Global post‑marketing safety surveillance of Tumor Treating Fields (TTFields) therapy in over 25,000 patients with CNS malignancies treated between 2011-2022.

Autor: Mrugala MM; Mayo Clinic College of Medicine and Science, Mayo Clinic, Phoenix/Scottsdale, Arizona, USA. Mrugala.Maciej@mayo.edu., Shi W; Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, USA., Iwomoto F; Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center, New York, NY, USA., Lukas RV; Department of Neurology, Northwestern University, Chicago, IL, USA., Palmer JD; The Department of Radiation Oncology, The James Cancer Hospital, Ohio State University Wexner Medical Center, Columbus, OH, USA., Suh JH; Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA., Glas M; Division of Clinical Neurooncology, Department of Neurology, University Hospital Essen, University Duisburg-Essen, West German Cancer Center (WTZ) and German Cancer Consortium, Partner Site, Essen, Germany.
Jazyk: angličtina
Zdroj: Journal of neuro-oncology [J Neurooncol] 2024 Aug; Vol. 169 (1), pp. 25-38. Date of Electronic Publication: 2024 Jun 29.
DOI: 10.1007/s11060-024-04682-7
Abstrakt: Background: Tumor Treating Fields (TTFields) are alternating electric fields that disrupt cancer cell processes. TTFields therapy is approved for recurrent glioblastoma (rGBM), and newly-diagnosed (nd) GBM (with concomitant temozolomide for ndGBM; US), and for grade IV glioma (EU). We present an updated global, post-marketing surveillance safety analysis of patients with CNS malignancies treated with TTFields therapy.
Methods: Safety data were collected from routine post-marketing activities for patients in North America, Europe, Israel, and Japan (October 2011-October 2022). Adverse events (AEs) were stratified by age, sex, and diagnosis.
Results: Overall, 25,898 patients were included (diagnoses: ndGBM [68%], rGBM [26%], anaplastic astrocytoma/oligodendroglioma [4%], other CNS malignancies [2%]). Median (range) age was 59 (3-103) years; 66% patients were male. Most (69%) patients were 18-65 years; 0.4% were < 18 years; 30% were > 65 years. All-cause and TTFields-related AEs occurred in 18,798 (73%) and 14,599 (56%) patients, respectively. Most common treatment-related AEs were beneath-array skin reactions (43%), electric sensation (tingling; 14%), and heat sensation (warmth; 12%). Treatment-related skin reactions were comparable in pediatric (39%), adult (42%), and elderly (45%) groups, and in males (41%) and females (46%); and similar across diagnostic subgroups (ndGBM, 46%; rGBM, 34%; anaplastic astrocytoma/oligodendroglioma, 42%; other, 40%). No TTFields-related systemic AEs were reported.
Conclusions: This long-term, real-world analysis of > 25,000 patients demonstrated good tolerability of TTFields in patients with CNS malignancies. Most therapy-related AEs were manageable localized, non-serious skin events. The TTFields therapy safety profile remained consistent across subgroups (age, sex, and diagnosis), indicative of its broad applicability.
(© 2024. The Author(s).)
Databáze: MEDLINE
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