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Global post­marketing safety surveillance of Tumor Treating Fields (TTFields) therapy in over 25,000 patients with CNS malignancies treated between 2011-2022.
Mrugala, Maciej M; Shi, Wenyin; Iwomoto, Fabio; Lukas, Rimas V; Palmer, Joshua D; Suh, John H; Glas, Martin.
Afiliación
  • 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.
J Neurooncol ; 169(1): 25-38, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38949692
ABSTRACT

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.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Terapia por Estimulación Eléctrica Límite: Adolescent / Adult / Aged / Aged80 / Child / Child, preschool / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: J Neurooncol Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Terapia por Estimulación Eléctrica Límite: Adolescent / Adult / Aged / Aged80 / Child / Child, preschool / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: J Neurooncol Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos