NCMP-21. REAL-WORLD SURVEILLANCE DATA FOR TUMOR TREATING FIELDS AFFIRM THE TOLERABILITY OF TUMOR TREATING FIELDS FOR THE TREATMENT OF GLIOBLASTOMA IN THE UNITED STATES

Abstract

INTRODUCTION: Tumor treating fields (TTFields) are a non-invasive, anti-mitotic therapy for the treatment of recurrent and newly diagnosed glioblastoma (GBM) and were approved for each indication in the United States (US) in 2011 and 2015, respectively, based on efficacy and safety data from the EF-11 and EF-14 clinical trials). In both trials, the most common adverse effect (AE) associated with TTFields therapy were mild to moderate skin toxicity underneath the transducer arrays of the Optune device. US postmarketing surveillance data collected for recurrent and newly diagnosed GBM patients treated with TTFields were analyzed to assess the real-world safety profile of TTFields for GBM. METHODS: A review of the clinical information for recurrent and newly diagnosed GBM treated with TTFields in the United States identified 6,494 patients. The safety data obtained from post-market surveillance in all 6,494 patients were analyzed to identify AEs based on the MedDRA body system (system organ class) preferred terms. RESULTS: Forty five percent (2,941/6,494) of GBM patients experienced at least 1 AE while receiving TTFields treatment. Patients reporting general AEs include: 9% electric sensations, 4% fatigue, 9% heat sensation and 5% pain reported pain in any location. Nervous system AEs included headache (6%) and seizure (8%). The most common AE were skin reactions that were reported by 1,807 patients (28%). CONCLUSIONS: Analysis of real-world safety data for TTFields treatment in the US did not reveal any new safety signals for TTFields in the treatment of recurrent or newly diagnosed GBM. The most common AE related to TTFields were skin irritation under the transducer arrays. Skin reactions can be managed with topical treatments and slight adjustment of the transducer arrays to minimize skin irritation. Analyses of post-marketing US safety data corroborate the tolerability of TTFields for GBM patients observed in the Phase 3 clinical trials.