Goldman Stewart, Margol Ashley, Hwang Eugene I, Tanaka Kazuhiro, Suchorska Bogdana, Crawford John R, Kesari Santosh
Phoenix Children's Hospital, University of Arizona College of Medicine, Phoenix, AZ, United States.
Children's Hospital Los Angeles, Keck School of Medicine of University of Southern California, Los Angeles, CA, United States.
Front Oncol. 2022 Jul 29;12:958637. doi: 10.3389/fonc.2022.958637. eCollection 2022.
There is an unmet need to develop effective and tolerable treatments for pediatric patients with malignant central nervous system tumors. This is especially essential for pediatric patients with aggressive brain tumors such as high-grade gliomas, which have a typical survival rate of under 2 years. Tumor Treating Fields (TTFields) are locoregional, noninvasive electric fields that produce an antimitotic effect on cancerous cells when applied to the skin arrays. TTFields therapy (200 kHz) is currently approved in adult patients with newly diagnosed glioblastoma (GBM), with temozolomide, and recurrent GBM as monotherapy. Positive preclinical and clinical data have encouraged off-label use of TTFields therapy in pediatric patients with brain tumors, and this study aims to explore the safety of TTFields therapy in pediatric patients (0-18 years of age) based on data from an unsolicited post-marketing surveillance safety database. The real-world data reported here demonstrate that TTFields therapy has a favorable safety profile for pediatric patients with brain tumors, with no new safety signals observed. Findings from this study warrant further research into the efficacy of TTFields therapy, as well as its potential impact on the quality of life in pediatric patients.
对于患有恶性中枢神经系统肿瘤的儿科患者，开发有效且耐受性良好的治疗方法仍存在未满足的需求。这对于患有侵袭性脑肿瘤（如高级别胶质瘤）的儿科患者尤为重要，这类肿瘤的典型生存率不到2年。肿瘤治疗电场（TTFields）是一种局部区域的非侵入性电场，当应用于皮肤阵列时，会对癌细胞产生抗有丝分裂作用。TTFields疗法（200kHz）目前已被批准用于新诊断的胶质母细胞瘤（GBM）成年患者，与替莫唑胺联合使用，以及复发性GBM的成年患者作为单一疗法。临床前和临床的阳性数据促使TTFields疗法在患有脑肿瘤的儿科患者中进行了超说明书用药，本研究旨在基于一个主动提交的上市后监测安全数据库的数据，探讨TTFields疗法在儿科患者（0至18岁）中的安全性。此处报告的真实世界数据表明，TTFields疗法对患有脑肿瘤的儿科患者具有良好的安全性，未观察到新的安全信号。本研究的结果值得进一步研究TTFields疗法的疗效，以及其对儿科患者生活质量的潜在影响。
