NEJM:Avelumab加阿西替尼与舒尼替尼治疗晚期肾细胞癌的疗效比较

2019-03-21 xing.T 网络

由此可见,在接受这些药物作为晚期肾细胞癌的一线治疗的患者中,使用Avelumab加阿西替尼的无进展生存期明显长于舒尼替尼。

在单组1b期试验中,Avelumab加阿西替尼可使晚期肾细胞癌患者客观反应。这项涉及先前未治疗的晚期肾细胞癌患者的3期试验比较了Avelumab加阿西替尼与标准舒尼替尼治疗的疗效。

近日,顶级医学期刊NEJM上发表了一篇研究文章,研究人员以1:1的比例随机分配患者,每2周静脉注射Avelumab(每公斤体重10 mg),每天口服两次阿西替尼(5 mg)或每日一次口服舒尼替尼(50 mg),持续4周(6周一个周期)。两个独立的主要终点是程序性死亡配体1(PD-L1)阳性肿瘤患者的无进展生存期和总生存期。一个关键的次要终点是总体人群的无进展生存期; 其他终点包括客观反应和安全性。

该研究共有886名患者被分配接受Avelumab加阿西替尼(442名患者)或舒尼替尼(444名患者)治疗。在560例PD-L1阳性肿瘤患者(63.2%)中,Avelumab加阿西替尼组的中位无进展生存期为13.8个月,而舒尼替尼组为7.2个月(疾病进展或死亡风险比为0.61; 95%置信区间[CI]为0.47-0.79; P<0.001); 在总体人群中,Avelumab加阿西替尼组中位无进展生存期为13.8个月,而舒尼替尼组为8.4个月(风险比为0.69; 95%CI为0.56-0.84; P<0.001)。在PD-L1阳性肿瘤患者中,Avelumab加阿西替尼组的客观缓解率为55.2%,舒尼替尼组的客观缓解率为25.5%; 中位随访时,两组总生存期分别为11.6个月和10.7个月,分别有37例患者和44例患者死亡。Avelumab-阿西替尼组99.5%的患者和舒尼替尼组99.3%的患者在治疗期间发生不良事件;这些事件在各组的71.2%和71.5%的患者中为3级或更高。

由此可见,在接受这些药物作为晚期肾细胞癌的一线治疗的患者中,使用Avelumab加阿西替尼的无进展生存期明显长于舒尼替尼。

原始出处:


Robert J. Motzer,et al.Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.NEJM.2019.https://www.nejm.org/doi/full/10.1056/NEJMoa1816047

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    2019-05-31 snf701207
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    2019-03-22 fangcong
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    2019-03-21 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2019-03-21 飛歌

    学习了很有用不错

    0

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    2019-03-21 飛歌

    学习了很有用不错

    0

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