The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Box 3624, Durham, NC 27710, USA.
Br J Cancer. 2009 Dec 15;101(12):1995-2004. doi: 10.1038/sj.bjc.6605411. Epub 2009 Nov 10.
We evaluated the efficacy of imatinib mesylate in addition to hydroxyurea in patients with recurrent glioblastoma (GBM) who were either on or not on enzyme-inducing anti-epileptic drugs (EIAEDs).
A total of 231 patients with GBM at first recurrence from 21 institutions in 10 countries were enrolled. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 600 mg per day for patients not on EIAEDs and at 500 mg twice a day if on EIAEDs. The primary end point was radiographic response rate and secondary end points were safety, progression-free survival at 6 months (PFS-6), and overall survival (OS).
The radiographic response rate after centralised review was 3.4%. Progression-free survival at 6 months and median OS were 10.6% and 26.0 weeks, respectively. Outcome did not appear to differ based on EIAED status. The most common grade 3 or greater adverse events were fatigue (7%), neutropaenia (7%), and thrombocytopaenia (7%).
Imatinib in addition to hydroxyurea was well tolerated among patients with recurrent GBM but did not show clinically meaningful anti-tumour activity.
我们评估了甲磺酸伊马替尼联合羟脲在接受或未接受酶诱导抗癫痫药物（EIAEDs）治疗的复发性胶质母细胞瘤（GBM）患者中的疗效。
共有来自 10 个国家的 21 个机构的 231 名复发性 GBM 患者入组。所有患者均接受每天两次 500mg 的羟脲治疗。对于未使用 EIAEDs 的患者，给予伊马替尼 600mg/天；对于使用 EIAEDs 的患者，给予伊马替尼 500mg/天，每天两次。主要终点是影像学反应率，次要终点是安全性、6 个月无进展生存率（PFS-6）和总生存率（OS）。
经中心审查后，影像学反应率为 3.4%。6 个月无进展生存率和中位 OS 分别为 10.6%和 26.0 周。EIAED 状态似乎不影响预后。最常见的 3 级或更高级别的不良事件为疲劳（7%）、中性粒细胞减少（7%）和血小板减少（7%）。
在复发性 GBM 患者中，甲磺酸伊马替尼联合羟脲耐受性良好，但未显示出有临床意义的抗肿瘤活性。
