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

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 over...

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Published in:JAMA : the journal of the American Medical Association 2017-12, Vol.318 (23), p.2306-2316
Main Authors: Stupp, Roger, Taillibert, Sophie, Kanner, Andrew, Read, William, Steinberg, David M, Lhermitte, Benoit, Toms, Steven, Idbaih, Ahmed, Ahluwalia, Manmeet S, Fink, Karen, Di Meco, Francesco, Lieberman, Frank, Zhu, Jay-Jiguang, Stragliotto, Giuseppe, Tran, David D, Brem, Steven, Hottinger, Andreas F, Kirson, Eilon D, Lavy-Shahaf, Gitit, Weinberg, Uri, Kim, Chae-Yong, Paek, Sun-Ha, Nicholas, Garth, Bruna, Jordi, Hirte, Hal, Weller, Michael, Palti, Yoram, Hegi, Monika E, Ram, Zvi
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Agents, Alkylating - adverse effects
Antineoplastic Agents, Alkylating - therapeutic use
Brain cancer
Cell division
Central nervous system
Chemoradiotherapy
Chemotherapy
Clinical trials
Dacarbazine - adverse effects
Dacarbazine - analogs & derivatives
Dacarbazine - therapeutic use
Disease-Free Survival
Electric fields
Electric Stimulation Therapy
Female
Follow-Up Studies
Glioblastoma
Glioblastoma - drug therapy
Glioblastoma - radiotherapy
Glioblastoma - surgery
Humans
Maintenance
Maintenance Chemotherapy
Male
Middle Aged
Mitosis
Nervous system
Original Investigation
Patients
Portable equipment
Scalp
Skin
Statistical analysis
Survival
Survival Analysis
Temozolomide
Toxicity
Tumors
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Summary: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 
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2017.18718