Article
TTFields in anaplastic meningioma – surveillance safety analysis
TTFields beim anaplastischen Meningeom – Surveillance-Analyse zur Verträglichkeit
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Authors
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Christian Mawrin
- Otto-von-Guericke-Universität Magdeburg, Institut für Neuropathologie, Magdeburg, Deutschland
| Published: | June 4, 2021 |
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Outline
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Objective: Anaplastic meningioma is the most malignant type of meningioma, characterized by aggressive intracranial growth. Only few treatment options exist to date for patients suffering from this tumour. For another malignant intracranial tumour with limited treatment options – glioblastoma – an additional treatment modality has been established in recent years: alternating electric fields, called TTFields, generated by a portable device and applied to the tumour via arrays attached to the scalp. The effect of this treatment modality has been studied already in patient-derived meningioma cells and demonstrated decreased cell proliferation. Clinical trials are currently under way to analyse safety and efficacy of TTFields in meningioma patients. This analysis aims at collating data on safety of TTFields in anaplastic meningioma patients monitored within the scope of post-marketing surveillance.
Methods: Unsolicited safety data of anaplastic meningioma patients treated with TTFields were evaluated in the context of post-marketing surveillance and were systematically analyzed for this study. The MedDRA body system (system organ class (SOC) and preferred terms) was utilized. Data cut-off was October 31, 2020.
Results: Out of more than 17,000 TTFields-treated patients, 34 patients were treated with TTFields for anaplastic meningioma diagnosis in Germany, Israel, and the USA to date. Ten patients were female (29%), 24 were male (71%); their median age was 57 years (range 26-74 years). In total, 61 adverse events (AE) were reported, with 18 patients reporting at least one AE. Of those 61 AEs, 39 were assessed to be potentially related to TTFields therapy. The most commonly reported AEs were electric sensation (9 patients, 26%) and skin reactions (7 patients, 21%). There were no serious adverse events related to TTFields reported.
Conclusion: This safety surveillance analysis of patients with anaplastic meningioma treated with TTFields revealed no serious systemic adverse events associated with TTFields and no new safety signals, supporting safe use of TTFields in this tumour type. Prospective, randomized clinical trials are needed to further shed light on safety and efficacy of TTFields in anaplastic meningioma.
