在患有复发性/逆转性多发性骨髓瘤的患者中,梅尔夫卢芬治疗的结果
Shahrier Hossain1, Clifton Mo2, Sarah Patches3
1Department of Pharmacy, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
European journal of haematology
|February 23, 2025
概括
梅尔法兰胺 (melflufen) 加上德克萨米他在现实环境中显示出临床上有意义的疗效和可管理的毒性,在重度预先治疗的复发性/耐药性多发性髓瘤 (RRMM) 患者中. 这证实了临床试验的发现.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 梅尔法兰胺 (melflufen) 与德甲结合在欧洲被批准用于复发性/耐药性多发性骨髓瘤 (RRMM) 患者,这些患者已经接受过至少三个先前的治疗线.
- 在临床试验之外,现实世界的数据对于了解不同患者群体的治疗有效性和安全性至关重要.
研究的目的:
- 评估melphalan flufenamide加dexamethasone在现实世界的一组重量预治疗RRMM患者的疗效和安全性.
- 在实际的临床环境中评估治疗结果和不良事件.
主要方法:
- 在美国达纳-法伯癌症研究所对12名重度预治疗的RRMM患者进行了回顾性分析.
- 检查了基线特征,疗效终点 (总体反应率,反应类型) 和安全结果 (不良事件,中止原因).
- 患者接受了前期治疗线的中位数为5.5,其中一些患者患有外骨髓性疾病,高风险细胞遗传学或之前的自身干细胞移植.
主要成果:
- 总体响应率 (ORR) 为55%,包括完全响应 (27%) 和部分响应 (18%).
- 在42%的患者中观察到稳定的疾病.
- 副作用主要是血液学和可控的;感染发生在两个患者 (2级). 停止使用梅尔夫因疾病进展 (42%),市场退出 (33%),不良事件 (17%) 和无关的突然死亡 (8%) 而导致.
结论:
- 在RRMM患者的现实环境中,梅尔法兰胺和德克萨米他在临床上显示出有意义的疗效.
- 观察到的安全性概况与临床试验数据一致,显示可控毒性.
- 这些发现支持melflufen在常规临床实践中对重度预先治疗的RRMM患者的有用性.
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