By Denise Grady – New York Times.
An electrical device glued to the scalp can slow cancer growth and prolong survival in people with the deadliest type of brain tumour.
The device is not a cure and, on average, adds only a few months of life when used along with the standard regimen of surgery, radiation and chemotherapy. Some doctors have questioned its usefulness. But scientists conducting a new study said the device was the first therapy in a decade to extend life in people with glioblastomas, brain tumours in which median survival is 15 months even with the best treatment.
The disease affects about 10,000 people a year in the United States and is what killed Senator Edward M. Kennedy in 2009. It is so aggressive and hard to treat that even seemingly small gains in survival are considered important.
The new findings mean the device should become part of the standard care offered to all patients with newly diagnosed glioblastomas, the researchers conducting the study said. The equipment consists of four pads carrying transducer arrays that patients glue to their scalps and change every few days. Wires lead to a six-pound operating system and power supply.
Except for some scalp irritation, the device has no side effects, the study found. But patients have to wear it more or less around the clock and must keep their heads shaved. It generates alternating, low-intensity electrical fields — so-called tumour-treating fields — that can halt tumour growth by stopping cells from dividing, which leads to their death. The researchers said the technology might also help treat other cancers, and would be tested in mesothelioma and cancers of the lung, ovary, breast and pancreas.
The equipment is made by Novocure, a company with headquarters on Jersey, an English island off the coast of France. It also has a research centre in Israel and operations in the United States. The company is paying for the study, which involves 700 patients in 12 countries.
Novocure’s device has been approved in the United States since 2011, but only to treat recurrent glioblastomas, not newly diagnosed ones. It costs $21,000 a month, and some insurers cover it. So far, Novocure has been providing it free to patients without insurance coverage, according to William F. Doyle, the company’s executive chairman.
The study tested the device in newly diagnosed cases. The results were presented on Saturday in Miami, at a meeting of the Society for Neuro-Oncology, by Dr. Roger Stupp, the study director and chairman of the department of oncology and cancer at the University Hospital of Zurich.
The data came from the first 315 patients, who were followed from 18 to 60 months. They were assigned at random to one of two groups: 105 received standard treatment alone, usually consisting of surgery, radiation and the chemotherapy drug temozolomide; the other 210 received standard treatment and the electrical device
Patients who wore the device fared better than those who did not: Their median survival was 19.6 months, compared with 16.6 months in those on standard treatment alone. Among those with the device, 43 percent survived two years, compared with 29 percent among those receiving only standard therapy.
“It was a surprise, and better than we would have expected,” Dr. Stupp said in an interview.
The study design called for a data analysis partway through to monitor the patients’ safety. When the monitoring board saw how much better patients were doing with the electrical fields, it recommended that the study be stopped so that the device could be offered to everyone. It was the first time that a monitoring board had recommended stopping a brain-cancer study because one treatment was so much better than another.
Dr. Patrick Y. Wen, director of neuro-oncology at Dana-Farber Cancer Institute in Boston, who was not involved with the study, said that until now, there had been some skepticism among doctors about the treatment.
But “these results seem real,” Dr. Wen said. “With these results, I think more people would definitely use it.”
Dana-Farber does not use the device, he said, but with the new data, “I think some patients will probably want to have it, and we will probably plan to use it going forward.” A three-month increase in survival may not sound like much, he said, “but for our patients, it’s not trivial.”
Another neuro-oncologist not associated with the study, Dr. Nicholas Butowski of the University of California, San Francisco, described the Novocure device as “polarizing” and said, “Some of my colleagues just do not believe in it.”
But Dr. Butowski added: “Perhaps it does work in some patients. It’s got logic behind it.” He said he would use it, though he suspected that the benefit was relatively small…read more.