Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma
Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma
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DOI：
10.1056/nejmoa043330
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发表时间：
2005-03-10
影响因子：
158.5
通讯作者：
Ryan, G
中科院分区：
文献类型：
--
作者：
Stupp, R;Mason, WP;Ryan, G
背景：胶质母细胞瘤是成人最常见的原发性脑肿瘤，通常是迅速致命的。目前新诊断的胶质母细胞瘤的标准治疗是在可行的范围内进行手术切除，然后进行辅助放疗。在这项试验中，我们比较了单独放疗与放疗联合替莫唑胺（与放疗同时或放疗后给药）的疗效和安全性。方法：新诊断的、经组织学证实的胶质母细胞瘤患者被随机分配接受单独放疗（每周5天，共6周，每日2戈伊的分次局灶性照射，共60戈伊）或放疗加连续每日替莫唑胺（每天每平方米体表面积75毫克，每周7天，从放疗的第一天到最后一天），随后是6个周期的辅助替莫唑胺（在每个28天周期中，150至200 mg/m2，持续5天）。主要终点是总生存率。结果：共有来自85个中心的573例患者接受了随机分组。中位年龄为56岁，84%的患者接受过减瘤手术。中位随访时间为28个月，放疗加替莫唑胺组的中位生存期为14.6个月，单纯放疗组为12.1个月。放疗加替莫唑胺组未校正的死亡风险比为0.63（95%可信区间为0.52 - 0.75; P
BACKGROUND:Glioblastoma, the most common primary brain tumor in adults, is usually rapidly fatal. The current standard of care for newly diagnosed glioblastoma is surgical resection to the extent feasible, followed by adjuvant radiotherapy. In this trial we compared radiotherapy alone with radiotherapy plus temozolomide, given concomitantly with and after radiotherapy, in terms of efficacy and safety.METHODS:Patients with newly diagnosed, histologically confirmed glioblastoma were randomly assigned to receive radiotherapy alone (fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) or radiotherapy plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was overall survival.RESULTS:A total of 573 patients from 85 centers underwent randomization. The median age was 56 years, and 84 percent of patients had undergone debulking surgery. At a median follow-up of 28 months, the median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone. The unadjusted hazard ratio for death in the radiotherapy-plus-temozolomide group was 0.63 (95 percent confidence interval, 0.52 to 0.75; P