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在以前未经治疗的慢性淋巴细胞白血病患者中,伦布西尔加伦布西尔与单独的伦布西尔相比 (补充1):一个随机的,多中心的,开放的第三阶段试验

Peter Hillmen¹, Tadeusz Robak², Ann Janssens³

¹Department of Haematology, St James's University Hospital, Leeds, UK.

Lancet (London, England)

|April 18, 2015

概括

在老年慢性淋巴细胞白血病患者中,添加ofatumumab与ambucil显著改善了无进展生存率,这些患者不符合fludarabine的条件. 这种组合为这个具有挑战性的患者群体提供了可容忍和有效的治疗选择.

科学领域:

血液学血液学血液学
在瘤学瘤学.
临床试验临床试验

背景情况:

老年患者或患有慢性淋巴细胞白血病 (CLL) 相关疾病的患者因不耐受基于fludarabine的化学免疫疗法而面临治疗挑战.
ambucil是一种标准的治疗方法,但它的疗效可能是有限的.
对于不适合强化治疗的CLL患者,需要有效和耐受的治疗选择.

研究的目的:

为了评估添加ofatumumab与单独的ambucil相比,在未经治疗的CLL患者中添加ofatumumab的疗效和安全性.
为了确定这种组合治疗是否改善老年患者或患有并发症的患者的临床结果.

主要方法:

在16个国家的109个中心进行了一项随机的,开放的,第三阶段试验.
没有接受过治疗的不符合fludarabine资格的CLL患者被随机分配 (1:1) 接受口服伦布西尔或伦布西尔加上静脉注射ofatumumab3-12个周期.
主要终点是无进展生存期 (PFS),由独立的掩盖审查委员会评估.

主要成果:

这项研究招募了447名患者 (平均年龄为69岁).
与单独使用ambucil (13.1个月) 相比,ambucil加 ofatumumab组 (22.4个月) 的中位数PFS显著更长 (HR0.57,p<0.0001).
3级或更高的不良事件在组合治疗中更频繁 (50%与43%相比),主要是中性质减退;感染类似,输液相关事件发生在10%的患者中.

结论:

添加ofatumumab与ambucil显示,在未经治疗的老年或并发性疾病的CLL患者中,PFS的临床显著改善.
组合疗法呈现出可管理的副作用概况,使其成为无法耐受密集治疗的患者的有价值的治疗选择.

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