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拉考沙胺单药治疗 BTRE(脑肿瘤相关性癫痫):一项意大利多中心回顾性研究的结果。

Lacosamide in monotherapy in BTRE (brain tumor-related epilepsy): results from an Italian multicenter retrospective study.

机构信息

Division of Neuro-Oncology, Dept. Neuroscience, University and City of Health and Science Hospital, Via Cherasco 15, 10126, Torino, Italy.

Division of Neurology, Modena University Hospital, Modena, Italy.

出版信息

J Neurooncol. 2022 May;157(3):551-559. doi: 10.1007/s11060-022-03998-6. Epub 2022 Apr 9.

Abstract

PURPOSE

Lacosamide (LCM) is a third-generation anti-seizure medication (ASM) approved for focal onset epilepsy in patients aged ≥ 4.378 Previous studies have reported an efficacy of LCM as add-on treatment in brain tumor-related epilepsy (BTRE). To date, there are no studies in the literature focusing on lacosamide used in monotherapy to treat BTRE. In our retrospective study we investigated efficacy and tolerability of LCM in monotherapy in a multicenter national cohort of primary brain tumor patients.

METHODS

We collected from 12 Italian Centers 132 patients with primary brain tumors who were treated with LCM in monotherapy. For each patient we evaluated seizure freedom at 3 and 6 months (primary endpoints), side effects and drop-out rate (secondary endpoints).

RESULTS

Overall, LCM led to seizure freedom in 64.4% of patients at 3 months and 55% at 6 months. Patients who used two or more ASMs before LCM had a worse seizure control than patients in monotherapy with LCM as first choice. In 14 patients, we observed seizure control despite tumor progression on magnetic resonance (MRI). Multivariate analysis showed that gross-total resection at diagnosis was significantly associated with higher seizure freedom rate at 6 months. Side effects were mainly mild (grade 1-2 according to CTCAE classification) and drop-out rate was low (1.5%). Main side effects were dizziness and somnolence.

CONCLUSIONS

This is the first study showing a good efficacy and tolerability of LCM when used in monotherapy in BTRE. Further prospective studies are needed to confirm these preliminary data, investigating also quality of life and neurocognitive functions.

摘要

目的

拉考沙胺(LCM)是一种第三代抗癫痫药物(ASM),适用于 4.378 岁及以上局灶性癫痫发作的患者。先前的研究报告了 LCM 作为附加治疗在脑肿瘤相关癫痫(BTRE)中的疗效。迄今为止,文献中尚无关于单独使用 LCM 治疗 BTRE 的研究。在我们的回顾性研究中,我们调查了 LCM 在多中心国家脑肿瘤患者队列中的单药治疗的疗效和耐受性。

方法

我们从 12 个意大利中心收集了 132 名接受 LCM 单药治疗的原发性脑肿瘤患者。对于每个患者,我们评估了 3 个月和 6 个月时的无癫痫发作(主要终点)、副作用和停药率(次要终点)。

结果

总体而言,LCM 在 3 个月时使 64.4%的患者无癫痫发作,在 6 个月时使 55%的患者无癫痫发作。在使用 LCM 之前使用两种或更多种 ASM 的患者的癫痫控制情况比将 LCM 作为首选的单药治疗患者差。在 14 名患者中,尽管磁共振成像(MRI)显示肿瘤进展,但我们观察到了癫痫控制。多变量分析显示,诊断时的大体全切除与 6 个月时更高的无癫痫发作率显著相关。副作用主要为轻度(根据 CTCAE 分级为 1-2 级),停药率低(1.5%)。主要副作用为头晕和嗜睡。

结论

这是第一项研究,表明 LCM 在 BTRE 中单独使用时具有良好的疗效和耐受性。需要进一步的前瞻性研究来证实这些初步数据,同时还需要研究生活质量和神经认知功能。

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