Evidence map›Paper›PMID 34692470›Full record

ArticleFrontiers in oncology2021

Efficacy and Safety of Tumor Treating Fields (TTFields) in Elderly Patients with Newly Diagnosed Glioblastoma: Subgroup Analysis of the Phase 3 EF-14 Clinical Trial.

Zvi Ram, Chae-Yong Kim, Andreas F Hottinger, Ahmed Idbaih, Garth Nicholas, Jay-Jiguang Zhu

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00916409 (A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% 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.

NCT00916409 phase3completednot on this map

A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

TypeinterventionalSponsorNovoCure Ltd.Ran2009 to 2017Enrolled700ConditionsGlioblastoma MultiformeArmsNovoTTF-100A device, Temozolomide
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Management of glioblastoma in the elderly.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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  5. Review
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  7. Article
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  14. Glioblastoma Therapy: Past, Present and Future.International journal of molecular sciences · 2024
    Review
  15. Treatment advances in high-grade gliomas.Frontiers in oncology · 2024
    Review
  16. Review
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  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 6 institutions in 6 countries.

Zvi RamDepartment of Neurosurgery, Tel Aviv Medical Center and Tel Aviv University School of Medicine, Tel Aviv, Israel.
Chae-Yong KimDepartment of Neurosurgery, Seoul National University College of Medicine, Seoul, South Korea.
Andreas F HottingerDepartment of Clinical Neuroscience, CHUV Lausanne University Hospital & University of Lausanne, Lausanne, Switzerland.
Ahmed IdbaihService de Neurologie 2-Mazarin, Sorbonne Université, Inserm, CNRS, UMR S 1127, Institut du Cerveau, ICM, AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Service de Neurologie 2-Mazarin, Paris, France.
Garth NicholasDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.
Jay-Jiguang ZhuDepartment of Neurosurgery, University of Texas Health Science Center at Houston, Houston, TX, United States.
Institut du Cerveau · FRSeoul National University · KRTel Aviv Sourasky Medical Center · ILThe University of Texas Health Science Center at Houston · USUniversity of Lausanne · CHWilfrid Laurier University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUnderstudied elderly patients comprise a large segment of high-risk patients with glioblastoma (GBM) that are challenging to treat. Tumor Treating Fields (TTFields) is a locoregional, noninvasive, antimitotic therapy delivering low-intensity, intermediate-frequency alternating electric fields to the tumor. In the phase 3 EF-14 clinical trial, TTFields (200 kHz) improved median progression-free survival (PFS) and median overall survival (OS) in patients with newly diagnosed GBM (ndGBM) when added concomitantly to maintenance temozolomide (TMZ). This EF-14 subgroup analysis evaluated the safety and efficacy of TTFields in elderly patients.

methodsAll 134 patients who are ≥65 years of age were included (TTFields/TMZ combination, n=89; TMZ monotherapy, n=45; 2:1 ratio of randomization). PFS and OS were analyzed using Kaplan-Meier methodology (α=0.05). Health-related quality-of-life (HRQoL) was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire QLQ-C30 supplemented with the brain tumor module (QLQ-BN20). Adverse events (AEs) were evaluated using Common Terminology Criteria for AEs (CTCAE) v4.0.

resultsThe PFS was 6.5 months in patients randomized to the treatment group with TTFields/TMZ combination

conclusionsCombining TTFields with maintenance TMZ significantly improved PFS and OS in elderly patients with ndGBM in the phase 3 EF-14 clinical trial, without significant increases in systemic toxicity or negatively affecting patient HRQoL. TTFields-related skin AEs were low-grade and manageable. CLINICAL

trial registrationhttps://clinicaltrials.gov/ct2/show/NCT00916409, identifier: NCT00916409.

Indexed as

efficacy and safetyelderly patientsnewly diagnosed glioblastomaphase 3 clinical trialquality-of-lifetemozolomideTTFieldsTumor Treating Fields

Identifiers

PMID34692470
PMCPMC8526342
OpenAlexW3204055340

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.