延长nivolumab的剂量间隔:在未经选择的癌症患者中进行基于模型的模拟
Alicja Puszkiel1,2, Guillaume Bianconi3, Blaise Pasquiers4,5
1Université Paris Cité, Faculté de Pharmacie de Paris, INSERM UMR-S1144, Paris, France. alicja.puszkiel@aphp.fr.
British journal of cancer
|March 27, 2024
概括
延长尼沃卢马布剂量间隔保持有效性,同时可能改善患者的生活质量并降低成本. 模拟表明Q6W或Q8W方案可能是标准Q2W或Q4W计划的可行替代方案.
科学领域:
- 药理动力学 药理动力学
- 在瘤学瘤学.
- 药物经济学 药物经济学
背景情况:
- 降低nivolumab剂量强度可能会提高患者的生活质量并降低财务负担.
- 在改变剂量策略时,保持治疗疗效至关重要.
研究的目的:
- 在转移性癌症患者中开发nivolumab的人口药理动力学 (PK) 模型.
- 模拟延长间隔的尼沃卢马布疗法,以保持最小有效血度 (MEPC).
主要方法:
- 使用Monolix软件开发了一种具有线性淘汰的双隔间PK模型.
- 分析了来自364名患者的992个尼沃卢马布度.
- 在90%以上的患者中,模拟延长间隔的治疗方案以保持稳定状态最低度 (Cmin,ss) 超过MEPC (1.5或2.5 mg/L).
主要成果:
- 将剂量间隔延长到Q6W (从Q2W) 和Q8W (从Q4W) 在>95%的患者中保持Cmin,ss高于2.5 mg/L.
- 在>91%的患者中,Q8W和Q10W的剂量间隔保持了Cmin,ss高于1.5 mg/L.
- 与标准的240毫克Q2W疗法相比,240毫克Q6W疗法可以将年度治疗费用降低三倍.
结论:
- 延长间隔的尼沃卢马布疗法显示出维持治疗度的潜力.
- 需要进行进一步的临床试验,以确认这些扩展方案与标准剂量相比没有劣势.
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