METHODS: A total of 1057 glioblastoma patients were identified by National Health Insurance Research Database and Cancer Registry in 2008-2015. Eligible criteria included those receiving surgery, adjuvant radiotherapy and temozolomide, and without other cancer diagnoses. Survival between patients taking concurrent AED for 14 days or more during chemo-radiotherapy (AED group) and those who did not (non-AED group) were compared, and subgroup analyses for those with valproic acid (VPA), levetiracetam (LEV), or phenytoin were performed. Multivariate analyses were used to adjust for confounding factors.
RESULTS: There were 642 patients in the AED group, whereas 415 in the non-AED group. The demographic data was balanced except trend of more patients in the AED group had previous drug history of AEDs (22.6% vs. 18%, P 0.078). Overall, the AED group had significantly increased risk of mortality (HR = 1.18, P 0.016) compared to the non-AED group. Besides, an adverse dose-dependent relationship on survival was also demonstrated in the AED group (HR = 1.118, P 0.0003). In subgroup analyses, the significant detrimental effect was demonstrated in VPA group (HR = 1.29,P 0.0002), but not in LEV (HR = 1.18, P 0.079) and phenytoin (HR = 0.98, P 0.862).
CONCLUSIONS: Improved survival was not observed in patients with concurrent AEDs during chemo-radiotherapy. Our real-world data did not support prophylactic use of AEDs for glioblastoma patients.
方法:2008-2015年,国家健康保险研究数据库和癌症登记处共确定了1057例胶质母细胞瘤患者。符合条件的标准包括接受手术的人,辅助放疗和替莫唑胺,没有其他癌症诊断。比较放化疗期间同时服用AED14天或更长时间的患者(AED组)和未服用AED的患者(非AED组)之间的生存率,以及对丙戊酸(VPA)患者的亚组分析,左乙拉西坦(LEV),或苯妥英进行。多变量分析用于校正混杂因素。
结果:AED组642例,而非AED组的415。人口统计学数据是平衡的,除了AED组中更多的患者有AED的既往用药史(22.6%vs.18%,P0.078)。总的来说,与非AED组相比,AED组的死亡风险显著增加(HR=1.18,P0.016).此外,在AED组中也证实了对生存的不良剂量依赖性关系(HR=1.118,P0.0003).在亚组分析中,在VPA组(HR=1.29,P0.0002),但不在LEV(HR=1.18,P0.079)和苯妥英(HR=0.98,P0.862)中。
结论:在放化疗期间并发AED的患者未观察到生存改善。我们的实际数据不支持胶质母细胞瘤患者预防性使用AED。