在复发性或耐火性地幔细胞淋巴瘤 (SYMPATICO) 中Ibrutinib加venetoclax:一个多中心的,随机的,双盲的,安慰剂控制的,第三阶段研究
Michael Wang1, Wojciech Jurczak2, Marek Trneny3
1Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
结合易布鲁替尼和威尼托克拉克斯可显著改善了复发性或耐火性地幔细胞淋巴瘤 (MCL) 患者的无进展生存率. 这种治疗表明了积极的益处风险概况,为MCL患者提供了新的治疗选择.
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:
- 膜细胞淋巴瘤 (MCL) 是一种罕见的非霍奇金淋巴瘤.
- 复发或耐药的MCL会带来重大治疗挑战.
- 易布鲁替尼和维尼托克拉克斯是具有不同的机制的向疗法.
研究的目的:
- 评估ibrutinib-venetoclax联合治疗的疗效和安全性.
- 在复发性/耐药性MCL中比较ibrutinib-venetoclax与ibrutinib-placebo.
- 评估无进展生存期 (PFS) 作为主要终点.
主要方法:
- 第三阶段,多中心,随机,双盲,安慰剂控制的SYMPATICO试验.
- 267名患有复发性/耐药性MCL的患者随机分配给ibrutinib-venetoclax或ibrutinib-安慰剂.
- 主要终点:由研究人员评估的PFS. 在所有接受治疗的患者中评估了安全性.
主要成果:
- 艾布鲁替尼-维内托克拉克斯治疗中位数PFS为31.9个月,而艾布鲁替尼-安慰剂治疗中为22.1个月 (HR 0.65,p=0.0052).
- 常见的3-4级不良事件包括中性质衰竭和血小板衰竭.
- 两组患者中有60%发生严重不良事件;与治疗相关的死亡很少 (2%).
结论:
- 易布鲁替尼-维内托克拉克斯显著改善了复发性/耐药性MCL的PFS.
- 安全性概况与已知的个体药物毒性相一致.
- 这种组合证明了MCL治疗的有利益处风险概况.
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