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新辅助剂阿贝马西克利布加莱特罗与莱特罗对比在HR+/HER2-高增殖性乳腺癌患者的化疗

Miguel Martín¹, Angel L Guerrero-Zotano², María E Pérez-López³

¹Department of Medical Oncology, Hospital General Universitario Gregorio Marañón Instituto de Investigacion Sanitaria Gregorio Marañon, CIBERONC, Universidad Complutense, Madrid. Madrid Spain.

Clinical cancer research : an official journal of the American Association for Cancer Research

|December 12, 2025

概括

卡拉贝拉试验发现,12个月的莱特醇加上abemaciclib与高风险HR+/HER2-乳腺癌的化疗不相似. 然而,它显示了较少增殖瘤的可比结果.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

新辅助化疗是高风险激素受体阳性,人体表皮生长因子受体2-阴性 (HR+/HER2-) 乳腺癌的标准.
评估新型治疗策略对于改善患者的治疗结果至关重要.

研究的目的:

评估12个月的莱特醇加上abemaciclib作为高风险HR+/HER2-乳腺癌标准化疗的替代方案.
为了比较莱特醇/阿贝马西克利布与化疗在实现残留癌症负担 (RCB) 0-I响应方面的疗效.

主要方法:

第二阶段,开放标签CARABELA试验随机对200名HR+/HER2-II-III阶段乳腺癌患者 (Ki-67 ≥20%) 进行12个月的莱特醇/阿贝马西克利布或6个月的化疗.
主要终点:RCB 0-I 利率. 二级终点:临床响应率 (CRR),Ki-67和复发率® (RS) 与瘤响应的相关性.
用于评估治疗相似性的贝叶斯设计.

主要成果:

在Letrozole/abemaciclib组中,RCB 0-I达到13%,而在化疗组中达到18%,没有显示相似性.
莱特醇/阿贝马西克利布的临床响应率为78%,化学疗法为71% (P=0.26).
在治疗组之间观察到较低扩散的瘤 (Ki-67 <30%或RS <26) 中,类似的RCB 0-I率.

结论:

莱特醇/阿贝马西克利布在实现高风险HR+/HER2-乳腺癌的RCB 0-I方面没有显示出与化疗相似的疗效.
在患有较少增殖瘤的患者中 (RS <26或Ki-67 <30%),莱特zole/abemaciclib显示出与化疗相似的结果.
莱特zole/abemaciclib可能是一个潜在的替代 (新) 辅助化疗在选择的患者,具有较少的攻击性瘤特征.

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