JAMA Oncol:Vistusertib联合阿那曲唑治疗激素受体阳性子宫内膜癌

2022-05-16 Nebula MedSci原创

阿纳曲唑加用mTOR抑制剂Vistusertib可改善激素受体阳性复发性/转移性子宫内膜癌患者预后

子宫内膜癌通常是激素依赖性的,可采用芳香酶抑制剂治疗。既往研究在子宫内膜癌中观察到PI3K-AKT-mTOR通路失调驱动激素抵抗,提示可将mTOR抑制剂与内分泌治疗联合使用。

本研究(VICTORIA)旨在评估mTOR抑制剂Vistusertib联合阿那曲唑治疗激素受体阳性复发性或转移性子宫内膜癌的安全性和有效性。

这是一项多中心、开放标签、随机化的临床试验,于2016年4月-2019年10月期间招募了75位激素受体阳性的复发性/转移性子宫内膜癌患者,随机2:1分成两组,予以Vistusertib(125mg*2次/天,2天/周)和阿那曲唑(1mg/天,口服)或单服用阿那曲唑。主要终点是严重不良反应事件和第8周时的无进展率(8wk-PFR)。次要终点是客观缓解率、缓解持续时间、无进展生存期(PFS)、总生存率和不良事件发生率。


两组的无进展生存率

在入组的75位患者中,73位(中位年龄 69.5岁)接受了研究治疗:联合组49位,阿纳曲唑组24位。联合组和阿纳曲唑组的第8周无进展率分别是67.3%和39.1%。未观察到显著的严重不良反应事件。联合组和阿纳曲唑组的总反应率分别是24.5%和17.4%。中位随访了27.7个月时,联合组和阿纳曲唑组的中位无进展生存期分别是5.2个月和1.9个月


两组的不良反应发生情况

与Vistusertib相关的最常见的不良反应(≥2级)有疲劳、淋巴细胞减少、高血糖和腹泻。

总而言之,该研究结果显示,阿纳曲唑加用mTOR抑制剂Vistusertib可提高激素受体阳性复发性/转移性子宫内膜癌患者的无进展率、缓解率,延长无进展生存期,且不良反应可控。

 

原始出处:

Heudel P, Frenel J, Dalban C, et al. Safety and Efficacy of the mTOR Inhibitor, Vistusertib, Combined With Anastrozole in Patients With Hormone Receptor Positive Recurrent or Metastatic Endometrial Cancer: The VICTORIA Multicenter, Open-label, Phase 1/2 Randomized Clinical Trial. JAMA Oncol. Published online May 12, 2022. doi:10.1001/jamaoncol.2022.1047.

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    2022-09-16 minlingfeng
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    2022-05-15 肿瘤克星

    JAMA上文章都是顶级的,谢谢梅斯及时上新

    0

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