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Lancet Oncol:Ofatumumab维持治疗慢性淋巴细胞白血病效果

2015-09-14 崔倩 译 MedSci原创

Ofatumumab是人类抗CD20单克隆抗体,其已经被证明在单一治疗难治慢性淋巴细胞白血病方面有疗效。研究人员评估了对于慢性淋巴细胞白血病复发再诱导治疗后的患者,ofatumumab进行维持治疗 vs 观察的安全性和疗效性。在这个开放性,多中心,随机3期研究中,招募的患者年龄在18岁或以上,来自24个国家130中心,这些患者都患有慢性淋巴细胞性白血病并在曾在二线或三线治疗后完全或部分缓解。符合条

Ofatumumab是美国食品药品管理局(FDA)最新审批的新药全人源化靶向抗CD20单克隆抗体,其已被证明在单一治疗难治慢性淋巴细胞白血病方面有疗效。研究人员评估了对于慢性淋巴细胞白血病复发再诱导治疗后的患者,ofatumumab维持治疗 vs 观察的安全性和疗效性。

在这个开放性、多中心、随机3期研究中,招募的患者年龄在18岁或以上,来自24个国家的130个中心,这些患者都患有慢性淋巴细胞性白血病并曾在二线或三线治疗后完全或部分缓解。符合条件的患者WHO性能状态为0-2,在之前3个月内进行了反应评估,没有难治性疾病,自身免疫性溶血性贫血需要治疗,慢性或活动性感染需要治疗,也未在此前接受维持治疗或自体或异基因干细胞移植手术。研究人员使用由中央计算机系统和交互式语音识别系统产生的随机化列表,随机分配(1:1)患者接受ofatumumab(300mg,1周后1000mg,每8周一次长达2年)或经过观察。随机分组进行分层通过之前治疗的数量和方式以及诱导治疗后缓解状态进行分成(四块大小)。治疗分配是开放性的。主要终点是在意向治疗人群中研究者评估的无进展生存期。研究人员在计划研究事件(疾病进展或死亡)三分之二后报告一个预先设定的中期分析的结果后。

在2010年5月6日和2014年6月19日之间,研究人员招收了474例患者:238例患者随机分配接受ofatumumab维持治疗,236例接受观察。ofatumumab组的1例(<1%)患者没有接受分配的干预(同意撤销)。中位随访时间为19.1个月(IQR 10.3-28.8)。ofatumumab组患者的无进展生存期明显改善(29.4个月,95%Cl 26.2-34.2),与观察组相比(15.2个月,11.8-18.8;危险比0.50,95%Cl 0.38-0.66,P<0.000)。最后一次治疗后60天最常见的3级或以上不良事件为中性粒细胞减少(ofatumumab组56例患者[24%] vs 观察组23例患者[10%])和感染(31[13 %] vs 20[8%)]。ofatumumab组中的20例患者(8%)和观察组中的3例患者(1%)因不良事件导致治疗永久终止。截至最后一次治疗后60天,ofatumumab治疗组发生相关的不良事件死亡2例,观察组发生5例;无死亡病例归因于研究药物。

这些数据对于复发慢性淋巴细胞白血病患者最佳维护策略是重要的,特别是针对目前的靶向药物,其中有许多是直到病情发展才使用。

原始出处:

Marinus H J van Oers, Kazimierz Kuliczkowski, Lukáš Smolej,et al.Ofatumumab maintenance versus observation in relapsed chronic lymphocytic leukaemia (PROLONG),Lancet Oncology,2015.9.13

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    2016-08-18 snf701207
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    2016-08-07 minlingfeng
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    2016-07-08 howi
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