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伊布鲁替尼与坦西洛斯在复发性或耐火性地幔细胞淋巴瘤患者中:国际随机开放的第三阶段研究

Martin Dreyling¹, Wojciech Jurczak², Mats Jerkeman³

¹Department of Medicine III, Klinikum der Universität München, Campus Grosshadern, Munich, Germany.

Lancet (London, England)

|December 18, 2015

概括

在患有复发性或耐药性地幔细胞淋巴瘤的患者中,易布鲁替尼显著改善了无进展的存活率,并且比泰米西洛利木斯更能耐受. 这项研究支持ibrutinib

科学领域:

血液学
癌症学
临床试验

背景情况:

膜细胞淋巴瘤 (MCL) 是一种具有不良预后的侵袭性B细胞恶性瘤.
在复发性或耐药性MCL中,ibrutinib和temsirolimus均表现出单剂活性.
进行了第三期研究,以比较ibrutinib与temsirolimus的疗效和安全性.

研究的目的:

在患有复发性或耐火性地幔细胞淋巴瘤的患者中,比较于temsirolimus,评估ibrutinib的疗效和安全性.
主要假设:与西洛相比,易布鲁替尼显著改善了无进展生存期 (PFS).

主要方法:

随机的,开放的,多中心的3期临床试验,涉及280名复发性/耐药性MCL的患者.
患者接受口服易布鲁替尼 (每日560毫克) 或静脉注射西洛 (剂量因周期而异).
主要终点:由蒙面独立审查委员会评估的无进展生存率.

主要成果:

易布鲁替尼在PFS的显著改善与temsirolimus相比 (PFS的中位数为14. 6个月与6. 2个月;p< 0. 0001).
易布鲁替尼的安全性较好,发生3级或更高的不良事件较少 (68% vs 87%).
相比于temsirolimus,由于不良事件而停止服用ibrutinib的患者较少 (6%对26%).

结论:

在复发性/ 耐药性MCL患者中,易布鲁替尼治疗导致显著的PFS改善和更好的耐受性.
这些发现支持ibrutinib在该患者群体中的益处风险比率.

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