EFFECTS OF CONCURRENT TOPOTECAN AND RADIATION ON 6-MONTH PROGRESSION-FREE SURVIVAL IN THE PRIMARY TREATMENT OF GLIOBLASTOMA MULTIFORME
EFFECTS OF CONCURRENT TOPOTECAN AND RADIATION ON 6-MONTH PROGRESSION-FREE SURVIVAL IN THE PRIMARY TREATMENT OF GLIOBLASTOMA MULTIFORME
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DOI：
10.1016/j.ijrobp.2009.04.015
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发表时间：
2009-09-01
影响因子：
7
通讯作者：
Meyer, Martin
中科院分区：
文献类型：
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作者：
Grabenbauer, Gerhard G.;Gerber, Klaus-Dieter;Meyer, Martin
目的：报告一个前瞻性的，随机的，第二阶段的放射治疗与拓扑替康的治疗glioblastoma.Patients和方法：纳入标准是胶质母细胞瘤的组织学，年龄< 60岁，东部肿瘤协作组状态0-2。根据递归分割分析分类、中心和酶诱导抗癫痫药物对患者进行分层。每3个月进行一次磁共振成像扫描、神经系统检查和生活质量评估。主要终点是6个月时的无进展生存率（6-m-PFS）。本试验设计为一项探索性、随机化、II期试验，入组140例患者，以检测6-m-PFS的15-20%差异。计划在60例患者后进行中期分析。中位随访时间为14个月（范围：1-50个月）。结果：6-m-PFS为56%和40%的患者与拓扑替康，分别。这种好处在两个月内消失了。平均（范围）无进展生存时间分别为8（5-10.9）个月和6.7（4-9.5）个月，患者与拓扑替康，分别。相应的2年总生存率分别为28%和22%。（无显著性差异），平均（范围）生存时间为20.7（13.9-27.5）个月vs. 18.9个月（13.5-24.4）个月（无显著差异）。结论：与仅接受放疗的患者相比，接受托泊替康联合放疗的患者的6-m-PFS轻微但可测量的增加16%。这些数据可能支持进一步研究拓扑替康治疗胶质母细胞瘤。(c)2009 Elsevier Inc.
Purpose: To report a prospective, randomized, Phase II trial of radiotherapy with and without topotecan for the treatment of glioblastoma.Patients and Methods: Inclusion criteria were histology of glioblastoma, age < 60 years, and Eastern Cooperative Oncology Group status 0-2. Patients were stratified according to recursive partitioning analysis class, center, and enzyme-inducing antiepileptic medication. Magnetic resonance imaging scans, neurologic examinations, and quality of life assessments were done every 3 months. The primary endpoint was the progression-free survival rate at 6 months (6-m-PFS). This trial was designed as an exploratory, randomized, Phase II trial with an accrual of 140 patients to detect a difference of 15-20% in 6-m-PFS. An interim analysis was scheduled after 60 patients. Median follow-up was 14 months (range, 1-50 months).Results: The 6-m-PFS was 56% and 40% for patients with and without topotecan, respectively. This benefit disappeared within 2 months. Mean (range) progression-free survival time was 8 (5-10.9) months and 6.7 (4-9.5) months for patients with and without topotecan, respectively. The corresponding 2-year-overall survival rates were 28% vs. 22% (nonsignificant difference), and mean (range) survival time was 20.7 (13.9-27.5) months vs. 18.9 (13.5-24.4) months (nonsignificant difference).Conclusions: A slight but measurable increase of 16% was detected in 6-m-PFS for patients receiving topotecan with radiation as compared with patients having radiotherapy alone. These data might support further investigations into topotecan for the treatment of glioblastoma. (c) 2009 Elsevier Inc.