The safety profile of Tumor Treating Fields (TTFields) therapy in glioblastoma patients with ventriculoperitoneal shunts
| العنوان: | The safety profile of Tumor Treating Fields (TTFields) therapy in glioblastoma patients with ventriculoperitoneal shunts |
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| المؤلفون: | Nancy Ann Oberheim-Bush, Wenyin Shi, Michael W. McDermott, Alexander Grote, Julia Stindl, Leonardo Lustgarten |
| المصدر: | Journal of neuro-oncology, vol 158, iss 3 |
| بيانات النشر: | Springer Science and Business Media LLC, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Cancer Research, Oncology and Carcinogenesis, Neurosciences, TTFields, Ventriculoperitoneal Shunt, Brain Disorders, Brain Cancer, Tumor Treating Fields therapy, Neoplasm Recurrence, Rare Diseases, Local, Neurology, Oncology, Humans, Oncology & Carcinogenesis, Neurology (clinical), Neoplasm Recurrence, Local, Safety, Glioblastoma, Hydrocephalus, Retrospective Studies, Cancer |
| الوصف: | Introduction Tumor Treating Fields (TTFields, 200 kHz) therapy is a noninvasive, locoregional cancer treatment approved for use in newly diagnosed glioblastoma (GBM), recurrent GBM, and malignant pleural mesothelioma. GBM patients with hydrocephalus may require implantation of a ventriculoperitoneal (VP) shunt, however, the current TTFields therapy label does not include the use of VP shunts in GBM patients due to insufficient safety data. This analysis evaluates the safety of TTFields therapy use in this population. Methods Unsolicited post-marketing global surveillance data from patients with GBM and a VP shunt (programmable/non-programmable) who received TTFields therapy between November 2012–April 2021 were retrospectively analyzed. Adverse events (AEs) were assessed using the Medical Dictionary for Regulatory Activities version 24.0. Results Overall, 156 patients with VP shunts were identified and included in this analysis. In total, 77% reported ≥ 1 AE; the most common TTFields therapy-related AEs were non-serious and localized, beneath-array skin AEs (43%). The incidence and categories of AEs were comparable between patients with or without VP shunts. Six patients with VP shunts experienced seven serious TTFields therapy-related AEs: skin erosion at the shunt site (n = 3); wound dehiscence at the shunt site (n = 2) and at the resection scar (n = 2). No shunt malfunctions were deemed related to TTFields therapy. Conclusions In the real-world setting, TTFields therapy in GBM patients with VP shunts demonstrated good tolerability and a favorable safety profile. There was no evidence that TTFields therapy disrupted VP shunt effectiveness. These results suggest TTFields therapy may be safely used in patients with VP shunts. |
| وصف الملف: | application/pdf |
| تدمد: | 1573-7373 0167-594X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d566af62e703b535a15ac0c4e3865b36Test https://doi.org/10.1007/s11060-022-04033-4Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d566af62e703b535a15ac0c4e3865b36 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15737373 0167594X |
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