LONG-TERM POST-MARKETING SURVEILLANCE DATA FROM ELDERLY PATIENTS WITH CENTRAL NERVOUS SYSTEM MALIGNANCIES TREATED WITH TUMOR TREATING FIELDS (TTFIELDS) THERAPY
نویسندگان
چکیده
Abstract AIMS Glioblastoma (GBM) has a poor prognosis, which is compounded by an increase in treatment-related toxicity with age. TTFields are electric fields that exert physical forces to disrupt cellular processes critical for cancer cell viability. Subgroup analysis of the phase 3 EF-14 study demonstrated therapy be well-tolerated patients ≥65 years newly diagnosed (nd) GBM. We report safety data elderly from global post- marketing surveillance (PMS) central nervous system (CNS) malignancies receiving TTFields. METHOD PMS was collected (October 2011–March 2022) North America, Europe, Middle East, Africa, and Japan. Adverse events (AEs) were categorized using MedDRA version 25.1. RESULTS Overall, 25,898 included (diagnoses: ndGBM [68%], recurrent GBM [26%], anaplastic astrocytoma/oligodendroglioma [4%], other [2%]). Of these, 7808 (30%) (>65 years). 75% experienced ≥1 AE, 57% related TTFields; comparable frequencies overall population (73% 56%, respectively). The most common AE skin reaction (45%; population: 43%). Incidence fall fracture 1% <1%, respectively. ‘quality-of-life decreased’ 2% (elderly overall). No systemic toxicities reported, regardless age group. CONCLUSIONS These real-world demonstrate tolerable profile CNS malignancies, consistent subgroup EF-14, no new signals. Most AEs localised, manageable, mild–moderate reactions.
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ژورنال
عنوان ژورنال: Neuro-oncology
سال: 2023
ISSN: ['1523-5866', '1522-8517']
DOI: https://doi.org/10.1093/neuonc/noad147.007