ECC 2015:依维莫司能显著延长无功能的胃肠道和肺神经内分泌肿瘤(RADIANT-4研究)

2015-10-01 MedSci MedSci原创

               当地时间9月26日12:30,在ECC2015召开的第二次新闻发布会上,又有两项重要的最新研究摘要(LateBreakingAbstract)——RADIANT-4和NETTER-1研究亮相。在此对RADIANT-4研究作一简介。  &nb

       

        当地时间9月26日12:30,在ECC2015召开的第二次新闻发布会上,又有两项重要的最新研究摘要(LateBreakingAbstract)——RADIANT-4和NETTER-1研究亮相。在此对RADIANT-4研究作一简介。

        

RADIANT-4研究的主要研究者、来自美国的JamesYao教授指出,神经内分泌肿瘤(NET)是少见病、不可治愈,且目前的治疗选择很有限,尤其是在进展为晚期时。依维莫司是一种mTOR抑制剂,既往Ⅱ~Ⅲ期研究显示依维莫司对各种起源的晚期NET都有抗肿瘤活性。RADIANT-4研究作为首项评估依维莫司用于无功能的胃肠道NET和肺NET的安慰剂对照、双盲Ⅲ期临床试验,共入组302例患者,按2∶1的比例分别接受依维莫司治疗或安慰剂,治疗直至进展或出现不能耐受的毒性反应。

结果显示,研究达到了主要研究终点,依维莫司组较安慰剂组使中心评估的无进展生存(PFS)期改善达2.8倍(11个月对3.9个月,P<0.00001),降低疾病进展风险达52%[风险比(HR)0.48]。研究者评估的PFS期有相似结果,依维莫司组有显著延长(14个月对5.5个月,HR0.39,P<0.00001)。在总生存(OS)方面,依维莫司组也显示有延长趋势,但目前仅是中期分析数据,下一次的OS分析数据有望在2016年公布。Yao教授认为,“虽然我们已知依维莫司可延缓胰腺NET的生长,但该项研究首次让我们看到依维莫司对其他部位起源的NET也有效,有望成为胰腺NET或肺NET的新治疗选择。”

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    2016-01-03 gwc392
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    2016-04-09 仁医06
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