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NEJM:纳武单抗联合易普利姆玛用于黑色素瘤脑转移

2018-08-23 zhangfan MedSci原创

研究认为纳武单抗联合易普利姆玛可改善黑色素瘤脑转移患者病情,具有显著的颅内疗效

黑色素瘤患者脑转移是导致患者神经残疾以及死亡的主要因素,先前的研究考察了纳武单抗联合易普利姆玛治疗多种黑色素转移癌的疗效。近日研究人员考察了纳武单抗联合易普利姆玛治疗黑色素瘤脑转移的效果。

本次研究为II期临床研究,黑色素瘤非辐射性脑转移患者参与,患者存在至少1个可测量病灶,直径0.5-3厘米,无神经症状。患者接受1mg/kg体重的纳武单抗联合3mg/kg体重的易普利姆玛,每3周1次,最多给药4次,随后接受每2周3mg/kg体重的纳武单抗维持治疗,直到病情进展或不可接受的不良事件。主要的终点是颅内临床效益,定义为至少6个月疾病稳定、完全响应或部分响应的患者的百分比。

94名患者参与研究,随访14.0个月。57%的患者达到终点事件,其中完全响应率26%,部分响应率为30%,6个月以上疾病稳定率为2%。55%的患者出现3或4级不良事件,其中7%的患者出现中枢神经系统不良事件。1名患者死于免疫相关的心肌炎。未发现新的不良事件。

研究认为纳武单抗联合易普利姆玛可改善黑色素瘤脑转移患者病情,具有显著的颅内疗效。

原始出处:

Hussein A. Tawbi et al. Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain. N Engl J Med.August 23 2018.

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    2019-07-18 sunylz
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    2018-08-25 Jackie Li

    学习

    0

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