Dr. Eric Wong, a neurologist with an engineering background, had a hunch that an experimental scalp device to treat brain tumors using electromagnetic fields would work. But some other researchers scoffed at Wong, co-director of the tumor center at Beth Israel Deaconess Medical Center.
Doctors at Dana-Farber Cancer Institute, for example, rejected Wong’s request in 2010 to join a study of the device in patients with glioblastomas — the deadly type of brain cancer that killed Senator Edward M. Kennedy — because they doubted the electromagnetic fields could penetrate the skull.
So Wong wound up referring patients to other facilities — Tufts Medical Center and Lahey Hospital — participating in a study of the device, called Optune, in newly diagnosed glioblastoma patients.
Wong’s hunch gained considerable traction in November, with promising results from the first 315 patients enrolled in those trials: Those patients randomly assigned to use the device, along with standard chemotherapy and radiation, lived for 19.6 months, on average, compared with 16.6 months for those who used standard treatments alone.
An independent monitoring board confirmed the results and ordered the trial stopped early — highly unusual for a brain tumor treatment. In early December, the US Food and Drug Administration allowed all of the patients enrolled in the study to switch to the promising device.
Executives from Novocure, the company that makes Optune, said they expect to receive FDA approval for use of the device within the next year as a first-line treatment for 10,000 US patients newly diagnosed with glioblastomas every year. Novocure’s US office is in Portsmouth, N.H., and it has 100 employees.
“I don’t want to give patients false hope since these are still very difficult to treat tumors,” said Wong, who received a grant from the company to help run the study of the device. “But in the short term, the device provides a longer period of tumor control.”
Despite the company’s name, Novocure’s device does not present a potential cure for this highly aggressive form of brain cancer. The study results, however, have convinced some initial skeptics that the device has therapeutic potential.
“We plan to offer it going forward,” if it is approved by the FDA, said the director of neuro-oncology at Dana-Farber, Dr. Patrick Wen, who served on the board that reviewed and rejected Wong’s research proposal several years ago. “It increased overall survival by about three months. That’s not a huge amount of time, but it’s not trivial for our patients.”
Patients such as Robert De Robertis.
After wearing Optune for 10 months as part of the study, De Robertis, a 52-year-old engineer who works in Andover, said he plans to continue using it indefinitely to help prevent a recurrence of his glioblastoma.
“I feel doing something is better than doing nothing,” he said. His work colleagues, he added, have gotten used to him wearing a skullcap to work to cover the bandages.
Optune was approved by the FDA three years ago for use only in patients with recurrent glioblastomas, but Wen said it doesn’t offer any survival advantage over standard treatments in those cases. It also costs $21,000 a month, which some insurers, including Medicare, refuse to cover.
The sophisticated system involves covering a shaved scalp with insulated electrical transducers, which transform electricity into electromagnetic energy. The transducer devices are affixed to the skin with wide overlapping bandages, giving the appearance of a high-tech shower cap. Electromagnetic fields — generated from electricity produced via a 6-pound battery pack that patients carry on their backs — pass through the skull and brain tissue, and target rapidly reproducing tumor cells, disrupting their delicate process of cell division.
The electromagnetic fields don’t damage the brain’s healthy neurons and anatomical structures because those structures are not undergoing cell division. The fields exert force on proteins — which become electrically charged when the tumor cell is in the process of dividing — and that halts the cell division and destroys the cancer cells.
“Unlike in other areas of the body, there aren’t many healthy cells in the brain that divide rapidly,” said Dr. Julian Wu, who helped conduct the Optune study and who serves as chief of the division of neurosurgical oncology at Tufts Medical Center.
While chemotherapy can destroy rapidly dividing healthy blood cells along with tumor tissue, the Optune treatment is limited to a local area in the brain. For this reason, patients who use the device experience no side effects beyond mild skin irritation.
They do, though, experience the inconvenience of having to wear the contraption as much as possible throughout the day and at night, and must learn how to switch out the transducers every three or four days. Novocure staff make home visits to teach patients how to use the device, which accounts for some of the high monthly cost, Novocure executive chairman Bill Doyle said. The company picks up the tab for patients who are denied coverage, he said.
While the initial studies provide proof of concept that tumor-treating field therapy works, Novocure plans to test Optune for other cancers including lung, pancreatic, and ovarian, as well as cancers that metastasize to the brain.
Still, FDA approval is no sure thing, nor is future insurance coverage for the device.
“Obviously, there has been some skepticism about tumor-treating field therapy,” said Dr. J. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society. “We have to wait for the FDA review of the research to make sure it was done properly.” He and Wen both expressed concerns about the cost of the device.
Patients in the clinical trials are instructed to use the device for two years, but they can choose to use it for much longer, and many do — not wanting to give up the security of a treatment that they believe is keeping their tumor cells at bay. Usually, the company will continue to pay the cost if patients keep using the device after the trial.
The Rev. Kevin O’Connell, a Jesuit priest at Campion Renewal Center in Weston, decided to stop using the device last July when he reached the two-year mark.
“From my point of view, the obvious next step for my participation in the clinical trial was to stop to see if the treatment was successful at postponing the return of my tumor,” he explained, though he said his doctors at Tufts Medical Center left the decision up to him.
His most recent MRI showed no sign of the tumor’s return, three years after his initial diagnosis. “I feel very confident,” the 76-year-old said. “I’m paying attention and carefully monitoring but try not to be too worried about what might happen.”