Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial.

Détails

Ressource 1Télécharger: jama.pdf (587.03 [Ko])
Etat: Public
Version: Final published version
ID Serval
serval:BIB_868908B10151
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial.
Périodique
JAMA
Auteur(s)
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., Burna J., Hirte H., Weller M., Palti Y., Hegi M.E., Ram Z.
ISSN
1538-3598 (Electronic)
ISSN-L
0098-7484
Statut éditorial
Publié
Date de publication
19/12/2017
Peer-reviewed
Oui
Volume
318
Numéro
23
Pages
2306-2316
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Résumé
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.
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.
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.
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).
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.
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.
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.
clinicaltrials.gov Identifier: NCT00916409.

Mots-clé
Adult, Aged, Antineoplastic Agents, Alkylating/adverse effects, Antineoplastic Agents, Alkylating/therapeutic use, Chemoradiotherapy, Dacarbazine/adverse effects, Dacarbazine/analogs & derivatives, Dacarbazine/therapeutic use, Disease-Free Survival, Electric Stimulation Therapy, Female, Follow-Up Studies, Glioblastoma/drug therapy, Glioblastoma/radiotherapy, Glioblastoma/surgery, Humans, Maintenance Chemotherapy, Male, Middle Aged, Mitosis, Survival Analysis
Pubmed
Web of science
Open Access
Oui
Création de la notice
22/12/2017 11:30
Dernière modification de la notice
20/08/2019 14:45
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