70 岁以上新诊断胶质母细胞瘤患者接受低分割放疗联合替莫唑胺同期放化疗及辅助替莫唑胺治疗的 II 期研究的中期结果。

Interim Results of a Phase II Study of Hypofractionated Radiotherapy with Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients over 70 Years Old with Newly Diagnosed Glioblastoma.

机构信息

Department of Radiation Oncology and the James Graham Brown Cancer Center, University of Louisville Hospital, Louisville, Kentucky, USA.

Department of Neurosurgery, University of Louisville, Louisville, Kentucky, USA.

出版信息

Oncology. 2018;95(1):39-42. doi: 10.1159/000488395. Epub 2018 Apr 25.

DOI:10.1159/000488395

PMID:29694955

Abstract

OBJECTIVE

In this phase II study, we investigate clinical outcomes and tolerability of hypofractionated radiotherapy (HRT) combined with temozolomide (TMZ) to treat elderly patients with glioblastoma (GBM).

METHODS

Patients 70 years of age or older with newly diagnosed GBM received HRT to a dose of 34 Gy given in ten fractions over 2 weeks, delivered with concurrent and adjuvant TMZ.

RESULTS

In this interim analysis, ten patients were enrolled on trial from 12/1/2015 to 4/5/2017. With a median follow-up of 9 months (range 3-12 months), median progression-free survival (PFS) was 6 months. The median overall survival (OS) has not been reached. Estimated 1-year OS and PFS rates were 53.3 and 44.4%, respectively. All patients completed the full course of RT, with no patients developing grade 3 or higher adverse events from treatment.

CONCLUSIONS

The preliminary results of our phase II trial suggest HRT delivered over 2 weeks with concurrent and adjuvant TMZ is well tolerated in elderly patients with GBM without compromising clinical outcomes.

摘要

目的

在这项 II 期研究中，我们研究了低分割放疗（HRT）联合替莫唑胺（TMZ）治疗老年胶质母细胞瘤（GBM）患者的临床结果和耐受性。

方法

70 岁及以上的新诊断为 GBM 的患者接受 HRT，剂量为 34 Gy，分 10 次在 2 周内给予，同时给予 TMZ 治疗。

结果

在本次中期分析中，2015 年 12 月 1 日至 2017 年 4 月 5 日期间，共有 10 名患者入组。中位随访时间为 9 个月（范围 3-12 个月），中位无进展生存期（PFS）为 6 个月。中位总生存期（OS）尚未达到。估计 1 年 OS 和 PFS 率分别为 53.3%和 44.4%。所有患者均完成了全程放疗，无患者因治疗出现 3 级或更高级别的不良事件。