Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial
| Autor: | Jay-Jiguang Zhu, Manmeet Ahluwalia, Sun Ha Paek, Steven Brem, Francesco Di Meco, David M. Steinberg, Zvi Ram, Steven A. Toms, Chae-Yong Kim, Garth Nicholas, David Tran, Andreas F. Hottinger, Andrew A. Kanner, Ahmed Idbaih, Giuseppe Stragliotto, Gitit Lavy-Shahaf, Michael Weller, Eilon D. Kirson, Frank S. Lieberman, Uri Weinberg, Monika E. Hegi, Yoram Palti, Sophie Taillibert, Roger Stupp, H Hirte, William L. Read, Benoit Lhermitte, Jordi Burna, Karen Fink |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Oncology
Organelle assembly Adult Male medicine.medical_specialty Population Mitosis Electric Stimulation Therapy Disease-Free Survival law.invention Maintenance Chemotherapy 03 medical and health sciences Aged Antineoplastic Agents Alkylating/adverse effects Antineoplastic Agents Alkylating/therapeutic use Chemoradiotherapy Dacarbazine/adverse effects Dacarbazine/analogs & derivatives Dacarbazine/therapeutic use Female Follow-Up Studies Glioblastoma/drug therapy Glioblastoma/radiotherapy Glioblastoma/surgery Humans Middle Aged Survival Analysis 0302 clinical medicine Randomized controlled trial law Internal medicine Temozolomide Medicine education Antineoplastic Agents Alkylating Survival analysis Original Investigation education.field_of_study Brain Neoplasms business.industry General Medicine Interim analysis Clinical trial Dacarbazine 030220 oncology & carcinogenesis Quality of Life business Glioblastoma 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | JAMA, vol. 318, no. 23, pp. 2306-2316 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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