Clin Cancer Res：首次人源性I期研究评估了PI3K/mTOR抑制剂GDC-0084在胶质瘤患者中的应用

2021-04-13 MedSci原创 MedSci原创

胶质母细胞瘤是最常见的原发性脑肿瘤，PI3K/AKT/mTOR通路的激活与胶质母细胞瘤的发生密切相关。GDC-0084是一种口服、脑穿透性的PI3K和mTOR小分子抑制剂。近日，研究人员在复发性高等级

胶质母细胞瘤是最常见的原发性脑肿瘤，PI3K/AKT/mTOR通路的激活与胶质母细胞瘤的发生密切相关。GDC-0084是一种口服、脑穿透性的PI3K和mTOR小分子抑制剂。近日，研究人员在复发性高等级胶质瘤患者中进行了一项首次人源性I期研究，以评估GDC-0084治疗的安全性和耐受性，并确定GDC-0084的剂量限制性毒性（DLT）特征，研究结果已发表于Clin Cancer Res。

研究共纳入了8个队列的47名预处理的患者（2-65毫克）。剂量限制性毒性包括1例2级心动过缓和3级心肌缺血(15mg)、3级口腔炎(45mg)和2例3级黏膜炎症(65mg)；MTD为45mg/天。GDC-0084表现出线性和剂量比的PK，半衰期(19小时)支持每日一次的剂量。

在45mg/天时，GDC-0084的稳态浓度超过临床前的目标浓度，在异种移植模型中产生抗肿瘤活性。26%的患者（7/27）FDG-PET显示代谢部分反应。在剂量≥45mg/天时，正常脑的中位标准化摄取值有下降趋势，提示药物渗透至中枢神经系统。在两份切除标本中，GDC-0084在肿瘤和脑组织中检测到相似的水平，脑组织/肿瘤与血浆的总游离药物比值分别>1和>0.5。最佳总体反应是19例患者病情稳定（40%），26例患者病情进展（55%）；2例患者（4%）无评价。

综上所述，该研究结果表明，GDC-0084表现出典型的PI3K/mTOR抑制剂相关毒性。来自脑肿瘤组织的FDG-PET和浓度数据表明，GDC-0084通过了血脑屏障。

原始出处：

Patrick Y Wen, et al., First-in-Human Phase I Study to Evaluate the Brain-Penetrant PI3K/mTOR Inhibitor GDC-0084 in Patients with Progressive or Recurrent High-Grade Glioma. Clin Cancer Res. 2020 Apr 15;26(8):1820-1828. doi: 10.1158/1078-0432.CCR-19-2808.

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2021-12-09 jklm09

#抑制剂#

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2021-04-22 科研科研科研

胶质瘤患者

73 0
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2021-04-15 ms1292405679162969

#PI3K#

43 0
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2021-04-15 yankaienglish

#mTOR抑制剂#

48 0
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2021-04-13 ms2000000808572741

受益匪浅

69 0
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2021-04-13 梅干儿

三人行，必有我师。 #梅斯医学科研互助群# 欢迎您的加入，添加【梅斯医学科研助手WeChat：medsci_2021】邀您进群！【社群简介】👉 梅斯医学目前已建立覆盖肿瘤、心血管、神经、消化、内分泌、呼吸等30个科室的学习交流社群。【入群福利】👉 群内可实时交流病例，提问同行，跨群讨论，每天更新前沿医学资讯和指南共识，每周推出至少1场专业直播，不时共享科研干货，入群即可获得100份SCI写作攻略！

56 0
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2021-04-13 梅干儿

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