Evidence map›Paper›PMID 32535723›Full record

ArticleJournal of neuro-oncology2020

Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice.

Wenyin Shi, Deborah T Blumenthal, Nancy Ann Oberheim Bush, Sied Kebir, Rimas V Lukas, Yoshihiro Muragaki, Jay-Jiguang Zhu, Martin Glas

Erratum issuedOpen access · hybridAbstract read
In one paragraph

Article in Journal of neuro-oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Neuromodulation in Neuro-Oncology: A Scoping Review.Journal of personalized medicine · 2026
    Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Testing the effects of topical skin care products on Tumor Treating Fields (TTFields) adhesiveness of arrays and delivery of electric currents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  10. The therapeutic efficacy and application prospects of tumor-treating fields (TTFields) in resolving malignant tumors of central nervous system.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  11. Review
  12. Association of tumor treating fields (TTFields) therapy with overall survival in newly diagnosed glioblastoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. [Simulation model of tumor-treating fields].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2024
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 4 countries.

Wenyin ShiDepartment of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, 19107, USA. Wenyin.Shi@jefferson.edu.ORCID http://orcid.org/0000-0002-6336-3912
Deborah T BlumenthalNeuro-Oncology Unit, Division of Oncology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Nancy Ann Oberheim BushDepartment of Neurological Surgery and Neurology, University of California San Francisco, San Francisco, CA, USA.
Sied KebirDivision of Clinical Neurooncology, Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Rimas V LukasDepartment of Neurology, Northwestern University, Chicago, IL, USA.
Yoshihiro MuragakiFaculty of Advanced Techno-Surgery, Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University, Tokyo, Japan.
Jay-Jiguang ZhuMcGovern Medical School and Memorial Hermann Hospital at Texas Medical Center, University of Texas Health Science Center at Houston, Houston, TX, USA.
Martin GlasDivision of Clinical Neurooncology, Department of Neurology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Essen University Hospital · DEMemorial Hermann · USNorthwestern University · USTel Aviv University · ILThomas Jefferson University · USTokyo Women's Medical University · JPUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTumor 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.

methodsUnsolicited, 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).

resultsOf 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).

conclusionsThis 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.

Indexed as

Patient SafetyAdolescentAdultAgedAged, 80 and overBrain NeoplasmsChildChild, PreschoolElectric Stimulation TherapyFemaleFollow-Up StudiesGliomaGlobal HealthHumansMaleMiddle AgedGlioblastomaReal-worldSafety surveillanceSkin adverse eventsTolerabilityTTFields

Identifiers

PMID32535723
PMCPMC7438370
OpenAlexW3034397908

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.