肿瘤治疗场 (TTFields) 是破坏癌细胞过程的交变电场。 TTFields 疗法被批准用于治疗复发性胶质母细胞瘤 (rGBM) 和新诊断的 (nd) GBM（联合替莫唑胺治疗 ndGBM；美国）以及 IV 级胶质瘤 (EU)。我们对接受 TTFields 治疗的中枢神经系统恶性肿瘤患者进行了更新的全球上市后监测安全性分析。安全性数据是从北美、欧洲、以色列和日本患者的常规上市后活动中收集的（2011 年 10 月至 2022 年 10 月） ）。不良事件 (AE) 按年龄、性别和诊断进行分层。总共纳入了 25,898 名患者（诊断：ndGBM [68%]、rGBM [26%]、间变性星形细胞瘤/少突胶质细胞瘤 [4%]、其他 CNS 恶性肿瘤 [2 %]）。中位年龄（范围）为 59（3-103）岁； 66%的患者是男性。大多数 (69%) 患者年龄在 18-65 岁之间； 0.4% 年龄 < 18 岁； 30% 的年龄> 65 岁。全因和 TTFields 相关 AE 分别发生在 18,798 名 (73%) 和 14,599 名 (56%) 患者中。最常见的与治疗相关的 AE 是阵列下皮肤反应 (43%)、电感（刺痛感；14%）和热感（温暖感；12%）。儿童（39%）、成人（42%）和老年（45%）组以及男性（41%）和女性（46%）中与治疗相关的皮肤反应具有可比性；诊断亚组之间的情况相似（ndGBM，46%；rGBM，34%；间变性星形细胞瘤/少突胶质细胞瘤，42%；其他，40%）。没有报告与 TTFields 相关的系统性 AE。这项针对超过 25,000 名患者的长期、真实世界分析证明了 TTFields 在 CNS 恶性肿瘤患者中具有良好的耐受性。大多数与治疗相关的 AE 是可控制的局部非严重皮肤事件。 TTFields 治疗安全性在各个亚组（年龄、性别和诊断）中保持一致，表明其广泛的适用性。© 2024。作者。

Tumor Treating Fields (TTFields) are alternating electric fields that disrupt cancer cell processes. TTFields therapy is approved for recurrent glioblastoma (rGBM), and newly-diagnosed (nd) GBM (with concomitant temozolomide for ndGBM; US), and for grade IV glioma (EU). We present an updated global, post-marketing surveillance safety analysis of patients with CNS malignancies treated with TTFields therapy.Safety data were collected from routine post-marketing activities for patients in North America, Europe, Israel, and Japan (October 2011-October 2022). Adverse events (AEs) were stratified by age, sex, and diagnosis.Overall, 25,898 patients were included (diagnoses: ndGBM [68%], rGBM [26%], anaplastic astrocytoma/oligodendroglioma [4%], other CNS malignancies [2%]). Median (range) age was 59 (3-103) years; 66% patients were male. Most (69%) patients were 18-65 years; 0.4% were < 18 years; 30% were > 65 years. All-cause and TTFields-related AEs occurred in 18,798 (73%) and 14,599 (56%) patients, respectively. Most common treatment-related AEs were beneath-array skin reactions (43%), electric sensation (tingling; 14%), and heat sensation (warmth; 12%). Treatment-related skin reactions were comparable in pediatric (39%), adult (42%), and elderly (45%) groups, and in males (41%) and females (46%); and similar across diagnostic subgroups (ndGBM, 46%; rGBM, 34%; anaplastic astrocytoma/oligodendroglioma, 42%; other, 40%). No TTFields-related systemic AEs were reported.This long-term, real-world analysis of > 25,000 patients demonstrated good tolerability of TTFields in patients with CNS malignancies. Most therapy-related AEs were manageable localized, non-serious skin events. The TTFields therapy safety profile remained consistent across subgroups (age, sex, and diagnosis), indicative of its broad applicability.© 2024. The Author(s).