Artikel
TTFields in WHO grade III glioma – post-marketing surveillance analysis suggests favourable tolerance
TTFields in WHO Grad III Gliomen – Post-Marketing Surveillance-Analyse spricht für gute Verträglichkeit
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Autoren
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Almuth F. Keßler
- Universitätsklinikum Würzburg, Abteilung für Neurochirurgie, Würzburg, Deutschland
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Rainer Ritz
- Schwarzwald-Baar Klinikum, Klinik für Neurochirurgie, Villingen-Schwenningen, Deutschland
| Veröffentlicht: | 26. Juni 2020 |
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Gliederung
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Objective: Even with meaningful advancements in the molecular classification as well as growing data for specific therapy regimens, grade III glioma treatment is yet indistinct. Usually, this entity is treated similar to grade IV glioma: with resection and radio/chemotherapy. Tumour treating fields (TTFields) therapy is approved to treat newly diagnosed and recurrent glioblastoma and is also used by some physicians to treat patients with a grade III glioma. Further evaluation of the use of TTFields in grade III glioma is currently the subject of different clinical trials. This present study analysed safety data from post-marketing surveillance of TTFields treated grade III glioma patients in Germany to assess tolerance.
Methods: Available post-marketing surveillance data of patients treated with TTFields were revised. Reported adverse events (AEs) of grade III glioma patients (anaplastic astrocytoma and anaplastic oligodendroglioma) were investigated according to the MedDRA body system with system organ classes (SOCs) and preferred terms. Data cut-off was November 15, 2019.
Results: At data cut-off, a total number of 120 patients (32 % female, 68 % male) with grade III glioma were treated in Germany and were therefore included in the present analysis. Of those, 66 % reported one or more AEs. The most common reported AE was skin reactions with an incidence of 34 %. AEs related to the nervous system were reported by 30 %, comprising headache in 8 % and seizure in 12 %. 28 % of the patients reported general disorders, most of them (14 %) general physical health deterioration.
Conclusion: Our analysis of data on TTFields treated patients with grade III glioma from post-marketing surveillance in Germany revealed no serious adverse events related to TTFields and thus no reportable events in this subgroup. The incidence of skin reaction, the most common AE related to TTFields reported in the phase III trials for newly diagnosed (EF-14) and recurrent glioblastoma (EF-11) were seen similarly in this surveillance analysis of grade III glioma patients. Currently active clinical trials in this patient subgroup will contribute further to our understanding of safety and efficacy of TTFields therapy in grade III glioma.
