DOI: 10.1097/01.NT.0000480945.19098.7e

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Issn Print: 1533-7006

Publication Date: 2016/02/04


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A Device Emitting Low-Intensity Alternative Electrical Fields Along with Chemotherapy Significantly Prolonged Survival and Progression–Free Status in Glioblastoma, New Study Finds

Jamie Talan

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Excerpt

A therapeutic device that delivers low-intensity alternating electrical fields to the brains of patients with glioblastoma along with temozolomide (TMZ) chemotherapy increased survival and progression-free status in glioblastoma patients, a new analysis found. At two years follow-up, 43 percent of patients in the group that received both maintenance therapies were still alive, compared with 29 percent in those who were only on TMZ.
The addition of a therapeutic device that delivers low-intensity alternating electrical fields to the brains of patients with glioblastoma (GBM) along with chemotherapy increased survival by an average of three months, according to a study published in the December 15, 2015, issue of the Journal of the American Medical Association.
In order to receive the tumor-treating fields (TTFields), people have their skulls shaved and wear four sets of electrode arrays (a total of 36 electrodes) that cover the whole brain. The arrays are attached to a battery-operated device that delivers the electrical fields; it must be worn 18-hours a day and charged continuously.
A planned interim analysis found a significant difference in patients randomized to receive maintenance temozolomide (TMZ) alone and those who were administered the same chemotherapy plus TTFields, marketed as Optune. The analysis is based on the first 315 patients who have been followed for at least 18 months since randomization; commonly, by that time, the majority of patients will have progressed or died of the disease.
The analysis showed a 26 percent reduced risk of death (HR 0.74, 95% CI 0.56-0.98), which translated to a two-year survival rate of 43 percent in patients on TMZ and TTFields, compared with 29 percent in patients on TMZ alone. Based on these results, the independent data monitoring committee recommended that the trial be closed and results made publicly available.
In preclinical studies, TTFields interfered with tumor growth by interrupting or blocking cell division and organelle assembly, ultimately leading to apoptosis.
In October 2015, the US Food and Drug Association (FDA) used these data to approve the use of TTFields as an adjunct therapy for patients newly diagnosed with GBM. The device was initially tested in a clinical trial of 237 patients with recurrent GBM who eceived either TTFields therapy or the best standard of care alone, but not both combined. The overall survival was the same in both groups and the side effects were minimal. With few treatment options for patients, the FDA approved it for recurrent GBM in 2011.
Still, neuro-oncologists have been slow to embrace the novel device. Roger Stupp, MD, a professor and chairman of the department of oncology and the Cancer Center at the University of Zurich and University Hospital Zurich, and the lead investigator of both studies, is hoping that the new findings reported in JAMA will put an end to the skepticism. “I think this is the new standard of care,” he said. “We just need to figure out how best to implement it and find the right patients who would get value from using it.”
Novocure, a company in Portsmouth, NH, developed and sells the device.
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