Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice
Open accessAbstract
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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Data from clinical trials and extensive safety studies in healthy animals have shown that TTFields are not associated with significant systemic toxicities.
“Although we have not tested the effect of TTFields on cytoskeletal architecture of non-cancerous cells, data from clinical trials and extensive safety studies in healthy animals have shown that TTFields are not associated with significant systemic toxicities [7,37].”
From Tumor Treating Fields (TTFields) Hinder Cancer Cell Motility through Regulation of Microtubule and Actin Dynamics (2020) · cites this paper as [37]
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- Authors
- Shi, W., Blumenthal, D. T., Oberheim Bush, N. A., Kebir, S., Lukas, R. V., Muragaki, Y., Zhu, J.-J., & Glas, M.
- Affiliations
- Thomas Jefferson University (US)
- Tel Aviv University (IL)
- Essen University Hospital (DE)
- Northwestern University (US)
- Tokyo Women's Medical University (JP)
- Memorial Hermann (US)
- Corresponding author
- Shi, Wenyin
- ORCID
- Venue
- Journal of Neuro-Oncology
- Published
- 2020-06-13
- Volume
- 148
- Issue
- 3
- Pages
- 489-500
- ISSN
- 0167-594X (ISSN-L)
- 1573-7373
- PMC
- PMC7438370
- OpenAlex
- W3034397908
- Cited by
- 61
- References
- 44
- Citations by year
- 2026: 8 · 2025: 6 · 2024: 9 · 2023: 8 · 2022: 18 · 2021: 10 · 2020: 2
- FWCI
- 4.91
- Type
- journal article
- Language
- en
- Update notices
- correction (2021-01-04)
- Open access
- hybrid
- doi.org
- Locations
- Journal of Neuro-Oncology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Funders
- Novocure Inc
- Topics
- Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biophysics › Electromagnetic Fields and Biological Effects
- Keywords
- fields, tumor treating fields, glioblastoma, high-grade glioma, adverse events, skin irritation, post-marketing surveillance, real-world clinical practice, anaplastic astrocytoma, oligodendroglioma, brain tumors, antimitotic therapy, heat sensation, headache, pediatric patients, elderly patients, safety profile
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Brain Neoplasms, Child, Child, Preschool, Electric Stimulation Therapy, Female, Follow-Up Studies, Glioma, Humans, Male, Middle Aged, Practice Patterns, Physicians', Product Surveillance, Postmarketing, Retrospective Studies, Global Health, Young Adult, Neoplasm Grading, Patient Safety
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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