Keime-Guibert Florence, Chinot Olivier, Taillandier Luc, Cartalat-Carel Stéphanie, Frenay Marc, Kantor Guy, Guillamo Jean-Sébastien, Jadaud Eric, Colin Philippe, Bondiau Pierre-Yves, Meneï Philippe, Loiseau Hugues, Bernier Valérie, Honnorat Jérôme, Barrié Maryline, Mokhtari Karima, Mazeron Jean-Jacques, Bissery Anne, Delattre Jean-Yves
Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris; INSERM Unité 711, Paris, France.
N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.
There is no community standard for the treatment of glioblastoma in patients 70 years of age or older. We conducted a randomized trial that compared radiotherapy and supportive care with supportive care alone in such patients.
Patients 70 years of age or older with a newly diagnosed anaplastic astrocytoma or glioblastoma and a Karnofsky performance score of 70 or higher were randomly assigned to receive supportive care only or supportive care plus radiotherapy (focal radiation in daily fractions of 1.8 Gy given 5 days per week, for a total dose of 50 Gy). The primary end point was overall survival; secondary end points were progression-free survival, tolerance of radiotherapy, health-related quality of life, and cognition.
We randomly assigned 85 patients from 10 centers to receive either radiotherapy and supportive care or supportive care alone. The trial was discontinued at the first interim analysis, which showed that with a preset boundary of efficacy, radiotherapy and supportive care were superior to supportive care alone. A final analysis was carried out for the 81 patients with glioblastoma (median age, 73 years; range, 70 to 85). At a median follow-up of 21 weeks, the median survival for the 39 patients who received radiotherapy plus supportive care was 29.1 weeks, as compared with 16.9 weeks for the 42 patients who received supportive care alone. The hazard ratio for death in the radiotherapy group was 0.47 (95% confidence interval, 0.29 to 0.76; P=0.002). There were no severe adverse events related to radiotherapy. The results of quality-of-life and cognitive evaluations over time did not differ significantly between the treatment groups.
Radiotherapy results in a modest improvement in survival, without reducing the quality of life or cognition, in elderly patients with glioblastoma. (ClinicalTrials.gov number, NCT00430911 [ClinicalTrials.gov].).
对于70岁及以上的胶质母细胞瘤患者,目前尚无统一的社区治疗标准。我们开展了一项随机试验,比较了放疗联合支持治疗与单纯支持治疗在这类患者中的效果。
年龄在70岁及以上、新诊断为间变性星形细胞瘤或胶质母细胞瘤且卡氏评分70分及以上的患者,被随机分配接受单纯支持治疗或支持治疗加放疗(每周5天,每天分次给予局部照射1.8 Gy,总剂量50 Gy)。主要终点是总生存期;次要终点包括无进展生存期、放疗耐受性、健康相关生活质量和认知功能。
我们从10个中心随机分配了85例患者,分别接受放疗联合支持治疗或单纯支持治疗。在首次中期分析时试验提前终止,该分析表明,在预设的疗效边界下,放疗联合支持治疗优于单纯支持治疗。对81例胶质母细胞瘤患者(中位年龄73岁;范围70至85岁)进行了最终分析。中位随访21周时,接受放疗加支持治疗的39例患者的中位生存期为29.1周,而接受单纯支持治疗的42例患者为16.9周。放疗组的死亡风险比为0.47(95%置信区间,0.29至0.76;P = 0.002)。没有与放疗相关的严重不良事件。随着时间推移,各治疗组在生活质量和认知评估结果上没有显著差异。
对于老年胶质母细胞瘤患者,放疗可适度提高生存率,且不降低生活质量或认知功能。(临床试验注册号,NCT00430911 [ClinicalTrials.gov]。)