新型抗癌药物的剂量选择:揭示所选剂量与所需剂量之间的差距
Catharina J P Op 't Hoog1, Niven Mehra2, Marc Maliepaard3
1Department of Pharmacy, Radboud University Medical Center, Nijmegen, Netherlands.
The Lancet. Oncology
|August 1, 2024
概括
传统的抗癌药物剂量选择可能会导致可避免的毒性. 为最近批准的癌症疗法优化剂量和疗法可以提高患者的安全性和方便性.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验设计 临床试验设计
背景情况:
- 传统的抗癌药物剂量选择依赖于3+3期1试验的最大耐受剂量 (MTD).
- 这种MTD方法可能不会产生针对性和免疫调节剂的最佳剂量,从而导致潜在的毒性和患者不便.
研究的目的:
- 评估监管机构批准的抗癌药物的剂量选择的理由和验证.
- 确定剂量优化的机会,以提高患者的安全性和方便性.
主要方法:
- 2020年1月1日至2023年6月30日期间,欧洲药物管理局 (EMA) 和美国食品和药物管理局 (FDA) 批准的抗癌药物的审查.
- 分析剂量选择的理由和确定剂量优化候选者的分析.
主要成果:
- 在最近批准的31种抗癌药物中,20种 (65%) 被确定为剂量优化的潜在候选药物.
- 剂量优化可能包括降低剂量 (10种药物,32%) 或调整剂量方案 (10种药物,32%).
- 对9种药物 (29%) 进行剂量选择是充分合理的;对2种药物 (6%) 的数据是不确定的.
结论:
- 最近批准的抗癌药物的很大一部分可能会从剂量优化中受益.
- 建议实施改进的剂量选择策略,包括早期使用生物标志物和适应性试验设计.
- 优化抗癌药物剂量和治疗方案可以提高安全性和患者的便利性.
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