AVAglio: Phase 3 Trial of Bevacizumab Plus Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
AVAglio: Phase 3 Trial of Bevacizumab Plus Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
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DOI：
10.1007/s12325-011-0007-3
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发表时间：
2011-04-01
影响因子：
3.8
通讯作者：
Cloughesy, T.
中科院分区：
文献类型：
--
作者：
Chinot, O. L.;Rouge, T. de la Motte;Cloughesy, T.
尽管使用当前的标准护理疗法进行治疗，但新诊断的多形性胶质母细胞瘤（GBM）患者表现出令人沮丧的肿瘤。贝伐珠单抗已在复发性GBM患者中显示出活性，2期试验表明贝伐珠单抗与标准治疗的组合对于新诊断的GBM患者是可行的和有效的。贝伐珠单抗已被美国批准用于既往治疗后进行性GBM患者的单药治疗，但尚未获得欧洲GBM患者的批准。在新诊断的GBM患者中启动了III期研究，目前正在招募患者。我们描述了AVAglio 3期注册试验的方案，该试验旨在评估贝伐单抗与标准治疗相结合治疗新诊断GBM患者的疗效和安全性。
Despite treatment with the current standard-of-care therapies, patients with newly diagnosed glioblastoma multiforme (GBM) exhibit dismal prognoses. Bevacizumab has demonstrated activity in patients with recurrent GBM and phase 2 trials indicate that the combination of bevacizumab with standard-of-care therapy is feasible and active for patients with newly diagnosed GBM. Bevacizumab has been granted US approval for use as single-agent therapy for patients with progressive GBM following prior therapy, although it has not received approval for use in patients with GBM in Europe. Phase 3 studies have been initiated in patients with newly diagnosed GBM and are currently recruiting patients. We describe the protocol for the AVAglio phase 3 registration trial, which is designed to evaluate the efficacy and safety of combining bevacizumab with standard-of-care therapy in patients with newly diagnosed GBM.