在PIK3CA突变高级乳腺癌中使用Inavolisib的整体存活率
Komal L Jhaveri1,2, Seock-Ah Im3, Cristina Saura4
1Breast and Early Drug Development Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York.
The New England journal of medicine
|June 2, 2025
概括
与palbociclib-fulvestrant相结合的inavolisib显著改善了PIK3CA突变乳腺癌患者的整体存活率. 与安慰剂相比,这种联合治疗显示出显著的生存益处,尽管副作用增加,如高血糖症和口腔炎.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 在INAVO120试验中,研究了inavolisib加Palbociclib-fulvestrant在PIK3CA突变,HR+,HER2-晚期或转移性乳腺癌患者中,这些患者先前在内分泌治疗中复发.
- 以前的研究结果显示,这种组合疗法对无进展的生存有好处.
研究的目的:
- 报告INAVO120第3期试验的最终整体生存 (OS) 分析.
- 为提供最新的Inavolisib加Palbociclib-fulvestrant的疗效和安全性数据.
主要方法:
- 随机,双盲,安慰剂对照试验,涉及325名患有PIK3CA突变,HR+,HER2-晚期或转移性乳腺癌的患者.
- 患者接受了纳沃利西布加上Palbociclib-fulvestrant或安慰剂加上Palbociclib-fulvestrant.
主要成果:
- 中位数的生存寿命是34.0个月的inavolisib与27.0个月的安慰剂 (HR=0.67,P=0.02),表明显著的生存益处.
- 对象反应率为inavolisib的62.7%和安慰剂的28.0% (P<0.001).
- 观察到高血糖,口炎,胃肠道和眼部毒性的较高发病率与inavolisib.
结论:
- 伊纳沃利西布加上palbociclib-fulvestrant显著改善了PIK3CA突变的晚期或转移性乳腺癌患者的整体存活率.
- 观察到的生存益处必须与增加特定不良事件的风险进行权衡,包括高血糖和口腔炎.
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