Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study
Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study
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DOI：
10.1016/s0140-6736(11)61742-x
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发表时间：
2011-12-10
期刊：
影响因子：
168.9
通讯作者：
Yao, James C.
中科院分区：
文献类型：
--
作者：
Pavel, Marianne E.;Hainsworth, John D.;Yao, James C.
依维莫司是一种口服雷帕霉素靶蛋白（mTOR）抑制剂，在晚期胰腺神经内分泌肿瘤患者中显示出抗肿瘤活性。我们的目的是评估依维莫司加奥曲肽长效可重复（LAR）在低级别或中等级别的神经内分泌肿瘤（类癌）患者的组合。我们做了一个随机，双盲，安慰剂对照，3期研究比较10毫克，每天口服依维莫司与安慰剂，都与30毫克肌内奥曲肽LAR每28天。通过交互式语音应答系统进行随机化。参与者年龄在18岁或以上，患有低度或中度晚期（不可切除的局部晚期或远处转移性）神经内分泌肿瘤，并且在过去12个月内通过放射学评估确定疾病进展。我们的主要终点是无进展生存期。经两次中期分析调整后，最终分析时预先设定的边界为p
Background Everolimus, an oral inhibitor of the mammalian target of rapamycin (mTOR), has shown antitumour activity in patients with advanced pancreatic neuroendocrine tumours. We aimed to assess the combination of everolimus plus octreotide long-acting repeatable (LAR) in patients with low-grade or intermediate-grade neuroendocrine tumours (carcinoid).Methods We did a randomised, double-blind, placebo-controlled, phase 3 study comparing 10 mg per day oral everolimus with placebo, both in conjunction with 30 mg intramuscular octreotide LAR every 28 days. Randomisation was by interactive voice response systems. Participants were aged 18 years or older, with low-grade or intermediate-grade advanced (unresectable locally advanced or distant metastatic) neuroendocrine tumours, and disease progression established by radiological assessment within the past 12 months. Our primary endpoint was progression-free survival. Adjusted for two interim analyses, the prespecified boundary at final analysis was p