Novel Treatment Approaches in Glioblastoma - Episode 11
Transcript:Maciej Mrugala, MD, PhD, MPH: In patients who are reluctant to use the device, I think that the best way to explain the benefits of the device is to really discuss the data from the interim analysis of the EF-14 study, which tested the device in newly-diagnosed patients, and identify the fact that, indeed, the device adds months to the overall survival. Sometimes it’s really hard to talk about it with some patients, given the still very short survival in glioblastoma. Talking specifically about the numbers is very traumatic to some patients because they don’t necessarily want to focus on how many months they have left. But, I think that data-driven discussion is probably the best because it can, again, show the patients that that is the evidence. So, that’s my approach.
The second issue is to talk to the patients about what does it mean to actually use the device, how is it going to affect their life. It’s a very individual decision, depending on a patient’s activity level. Are they kind of sporty types who like to exercise a lot and be all over the place and move around or are they more of a sedentary-type person who spends most of the time at home anyway? It also heavily depends on the support system they have. I find it really encouraging to see spouses or family members of the patients who are very supportive.
I think that the patients that are more successful with deciding about potentially using the device are patients who have good support systems, either a spouse, a friend, or a large family that can encourage the patient to use it and help with the treatment area changes. And sometimes having a team approach to this helps the patient deal with the side effects. Patients sometimes feel more empowered that there are others supporting them in this, and they wear the device more consistently. So, I think when we’re discussing this, as I said before, the first approach is to really talk about the data: is it going to be beneficial to you, are you going to feel better if you use it? And then, the second part of the discussion is more practical. Yes, it can be beneficial to you, but it’s going to require that you wear it 24/7. If you use it, that’s what it’s going to mean, so do you feel you can handle it?
In some cases, I also try to put the patient who’s considering using the device with a patient that’s already been using it, to have a first-hand report of experience. And I’ve been successful in getting patients together; they frequently talk on the phone first, and then sometimes they decide to meet and go over their experience. The patients who have done well over a prolonged period of time are the patients that can really bring hope and make it easier for newly-diagnosed patients to potentially make the decision to use the device. So, that was my third line of discussion, and I frequently use this if I see that the patient is somewhat hesitant, but potentially a good candidate for treatment.
Daniela Bota, MD: What I tell my patients when they are trying to decide should they use the device or should they not use the device is related to what is the current state of knowledge in glioblastoma treatment. And we start with the fact that there is no one treatment that can cure glioblastoma. Everything that we do, it’s adding more and more treatment as we research them, and we get them validated to improve the survival and hopefully to improve their quality of life. So, we go back to the fact that using great surgical modalities to get the best surgery. Using the radiation and the Temodar prolongs their lives. And now Optune is the next step on trying to prolong our patients’ life.
We also talk about clinical trials. We are an academic center, I’m the primary investigator of numerous clinical trials. And I present them with the idea that, although clinical trials are new exciting science, and they are very promising, we also have to consider that clinical trials have not been evaluated to the level of high review that was required of Optune to get approved as the treatment of glioblastoma. Because even a clinical trial that is a phase III, it’s one step behind being an FDA-approved treatment. You have to have a successful phase III with a meaningful difference in overall survival in order to become an approved treatment.
Suriya Jeyapalan, MD, MPH: When I have these discussions with patients regarding Optune, I discuss the device. We do have a model in our medical center, but what I usually do is direct them to the website. I talk to them right at the beginning of radiation. The way the original trial was set was that the device didn’t start until 1 month after with radiation. So, I usually have this discussion sometime during the 6 weeks of the radiation. I talk to them about the device, talk to them about the trial, direct them to the website and say, “Go ahead and come up with all your questions. You have 10 weeks because we’re not even going to start it until 1 month after radiation, and just ask me about what you want to know about the device.”
What I also do at that time is start the process. I say, “It takes a while for your insurance company to approve this. We have some time here. Go ahead and sign the consent for it and then we’ll put the process through. And if you decide at the end that you don’t want to have the device, you could just say no. We’ll stop the process and insurance approval, but at least we’ll know that when you’re ready for the device, you could get it.”
Daniela Bota, MD: My experience with educating patients about Optune is very hands on. We have a mannequin in our clinic, it’s called “Elektra.” We have the whole device setting. We have the batteries, so we actually run some trials in the clinic. We give the device to the patient; they can tactile feel it. They can look at it. They can look at pictures. There are people waiting in the waiting room that are wearing the device. So, it’s a lot about trying to recreate the experience. Because once you take the apprehension out of the startup of the device, actually people do very well with the device. We also teach the patients a lot about how the device works, the fact that it can inhibit cells from dividing. We will have to be subjected potentially to more side effects as many of the drugs that we take systemically have systemic side effects. And then, after we talk about all of those things, we do bring the patients back when the device is approved by the insurance companies, and we go again through more practical information like: when should we be called; how do you change electrodes; how do you treat the scalp redness or any scalp itchiness; and to make sure that the patients are fully prepared to deal with the device.
And one thing that I didn’t mention is that we don’t only talk about the patients. We talk about the patients and their families. The best success stories that I have with the use of Optune is where we have a family team—either parents and children or partners. These are people that work on this together and have a very well-set system to be able to change their electrodes, to be able to order new electrodes, make sure that the batteries are well charged, and to make sure that they have everything to the level that we achieve the compliance of 75% of the time, which is crucial in order for a device to work.
Transcript Edited for Clarity