Study: Electric Fields Skull Cap Improves Brain Cancer Survival
Bartlett resident Joyce Endresen was “shocked” when she was diagnosed with glioblastoma multiforme, an aggressive form of brain cancer.
“I didn’t expect anything like that to ever happen. I didn’t know anything about the disease at that time,” said Endresen, whose diagnosis came in December 2014 after doctors discovered a 6.5-centimeter tumor in her brain.
Each year, up to 20,000 people in the United States are diagnosed with glioblastoma, says Dr. Roger Stupp, a neuro-oncologist at Northwestern University who conducted the study while working for the University Hospital of Zurich.
Unfortunately, there is no cure for the disease; the majority of patients die within one to two years. But a new study offers hope: When used in conjunction with other treatments, a skull-worn medical device that delivers low-intensity electrical fields increased patient survival rates an average of five months.
“When I first started, less than 10 percent of patients with glioblastoma were alive at five years (after diagnosis). Now we’re at 12 to 15 percent,” Stupp said.
“The last time any form of treatment was shown to improve survival for patients with this disease was more than 10 years ago, when adding temozolomide (chemotherapy) to radiotherapy was shown to improve two-year survival rate from 10 percent to 27 percent.”
The device, dubbed Optune by the oncology company Novocure, delivers low-intensity, intermediate frequency alternating electric fields to disrupt the division of cancer cells through adhesive patches applied to a patient’s shaved head.
“If you perturb a cell with electric fields during its growing and dividing process, the cell can’t appropriately divide,” Stupp said. “Cells that do not properly divide have mechanisms built in them that will ultimately destroy themselves.”
Unlike other treatments, such as surgery or chemotherapy, the device delivers continuous treatment.
“If you have surgery, you come in and the surgery is done on a specific day, or if you have chemotherapy, it’s given over an hour or two. This is continuous exposure,” Stupp said of the device. “The majority of patients have it on 18 hours a day.”
The device is designed to be used indefinitely, said Stupp. Patients do take breaks from the treatment, he said, to take vacations or allow their skin to heal from any irritation caused from using the device.
The electric fields produced from the device can cause patients to feel a warming sensation on their skull and can irritate the skin, Stupp said. “Patients interrupt their treatment, allow the skin to recover, use a local ointment (on the skull) – it’s never a major issue.”
Endresen has been using the device since April 2015 and wears it openly. “I never cover it. I do put a light color hat on it to keep the sun off of it but I don’t wear a wig or cap every day,” she said.
Like most new technologies, Optune comes at a cost -- $21,000 per month, according to a company representative. The list price covers the device and transducer arrays, training and ongoing support, among other services.
“Novocure works with GBM (glioblastoma multiforme) patients to ensure access to Optune therapy, and to date, all patients prescribed Optune therapy have been able to access it,” a company representative said in a statement.
Endresen says her insurance covers nearly all of the cost except roughly $1,500 per year.
Study results, criticisms
Last week, Stupp presented the results of the latest trial studying the effectiveness of the device at the American Association for Cancer Research conference.
Nearly 700 adults who were diagnosed with glioblastoma participated in the yearslong study. After undergoing surgery or biopsy when feasible, participants received radiotherapy and chemotherapy.
Participants were randomly selected to receive treatment with the Optune device in addition to maintenance chemotherapy (466 patients received treatment via Optune while 229 only received chemotherapy). Those that did not receive the Optune treatment were not given a sham or placebo treatment, such as a device that did not emit the electric fields.
Placebos are commonly used in studies to help researchers understand the effectiveness of a new treatment and check for any side effects.
Stupp, who conducted the study and received travel assistance from Novocure, addressed criticisms of the lack of a sham treatment.
“It’s not feasible to really have a sham device without people realizing really quickly that it’s not real even if we heated the electrodes a little bit,” Stupp said. “Anyone who’s remotely tech savvy could figure out whether there’s a current or not.
“Also, we felt it was not ethical to impose a device and lying to the patients that we are administering this. ... There are not guinea pigs. We’re not experimenting on patients. We’re trying to treat them as best we can and to learn something from treating these patients.”
Median overall survival for patients receiving treatment via Optune was 20 months, compared with 15 months for those only receiving chemotherapy.
Survival rates for patients receiving Optune were 43 percent versus 31 percent for patients only receiving chemotherapy at two years; 26 percent versus 16 percent at three years, 20 percent versus 8 percent at four years, and 13 percent versus 5 percent at five years.
“We can tell we have improvement in progression of the disease and survival that were statistically significant,” Stupp said. “A substantial number of patients live longer and live well despite the disease. It also shows we don’t cure them yet, the curve still goes down. We still lose patients.
“That’s why at Northwestern we have a tremendous team we put together to further investigate and research to come up with better treatments in the future.”
As for Endresen, she’s been tumor free since December 2014. She says multiple factors could be the reason for her health, including early diagnosis and surgery, a tumor that responded well to chemotherapy and the use of Optune.
“I feel good. I’m doing most things I used to do,” she said. “I’ve been working full time with no medical leave since May 2015.”
Follow Kristen Thometz on Twitter: @KristenThometz
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