Abstract
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.
Highlights
The glioblastoma (GBM), the highest grade of malignant astrocytoma, is one of the most aggressive types of malignant tumor as well as the most common primary central nervous system (CNS) tumor in adults
alternating electric fields (AEF), which are applied in various situations both in daily life and the clinical setting, show a wide range of effects on living tissue depending on their frequency
The United States (US) clinical trial ACNS0126, which evaluated the efficacy of the standard, multidisciplinary treatment comprising surgical resection and chemoradiotherapy with TMZ followed by TMZ maintenance therapy, resulted in a three-year survival rate of 22% and a three-year progression-free survival (PFS) of 11% in all the subjects, including those with GBM and high-grade glioma (HGG) [5]
Summary
The glioblastoma (GBM), the highest grade of malignant astrocytoma, is one of the most aggressive types of malignant tumor as well as the most common primary central nervous system (CNS) tumor in adults. According to the Central Brain Tumor Registry of the United States (CBTRUS), GBM accounts for 14.5% of all primary CNS tumors (n= 415,411 in five years) while the proportion decreases to 2.9% in children and adolescents aged 0–19 years (n= 20,105 in five years) [1]. The median survival time is reportedly eight months according to the CBTRUS registry and approximately 15 months in selected patients in clinical trials [3,4]. Pediatric clinical trials are often conducted with eligibility criteria for both high-grade glioma (World Health Organization [WHO] classification grade 3) and GBM (grade 4), the prognosis of the patients is as poor as that of adults [5]. The same strategies used for adult GBM are usually applied to pediatric patients in clinical practice [5]. The present review article describes the introduction of this novel treatment modality and discusses its application to the treatment of pediatric brain tumors
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