Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial
Open accessAbstract
Importance: Tumor-treating fields (TTFields) is an antimitotic treatment modality that interferes with glioblastoma cell division and organelle assembly by delivering low-intensity alternating electric fields to the tumor. Objective: To investigate whether TTFields improves progression-free and overall survival of patients with glioblastoma, a fatal disease that commonly recurs at the initial tumor site or in the central nervous system. Design, Setting, and Participants: In this randomized, open-label trial, 695 patients with glioblastoma whose tumor was resected or biopsied and had completed concomitant radiochemotherapy (median time from diagnosis to randomization, 3.8 months) were enrolled at 83 centers (July 2009-2014) and followed up through December 2016. A preliminary report from this trial was published in 2015; this report describes the final analysis. Interventions: Patients were randomized 2:1 to TTFields plus maintenance temozolomide chemotherapy (n = 466) or temozolomide alone (n = 229). The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device. Temozolomide was administered to both groups (150-200 mg/m2) for 5 days per 28-day cycle (6-12 cycles). Main Outcomes and Measures: Progression-free survival (tested at α = .046). The secondary end point was overall survival (tested hierarchically at α = .048). Analyses were performed for the intent-to-treat population. Adverse events were compared by group. Results: Of the 695 randomized patients (median age, 56 years; IQR, 48-63; 473 men [68%]), 637 (92%) completed the trial. Median progression-free survival from randomization was 6.7 months in the TTFields-temozolomide group and 4.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the TTFields-temozolomide group vs 16.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Systemic adverse event frequency was 48% in the TTFields-temozolomide group and 44% in the temozolomide-alone group. Mild to moderate skin toxicity underneath the transducer arrays occurred in 52% of patients who received TTFields-temozolomide vs no patients who received temozolomide alone. Conclusions and Relevance: In the final analysis of this randomized clinical trial of patients with glioblastoma who had received standard radiochemotherapy, the addition of TTFields to maintenance temozolomide chemotherapy vs maintenance temozolomide alone, resulted in statistically significant improvement in progression-free survival and overall survival. These results are consistent with the previous interim analysis. Trial Registration: clinicaltrials.gov Identifier: NCT00916409.
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In newly diagnosed glioblastoma, 200 kHz TTFields combined with adjuvant temozolomide prolonged median overall survival by 4.9 months and median progression-free survival by 2.7 months compared with adjuvant temozolomide alone.
“Based on the results of a phase III clinical trial that showed 200 kHz TTFields in combination with adjuvant temozolomide chemotherapy prolonged the median overall survival (OS) in newly diagnosed GBM patients by 4.9 months (and prolonged median progression-free survival [PFS] by 2.7 months) compared to adjuvant temozolomide alone”
From Permeabilizing Cell Membranes with Electric Fields (2021) · cites this paper as [12]
The 5-year overall survival rate increased from 5% to 13% in the glioblastoma patient arm receiving 200 kHz TTFields.
“Of note, the 5-year OS rate increased from 5% to 13% in the glioblastoma patient arm receiving 200 kHz TTFields [12].”
From Permeabilizing Cell Membranes with Electric Fields (2021) · cites this paper as [12]
The overall survival benefit from adding 200 kHz TTFields was maintained across glioblastoma patient subgroups defined by MGMT promoter methylation status, extent of resection, region, age, Karnofsky performance score, and sex.
“The OS benefit due to the addition of 200 kHz TTFields therapy was maintained regardless of glioblastoma patient subgroup, i.e., MGMT promoter methylation status, extent of resection (biopsy, partial, gross total), region (U.S. vs. non-U.S.), age (<65 vs. ≥65 years), Karnofsky performance score (90–100 vs. ≤80), and sex [12].”
From Permeabilizing Cell Membranes with Electric Fields (2021) · cites this paper as [12]
Heat energy increases with increasing frequency and reaches maximal values at frequency ranges where TTFields have optimal anti-cancer efficacy, such as 200 kHz for glioblastoma and 150 kHz for pleural malignant mesothelioma.
“Heat energy increases with increasing frequency and reaches maximal values at frequency ranges where TTFields have optimal anti-cancer efficacy (e.g., 200 kHz for glioblastoma and 150 kHz for pleural malignant mesothelioma [12,13,59]).”
From Permeabilizing Cell Membranes with Electric Fields (2021) · cites this paper as [12]
TTFields has been shown to prolong median survival by 5 months in glioblastoma patients on maintenance temozolomide chemotherapy.
“Most recently, TTFields has been shown to prolong median survival (by 5 months) of glioblastoma patients on maintenance temozolomide chemotherapy2,9.”
From Tumor treating fields increases membrane permeability in glioblastoma cells (2018) · cites this paper as [2]
TTFields compliance (≥75% vs. <75%) was an independent predictor of overall survival in the retrospective analysis of the full EF-14 trial dataset, and duration of TTFields use also affected overall survival.
“TTFields compliance (≥75% vs. <75%) was an independent predictor of overall survival in the retrospective analysis of the full EF-14 trial dataset2 and the duration of use of TTFields was also found to affect overall survival60.”
From Tumor treating fields increases membrane permeability in glioblastoma cells (2018) · cites this paper as [2]
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- Authors
- Stupp, R., Taillibert, S., Kanner, A., Read, W., Steinberg, D. M., Lhermitte, B., Toms, S., Idbaih, A., Ahluwalia, M. S., Fink, K., Di Meco, F., Lieberman, F., Zhu, J.-J., Stragliotto, G., Tran, D. D., Brem, S., Hottinger, A. F., Kirson, E. D., Lavy-Shahaf, G., Weinberg, U., Kim, C.-Y., Paek, S.-H., Nicholas, G., Bruna, J., Hirte, H., Weller, M., Palti, Y., Hegi, M. E., & Ram, Z.
- Affiliations
- University of Zurich (CH)
- Centre National de la Recherche Scientifique (FR)
- Tel Aviv Sourasky Medical Center (IL)
- Emory University (US)
- Tel Aviv University (IL)
- Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland
- Geisinger Health System (US)
- Inserm U 1127, CNRS UMR 7225, Sorbonne Universités, UPMC Univ Paris 06 UMR S 1127, Institut du Cerveau et de la Moelle épinière, ICM, F-75013, Paris, France
- Cleveland Clinic (US)
- Baylor University Medical Center, Houston, Texas
- Istituto Nazionale Neurologico Carlo Besta, Milan, Italy
- University of Pittsburgh Medical Center (US)
- Tufts Medical Center (US)
- Karolinska University Hospital (SE)
- Barnes-Jewish Hospital (US)
- Moffitt Cancer Center (US)
- Centre Hospitalier Universitaire Vaudois (CH)
- Novocure Ltd, Israel
- Seoul National University (KR)
- Ottawa Hospital Research Institute (CA)
- Bellvitge University Hospital (ES)
- Juravinski Cancer Centre (CA)
- Corresponding author
- Stupp, Roger
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2017-12-19
- Volume
- 318
- Issue
- 23
- Pages
- 2306
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5820703
- OpenAlex
- W2778283729
- Cited by
- 2,644
- References
- 29
- Citations by year
- 2026: 304 · 2025: 368 · 2024: 397 · 2023: 377 · 2022: 363 · 2021: 324 · 2020: 250 · 2019: 168 · 2018: 90 · 2016: 1
- FWCI
- 79.80
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- SERVAL (Université de Lausanne) (publishedVersion, other-oa)
- IRIS (submittedVersion)
- HAL (submittedVersion)
- Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Funders
- Bristol-Myers Squibb
- Pfizer
- AstraZeneca
- Teva Pharmaceutical Industries
- Celldex Therapeutics
- Novocure
- Acceleron
- Five Prime Therapeutics
- Incyte
- NRG Oncology
- Servier
- Genentech
- Pharmacyclics
- National Cancer Institute
- UCB Pharma
- Topics
- Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biophysics › Electromagnetic Fields and Biological Effects
- Physical Sciences › Mathematics › Modeling and Simulation › Mathematical Biology Tumor Growth
- Keywords
- tumor treating fields, glioblastoma, temozolomide, maintenance chemotherapy, AC electric field, progression-free survival, overall survival, adjuvant therapy, adverse events, central nervous system relapse, antimitotic therapy, quality of life, patient-reported outcomes, fatigue
- MeSH terms
- Temozolomide, Adult, Aged, Dacarbazine, Electric Stimulation Therapy, Female, Follow-Up Studies, Glioblastoma, Humans, Male, Middle Aged, Mitosis, Survival Analysis, Disease-Free Survival, Antineoplastic Agents, Alkylating, Chemoradiotherapy, Maintenance Chemotherapy
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