一个第一阶段试验的纳布-帕克利塔塞尔结合吉姆西塔对于复发/耐火的儿科固体瘤
Jonathan Metts1,2, Kevin Ginn3, Zhulin He4
1Cancer and Blood Disorders Institute, Johns Hopkins All Children's Hospital, St Petersburg, Florida, USA.
Pediatric blood & cancer
|October 15, 2025
概括
在儿科固体瘤中,nab-paclitaxel和gemcitabine的推第二期剂量分别为240 mg/m2和675 mg/m2. 这种组合在复发或耐药病例中显示出有限的反应.
科学领域:
- 儿科瘤学 儿科瘤学
- 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:
- 纳布-帕克利塔塞尔的儿科最大耐受剂量 (MTD) 超过成人水平.
- 在儿科固体瘤中,对纳布-帕克利塔塞尔与吉姆奇塔宾的确定的MTD/RP2D至关重要.
研究的目的:
- 在儿科患者中确定nab-paclitaxel与gemcitabine结合的MTD/RP2D.
- 评估这种组合治疗的安全性,药理动力学和反应率.
主要方法:
- 第I阶段试验采用滚动六个设计,纳布-帕克利塔塞尔和固定的吉姆西塔的剂量不断升级.
- 纳布-帕克利塔塞尔剂量评估为180,210和240毫克/平方米.
- 评估了毒性,药理动力学和放射性反应;瘤组织分析了SPARC和CAV-1.
主要成果:
- 在剂量修改后,MTD被确定为nab-paclitaxel 240 mg/m2与gemcitabine 675 mg/m2.
- 频繁出现≥3级的血液毒性;观察到两个部分反应 (威尔姆斯瘤,骨肉瘤).
- 纳布-帕克利塔塞尔的药理动力学是线性的;SPARC在大多数瘤中存在,CAV-1很少出现.
结论:
- 在复发/耐药儿科固体瘤中,nab-paclitaxel和gemcitabine的MTD/RP2D分别为240 mg/m2和675 mg/m2.
- 在这个具有挑战性的患者群体中,观察到的反应有限.
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