梅尔夫卢芬在复发性/耐火性多发性骨髓瘤中耐火于先前的化剂:来自OCEAN研究的亚组分析
Fredrik H Schjesvold1,2, Heinz Ludwig3, Maria-Victoria Mateos4
1Oslo Myeloma Center, Department of Hematology, Oslo University Hospital, Oslo, Norway.
European journal of haematology
|November 16, 2023
概括
梅尔法兰 (Melphalan) 胺酸加上德克萨米他松 (dexamethasone) 在以前用基剂治疗的复发性/耐药性多发性骨髓瘤患者中显示出相似的无进展生存期 (PFS) 和整体生存期 (OS) 与波马利多米德. 在精选的抗基剂耐药患者中,梅尔弗鲁芬证明改善了PFS和OS.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 复发性/耐药性多发性骨髓瘤 (RRMM) 带来了治疗挑战,特别是在以前接触过化剂的患者中.
- 梅尔法兰胺 (melflufen) 是一种新的化-药物联合体,正在研究其在这种患者群体中的有效性.
- 海洋研究之前在RRMM中比较了梅尔弗卢芬加德克萨米与波马利多米德加德克萨米.
研究的目的:
- 为了对OCEAN研究进行后期的探索性分析.
- 为了评估梅尔弗卢芬加德克萨米与波马利多米德加德克萨米的疗效和安全性,在RRMM患者中,这些患者在先前的基剂治疗中是耐药的.
- 评估先前的自身干细胞移植 (ASCT) 和进展时间 (TTP) 对这一子组结果的影响.
主要方法:
- 分析了来自OCEAN研究的数据,重点是对先前基剂 (cyclophosphamide,melphalan) 耐药的患者.
- 在melflufen和pomalidomide手臂之间的无进展生存 (PFS) 和整体生存 (OS) 的比较.
- 在ASCT后或没有先前的ASCT后基于TTP的子组分析.
主要成果:
- 在153名基剂耐药患者中,梅尔弗卢芬和波马利多米德手臂的PFS和OS中位数相似 (PFS:5.6与4.7个月;OS:23.4与20.0个月).
- 在ASCT后≥36个月或没有先前ASCT的TTP的基剂耐药患者中,梅尔弗鲁芬与波马利多米德相比,显示了更长的中位数PFS和OS.
- 梅尔芬的安全性概况与之前的报告一致,表明可容忍性.
结论:
- 梅尔法兰胺在患有抗基剂多发性髓瘤的患者中是安全有效的.
- 与其他化剂相比,梅尔夫卢芬在特定患者亚组中可能表现出差异化的活性.
- 这些发现支持对先前暴露于基剂和特异性TTP特征的患者进行进一步的梅尔芬研究.
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