Multicentre CRC phase II trial of temozolomide in recurrent or progressive high-grade glioma
Multicentre CRC phase II trial of temozolomide in recurrent or progressive high-grade glioma
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DOI：
10.1007/s002800050691
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发表时间：
1997-10-01
影响因子：
3
通讯作者：
Brampton, MH
中科院分区：
文献类型：
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作者：
Bower, M;Newlands, ES;Brampton, MH
目的：进行性或复发性幕上高级别胶质瘤患者进入多中心II期试验，以评估替莫唑胺的疗效和毒性。方法：治疗方案为每天口服150-200 mg/m（2），连续5天，每28天重复一次。通过神经系统状态评价（MRC量表）和影像学联合进行缓解评价。结果：在103例符合条件的患者中，Il（11%）达到了客观缓解，另外48例（47%）病情稳定。中位缓解持续时间为4.6个月。间变性星形细胞瘤（III级）和多形性胶质母细胞瘤（III级）的缓解率相似。可预见的骨髓抑制是主要毒性。结论：在这种异质性患者人群中观察到的客观反应和可耐受的副作用支持了该药物在高级别胶质瘤中的进一步研究。
Purpose: Patients with progressive or recurrent supratentorial high-grade gliomas were entered into a multicentre phase II trial to evaluate the efficacy and toxicity of temozolomide. Methods: The treatment schedule was 150-200 mg/m(2) per day orally for 5 days repeated every 28 days. Response evaluation was by a combination of neurological status evaluation (MRC scale) and imaging. Results: Of 103 eligible patients enrolled, Il (11%)achieved an objective response and a further 48 (47%) had stable disease. The median response duration was 4.6 months. Response rates were similar for anaplastic astrocytomas (grade III) and glioblastoma multiforme (grade III) rumours. Predictable myelosuppression was the major toxicity. Conclusions: The observation of objective responses and tolerable side effects in this heterogeneous population of patients supports the further investigation of this agent in high-grade gliomas.