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

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.

Tumor treating fields for newly diagnosed high‐grade glioma based on the criteria of 2021 WHO CNS5: A retrospective analysis of Chinese patients in a single center

“… 39 Due to its favorable tolerability, TTFields therapy can be combined with maintenance chemotherapy or targeted therapy in patients with newly diagnosed brain tumors following surgical resection and radiotherapy. 40 …”

“…39 Due to its favorable tolerability, TTFields therapy can be combined with maintenance chemotherapy or targeted therapy in patients with newly diagnosed brain tumors following surgical resection and radiotherapy. 40 As a non-invasive and anti-mitotic treatment modality, TTFields received FDA approval in 2011 for recurrent GBM and in 2015 for newly diagnosed GBM. It has since been used in clinical practice in Europe, Japan, and Hong Kong, China.…”

Efficacy of tumour-treating fields therapy in recurrent glioblastoma: A narrative review of current evidence

“…[ 73 ] Exploring TTFields therapy in pediatric patients with malignant brain tumors further affirmed its safety, with limited harmful effects recorded. [ 74 ] Insights from experts regarding dermatologic adverse events tied to TTFields therapy highlighted manageable skin events as the most common concern, addressable through topical interventions. [ 75 ] TTFields therapy exhibits a favorable safety profile, predominantly characterized by mild-to-moderate skin-related side effects.…”

“…In light of the limitations of conventional therapies for pediatric Central Nervous System malignancies, TTFields therapy emerges as a noninvasive avenue warranting exploration. [ 74 ] TTFields therapy demonstrated efficacy and safety in treating newly diagnosed Glioblastoma in Japanese patients, showcasing its potential as a patient-centered treatment option. [ 72 ] Acknowledging and incorporating patient opinions and preferences is pivotal for optimizing the utilization of TTFields therapy.…”

Identification and validation of COL6A1 as a novel target for tumor electric field therapy in glioblastoma

“…Tumor electric field therapy (TEFT) represents the only innovative modality approved and incorporated into the National Comprehensive Cancer Network (NCCN) guidelines for GBM in the past decade. 5 , 6 It utilizes low‐intensity (1–3 V/cm), intermediate‐frequency (100–300 kHz), alternating electric fields to generate non‐uniform fields that disrupt late‐stage mitotic spindle formation during cytokinesis, causing cell cycle arrest and apoptosis of tumor cells. 7 , 8 , 9 As such, TEFT exerts potent inhibitory effects on highly proliferative cells, with minimal impact on normal tissues.…”