Department of Neurosurgery, Seoul National University College of Medicine, Seoul, South Korea.
Neuro-Oncology Division of Department of Neurosurgery, SNU Bundang Comprehensive Cancer Hospital and Bundang Clinical Neuro-Science Institute, Seoul National University Bundang Hospital, Seongnam, South Korea.
J Neurooncol. 2020 Feb;146(3):399-406. doi: 10.1007/s11060-019-03361-2. Epub 2020 Feb 4.
Tumor treating fields (TTFields) are anti-mitotic, non-invasive loco-regional cancer therapy comprising low intensity, intermediate frequency alternating electric fields. TTFields plus Temozolomide (TTFields/TMZ) extended survival versus TMZ alone in newly diagnosed glioblastoma (GBM) patients in the EF-14 trial. We report on Korean newly diagnosed GBM patients who participated in the EF-14 trial.
Thirty-nine participants of the EF-14 trial were enrolled at 8 sites in South Korea. Patients (24 TTFields/TMZ; 14 TMZ alone) received: TTFields (200 kHz) for > 18 h/day; TMZ at 120-150 mg for 5 days per a 28 day cycle. Safety and efficacy were assessed.
Patient baseline characteristics were balanced in the 2 arms and the mean age was 52.1 years, 66.7% were male with a mean KPS of 90. Safety incidence was comparable between the 2 arms. In the TTFields/TMZ arm, 30% suffered from skin irritation versus 52% in the entire study population. No TTFields-related serious adverse events were reported. The median progression-free survival (PFS) in the TTFields/TMZ arm was 6.2 months (95% CI 4.2-12.2) versus 4.2 (95% CI 1.9-11.2) with TMZ alone (p = 0.67). Median overall survival was 27.2 months (95% CI 21-NA) with TTFields/TMZ versus 15.2 months (95% CI 7.5-24.1; HR 0.27, p = 0.01) with TMZ alone.
Median OS and 1- and 2-year survival rates were higher with TTFields/TMZ and similar to the entire EF-14 population. About 30% of patients reported skin irritation, a lower rate than seen in the entire EF-14 population. These results demonstrate the efficacy and safety of TTFields in Korean newly diagnosed glioblastoma patients.
Clinicaltrials.gov Identifier: NCT00916409.
肿瘤治疗电场（TTFields）是一种抗有丝分裂、非侵入性的局部区域癌症治疗方法，包括低强度、中频交替电场。在 EF-14 试验中，TTFields 联合替莫唑胺（TTFields/TMZ）与单独使用 TMZ 相比，延长了新诊断胶质母细胞瘤（GBM）患者的生存期。我们报告了参加 EF-14 试验的韩国新诊断 GBM 患者的情况。
在韩国的 8 个地点招募了 39 名 EF-14 试验的参与者。患者（24 名 TTFields/TMZ；14 名 TMZ 单独使用）接受：每天超过 18 小时的 TTFields（200 kHz）；TMZ 剂量为 120-150mg，每 28 天周期使用 5 天。评估安全性和疗效。
两组患者的基线特征平衡，平均年龄为 52.1 岁，66.7%为男性，平均 KPS 为 90。两组的安全性发生率相当。在 TTFields/TMZ 组，30%的患者出现皮肤刺激，而整个研究人群中这一比例为 52%。未报告与 TTFields 相关的严重不良事件。TTFields/TMZ 组的中位无进展生存期（PFS）为 6.2 个月（95%CI 4.2-12.2），而 TMZ 单独组为 4.2 个月（95%CI 1.9-11.2）（p=0.67）。TTFields/TMZ 组的中位总生存期为 27.2 个月（95%CI 21-NA），而 TMZ 单独组为 15.2 个月（95%CI 7.5-24.1；HR 0.27，p=0.01）。
TTFields/TMZ 组的中位总生存期和 1 年及 2 年生存率均高于 TMZ 单独组，与整个 EF-14 人群相似。约 30%的患者报告出现皮肤刺激，这一比例低于整个 EF-14 人群。这些结果表明 TTFields 在韩国新诊断胶质母细胞瘤患者中的疗效和安全性。
Clinicaltrials.gov 标识符：NCT00916409。
