Artikel
Safety and adverse event profile of tumour treating fields use in the EMEA region – a real-world data analysis
Sicherheitsprofil von Tumortherapiefeldern (TTFields) in der EMEA Region – Datenanalyse aus der klinischen Routine
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Autoren
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Martin Glas
- Universitätsklinikum Essen, Klinik für Neuroonkologie, Essen, Deutschland; Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland
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Sied Kebir
- Universitätsklinikum Essen, Klinik für Neuroonkologie, Essen, Deutschland; Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland
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Lazaros Lazaridis
- Universitätsklinikum Essen, Klinik für Neuroonkologie, Essen, Deutschland; Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland
| Veröffentlicht: | 8. Mai 2019 |
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Gliederung
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Objective: Tumor treating fields (TTFields) are an established treatment for glioblastoma (GBM) that affects rapidly dividing glioma cells through the action of low-intensity, intermediate frequency (200kHz) alternating electric fields. TTFields are administered to GBM patients using the Optune® system, designed to minimize the impact of treatment on daily activities and health related quality of life. The efficacy of TTFields in newly diagnosed GBM (ndGBM) was demonstrated in the EF-14 phase 3 trial (n=695). Optune + temozolomide significantly improved survival compared to temozolomide alone (median OS: 20.9 vs 16.0 months).
Methods: This retrospective analysis evaluated the surveillance data on patients within the EMEA region by country (Germany, Switzerland, Israel, and other EMEA countries), who received treatment with Optune from 2011 to April 2018. Adverse events (AEs) reported to the Novocure safety department were analyzed based on the MedDRA body system (system organ class) preferred terms.
Results: Globally, a total of 8025 patients were treated with Optune (ndGBM 46.1%, recurrent GBM 46.2%, other 7.7%) of whom 1496 (19%) patients were treated in the EMEA region. As expected, skin reaction was the most prevalent adverse event affecting 25% of patients in this cohort. Other AEs included general decline in health (24%), nervous system disorders (18%), injury at any location (5%), gastrointestinal disorders (4%), and musculoskeletal disorders (3%).
Conclusion: This retrospective analysis demonstrates the safety profile of Optune in an EMEA patient cohort. The most common adverse event registered was skin reaction, which was also found in the phase 3 EF-11 trial for recurrent GBM and in the EF-14 trial for ndGBM patients. No other device-related adverse events were reported. There were no meaningful differences in the reported incidences of AEs across the EMEA countries. In summary, these results emphasize the safety of Optune in GBM treatment and its consequent adoption in the EMEA region.
