布伦图西马布维多丁组合治疗复发性扩散性大B细胞淋巴瘤
Nancy L Bartlett1, Uwe Hahn2, Won-Seog Kim3
1Division of Oncology, Washington University School of Medicine, Siteman Cancer Center, St Louis, MO.
概括
布伦图西马布维多丁加上莱纳利多米德和瑞图西马布显著改善了复发或耐药的扩散大B细胞淋巴瘤患者的整体存活率. 这种组合疗法在重度预治疗的个体中显示出可管理的安全性.
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:
- 复发性或耐火性扩散性大B细胞淋巴瘤 (DLBCL) 呈现出显著的未满足需求.
- 布伦图西马布维多丁 (BV) 已在R/R DLBCL的单疗法或组合疗法中显示出先前的疗效.
研究的目的:
- 为了评估布伦图西马布维多丁 (BV) 与莱纳利多米德 (Len) 和利图西马布 (R) 结合的疗效和安全性,与安慰剂加Len和R相比,在R/RDLBCL患者中.
主要方法:
- 一项随机,双盲,安慰剂对照的第三期试验 (ECHELON-3) 招募了230名R/R DLBCL患者.
- 患者接受了BV + Len + R或安慰剂 + Len + R.
- 主要终点是整体生存 (OS);次要终点包括无进展生存 (PFS) 和客观反应率 (ORR).
主要成果:
- 在BV + Len + R (13.8个月) 与安慰剂 + Len + R (8.5个月) (HR,0.63;P = .009) 中,中位数的生存时间显着更长.
- 中位数的PFS (4.2与2.6个月;HR,0.53;P<.001) 和ORR (64%与42%;P<.001) 也得到了显著的改善.
- 完整应答率为BV + Len + R的40%和安慰剂 + Len + R的19%.
结论:
- 布伦图西马布维多丁 (Brentuximab vedotin) 加上莱纳利多米德 (lenalidomide) 和瑞图西马布 (rituximab) 在重度预治疗的R/RDLBCL患者中显示出具有统计学意义的生存益处.
- 组合疗法表现出可管理的安全性概况,在两只手臂中治疗出现的不良事件的发生率相似.
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