There is no more accurate description of "thinking outside the box" than when talking about Optune, the Israeli innovation that fights glioblastoma (GBM), a particularly aggressive form of brain cancer.
Until now, there has been no effective cure for this cancer. In fact, the last time a treatment was approved for glioblastoma was 15 years ago, when a chemotherapy drug was approved, which did extend the lives of patients, but only for a very short time.
Glioblastoma is the most common and aggressive primary brain cancer. Every year in Israel, some 200 people are diagnosed with the disease, and 200 patients die from it. The average survival time after surgery combined with radiotherapy and chemotherapy (the standard treatment to date) is only 70 weeks.
In most patients, the tumor will return after treatment. In such cases, repeat surgery, radiotherapy, chemotherapy or other experimental treatments may be performed. In practice, due to the lack of effective treatment for this tumor, many experts believe that after a recurrence of the disease, there is no room for further treatment. The goal of treatment at this stage is symptomatic relief only, and consideration should be given to the benefit of the treatment in relation to the damage it may cause and its effect on the patient's quality of life.
To date, and despite multiple clinical trials, no drug has been found to prolong survival in patients with GBM recurrence, and no drug has been found to be significantly more effective than another.
Optune emerged from this despair. The technology, conceived by Israeli Prof. Yoram Palti, creates electromagnetic fields that interfere with cancer cells' ability to divide and multiply, causing them to stop growing.
Fighting brain cancer from the outside
The idea behind the development is that molecules in the body have an electrical charge that can be manipulated. The transducers are attached to the patient's head and deliver alternating electric currents. The result of the electric field leads to abnormal division of cancer cells, and when the new cells divide improperly, they die.
This description, which may sound like science fiction, was indeed received with a cold shoulder by the medical community at first. That is, until the results of the studies appeared.
The latest research work comes from the European Conference on Neuro-Oncology in Stockholm, held a few weeks ago. At the conference, a case was reported of the complete disappearance of the cancerous tumor in the brain following Optune therapy, in cases where it was not possible to remove the entire tumor surgically.
Cases where the tumor cannot be entirely removed surgically are considered the most difficult with very low survival chances. In the three cases presented, a complete disappearance of the cancerous tumor was observed after treatment with the Optune technology.
The trials included patients who underwent partial tumor removal and then radiation therapy and chemotherapy, but part of the tumor remained. They continued to have chemotherapy combined with Optune, and all of the patients experienced a complete disappearance of the tumor.
Monitoring of the patients' condition lasted between seven and 40 months after the start of treatment, and positive results to the treatment continue.
Patient survival chances doubled
This information was added to the data presented at the American Conference on Cancer Research and the American Conference on Neuro-Oncology, which showed that 30 percent of GBM patients using the technology for more than 90 percent of the time had a five year survival rate.
The results of the studies show a dramatic improvement in the life expectancy of all patients: one in seven patients will live five years, compared with one in 20 without the treatment.
In other words, the survival rate of patients more than doubled and the risk of mortality from glioblastoma dropped to 35 percent. These figures are impressive in light of the fact that, until now, the average life expectancy of patients was only 15-16 months.
"In reality, this treatment has no alternative," said Prof. Tali Siegel, chairman of the neuro-oncology forum and a neurobiological oncologist at Beilinson Hospital at the Rabin Medical Center in Petah Tikva. "There is the standard treatment that includes radiation and chemotherapy, and that's it. This is what modern medicine has to offer these patients. So there was tremendous excitement when the studies indicated that the use of the device led to an extension in life expectancy."
"This is something that is very foreign in modern medicine," added Prof. Siegel. "I don't know of any treatment that uses electric fields outside the body that can inhibit tumor growth. The idea is very original and unusual, but its efficiency is proven. That is why it takes time for doctors to get used to it as a standard treatment, but the results are clear."
"There are still some doctors who doubt it, because it is very foreign to them, but research has proven its efficiency and the research was conducted under the strictest standards, and that is why the technology has entered the international protocol as standard treatment," she went on to explain.
"Despite its impact on cancer cells, the new technology does not interfere with electrical activity in the brain and does not damage healthy tissue," said Dr. Eilon Kirsson, scientific director and research and development officer at Novocor, developer of Optune, adding: "This technology changed the natural course of glioblastoma and brought about a situation in which not all patients die from it."
"As soon as we've been able to stop the cancer cells from completing their division process, which causes the tumor to stop growing," Kirsson continued, "the disease has become one that can be fought. In the division of cells, there is a phase in which the DNA replicates, each chromosome lines up near its 'sister' chromosome, and the cell takes the shape of an hourglass, and then the two parts are disconnected from each other. The electric fields do not allow this to happen, because the molecules are rotating in the direction of the field, which is induced externally. Turning off the battery-operated machine terminates the electric field, for that reason the treatment must be continuous."
And this is precisely one of the main drawbacks of this technology. To benefit from effective treatment of the disease, the skullcap must be worn seven days a week, 24 hours a day. "There are patients who cannot abide by that," said Prof. Tali Siegel. "They don't want to go outside declaring to the world that they are brain cancer patients by wearing the skullcap outside the home, and therefore they give up on the treatment."
Another major drawback of the treatment is its price tag, about NIS 700,000 annually. Israel's national healthcare basket was offered the treatment at a reduced price of NIS 200,000. It was rated a high priority, but ultimately did not make it in.
As of now, patients are receiving the technology free of charge as a compassionate treatment, but this will only last for a limited time.
'I say I'm connected to WiFi and everyone laughs'
Michael Paransky, 58, from Migdal Ha'Emek, has been wearing his Optune skullcap for a year. He worked as a nurse at Maccabi Health Services until he was diagnosed after coming home from work a year ago with a headache and nausea. He rushed to the hospital, where they discovered he had had a stroke. A more thorough study at the Rambam Medical Center in Haifa revealed he had glioblastoma.
"I am an optimist by nature," he said. "So I really read about it on the internet, and what's written there is very discouraging, but I decided to focus on the positive side and was encouraged that at least this tumor in my brain does not spread metastasis to other parts of the body."
Unlike other patients, Paransky did not undergo surgery to remove the tumor, because of its very sensitive location in the brain. After completing the rounds of radiation therapy and chemotherapy, he received the Optune this March, and since then he rarely takes it off.
"I use it for a large percentages of the time," he said proudly, "except for an hour and a half in the evening, when I take it off, go for a walk with the dog and take a shower, the skullcap is on me all the time. Recently, I went to visit friends in Ukraine and with the doctor's consent I left the skullcap at home because I did not want to get involved with the airport security there."
And does it help? Is there an improvement in the medical condition?
"Certainly. Every three months I do an MRI, and the tumor shrinks from time to time, which I assume is the result of a combination of all the treatments, including the Optune."
People don't ask questions when they see you on the street with the skullcap?
"Of course they ask, not every day does one see someone with electrodes on their head and wires coming out of them, so I tell them I'm connected to Wi-Fi and everyone laughs."