对于患有复发性或耐火性固体瘤的儿童,阿特佐利祖马布与化疗相结合的可行性
Matthew E Campbell1, Sonja Stutzman1, Sharon Primeaux1
1Division of Hematology/Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Pediatric blood & cancer
|September 12, 2025
概括
维塔斯试验发现,将阿特佐利祖马布 (免疫检查点抑制剂) 与化疗相结合是可行的,并且在患有复发或耐药固体瘤的儿童中耐受好. 这种组合治疗显示出有希望的结果,没有观察到剂量限制性毒性.
科学领域:
- 儿科瘤学 儿科瘤学
- 免疫治疗是一种免疫疗法.
- 固体瘤是一种固体瘤.
背景情况:
- 免疫检查点抑制剂 (ICI) 与化疗相结合可能会增强儿科固体瘤的治疗反应.
- 在VITAS研究中,研究了在患有复发或耐药固体瘤的儿童中,将阿特佐利祖马布与化疗结合使用的可行性.
研究的目的:
- 确定在患有复发性或耐火性固体瘤的儿科患者中,将阿特佐利祖马布与温克里斯,伊利诺特坎和特莫佐洛米德结合使用的可行性和安全性.
- 评估剂量限制性毒性 (DLT) 作为VITAS试验初始阶段的主要终点.
主要方法:
- 一个I期临床试验 (NCT04796012) 招募了患有复发/耐药固体瘤的儿科患者 (≥6个月至≤18岁),这些患者以前没有接受过ICI.
- 患者在21天的循环中接受了阿特佐利祖马布,温克里斯,伊利诺特坎和泰莫索洛米德.
- 主要终点是前两个周期内DLT的发生率.
主要成果:
- 六名患有狂肌肉瘤,骨肉瘤或尤文肉瘤的儿科患者可以评估毒性.
- 没有患者出现剂量限制性毒性;一名患者患有2级免疫相关大肠炎.
- 四名患者经历了3级以上的不良事件,包括中性质衰竭和发烧性中性质衰竭. 一名患者实现了部分反应,另一个患者病情稳定.
结论:
- 与温克里斯, irinotcan 和 temozolomide 结合使用的阿特佐利祖马布在患有复发性或耐火性固体瘤的儿科患者中是可行的,并且耐受性良好.
- 这项研究支持进一步调查这种治疗方案的疗效,目前II期队列正在评估其在拉布地米索瘤的疗效.
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