Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma
Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma
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DOI：
10.1056/nejmoa1611977
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发表时间：
2017-03-16
影响因子：
158.5
通讯作者：
Mason, Warren P.
中科院分区：
文献类型：
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作者：
Perry, James R.;Laperriere, Normand;Mason, Warren P.
胶质母细胞瘤与老年人预后不良有关。当替莫唑胺化疗加标准放疗（6周60戈伊）时，70岁或更年轻患者的生存率增加。在老年患者中，更方便的较短疗程的放疗是常用的，但添加替莫唑胺的好处，以较短的疗程放疗是unknown. METHODS我们进行了一项试验，涉及患者65岁或以上的新诊断的胶质母细胞瘤。患者被随机分配到单独接受放疗（40戈伊，15次）或放疗伴随和辅助替莫唑胺。结果共562例患者进行随机分组，每组281例。中位年龄为73岁（范围：65 - 90岁）。放疗联合替莫唑胺治疗的中位总生存期长于单纯放疗（9.3个月vs. 7.6个月;死亡风险比，0.67; 95%可信区间[CI]，0.56 - 0.80; P <0.001），中位无进展生存期也是如此。（5.3个月vs. 3.9个月;疾病进展或死亡的风险比为0.50; 95% CI为0.41至0.60; P <0.001）。在165例甲基化O-6-甲基鸟嘌呤-DNA甲基转移酶（MGMT）状态患者中，放疗加替莫唑胺组的中位总生存期为13.5个月，单纯放疗组为7.7个月（死亡风险比为0.53; 95%CI为0.38~0.73; P <0.001）。在189例未甲基化MGMT状态的患者中，放疗加替莫唑胺组的中位总生存期为10.0个月，单纯放疗组为7.9个月（死亡风险比为0.75; 95%CI为0.56 - 1.01; P = 0.055;相互作用P = 0.08）。生活质量是相似的两个试验groups.CONCLUSIONS在老年胶质母细胞瘤患者中，除了替莫唑胺短程放疗导致较长的生存期比单独短程放疗。由加拿大癌症协会研究所和其他人资助;临床试验。政府编号，NCT00482677。）
BACKGROUND Glioblastoma is associated with a poor prognosis in the elderly. Survival has been shown to increase among patients 70 years of age or younger when temozolomide chemotherapy is added to standard radiotherapy (60 Gy over a period of 6 weeks). In elderly patients, more convenient shorter courses of radiotherapy are commonly used, but the benefit of adding temozolomide to a shorter course of radiotherapy is unknown.METHODS We conducted a trial involving patients 65 years of age or older with newly diagnosed glioblastoma. Patients were randomly assigned to receive either radiotherapy alone (40 Gy in 15 fractions) or radiotherapy with concomitant and adjuvant temozolomide.RESULTS A total of 562 patients underwent randomization, 281 to each group. The median age was 73 years (range, 65 to 90). The median overall survival was longer with radiotherapy plus temozolomide than with radiotherapy alone (9.3 months vs. 7.6 months; hazard ratio for death, 0.67; 95% confidence interval [CI], 0.56 to 0.80; P< 0.001), as was the median progression-free survival (5.3 months vs. 3.9 months; hazard ratio for disease progression or death, 0.50; 95% CI, 0.41 to 0.60; P< 0.001). Among 165 patients with methylated O-6-methylguanine-DNA methyltransferase (MGMT) status, the median overall survival was 13.5 months with radiotherapy plus temozolomide and 7.7 months with radiotherapy alone (hazard ratio for death, 0.53; 95% CI, 0.38 to 0.73; P< 0.001). Among 189 patients with unmethylated MGMT status, the median overall survival was 10.0 months with radiotherapy plus temozolomide and 7.9 months with radiotherapy alone (hazard ratio for death, 0.75; 95% CI, 0.56 to 1.01; P = 0.055; P = 0.08 for interaction). Quality of life was similar in the two trial groups.CONCLUSIONS In elderly patients with glioblastoma, the addition of temozolomide to short-course radiotherapy resulted in longer survival than short-course radiotherapy alone. Funded by the Canadian Cancer Society Research Institute and others; ClinicalTrials. gov number, NCT00482677.)