CDK4/6抑制剂联合内分泌疗法治疗HR+/HER2-乳腺癌疗效和安全性的Meta分析  

Efficacy and safety of CDK4/6 inhibitors in combination with endocrine therapy for HR+/HER2‒ breast cancer: a meta-analysis

作　　者：穆玉晶 冯雪[1] 孔健达 左禧萌 汪唐顺[1] 史晓光[1] MU Yujing;FENG Xue;KONG Jianda;ZUO Ximeng;WANG Tangshun;SHI Xiaoguang(Department of General Surgery,Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100007,P.R.China;College of Sports Science,Qufu Normal University,Jining 273100,P.R.China)

机构地区：[1]北京中医药大学东直门医院普外科,北京100007 [2]曲阜师范大学体育科学学院,山东济宁273100

出　　处：《中国循证医学杂志》2024年第3期280-287,共8页Chinese Journal of Evidence-based Medicine

基　　金：湖北陈孝平科技发展基金会专项基金(编号:CXPJJH12000002-2020010)。

摘　　要：目的系统评价CDK4/6抑制剂联合内分泌疗法治疗HR+/HER2-乳腺癌的疗效和安全性。方法计算机检索PubMed、Cochrane Library、Web of Science、WanFang Data和CNKI数据库以及美国临床肿瘤学会(ASCO)、欧洲医学肿瘤学会(ESMO)和圣安东尼奥乳腺癌研讨会(SABCS)网站,搜集有关CDK4/6抑制剂联合内分泌疗法治疗HR+/HER2-乳腺癌的随机对照试验,检索时限均从建库至2023年7月5日。由2位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4和Stata 14.0软件进行Meta分析。结果共纳入8个研究,包括4580例患者。Meta分析结果显示:联合治疗组患者的总生存期和无进展生存期明显长于单独内分泌治疗组[HR=0.80,95%CI(0.73,0.89),P<0.05;HR=0.54,95%CI(0.50,0.59),P<0.05]。联合治疗组患者的客观缓解率和临床获益率高于单独内分泌治疗组[RR=1.47,95%CI(1.34,1.62),P<0.05;RR=1.20,95%CI(1.11,1.30),P<0.05]。此外,联合治疗组的中性粒细胞减少、白细胞减少等血液毒性事件的发生率更高,但恶心、腹泻及头痛等不良反应发生率两组差异均无统计学意义。结论CDK4/6抑制剂联合内分泌疗法治疗HR+/HER2-乳腺癌患者可提高总生存期、无进展生存期、临床获益率及客观缓解率,具有显著的远期及近期疗效;但该方案使部分不良反应的发生率升高,临床用药需警惕严重不良反应的发生。Objective To systematically review the efficacy and safety of CDK4/6 inhibitors in combination with endocrine therapy for HR+/HER2‒breast cancer.Methods The PubMed,Cochrane Library,Web of Science,WanFang Data,CNKI,American Society of Clinical Oncology(ASCO),European Society of Medical Oncology(ESMO)and San Antonio Breast Cancer Symposium(SABCS)databases were electronically searched to collect randomized controlled trials on CDK4/6 inhibitors in combination with endocrine therapy for HR+/HER2‒breast cancer from inception to July 5,2023.Two reviewers independently screened the literature,extracted data,and assessed the risk of bias of the included studies.Meta-analysis was then performed using RevMan 5.4 software and Stata 14.0 software.Results A total of 8 studies involving 4580 patients were included.The results of meta-analysis showed that overall survival and progressionfree survival were significantly longer in the combination therapy group than those in the endocrine therapy alone group(HR=0.80,95%CI 0.73 to 0.89,P<0.05;HR=0.54,95%CI 0.50 to 0.59,P<0.05).The results also showed that patients in the combination therapy group also had significantly higher rates of objective remission and clinical benefit than those in the endocrine therapy group alone(RR=1.47,95%CI 1.34 to 1.62,P<0.05;RR=1.20,95%CI 1.11 to 1.30,P<0.05).In addition,the combination treatment group also increased the incidence of haematological toxicity such as neutropenia and leucopenia,but the differences in the incidence of nausea,diarrhoea and headache were not statistically significant between the two groups.Conclusion The combination of CDK4/6 inhibitors with endocrine therapy for HR+/HER2‒breast cancer patients improve overall survival,progression-free survival,clinical benefit rate and objective remission rate,with significant long-term and near-term efficacy;however,this regimen increased the incidence of several adverse effects,and clinical use should be considered when considering the occurrence of serious adverse effects.

关 键 词：CDK4/6抑制剂 内分泌治疗 HR+/HER2-乳腺癌 系统评价 META分析 随机对照试验 

分 类 号：R737.9[医药卫生—肿瘤]