格利卫联合羟基脲治疗进展或复发性低度恶性神经胶质瘤的Ⅱ期临床研究。
Phase II study of Gleevec plus hydroxyurea in adults with progressive or recurrent low-grade glioma.
机构信息
The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina, USA.
出版信息
Cancer. 2012 Oct 1;118(19):4759-67. doi: 10.1002/cncr.26541. Epub 2012 Feb 27.
BACKGROUND
We evaluated the efficacy of imatinib plus hydroxyurea in patients with progressive/recurrent low-grade glioma.
METHODS
A total of 64 patients with recurrent/progressive low-grade glioma were enrolled in this single-center study that stratified patients into astrocytoma and oligodendroglioma cohorts. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg per day for patients not on enzyme-inducing antiepileptic drugs (EIAEDs) and at 500 mg twice a day if on EIAEDs. The primary endpoint was progression-free survival at 12 months (PFS-12) and secondary endpoints were safety, median progression-free survival, and radiographic response rate.
RESULTS
Thirty-two patients were enrolled into each cohort. Eleven patients (17%) had before radiotherapy and 24 (38%) had received before chemotherapy. The median PFS and PFS-12 were 11 months and 39%, respectively. Outcome did not differ between the histologic cohorts. No patient achieved a radiographic response. The most common grade 3 or greater adverse events were neutropenia (11%), thrombocytopenia (3%), and diarrhea (3%).
CONCLUSIONS
Imatinib plus hydroxyurea was well tolerated among recurrent/progressive LGG patients but this regimen demonstrated negligible antitumor activity.
背景
我们评估了伊马替尼联合羟脲在进展/复发性低级别胶质瘤患者中的疗效。
方法
这项单中心研究共纳入 64 例复发性/进展性低级别胶质瘤患者，将患者分为星形细胞瘤和少突胶质细胞瘤队列。所有患者每天接受两次羟脲 500mg。对于未使用酶诱导抗癫痫药物（EIAED）的患者，给予伊马替尼 400mg/天；对于使用 EIAED 的患者，给予伊马替尼 500mg/天，每天两次。主要终点是 12 个月时无进展生存（PFS-12），次要终点是安全性、中位无进展生存期和影像学反应率。
结果
每个队列纳入 32 例患者。11 例（17%）患者在放疗前接受治疗，24 例（38%）患者在化疗前接受治疗。中位 PFS 和 PFS-12 分别为 11 个月和 39%。组织学队列之间的结果无差异。没有患者出现影像学反应。最常见的 3 级或以上不良事件是中性粒细胞减少症（11%）、血小板减少症（3%）和腹泻（3%）。
结论
伊马替尼联合羟脲在复发性/进展性 LGG 患者中耐受良好，但该方案显示出轻微的抗肿瘤活性。
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