Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial
Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial
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DOI：
10.1016/s1470-2045(09)70025-7
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发表时间：
2009-05-01
期刊：
影响因子：
51.1
通讯作者：
Mirimanoff, Rene-Olivier
中科院分区：
文献类型：
--
作者：
Stupp, Roger;Hegi, Monika E.;Mirimanoff, Rene-Olivier
背景2004年，欧洲癌症研究和治疗组织（EORTC）和加拿大国家癌症研究所临床试验组（NCIC）进行的一项随机III期试验报告称，使用替莫唑胺和放疗联合辅助治疗的胶质母细胞瘤患者的中位生存期和2年生存期有所改善。我们报告的最后结果与中位数随访超过5 years.Methods新诊断的胶质母细胞瘤的成人患者随机分配到接受标准放疗或相同的放疗伴随替莫唑胺，随后长达6个周期的辅助替莫唑胺。甲基鸟嘌呤甲基转移酶基因的甲基化状态，MGMT是从206例患者的肿瘤组织中回顾性测定的。主要终点是总生存期。该试验在Clinicaltrials.gov注册，编号NCT 00006353。结果在2000年8月17日至2002年3月22日期间，573名患者被分配接受治疗。在5年随访期间，单纯放疗组286例患者中有278例（97%）死亡，联合治疗组287例患者中有254例（89%）死亡。总生存率为27.2%（95% CI 22.2-32.5）2年时，16.0%（12.0-20.6）3年时，12.1% 4年时为8.5-16.4，9.8%（6.4-14.0），替莫唑胺组为10.9%（7.6-14.8）、4.4%（2.4-7.2）、3.0%（1.4-5.7）和1.9%（0.6-4.4）（风险比0.6，95%CI 0.5-0.7; p
Background In 2004, a randomised phase III trial by the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) reported improved median and 2-year survival for patients with glioblastoma treated with concomitant and adjuvant temozolomide and radiotherapy. We report the final results with a median follow-up of more than 5 years.Methods Adult patients with newly diagnosed glioblastoma were randomly assigned to receive either standard radiotherapy or identical radiotherapy with concomitant temozolomide followed by up to six cycles of adjuvant temozolomide. The methylation status of the methyl-guanine methyl transferase gene, MGMT was determined retrospectively from the tumour tissue of 206 patients. The primary endpoint was overall survival. Analyses were by intention to treat. This trial is registered with Clinicaltrials.gov, number NCT00006353.Findings Between Aug 17, 2000, and March 22, 2002, 573 patients were assigned to treatment. 278 (97%) of 286 patients in the radiotherapy alone group and 254 (89%) of 287 in the combined-treatment group died during 5 years of follow-up. Overall survival was 27.2% (95% CI 22.2-32.5) at 2 years, 16.0% (12.0-20.6) at 3 years, 12.1% (8.5-16.4) at 4 years, and 9.8% (6.4-14.0) at 5 years with temozolomide, versus 10.9% (7.6-14.8), 4.4% (2.4-7.2), 3.0% (1.4-5.7), and 1.9% (0.6-4.4) with radiotherapy alone (hazard ratio 0.6, 95% CI 0.5-0.7; p