Makimoto Atsushi, Nishikawa Ryo, Terashima Keita, Kurihara Jun, Fujisaki Hiroyuki, Ihara Satoshi, Morikawa Yoshihiko, Yuza Yuki
Department of Hematology/Oncology, Tokyo Metropolitan Children's Medical Center, 2-8-29, Musashidai, Fuchu, Tokyo 183-8561, Japan.
Clinical Research Support Center, Tokyo Metropolitan Children's Medical Center, 2-8-29, Musashidai, Fuchu, Tokyo 183-8561, Japan.
Neurol Int. 2021 Apr 8;13(2):151-165. doi: 10.3390/neurolint13020015.
Tumor-treating fields (TTFields) are alternating electric fields applied continuously to the brain by attaching two-pair arrays on the scalp. Although TTFields therapy has demonstrated efficacy against supratentorial glioblastoma (GBM) in adults, its safety and efficacy in children have not been confirmed. Despite differences in the genetic etiology of the adult and pediatric forms of GBM, both have certain clinical behaviors in common, allowing us to test TTFields therapy in pediatric GBM. Recently, several, pediatric case-series using TTFields therapy have been published, and a few, prospective, pediatric studies are ongoing. Because GBMs are extremely rare in pediatric patients, where they comprise a wide variety of genetic subtypes, these pediatric studies are feasibility studies targeting various types of malignant brain tumor. Although they are important for confirming the safety and feasibility of TTFields therapy in the pediatric population, confirming its efficacy against each type of pediatric brain tumor, including the GBM, is difficult. Our clinical research team, therefore, planned an investigator-initiated clinical trial targeting pediatric supratentorial GBMs (as in adults) with the aim of expanding regulatory approval of TTFields therapy for pediatric GBM treatment based on safety and exploratory efficacy data in combination with the accumulated evidence on adult GBMs.
肿瘤治疗电场（TTFields）是通过在头皮上附着双对电极阵列持续施加于脑部的交变电场。尽管TTFields疗法已在成人幕上胶质母细胞瘤（GBM）的治疗中显示出疗效，但其在儿童中的安全性和疗效尚未得到证实。尽管成人和儿童形式的GBM在遗传病因上存在差异，但两者具有某些共同的临床行为，这使我们能够在儿童GBM中测试TTFields疗法。最近，已经发表了几项使用TTFields疗法的儿科病例系列，并且一些前瞻性儿科研究正在进行中。由于GBM在儿科患者中极为罕见，且包含多种遗传亚型，这些儿科研究是针对各种类型恶性脑肿瘤的可行性研究。尽管它们对于确认TTFields疗法在儿科人群中的安全性和可行性很重要，但要确认其对包括GBM在内的每种儿科脑肿瘤类型的疗效却很困难。因此，我们的临床研究团队计划开展一项由研究者发起的针对儿童幕上GBM（与成人情况相同）的临床试验，目的是基于安全性和探索性疗效数据，结合成人GBM的累积证据，扩大TTFields疗法用于儿童GBM治疗的监管批准范围。
