在不同剂量模式的nivolumab疗程之间评估安全结果
Joseph Elijah1, Igor Puzanov2, Benjamin Cresanti3
1School of Pharmacy and Pharmaceutical Sciences, Northeastern University, Boston, MA, USA.
概括
240mg Q2W 尼沃卢马布疗法增加了结肠炎风险,而480mg Q4W 增加了炎风险. 总体而言,与免疫疗法相关的不良反应 (irAEs) 类似,但与240mg Q2W疗法相比,显著的irAEs更高.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 药物监督 药物监督 药物监督
背景情况:
- 之前的研究表明,不同的尼沃卢马布剂量方案具有相似的安全性.
- 之前研究的局限性包括狭窄的患者群体,小样本大小和不足的统计能力.
- 这项研究旨在在各种固体瘤类型中比较不同的nivolumab剂量表的现实安全结果.
研究的目的:
- 评估和比较每两周 (Q2W) 和每四周 (Q4W) 服用尼沃卢马布之间的免疫治疗相关不良反应 (irAEs) 的发生率.
- 为了评估特定的IRAE,显著的IRAE和治疗中断率在nivolumab剂量方案之间的差异.
- 在各种固体瘤患者中提供不同尼沃卢马布剂量策略的安全性概况的真实数据.
主要方法:
- 一个单一中心的回顾性队列研究包括了患有固体瘤的成年患者,接受了240mg Q2W,480mg Q4W的nivolumab,或在这些剂量之间进行过渡.
- 数据是在2018年3月至2022年3月期间使用电子健康记录收集的.
- 主要终点是irAEs的发生率,次要终点包括显著的irAEs和中止原因,使用单变量和多变量方法进行分析.
主要成果:
- 240mg Q2W 尼沃卢马布治疗方案与大肠炎发病率显著增加有关.
- 480mg Q4W 尼沃卢马布治疗方案显示,炎发病率显著增加.
- 在队列之间没有观察到irAE发生率的总体差异,但在240mg Q2W和过渡队列中,显著的irAE更频繁.
结论:
- 不同的nivolumab剂量表 (240mg Q2W与480mg Q4W) 与不同的irAE配置文件有关.
- 临床医生在选择尼沃卢马布剂量方案时应了解这些特定的irAE风险.
- 这些发现突显了基于规定的尼沃卢马布剂量表的个性化患者监测的重要性.
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