The Optune device is a portable FDA-Approved device designated to treat glioblastoma (GBM). GBM is an aggressive tumor that forms in the tissue of the brain and spinal cord, according to the American Brain Tumor Association. Today, GBM is increasingly common. With Senator John McCain recently being diagnosis with having glioblastoma, this disease has been the topic of discussion, more now than ever. Dr. Simon Khagi is the director of the UNC Brain Tumor Program and is using the Optune device to treat his patients. According to Dr. Khagi, the state of North Carolina has 500 GBM cases per year. I was recently granted a brief opportunity to talk with Dr. Khagi and ask a few questions about the device and how it is being used to help his patients at UNC (Click on the title of the article to read the interview and learn more).
Q. Why did you decide to use the Optune device?
A. Glioblastoma (GBM) is a notoriously difficult to treat brain cancer that impacts thousands of patients every year in the US. Standard treatment usually revolves around surgery, radiation and chemotherapy. However, after receiving the standard of care, median survival is still a little more than one year. Newer treatments are desperately needed.
In 2011, the FDA approved the use of Optune® for patients with recurrent GBM. This approval was based on a study which demonstrated survival that was no different when compared to various chemotherapies used in the setting of recurrent disease. This represented the first new treatment for GBM in over a decade.
Subsequently, in 2015, Optune® gained FDA approval for use in newly diagnosed GBM. This decision was based on the evidence that suggested Optune®, when combined with standard chemotherapy, improved median overall survival by 4 months when compared to chemotherapy alone. In a disease with a survival of about 15 months, an additional 4 months is a big step in the right direction.
Being a neuro-oncologist and knowing the devastating impact of this disease on my patients, I became intrigued and encouraged by a potentially promising new therapy. Prior to joining UNC, I gained exposure to Optune® during my training. However, much of the clinical trial data was not yet mature enough for wider adoption of this new technology until the latter years of my training.
Since joining UNC, I’ve adopted Optune® as a fourth modality of treatment of GBM. Given the promising data surrounding its use in newly diagnosed GBM, I recommend this device to most of my patients when considering maintenance chemotherapy.
Q. What is the scientific rationale?
A. The technical term for Optune® is alternating electrical tumor treating fields (TTF). These TTFs are applied to a shaved scalp via “palm-sized” arrays, and positioned in such a way as to deliver an effective dose to an area of disease. Preclinical studies demonstrated that when an alternating electrical field (not a current) is applied to a biological system (i.e. cancer cells in a dish), there is evidence of marked cell death. Particularly, cancer cells were unable to line up their chromosomes (i.e. their DNA) and divide, a process known as mitosis. It was determined that 200 kHz was the ideal field frequency that should be used in the setting of GBM. Subsequent animal studies also demonstrated benefit with this technique.
Q. How does it help your patients?
A. The addition of Optune® to maintenance chemotherapy has been shown to be beneficial. However, it is a BIG commitment and one that patients should clearly understand. As I mentioned earlier, the addition of Optune® to maintenance chemotherapy increased survival by 4 months. These results are not insignificant, but come with the stipulation that the device must be worn at least 18 hours per day (preferably longer) to potentially improve survival. Studies have shown that patients who wear the device more than 18 hours per day have a better survival compared to those that are unable to do so. Patients need to maintain a shaved scalp and periodically remove the device in order to clean their skin. The arrays are connected to a power source via wires. These wires are typically braided and tucked under a shirt or a blouse. The power source can be a battery pack that patients can take with them (typically concealed in a backpack or satchel) when they’re up and about. While at home, resting or sleeping, the patient can connect the device to an outlet.
Many patients have reservations about wearing the device as they feel that it would interfere with their quality of life and independence. When explaining the intricacies of the device, I mention that the study did not reveal any significant untoward effects on quality of life. However, I find that the best examples come from real-life examples. One of these examples comes from my travels through the airport and seeing a patient wearing this device. He appeared free to do what he wanted and was just disembarking from a flight to California. The device was so inconspicuously concealed that I wouldn’t have noticed if not for the fact that I have a lot of experience prescribing it.
Special thanks to Dr. Simon Khagi.
Device image used with permission of Novocore