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在复发性或耐火性地幔细胞淋巴瘤 (ACE-LY-004) 中的阿卡拉布鲁替尼:单臂,多中心,第二阶段试验

Michael Wang¹, Simon Rule², Pier Luigi Zinzani³

¹Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Lancet (London, England)

|December 16, 2017

概括

在复发性或耐火性地幔细胞淋巴瘤患者中,阿卡拉布鲁丁尼显示出高响应率和持久生存率. 这种布鲁顿氨酸激酶抑制剂具有良好的安全性,表明其在治疗这一患者群体中的潜力.

科学领域:

癌症学
血液学
药理学

背景情况:

布鲁顿氨酸激酶 (BTK) 是被验证的地幔细胞淋巴瘤 (MCL) 的治疗点.
阿卡拉布鲁丁尼 (ACP-196) 是一种选择性BTK抑制剂,旨在减少非标效应.

研究的目的:

评估acalabrutinib在复发性或耐药性MCL患者中的疗效和安全性.
评估该患者组的整体应答率 (ORR),无进展生存率 (PFS) 和整体生存率 (OS).

主要方法:

在一项开放的第二阶段研究中,口服acalabrutinib (100 mg每天两次) 给了124名复发性/ 耐药性MCL的患者.
治疗持续到疾病进展或不可接受的毒性,主要终点是根据卢加诺分类的ORR.

主要成果:

高ORR为81% (完全响应:40%) 在中位随访时间为15. 2个月时观察到.
反应的中位持续时间,PFS和OS没有达到;12个月率为72% (DOR),67% (PFS) 和87% (OS).
常见的不良反应包括头痛 (38%),腹 (31%),疲劳 (27%),肌痛 (21%);最常见的是≥3级中性质减退 (10%) 和贫血 (9%).

结论:

在复发性/ 耐药性MCL中,acalabrutinib表现出显著的疗效,具有持久的反应和可管理的安全性.
这些发现支持acalabrutinib作为复发性或耐药性MCL患者的有前途的治疗选择.

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