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CDK4/6 抑制剂在乳腺癌中的安全性特征和临床影响概述——随机 II 期和 III 期临床试验的系统评价。

An Overview of the Safety Profile and Clinical Impact of CDK4/6 Inhibitors in Breast Cancer-A Systematic Review of Randomized Phase II and III Clinical Trials.

机构信息

Department of Oncology, "Carol Davila" University of Medicine and Pharmacy, 020021 Bucharest, Romania.

Department of Medical Oncology, Elias University Emergency Hospital, 011461 Bucharest, Romania.

出版信息

Biomolecules. 2023 Sep 20;13(9):1422. doi: 10.3390/biom13091422.

DOI:10.3390/biom13091422
PMID:37759823
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10526227/
Abstract

Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6is) have transformed the treatment of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer over the last decade. These inhibitors are currently established as first- and second-line systemic treatment choices for both endocrine-sensitive and -resistant breast cancer populations alongside endocrine therapy (ET) or monotherapy. Data on targeted therapy continue to mature, and the number of publications has been constantly rising. Although these drugs have been demonstrated to prolong overall survival (as well as progression-free survival (PFS) in breast cancer patients), changing the paradigm of all current knowledge, they also cause important adverse events (AEs). This review provides the latest summary and update on the safety profile of the three CDK4/6 inhibitors, as it appears from all major phase II and III randomized clinical trials regarding palbociclib, ribociclib, and abemaciclib, including the most relevant 15 clinical trials.

摘要

在过去的十年中,细胞周期蛋白依赖性激酶 4 和 6 抑制剂(CDK4/6is)改变了激素受体阳性(HR+)和人表皮生长因子受体 2 阴性(HER2-)乳腺癌的治疗方法。这些抑制剂目前被确立为内分泌敏感和抵抗的乳腺癌人群的一线和二线全身治疗选择,联合内分泌治疗(ET)或单药治疗。靶向治疗的数据继续成熟,出版物的数量也在不断增加。尽管这些药物已被证明可延长乳腺癌患者的总生存期(以及无进展生存期(PFS)),改变了所有现有知识的范式,但它们也会引起重要的不良反应(AEs)。这篇综述提供了关于三种 CDK4/6 抑制剂安全性概况的最新总结和更新,这是从所有主要的 II 期和 III 期随机临床试验中得出的,涉及 palbociclib、ribociclib 和 abemaciclib,包括 15 项最相关的临床试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/c58ae66fd226/biomolecules-13-01422-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/68ae7856e590/biomolecules-13-01422-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/2205cbbd83bf/biomolecules-13-01422-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/4403e45fe107/biomolecules-13-01422-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/c58ae66fd226/biomolecules-13-01422-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/68ae7856e590/biomolecules-13-01422-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/2205cbbd83bf/biomolecules-13-01422-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/4403e45fe107/biomolecules-13-01422-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5348/10526227/c58ae66fd226/biomolecules-13-01422-g004.jpg

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3
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