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RPA 分级 V 和 VI 级胶质母细胞瘤患者接受低分割放疗与替莫唑胺化疗的比较:一项随机 II 期试验。

Hypofractionated radiation therapy versus chemotherapy with temozolomide in patients affected by RPA class V and VI glioblastoma: a randomized phase II trial.

机构信息

Radiation Oncology Department, ASST Spedali Civili Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy.

Radiation Oncology Department, AOU Maggiore Della Carità, East Piedmont University, viale Mazzini 18, 28100, Novara, Italy.

出版信息

J Neurooncol. 2019 Jul;143(3):447-455. doi: 10.1007/s11060-019-03175-2. Epub 2019 May 4.

Abstract

INTRODUCTION

In RPA V-VI glioblastoma patients both hypofractionated radiotherapy and exclusive temozolomide can be used; the purpose of this trial is to compare these treatment regimens in terms of survival and quality of life.

METHODS

Patients with histologic diagnosis of glioblastoma were randomized to hypofractionated radiotherapy (RT-30 Gy in 6 fractions) and exclusive chemotherapy (CHT-emozolomide 200 mg/m/day 5 days every 28 days). Overall (OS) and progression free survival (PFS) were evaluated with Kaplan Maier curves and correlated with prognostic factors. Quality- adjusted survival (QaS) was evaluated according to the Murray model (Neurological Sign and Symptoms-NSS) RESULTS: From 2010 to 2015, 31 pts were enrolled (CHT: 17 pts; RT: 14pts). Four pts were excluded from the analysis. RPA VI (p = 0.048) and absence of MGMT methylation (p = 0.001) worsened OS significantly. Biopsy (p = 0.048), RPA class VI (p = 0.04) and chemotherapy (p = 0.007) worsened PFS. In the two arms the initial NSS scores were overlapping (CHT: 12.23 and RT: 12.30) and progressively decreased in both group and became significantly worse after 5 months in CHT arm (p = 0.05). Median QaS was 104 days and was significantly better in RT arm (p = 0.01).

CONCLUSIONS

The data obtained are limited by the poor accrual. Both treatments were well tolerated. Patients in RT arm have a better PFS and QaS, without significant differences in OS. The deterioration of the NSS score would seem an important parameter and coincide with disease progression rather than with the toxicity of the treatment.

摘要

简介

在 RPA V-VI 级胶质母细胞瘤患者中,均可采用低分割放疗和单独替莫唑胺治疗;本试验的目的是比较这两种治疗方案在生存和生活质量方面的差异。

方法

将组织学诊断为胶质母细胞瘤的患者随机分为低分割放疗组(30Gy,6 次分割)和单纯化疗组(CHT-替莫唑胺 200mg/m/天,28 天为 1 个周期)。采用 Kaplan-Meier 曲线评估总生存期(OS)和无进展生存期(PFS),并与预后因素进行相关性分析。采用 Murray 模型(神经症状和体征-NSS)评估质量调整生存(QaS)。

结果

2010 年至 2015 年,共纳入 31 例患者(CHT 组 17 例,RT 组 14 例),4 例患者被排除在分析之外。RPA VI 级(p=0.048)和 MGMT 甲基化缺失(p=0.001)显著降低 OS。活检(p=0.048)、RPA 分级 VI 级(p=0.04)和化疗(p=0.007)降低 PFS。在两个治疗组中,初始 NSS 评分重叠(CHT 组:12.23,RT 组:12.30),且在两组中均逐渐降低,在 CHT 组治疗 5 个月后显著恶化(p=0.05)。中位 QaS 为 104 天,RT 组显著优于 CHT 组(p=0.01)。

结论

由于入组人数较少,本研究结果受到限制。两种治疗方法均耐受良好。RT 组患者的 PFS 和 QaS 更好,OS 无显著差异。NSS 评分的恶化似乎是一个重要的参数,与疾病进展而非治疗毒性相一致。

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