本文旨在通过荟萃分析评估将 CDK 4/6 抑制剂 (CDK4/6i) 纳入 ET 辅助治疗 HR HER2 切除的早期乳腺癌 (ESBC) 患者的有效性。在本文中，我们编制了重点关注 CDK4/6i 用于高危侵袭性 HR 阳性和 HER2-ESBC 患者辅助治疗的随机临床试验。根据 PRISMA 指南进行了荟萃分析。我们确定了四项符合我们纳入标准的临床试验，并于 2020 年至 2024 年之间发表。这些试验的合并样本量为 17,749 名诊断为乳腺癌的患者。汇总分析获得的数据显示，与单独接受 ET 的组相比，ET 与 CDK4/6i 联合使用在无侵袭性疾病生存 (iDFS) 方面存在显着的有益趋势（HR = 0.81，95% CI： 0.67-0.98，p = 0.03）。值得注意的是，CDK4/6 抑制剂在 2 级（HR = 0.69，95% CI：0.59-0.81，p < 0.001）和 3 级（HR = 0.76，95% CI：0.65-0.89，p）中均表现出显着的有益效果。 <0.001）。使用 abemaciclib 和 ribociclib 治疗组的远处无复发生存期 (dRFS) 显着改善（HR = 0.65，95% CI：0.56-0.76，p < 0.001；HR = 0.72，95% CI：0.58- 0.89，p = 0.003，分别）。 CDK4/6i 在总生存期 (OS) 方面没有产生统计学上的显着差异（HR = 0.96，95% CI：0.77-1.19，p = 0.69）。与单独使用 ET 相比，CDK4/6i 与 ET 联合使用会增加不良事件的风险，特别是贫血和中性粒细胞减少症（OR = 9.12，95% CI = 5.04-16.48，p < 0.001）。 本文的研究结果与单独使用 ET 相比，当 ET 与 CDK4/6i 结合使用时，iDFS 显着改善。具体而言，使用 abemaciclib 和 ribociclib 进行治疗显示 dRFS 显着增强。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

This paper aimed to evaluate the effectiveness of incorporating CDK 4/6 inhibitors (CDK4/6i) into ET for the adjuvant treatment of HR + HER2-resected early-stage breast cancer (ESBC) patients, employing meta-analysis.In this paper, we compiled randomized clinical trials focusing on CDK4/6i used in the adjuvant treatment of high-risk invasive HR-positive and HER2-ESBC patients. A meta-analysis was performed in line with the PRISMA guidelines.We identified four clinical trials that met our inclusion criteria and were published between 2020 and 2024. These trials involved a combined sample size of 17,749 patients diagnosed with breast cancer. The data obtained from the pooled analysis revealed a remarkable beneficial trend in terms of invasive disease-free survival (iDFS) for the use of ET in combination with CDK4/6i compared to the group receiving ET alone (HR = 0.81, 95 % CI: 0.67-0.98, p = 0.03). Of note, CDK4/6 inhibitors demonstrated a notably beneficial effect in both grade 2 (HR = 0.69, 95 % CI: 0.59-0.81, p < 0.001) and grade 3 (HR = 0.76, 95 % CI: 0.65-0.89, p < 0.001). Significant improvements were noted in terms of distant relapse-free survival (dRFS) in the groups treated with abemaciclib and ribociclib (HR = 0.65, 95 % CI: 0.56-0.76, p < 0.001; HR = 0.72, 95 % CI: 0.58-0.89, p = 0.003, respectively). CDK4/6i didn't yield a statistically significant difference in overall survival (OS) (HR = 0.96, 95 % CI: 0.77-1.19, p = 0.69). The use of CDK4/6i with ET was associated with an increased risk of adverse events, particularly anemia and neutropenia, compared with ET alone (OR = 9.12, 95 % CI = 5.04-16.48, p < 0.001).The findings of this paper demonstrate a significant improvement in iDFS when ET is combined with CDK4/6i, compared to ET alone. Specifically, treatments with abemaciclib and ribociclib showed notable enhancements in dRFS.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.