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在激素受体阳性/HER2-/PIK3CA野生型先进乳腺癌中,VICTORIA-1试验Gedatolisib Plus Fulvestrant与或没有Palbociclib

Sara A Hurvitz¹, Rachel M Layman², Giuseppe Curigliano^3,4

¹Fred Hutchinson Cancer Center, University of Washington, Seattle, WA.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

|March 9, 2026

概括

加达托利西布与富尔韦斯特兰结合使用或不使用Palbociclib,显著改善了先进激素受体阳性,HER2阴性乳腺癌患者与PIK3CA野生型瘤的无进展生存率. 这种组合疗法提供了一个有前途的新治疗方案.

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:

激素受体阳性 (HR+),人体表皮生长因子受体2-阴性 (HER2-) 晚期乳腺癌仍然是一个重大的临床挑战.
在HR+乳腺癌中,PI3K/AKT/mTOR通路经常受到失调,这使其成为关键的治疗点.
格达托利西布是所有I类PI3K异型和mTORC1/mTORC2的强效抑制剂,旨在全面阻断PI3K/AKT/mTOR通路.

研究的目的:

评估基达托利西布治疗HR+,HER2-,PIK3CA野生型晚期乳腺癌患者的疗效.
为了比较吉达托利西布加富勒弗兰特 (双剂) 和吉达托利西布,帕尔博西克利布和富勒弗兰特 (三剂) 与富勒弗兰特单剂疗法的疗效.
评估无进展生存期 (PFS) 作为本III期随机试验的主要终点.

主要方法:

维多利亚-1试验 (NCT05501886) 是一项涉及392名患者的III期随机研究.
患者在CDK4/6抑制剂和芳酶抑制剂治疗期间或之后出现疾病进展.
治疗包括盖达托利西布三重剂,盖达托利西布双重剂或富勒弗兰特单疗法,PFS通过盲目的独立中央审查进行评估.

主要成果:

基达托利西布三重剂的中位数PFS为9.3个月,基达托利西布双重剂为7.4个月,相比之下,富勒弗兰特单疗法为2.0个月.
基达托利西布治疗显著降低了进展或死亡的风险 (HR 0.24 对于三倍,HR 0.33 对于双倍与富勒韦斯坦;P < .001).
3级以上与治疗相关的不良事件包括中性质减退 (62.3%在三重组中),口腔炎 (19.2%在三重组中) 和腹,由于TRAE的中止率较低 (2.3%三重组,3.1%双重组).

结论:

将盖达托利西布添加到富勒弗兰特,有或没有Palbociclib,可显著改善HR+/HER2-晚期乳腺癌和PIK3CA野生类型状态的患者的PFS.
基达托利西布治疗方案在这个患者群体中表现出显著的临床活性.
这些发现支持格达托利西布作为高级HR+/HER2-乳腺癌的有价值的治疗选择.

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