AC Camargo Cancer Center, São Paulo, Brazil.
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.
Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):931-938. doi: 10.1016/j.ijrobp.2017.03.037. Epub 2017 Mar 30.
To perform a subset analysis of survival outcomes in elderly patients with glioblastoma from a randomized phase 3 trial comparing 2 short-course radiation therapy (RT) regimens in elderly and/or frail patients.
The original trial population included elderly and/or frail patients with a diagnosis of glioblastoma. Patients joined the phase 3, randomized, multicenter, prospective, noninferiority trial; were assigned to 1 of 2 groups in a 1:1 ratio, either short-course RT (25 Gy in 5 fractions, arm 1) or commonly used RT (40 Gy in 15 fractions, arm 2); and were stratified by age (<65 years and ≥65 years), Karnofsky Performance Status (KPS), and extent of surgery. For the subset analysis in this study, only patients aged ≥65 years were evaluated (elderly and frail patients were defined as patients aged ≥65 years with KPS of 50%-70%; elderly and non-frail patients were defined as patients aged ≥65 years with KPS of 80%-100%); 61 of the 98 initial patients comprised the patient population, with 26 patients randomized to arm 1 and 35 to arm 2.
In this unplanned analysis, the short-course RT results were not statistically significantly different from the results of commonly used RT in elderly patients. The median overall survival time was 6.8 months (95% confidence interval [CI], 4.5-9.1 months) in arm 1 and 6.2 months (95% CI, 4.7-7.7 months) in arm 2 (P=.936). The median progression-free survival time was 4.3 months (95% CI, 2.6-5.9 months) in arm 1 and 3.2 months (95% CI, 0.1-6.3 months) in arm 2 (P=.706).
A short-course RT regimen of 25 Gy in 5 fractions is an acceptable treatment option for patients aged ≥65 years, mainly those with a poor performance status or contraindication to chemotherapy, which would be indicated in cases of methylated O6 methylguanine-DNA-methyltransferase promoter tumors.
对一项比较 2 种短程放疗方案在老年和/或虚弱型胶质母细胞瘤患者中的随机 3 期临床试验的生存结局进行亚组分析。
原始试验人群包括诊断为胶质母细胞瘤的老年和/或虚弱型患者。患者参加了这项 3 期、随机、多中心、前瞻性、非劣效性试验;以 1:1 的比例随机分配至 2 组,分别接受 25 Gy 分 5 次(第 1 组)或常规使用的 40 Gy 分 15 次(第 2 组)放疗;并根据年龄(<65 岁和≥65 岁)、卡氏功能状态评分(KPS)和手术范围进行分层。在本研究的亚组分析中,仅评估年龄≥65 岁的患者(老年和虚弱型患者定义为年龄≥65 岁且 KPS 为 50%-70%的患者;老年和非虚弱型患者定义为年龄≥65 岁且 KPS 为 80%-100%的患者);98 名初始患者中有 61 名构成了患者人群,其中 26 名患者被随机分配至第 1 组,35 名患者被随机分配至第 2 组。
在这项未计划的分析中,短程放疗结果与老年患者中常规放疗的结果无统计学差异。第 1 组的中位总生存时间为 6.8 个月(95%置信区间[CI]:4.5-9.1 个月),第 2 组为 6.2 个月(95%CI:4.7-7.7 个月)(P=.936)。第 1 组的中位无进展生存时间为 4.3 个月(95%CI:2.6-5.9 个月),第 2 组为 3.2 个月(95%CI:0.1-6.3 个月)(P=.706)。
25 Gy 分 5 次的短程放疗方案是年龄≥65 岁患者的一种可接受的治疗选择,主要适用于功能状态较差或对化疗有禁忌证的患者,对于甲基化 O6 甲基鸟嘌呤-DNA-甲基转移酶启动子肿瘤患者,则为首选治疗方案。