Investigators found median survival of 21 months for patients given the device plus chemo while those who had chemo alone had survival of 16 months. When combined with chemotherapy, patients have 13% increased chances of surviving for five years, compared to 5% of those who only undergo chemo. The British study was sponsored by Novocure, the company which makes the device.
It's sold in the U.S., Germany, Switzerland and Japan for adults with an aggressive cancer called glioblastoma multiforme, and is used with chemo after surgery and radiation to try to keep these tumors from recurring, as most do. When the cap is on, patients feel a little bit of heat on their heads.
"Tumor Treating Fields, or TTFields, are low intensity, alternating electric fields that disrupt cell division through physical interactions with key molecules during mitosis in solid tumor cancers", explained the maker of the treatment, Novocure. The company indicated that landmark analyses demonstrated a consistent, as well as, maintained improvement in overall survival at different periods. The two- and five-year survival rates were 43% vs. 31% (P = 0.0008) and 13% vs. 5% (P = 0.0037), respectively. Interim findings from EF-14, based on the experience of 315 patients, led to the FDA's approval of the device in 2015 for use in combination with adjuvant temozolomide, as a treatment for patients with newly diagnosed GBM following surgery, chemotherapy, and radiation.
"You can not argue with them - they're great results", chuckles Brigham and Women's Hospital chief of neurosurgery, Dr. Antonio Chiocca, noting also that the results are not likely a result of some kind of placebo effect. Dr. Andrew Lassman, brain tumor chief at the Columbia University Medical Center who also consults for Novocure said.
Many doctors, however, are skeptical of this treatment. In EF-14, adherence was more than 75 percent over the course of a median number of 8.2 TTFields/temozolomide one-month cycles of therapy.
'We celebrated two years of no tumor in December and went to South Africa'.
Side effects were minimal but included blood-count problems, weakness, fatigue and skin irritation from the electrodes.
The trial news sent NVCR stock up roughly 50%, putting it at highs last seen in July 2016, before the company plunged about 30% in a single day thanks to a disappointing second quarter. But with the addition of this device to current treatment, researchers hope to achieve better results. Pilot tests are also underway for other cancers, such as pancreatic tumors.