal advanced breast cancer:A meta analysis

作　　者：张慧慧 刘琳 盛佳丽 郑少江[1] ZHANG Huihui;LIU Lin;SHENG Jiali;ZHENG Shaojiang(Tumor Institute&Engineering Research Center for Hainan Biological Sample Resources of Major Diseases,the First Affiliated Hospital of Hainan Medical University,Haikou 570102,China)

机构地区：[1]海南医学院第一附属医院肿瘤研究所,重大疾病生物样本资源海南省工程研究中心,海南海口570102

出　　处：《海南医学院学报》2024年第22期1735-1743,共9页Journal of Hainan Medical University

基　　金：海南省临床医学中心资助项目(QWYH2021276)。

摘　　要：目的:对CDK4/6抑制剂联合氟维司群二线治疗Luminal型乳腺癌进行有效性及安全性评价。方法:根据检索式从Embase、PubMed、Web of Science、中国知网、万方医学网和维普网等数据库中网络检索与CDK4/6抑制剂联合氟维司群治疗Luminal型内分泌耐药乳腺癌有关的随机对照试验并进行筛选,使用Stata17.0和RevMan5.4软件对纳入的RCT进行评价及Meta分析。结果:纳入8篇文献,共5项RCT,纳入研究对象2466例。Meta分析结果显示,CDK4/6抑制剂联合氟维司群与单纯应用氟维司群相比可延长患者的无进展生存期[HR=0.51,95%CI(0.46,0.56),P<0.00001]及总生存期[HR=0.73,95%CI(0.65,0.83),P<0.00001],两组间差异具有统计学意义(P<0.05)。然而CDK4/6抑制剂联合氟维司群治疗时更容易造成中性粒细胞减少、白细胞计数下降、贫血、血小板下降及疲乏等不良反应,两组间差异具有统计学意义(P<0.05)。结论:与氟维司群加安慰剂相比,CDK4/6抑制剂联合氟维司群显著延长Luminal型乳腺癌患者的PFS和OS。用药过程中常见的不良反应是血液系统的中性粒细胞减少、白细胞计数下降、贫血、血小板下降及疲乏等,且3级及以上不良反应发生率可控,在临床治疗上获益较大。Objective:To assess the efficacy and safety of CDK4/6 inhibitors in conjunction with fulvestrant in the second-line therapy for luminal‑type advanced breast cancer.Methods:We meticulously selected randomised controlled trials evaluating the combination therapy of CDK4/6 inhibitors and fulvestrant for luminal‑type advanced breast cancer from January 2010 to January 2024.Studies were identified through extensive searches of databases including the PubMed,Web of Science,Embase,CNKI,Wanfang Data,and VIP.Data were then analyzed utilizing RevMan5.4 and Stata17.0 to perform a comprehensive meta‑analysis.Results:Our analysis incorporated data from 8 pertinent studies,encompassing 5 randomized controlled trials with a total of 2466 participants.The meta‑analysis indicated that,compared with the placebo plus fulvestrant cohort,the CDK4/6 inhibitor plus fulvestrant regimen enhanced progression‑free survival[HR=0.51,95%CI(0.46,0.56),P<0.00001]and overall survival[HR=0.73,95%CI(0.65,0.83),P<0.00001]in patients with breast cancer.Additionally,the CDK4/6 inhibitor plus fulvestrant group experienced an higher incidence of adverse effects such as neutropenia,anemia,leukopenia,platelet count decline,and fatigue when compared to the control group with statistically significant difference(P<0.05).Conclusion:CDK4/6 inhibitors combined with fulvestrant significantly prolongs both progression‑free and overall survival instances in patients with luminal‑type advanced breast cancer compared with placebo plus fulvestrant therapy.The regimen is predominantly characterized by hematologic toxicities including leukopenia,neutropenia,anaemia,platelet drop,and fatigue.However,the prevalence of high‑grade(grade 3 or above)adverse events remains within a controllable threshold,thereby enhancing the therapeutic index and conferring a net clinical benefit.

关 键 词：CDK4/6抑制剂 乳腺癌 内分泌耐药 有效性 安全性 META分析 

分 类 号：R737.9[医药卫生—肿瘤]