选择性晚期肉瘤中的gemcitabine加selinexor:西班牙肉瘤研究小组的第一阶段研究
Javier Martin-Broto1,2,3, Antonio Casado4, Gloria Marquina4
1Medical Oncology Department, Fundación Jimenez Diaz University Hospital, Madrid, Spain. jmartin@atbsarc.org.
Nature communications
|January 20, 2026
概括
这一第一阶段研究发现,将吉姆西塔与塞利尼克索结合使用是一种耐受性治疗晚期肉瘤的方法,为进一步的试验制定了推剂量.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 输出素-1 (XPO-1) 与固体瘤耐药性和预后不佳有关.
- 作为XPO-1抑制剂的Selinexor在瘤中表现出临床前和临床疗效.
研究的目的:
- 为了确定在晚期的肉瘤中组合gemcitabine和selinexor的推第二阶段剂量 (RP2D).
- 评估与这种联合治疗相关的安全性,疗效和生活质量.
主要方法:
- 一个I阶段,经典的3+3剂量升级研究.
- 晚期瘤的成年患者在21天的周期中每周接受吉米西塔和塞林克索.
- 招募了17名患者,以评估剂量限制性毒性并确定RP2D.
主要成果:
- 由于耐受性更好,推的第二阶段剂量 (RP2D) 确定在+2剂量级:凝胺 (1200 mg/m2) 和每周单素 (60 mg).
- 最常见的不良事件是中性质衰竭 (82.4%) 和血小板衰竭 (76.5%).
- 总体应答率 (ORR) 为31.25%,平均总生存期 (mOS) 为39.5个月.
结论:
- 结合吉姆西塔和塞利尼克索尔是一种耐受且可能有效的治疗先进的肉瘤.
- 目前正在进行第二阶段试验,以进一步研究这种组合在特定的肉瘤亚型中,如乳腺髓肉瘤和MPNST.
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