连续的PEGasparaginase剂量减少了儿科的过敏反应ALL:荷兰儿童瘤学小组ALL11随机试验
Inge M van der Sluis1,2, Leiah J Brigitha1,3, Marta Fiocco1,4,5
1Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands.
概括
连续服用佩加斯帕加斯 (PEGasp) 的剂量计划显著降低了ALL儿科患者的过敏反应和抗体形成. 这种方法没有增加毒性或影响治疗疗效,提供了更安全的替代方案.
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.
- 免疫学 免疫学 免疫学
背景情况:
- 阿斯巴拉基纳斯治疗对于治疗急性淋巴细胞白血病 (ALL) 是至关重要的.
- 过敏反应和对佩加斯帕加斯 (PEGasp) 的抗体形成可能会限制其有效性和安全性.
- 标准的非连续剂量计划可能会导致这些不良事件.
研究的目的:
- 为了比较儿科ALL患者在连续和非连续剂量方案之间对PEGasp的过敏反应的发生率.
- 评估剂量计划对抗体形成,阿斯巴拉基纳酶活性和其他毒性的影响.
- 评估剂量计划对治疗结果的影响,包括复发和生存率.
主要方法:
- 一项随机研究,涉及818名儿科患者 (年龄1-18岁) 用PEGasp治疗ALL.
- 312名中等风险组的患者随机分配,每两周接受14剂个性化PEGasp剂量,以连续或非连续的时间表.
- 过敏反应被定义为过敏,过敏类反应和无声无效;二级终点包括毒性,活性,抗体和结果.
主要成果:
- 与非连续方案相比,连续 PEGasp 剂量导致过敏反应 (2.6% vs 10.8%) 和失活反应 (1.3% vs 8.3%) 显著减少.
- 连续剂量手臂的抗体水平明显较低 (P < .01).
- 两组之间没有观察到与阿斯巴拉金酶相关的毒性或5年生存结果的重大差异.
结论:
- 连续使用PEGasp的剂量计划可以有效地防止抗体的形成,并在儿科ALL中禁用过敏反应.
- 这种表格是安全的,因为它不会增加毒性.
- 持续使用PEGasp剂量维持了治疗疗效,对生存率没有负面影响.
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