Insights From: Maciej Mrugala, MD, PhD, MPH, University of Washington Medical Center; Suriya Jeyapalan, MD, MPH, Tufts Medical Center; Daniela Bota, MD, UC Irvine Medical Center
Maciej Mrugala, MD, PhD, MPH: I have been using this technology for many years now. My center in Seattle was one of the first 15 sites approved to use this technology. So, overall, I have treated probably close to 30 patients or even more, if I include the clinical trial that our center participated in. Overall, my experience with the device is good. Most of the patients that I prescribed the device to were successful in terms of being able to use it and being able to be compliant; I did, however, have a few patients that couldn’t really tolerate the device, mostly because of the fact that they had to wear it basically 24/7, and to some of them it felt a little confining. And, to quote their words: “It was a reminder to them of the fact they’re sick, that they have a brain tumor.” But this was a minority of the patients. In most cases, patients embraced the technology and have used the device consistently.
My greatest success is treating a young woman in her 40s with glioblastoma who failed prior treatments. She had a lot of side effects associated with both cytotoxic chemotherapy as well as monoclonal antibodies, such as bevacizumab. We were really faced with either stopping all the treatments or trying tumor treating fields as a single modality, and we did the latter. The patient was very compliant with the treatment. She has been using it now for almost 3 years, again as a single treatment modality, and she remains stable. Her most recent MRI didn’t show tumor progression, and it’s really very encouraging to see that, that this technology can help patients who cannot otherwise have other treatment options like this woman who developed all these complications from prior treatments. So, I think that’s my greatest success story in terms of the length of treatment, and also patients’ compliance and an attitude towards this technology.
Daniela Bota, MD: My experience with using Optune now spans a number of years because we have embraced it from the time that the device was approved for the current glioblastoma. And we have treated probably around 100 patients with this device in our practice at the University of California-Irvine. We have many success stories of people going for years on the device and, including patients that, should they have participated on the EF-14 study, they would be on the long-term survival cohort. In my experience, once the device is accepted by the patient, it is not an imposition on the patient’s life. Patients adapt to it and they do a lot of their activities. One of my very nice patients come to my mind, and she’s actively traveling, taking cruises, and going biking. Because the device is so small and so portable, she can do all of those things wearing the device. Now we are looking at her having a great tumor response, and maintaining that great tumor response, for almost 2 years.
Suriya Jeyapalan, MD, MPH: At Tufts Medical Center, we probably have the oldest surviving patient who has used the device. We had put 17 patients on the trial, and 10 of them were randomized to the device with Temodar (temozolomide) radiation while the other 7 were randomized just to Temodar radiation. For those patients, everybody’s tumor came back except for the one guy who never took the device off his head. For the 9 patients who were randomized to the device, either the tumor came back or the trial basically was completed after 2 years, and they took it off their head.
Well, this one gentleman who was very, very determined, he decided that he was going to continue on it, and he has, and he still does now, 7 years later. All I’ve been able to tell him is that, of the 17 people we enrolled in the trial, he is the only one that the tumor has never come back. And so, when he asked me, “When can I take it off my head?”, I said, “I don’t know when you can take it off your head because you’re the only one who never took it off of their head, and you’re the only one whose tumor never came back.” And what he asked me in response to that was, “Why did the other people take it off of their head?” He couldn’t understand why anybody, if it was helping them or if they thought it was helping them, would take it off.
So, I’m faced with that when I talk to my new patients because they’re like, “Well, the trial was 2 years, it’s now commercially available, how long should we do it?” I say, “You’re going to have to make that decision yourself. We’ve proven in the trial 2 years, definitely, I would do it. After that, all I can say is that the other 9 patients, of everybody else that got the device, when they took it off, the tumor did come back. I can’t say that’s going to be the situation for you, but you can make that decision in 2 years on your own.”
Daniela Bota, MD: Based on the data that we just discussed and the FDA approval at the end of 2015 for newly-diagnosed patients, and the previous approval for the current disease, we recommend the device for both categories of patients. The difference is that the FDA approval for the device in newly-diagnosed patients is as a combination therapy, while the FDA approval for the recurrent patients is a single therapeutic modality.
Suriya Jeyapalan, MD, MPH: The device is FDA approved for both newly-diagnosed and recurrent GBMs. And in the recurrent GBM trial, which was the EF-11 trial—which I also participated in at another institution, Beth Israel in Boston—it was approved first. So, that was when we ran the newly-diagnosed trial. Some of the patients in the newly-diagnosed trial, when they recurred, if they were in the control arm, did essentially drop out of the trial and then get the device. It becomes this interesting phenomenon that we have the approval for both in the United States. And so, I give it to them upfront, and I have to say I do give a hard sell based on the results. You’re going to hear more about the results, about the EF-11 final analysis. But, essentially what happened is the 2-year overall survival, in people that got Temodar and the Optune, was 43% versus 30% in the patients that just got the Temodar alone. That’s about a 50% increase if you think about it, and so that’s huge. So, I give a big hard sell upfront. When it comes back in the recurrent setting, I give even a bigger hard sell about how now is the time to do it.
Maciej Mrugala, MD, PhD, MPH: Based on the recent data, I recommend the device is used in the newly-diagnosed setting in combination with temozolomide after initial treatment with radiation. In recurrent disease, it’s approved but it’s case by case, depending on what is the patient’s individual situation, what the progression looks like, and what kind of drugs have they been on before. So, of course, we discuss it, but not every patient embraces the use of the device at the first recurrence. Some patients feel like they might want to try it, but they feel that they would like to try other options first, like other chemotherapy agents before they try tumor treating fields. I think that, in my practice, I offer this to patients, but most of the patients in the recurrent setting typically want to try something else before they go to tumor treating fields. In newly-diagnosed patients, again, based on the very strong data that we have, a lot of patients are interested. Not everybody actually does it, but I would probably say, in my practice, maybe 60% of patients would consider using it up front, and then 40% are still somewhat reluctant to use it and want to just do temozolomide alone.