BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSION 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. CLINICAL TRIALS Clinicaltrials.gov Identifier: NCT00916409.

中文翻译：

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肿瘤治疗领域加替莫唑胺治疗新诊断的胶质母细胞瘤：EF-14 3 期试验中韩国患者的亚组分析。

背景技术肿瘤治疗场(TTFields)是抗有丝分裂、非侵入性局部区域癌症治疗，包括低强度、中频交变电场。在 EF-14 试验中，与单独使用 TMZ 相比，TTFields 加替莫唑胺 (TTFields/TMZ) 在新诊断的胶质母细胞瘤 (GBM) 患者中延长了生存期。我们报告了参加 EF-14 试验的韩国新诊断的 GBM 患者。方法 EF-14 试验的 39 名参与者在韩国的 8 个地点登记。患者（24 个 TTFields/TMZ；仅 14 个 TMZ）接受： TTFields (200 kHz) > 18 小时/天；TMZ 120-150 毫克，持续 5 天，每 28 天一个周期。评估了安全性和有效性。结果 两组患者基线特征平衡，平均年龄为 52.1 岁，66.7% 为男性，平均 KPS 为 90。两组的安全发生率相当。在 TTFields/TMZ 组中，30% 的人患有皮肤刺激，而在整个研究人群中为 52%。没有报告与 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)，而单独使用 TMZ 为 4.2 (95% CI 1.9-11.2) (p = 0.67)。TTFields/TMZ 的中位总生存期为 27.2 个月（95% CI 21-NA），而单独使用 TMZ 的中位总生存期为 15.2 个月（95% CI 7.5-24.1；HR 0.27，p = 0.01）。结论 TTFields/TMZ 的中位 OS 和 1 年和 2 年生存率更高，并且与整个 EF-14 人群相似。大约 30% 的患者报告有皮肤刺激，低于整个 EF-14 人群的比例。这些结果证明了 TTFields 在韩国新诊断的胶质母细胞瘤患者中的有效性和安全性。