Safety of Tumor Treating Fields (TTFields) therapy in pediatric patients with malignant brain tumors: Post-marketing surveillance data

Stewart Goldman; Ashley Margol; Eugene I Hwang; Kazuhiro Tanaka; Bogdana Suchorska; John R Crawford; Santosh Kesari

doi:10.3389/fonc.2022.958637

Safety of Tumor Treating Fields (TTFields) therapy in pediatric patients with malignant brain tumors: Post-marketing surveillance data

Front Oncol. 2022 Jul 29:12:958637. doi: 10.3389/fonc.2022.958637. eCollection 2022.

Authors

Stewart Goldman¹, Ashley Margol², Eugene I Hwang³, Kazuhiro Tanaka⁴, Bogdana Suchorska⁵, John R Crawford⁶, Santosh Kesari⁷

Affiliations

¹ Phoenix Children's Hospital, University of Arizona College of Medicine, Phoenix, AZ, United States.
² Children's Hospital Los Angeles, Keck School of Medicine of University of Southern California, Los Angeles, CA, United States.
³ Department of Oncology, Children's National Hospital, Washington, DC, United States.
⁴ Department of Neurosurgery, Kobe University, Kobe, Japan.
⁵ Department of Neurosurgery, Sana Kliniken Duisburg, Duisburg, Germany.
⁶ Department of Neurology, Children's Health of Orange County, Orange County, CA, United States.
⁷ Providence Southern California Research Clinical Institute, Saint John's Cancer Institute, Pacific Neuroscience Institute, Los Angeles, CA, United States.

Abstract

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 via 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.

Keywords: Tumor Treating Fields; adolescents; brain tumor; glioblastoma; pediatric; safety.