超越标准内分泌疗法:高风险早期乳腺癌的新辅助疗法

Barbara Dean, DMSc, PA-C, DFAAPA
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引用次数: 0

摘要

雌激素受体(ER)阳性、人类表皮生长因子受体 2(HER2)阴性早期乳腺癌(EBC)的标准辅助治疗方法是内分泌治疗(ET)。尽管采用了这种治疗方法,但仍有 20% 的患者病情会复发。细胞周期蛋白依赖性激酶4和6(CDK4/6)抑制剂与ET一起使用,对ER阳性、HER2阴性的转移性乳腺癌患者的总生存期(OS)有好处。临床试验正在研究口服 CDK4/6 抑制剂在ER 阳性、HER2 阴性 EBC 患者辅助治疗中的作用,这些患者在接受标准 ET 治疗的同时,在临床和病理上都有很高的复发风险。monarchE III 期随机对照试验的研究对象是接受标准 ET 治疗的 ER 阳性、HER2 阴性高风险 EBC 患者,以及接受标准 ET 和 CDK4/6 抑制剂 Abemaciclib 治疗的患者。主要终点数据显示,2年后,ET和abemaciclib治疗组的无侵袭性疾病生存率为92.2%,而ET治疗组为88.7%。5年后,一项预先计划的中期分析显示,无侵袭性疾病生存率继续得到绝对改善。OS的次要终点数据尚未成熟。Abemaciclib已被批准与ET一起用于ER阳性、HER2阴性的高危EBC患者。本文旨在回顾一个病例研究,以及将口服 CDK4/6 抑制剂作为这类高风险亚群患者辅助治疗的理由。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Beyond Standard Endocrine Therapy: A New Adjuvant Treatment in High-Risk Early Breast Cancer
The standard adjuvant treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) is endocrine therapy (ET). Despite this treatment, 20% of patients will have their disease recur. Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors with ET have shown overall survival (OS) benefit in ER-positive, HER2-negative breast cancer in the metastatic setting. Clinical trials are studying the role of oral CDK4/6 inhibitors in the adjuvant treatment of ER-positive, HER2-negative EBC patients who are clinically and pathologically at high risk for recurrence while on standard ET. The monarchE phase III, randomized, controlled trial, looked at one arm of high-risk ER-positive, HER2-negative EBC patients receiving standard ET and the second arm receiving standard ET with a CDK4/6 inhibitor, abemaciclib. Primary endpoint data showed improvement in invasive disease-free survival of 92.2% in the ET and abemaciclib arm vs. 88.7% in the ET arm at 2 years. At 5 years, a preplanned interim analysis showed continued absolute improvement in invasive disease-free survival. Secondary endpoint data for OS have not yet matured. Abemaciclib is approved for use with ET in patients with high-risk, ER-positive, HER2-negative EBC. This article aims to review a case study and the rationale for using oral CDK4/6 inhibitors as adjuvant treatment for this high-risk subset of patients.
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