辅助性术后大剂量放疗用于非典型和恶性脑膜瘤：一项 II 期平行非随机观察研究（EORTC 22042-26042）。
Adjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma: A phase-II parallel non-randomized and observation study (EORTC 22042-26042).
机构信息
Center for Proton Therapy, Paul Scherrer Institute, ETH Domain, Villigen, Switzerland; Radiation Oncology Department, University Hospital of Bern, Bern, Switzerland; Radiation Oncology Department, University Hospital of Zürich, Switzerland.
Radiation Oncology Department, Geneva University Hospital, Switzerland; Department of Radiation-Oncology, MAASTRO Clinic, & GROW School for Oncology, Maastricht University Medical Centre, The Netherlands.
出版信息
Radiother Oncol. 2018 Aug;128(2):260-265. doi: 10.1016/j.radonc.2018.06.018. Epub 2018 Jun 28.
PURPOSE
The therapeutic strategy for non-benign meningiomas is controversial. The objective of this study was to prospectively investigate the impact of high dose radiation therapy (RT) on the progression-free survival (PFS) rate at 3 years in WHO grade II and III meningioma patients.
MATERIALS AND METHODS
In this multi-cohorts non-randomized phase II and observational study, non-benign meningioma patients were treated according to their WHO grade and Simpson's grade. Patients with atypical meningioma (WHO grade II) and Simpson's grade 1-3 [Arm 1] entered the non-randomized phase II study designed to show a 3-year PFS > 70% (primary endpoint). All other patients entered the 3 observational cohorts: WHO grade II Simpson grade 4-5 [Arm 2] and Grade III Simpson grade 1-3 or 4-5 [Arm 3&4] in which few patients were expected.
RESULTS
Between 02/2008 and 06/2013, 78 patients were enrolled into the study. This report focuses on the 56 (median age, 54 years) eligible patients with WHO grade II Simpson's grade 1-3 meningioma who received RT (60 Gy). At a median follow up of 5.1 years, the estimated 3-year PFS is 88.7%, hence significantly greater than 70%. Eight (14.3%) treatment failures were observed. The 3-year overall survival was 98.2%. The rate of late signs and symptoms grade 3 or more was 14.3%.
CONCLUSIONS
These data show that 3-year PFS for WHO grade II meningioma patients undergoing a complete resection (Simpson I-III) is superior to 70% when treated with high-dose (60 Gy) RT.
目的
非良性脑膜瘤的治疗策略存在争议。本研究的目的是前瞻性研究高剂量放疗（RT）对 WHO 分级 II 级和 III 级脑膜瘤患者 3 年无进展生存率（PFS）的影响。
材料和方法
在这项多队列非随机 II 期和观察性研究中，非良性脑膜瘤患者根据其 WHO 分级和 Simpson 分级进行治疗。非典型脑膜瘤（WHO 分级 II 级）和 Simpson 分级 1-3 级的患者[臂 1]进入非随机 II 期研究，旨在显示 3 年 PFS>70%（主要终点）。所有其他患者进入 3 个观察队列：WHO 分级 II 级 Simpson 分级 4-5 级[臂 2]和分级 III 级 Simpson 分级 1-3 级或 4-5 级[臂 3&4]，这些队列预计患者人数较少。
结果
在 2008 年 2 月至 2013 年 6 月期间，共纳入 78 例患者参加研究。本报告重点介绍了 56 例（中位年龄 54 岁）符合条件的 WHO 分级 II 级 Simpson 分级 1-3 级脑膜瘤患者，他们接受了 RT（60Gy）。中位随访 5.1 年后，估计 3 年 PFS 为 88.7%，明显高于 70%。观察到 8 例（14.3%）治疗失败。3 年总生存率为 98.2%。晚期症状和体征 3 级或以上的发生率为 14.3%。
结论
这些数据表明，接受完全切除（Simpson I-III）的 WHO 分级 II 级脑膜瘤患者，接受高剂量（60Gy）RT 治疗后，3 年 PFS 优于 70%。
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