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复发性高级别胶质瘤(HGG)患者再放疗:单臂前瞻性 2 期研究结果。

Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study.

机构信息

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy.

Neurosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

出版信息

Radiother Oncol. 2022 Feb;167:89-96. doi: 10.1016/j.radonc.2021.12.019. Epub 2021 Dec 22.

DOI:10.1016/j.radonc.2021.12.019
PMID:34952000
Abstract

BACKGROUND AND PURPOSE

Standard of care for recurrent high grade glioma (HGG) is missing. Several treatment options have been investigated including re-irradiation (re-RT). Results are promising but provided by retrospective studies. We designed a single arm prospective phase II study aiming to evaluate efficacy, and toxicity of re-irradiation.

MATERIALS AND METHODS

Adults patients with good performance status, HGG diagnosis reclassified according to the new 2021 fifth edition WHO CNS classification, an interval time (IT) from previous RT ≥ 6 months were included. Outcome was evaluated by MRI imaging at 1 month, and every 3 months thereafter. Toxicities were evaluated in terms of radionecrosis occurrence, and neurocognitive status.

RESULTS

Ninety recurrent HGG patients were treated, 11 oligodendroglioma grade 3, 18 astrocytoma grade 3 and 4, and 61 glioblastoma grade 4. The median age was 54 years, and majority had KPS 90-100. The median IT between first-RT and re-RT was 24 months. Re-surgery has been performed in 56.6%, and chemotherapy in 53.3%. The median follow up time was 64 months; median overall survival (OS) time,1,2,3-year OS rates were 17 months (95%CI 14-19), 66.7%±4.9, 32.6%±5.0, and 22.2 ± 4.7. Prognostic factors impacting on survival were age (p = 0.0154), IT between first RT and re-RT (p = 0.0051), glioma grade (p = 0.0090), and IDH status (p = 0.0001). Radionecrosis grade 2-3 occurred in 9 (10%) patients; neurocognitive functions remained stable until disease progression.

CONCLUSION

Re-RT proved to be a safe and feasible treatment option with low toxicity. Younger patients with grade 3 IDH mutated gliomas, and a longer IT had the better outcome.

TRIAL REGISTRATION NUMBER

NCT02567539.

摘要

背景与目的

复发性高级别胶质瘤(HGG)缺乏标准治疗方法。已经研究了几种治疗选择,包括再放疗(re-RT)。结果很有希望,但都是来自回顾性研究。我们设计了一项单臂前瞻性 II 期研究,旨在评估再放疗的疗效和毒性。

材料与方法

纳入标准为表现状态良好、根据新的 2021 年第五版世界卫生组织中枢神经系统分类重新分类为 HGG 诊断、上次放疗(first-RT)后时间间隔(IT)≥6 个月的成人患者。通过 1 个月和此后每 3 个月的 MRI 成像评估疗效。以放射性坏死的发生和神经认知状态评估毒性。

结果

共治疗了 90 例复发性 HGG 患者,其中 11 例为少突胶质细胞瘤 3 级,18 例为星形细胞瘤 3 级和 4 级,61 例为胶质母细胞瘤 4 级。中位年龄为 54 岁,大多数为 KPS 90-100。first-RT 和 re-RT 之间的中位 IT 为 24 个月。56.6%的患者接受了再手术,53.3%的患者接受了化疗。中位随访时间为 64 个月;中位总生存(OS)时间、1、2、3 年 OS 率分别为 17 个月(95%CI 14-19)、66.7%±4.9、32.6%±5.0 和 22.2±4.7。影响生存的预后因素包括年龄(p=0.0154)、first-RT 和 re-RT 之间的 IT(p=0.0051)、胶质瘤分级(p=0.0090)和 IDH 状态(p=0.0001)。9 例(10%)患者发生 2-3 级放射性坏死;神经认知功能在疾病进展前保持稳定。

结论

re-RT 是一种安全可行的治疗选择,毒性低。年龄较小、IDH 突变的 3 级胶质瘤和较长 IT 的患者预后更好。

临床试验注册号

NCT02567539。

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