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Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice.
Shi, Wenyin; Blumenthal, Deborah T; Oberheim Bush, Nancy Ann; Kebir, Sied; Lukas, Rimas V; Muragaki, Yoshihiro; Zhu, Jay-Jiguang; Glas, Martin.
Afiliación
  • Shi W; Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, 19107, USA. Wenyin.Shi@jefferson.edu.
  • Blumenthal DT; Neuro-Oncology Unit, Division of Oncology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • Oberheim Bush NA; Department of Neurological Surgery and Neurology, University of California San Francisco, San Francisco, CA, USA.
  • Kebir S; Division of Clinical Neurooncology, Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
  • Lukas RV; West German Cancer Center, German Cancer Consortium, Partner Site Essen, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
  • Muragaki Y; Department of Neurology, Northwestern University, Chicago, IL, USA.
  • Zhu JJ; Lou & Jean Malnati Brain Tumor Institute at the Lurie Comprehensive Cancer Center, Northwestern University, Chicago, USA.
  • Glas M; Faculty of Advanced Techno-Surgery, Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University, Tokyo, Japan.
J Neurooncol ; 148(3): 489-500, 2020 Jul.
Article en En | MEDLINE | ID: mdl-32535723
INTRODUCTION: Tumor Treating Fields (TTFields; antimitotic treatment) delivers low-intensity, intermediate-frequency, alternating electric fields through skin-applied transducer arrays. TTFields (200 kHz) was FDA-approved in glioblastoma (GBM), based on the phase 3 EF-11 (recurrent GBM, rGBM) and EF-14 (newly diagnosed GBM, ndGBM) trials. The most common TTFields-related adverse event (AE) in both trials was array-associated skin irritation. We now report on TTFields-related AEs in the real-world, clinical practice setting. METHODS: Unsolicited, post-marketing surveillance data from TTFields-treated patients (October 2011-February 2019) were retrospectively analyzed using MedDRA v21.1 preferred terms, stratified by region (US, EMEA [Europe, Middle East, Africa], Japan), diagnosis (ndGBM, rGBM, anaplastic astrocytoma/oligodendroglioma, other brain tumors), and age (< 18 [pediatric], 18-64 [adults], ≥ 65 [elderly]; years of age). RESULTS: Of 11,029 patients, 53% were diagnosed with ndGBM and 39% were diagnosed with rGBM at any line of disease recurrence. Most were adults (73%), 26% were elderly, and the male-to-female ratio was ~ 2:1 (close to published ratios of typical GBM populations). The most commonly reported TTFields-related AE was array-associated skin reaction, occurring in patients with ndGBM (38%), rGBM (29%), anaplastic astrocytoma/oligodendroglioma (38%), and other brain tumors (31%); as well as 37% of pediatric, 34% of adult, and 36% of elderly patients. Most skin AEs were mild/moderate and manageable. Other TTFields-related AEs in patients with ndGBM/rGBM included under-array heat sensation (warmth; 11%, 10%, respectively) and electric sensation (tingling; 11%, 9%, respectively), and headache (7%, 6%, respectively). CONCLUSIONS: This TTFields safety surveillance analysis in > 11,000 patients revealed no new safety concerns, with a favorable safety profile comparable with published TTFields/GBM trials. The safety profile remained consistent among subgroups, suggesting feasibility in multiple populations, including elderly patients.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Pautas de la Práctica en Medicina / Neoplasias Encefálicas / Terapia por Estimulación Eléctrica / Seguridad del Paciente / Glioma Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Límite: Adolescent / Adult / Aged / Aged80 / Child / Child, preschool / Female / Humans / Male / Middle aged Idioma: En Revista: J Neurooncol Año: 2020 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 / Pautas de la Práctica en Medicina / Neoplasias Encefálicas / Terapia por Estimulación Eléctrica / Seguridad del Paciente / Glioma Tipo de estudio: Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Límite: Adolescent / Adult / Aged / Aged80 / Child / Child, preschool / Female / Humans / Male / Middle aged Idioma: En Revista: J Neurooncol Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos