Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, 610 University Ave, Toronto, ON, M5G2M9, Canada.
Azienda Unità Sanitaria Locale - Istituto di Ricovero e Cura a Carattere Scientifico Istituto delle Scienze Neurologiche, Bologna, Italy.
J Neurooncol. 2020 Aug;149(1):65-71. doi: 10.1007/s11060-020-03573-x. Epub 2020 Jul 6.
Tumor-related epilepsy may respond to chemotherapy. In a previously-published multi-centre randomized clinical trial of 562 elderly glioblastoma patients, temozolomide plus short-course radiotherapy conferred a survival benefit over radiotherapy alone. Seizure outcomes were not reported.
We performed an unplanned secondary analysis of this trial's data. The trial design has been previously reported. Seizures were recorded by clinicians as adverse events and by patients in quality of life questionnaires. A Chi-square test of seizure rates between the two groups (α = 0.05) and a Kaplan-Meier estimator of time-to-first self-reported seizure were planned.
Almost all patients were followed until they died. In the radiotherapy alone group, 68 patients (24%) had a documented or self-reported seizure versus 83 patients (30%) in the temozolomide plus radiotherapy group, Chi-square analysis showed no difference (p = 0.15). Patients receiving radiotherapy alone tended to develop seizures earlier than those receiving temozolomide plus radiotherapy (p = 0.054). Patients with seizures had shorter overall survival than those without seizures (hazard ratio 1.24, p = 0.02).
This study was not powered to detect differences in seizure outcomes, but temozolomide seemed to have minimal impact on seizure control in elderly patients with glioblastoma.
NCT00482677 2007-06-05.
肿瘤相关性癫痫可能对化疗有反应。在之前发表的一项多中心随机临床试验中，562 名老年胶质母细胞瘤患者接受替莫唑胺联合短程放疗与单纯放疗相比具有生存获益。未报告癫痫发作结果。
我们对该试验的数据进行了计划外的二次分析。试验设计先前已报道。癫痫发作由临床医生作为不良事件记录，由患者在生活质量问卷中记录。两组之间的癫痫发作率的卡方检验（α=0.05）和首次自我报告癫痫发作的 Kaplan-Meier 估计值的计划。
几乎所有患者都随访到死亡。在单独接受放疗的组中，68 名患者（24%）有记录或自我报告的癫痫发作，而接受替莫唑胺联合放疗的组中，83 名患者（30%）有记录或自我报告的癫痫发作，卡方分析显示无差异（p=0.15）。单独接受放疗的患者比接受替莫唑胺联合放疗的患者更早发生癫痫发作（p=0.054）。有癫痫发作的患者的总生存时间短于无癫痫发作的患者（风险比 1.24，p=0.02）。
本研究没有足够的能力来检测癫痫发作结果的差异，但替莫唑胺似乎对老年胶质母细胞瘤患者的癫痫发作控制影响较小。
NCT00482677 2007-06-05。
