OS5.5 Surveillance data demonstrates the tolerability of tumor treating fields in pediatric glioma patients. (19th September 2018) - Kinzel, A
Abstract: Background: There are few treatment options for pediatric patients with high grade gliomas Adult patients with newly diagnosed or recurrent glioblastoma multiforme have the option of treatment with tumor treating fields (TTFields), which have shown efficacy and safety in Phase 3 randomized trials. TTFields are a noninvasive anti-mitotic therapy administered via transducer arrays strategically arranged on the shaved scalp. TTFields are not approved for the treatment of high grade glioma in pediatric patients. Post-marketing surveillance data were collected for pediatric glioma patients receiving TTFields. Compiled safety data are presented for patients <18 years receiving TTFields for the treatment of glioma. Material and Methods: A review of the clinical information for pediatric patients (<18 years of age) treated with TTFields in the United States and Europe identified 30 patients. The safety data obtained from post-market surveillance in all 30 patients were analyzed to identify adverse events (AEs) based on the MedDRA body system (system organ class) preferred terms. Results: Sixteen (53%) pediatric patients experienced at least 1 AE while receiving TTFields treatment. Patients reported general AEs include: electric sensations in 10% (3/30); fatigue in 10% (3/30), heat sensation in 10% (3/30) and 17% reported pain (5/30) in any location. Nervous system AEs included headache (10%), seizure (7%) and balance disorder (7%). The most common AE were skin reactions that were reported by 7 patients (23%). One patient reported hyperhidrosis (3%). Conclusion: There were no unexpected AEs associated with TTFields in pediatric patients. The most frequently reported AEs were skin reactions likely related to the placement of TTFields transducers on the scalp; incidence was comparable to the rate of skin reactions reported in adult GBM patients. The tolerability of TTFields in pediatric patients from this post-marketing surveillance data support further investigations to assess efficacy and safety of TTFields in pediatric glioma patients.