河北医科大学学报 ›› 2024, Vol. 45 ›› Issue (6): 672-680.doi: 10.3969/j.issn.1007-3205.2024.06.009

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CDK4/6抑制剂联合非甾体芳香化酶抑制剂治疗晚期乳腺癌有效性和安全性的Meta分析

  

  1. 1.郑州大学附属儿童医院检验科，郑州市儿童感染与免疫重点实验室，河南 郑州 450000；
    2.郑州大学第三附属医院检验科，河南 郑州 450000

  • 出版日期:2024-06-25 发布日期:2024-06-25
  • 作者简介:弓伟华（1995-），女，河南郑州人，郑州大学附属儿童医院技师，医学硕士，从事疾病免疫学检验研究。
  • 基金资助:
    河南省医学科技攻关联合共建项目（LHGJ20220729）

Meta-analysis of the efficacy and safety of CDK4/6 inhibitors combined with nonsteroidal aromatase inhibitors for advanced breast cancer

  1. 1.Department of Clinical Laboratory, Children′s Hospital Affiliated to Zhengzhou University, Zhengzhou 
    Key Laboratory of Children′s Infection and Immunity, Henan Province, Zhengzhou 450000, China; 
    2.Department of Clinical Laboratory, the Third Affiliated Hospital of Zhengzhou University, 
    Henan Province, Zhengzhou 450000, China

  • Online:2024-06-25 Published:2024-06-25

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摘要： 目的 系统评价细胞周期蛋白依赖性激酶（cyclin dependent kinase，CDK）4/6抑制剂联合非甾体芳香化酶抑制剂治疗晚期乳腺癌的有效性与安全性。
 方法 计算机检索Pubmed、Cochrane图书馆、EMbase、中国知网、万方数据库和维普数据库，以收集CDK4/6抑制剂联合非甾体芳香化酶抑制剂治疗晚期乳腺癌的相关文献，检索时限均从建库至2023年02月01日。由2位研究者背对背筛选文献、提取数据并进行偏倚风险评估后，使用Rev Man 5.3软件进行Meta分析。
 结果 纳入Meta分析的文献有8篇，共2 706例患者。Meta分析结果显示，与安慰剂联合非甾体芳香化酶抑制剂治疗相比，CDK4/6抑制剂联合非甾体芳香化酶抑制剂治疗可延长晚期乳腺癌患者无进展生存期（RR=0.58，95%CI：0.51~0.64，P＜0.001）、提高客观缓解率（RR=1.34，95%CI：1.20~1.48，P＜0.001）和临床获益率（RR=1.11，95%CI：1.06~1.16，P＜0.001）。在安全性方面，CDK4/6抑制剂联合非甾体芳香化酶抑制剂治疗患者的3~4级不良反应发生率较高（RR=2.63，95%CI：2.17~3.19，P＜0.001）。其中，试验组白细胞减少、嗜中性粒细胞减少、贫血、乏力、呕吐及腹泻等不良反应发生率高于对照组（P＜0.05）；2组便秘和头疼的发生率差异无统计学意义（P＞0.05）。
 结论 CDK4/6抑制剂联合非甾体芳香化酶抑制剂治疗可延长晚期乳腺癌患者的无进展生存期、提高客观缓解率和临床获益率，但该方案可能导致3~4级不良反应发生率升高。


关键词: 乳腺肿瘤, CDK4/6抑制剂, 非甾体芳香化酶抑制剂

Abstract: Objective To systematically evaluate the efficacy and safety of cyclin dependent kinase (CDK) 4/6 inhibitors combined with nonsteroidal aromatase inhibitors for advanced breast cancer. 
Methods Pubmed, The Cochrane Library, EMbase, CNKI, WanFang Data, and VIP databases were electronically searched to collect relevant literature of CDK4/6 inhibitors combined with nonsteroidal aromatase inhibitors for advanced breast cancer from inception to February 1st, 2023. After back-to-back screening of the literature, data extraction, and evaluation of the risk of bias in the included studies, meta-analysis was performed using Rev Man 5.3 software. 
Results There were 8 articles included in the meta-analysis, with a total of 2 706 patients. Meta-analysis results showed that compared with placebo combined with nonsteroidal aromatase inhibitor, CDK4/6 inhibitor combined with nonsteroidal aromatase inhibitor could prolong progression-free survival (PFS) of patients with advanced breast cancer (RR=0.58, 95%CI: 0.51-0.64, P＜0.001), improve objective response rate (ORR) (RR=1.34, 95%CI: 1.20-1.48, P＜0.001) and clinical benefit rate (RR=1.11, 95%CI: 1.06-1.16, P＜0.001). In terms of safety, the incidence of grade 3-4 adverse reactions in patients treated with CDK4/6 inhibitors combined with nonsteroidal aromatase inhibitors was higher (RR=2.63, 95%CI: 2.17-3.19, P＜0.001). Among them, the incidence of adverse reactions such as leukopenia, neutropenia, anemia, fatigue, vomiting, and diarrhea in the experimental group was higher than that in the control group (P＜0.05). There was no significant difference in the incidence of constipation and headache between the two groups (P＞0.05). 
Conclusion CDK4/6 inhibitors combined with nonsteroidal aromatase inhibitors for the patients with advanced breast cancer could prolong PFS, improve ORR and clinical benefit rate, while increasing the incidence of grade 3 to 4 adverse reactions. 


Key words: breast neoplasms, CDK4/6 inhibitor, nonsteroidal aromatase inhibitors

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