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Taking Regorafenib for Metastatic Colorectal Cancer
Tanios S. Bekaii-Saab, MD, FACP: Tim has done great on clinical trials, and we will go through his experience in a bit. He has seen at least three, right Tim?
Timothy Willson: Yes.
Tanios S. Bekaii-Saab, MD, FACP: Three clinical trials, and we will dissect them. Kelley, you have been quite pivotal in helping Tim navigate some of these clinical trials, especially in terms of ensuring that he is well supported and able to get through them. Can you talk a bit, without necessarily too much detail, about how your own experience and knowledge has been able to help Tim navigate the complexities of some of these clinical trials?
Kelley Rone, APRN, DNP: One of the things that is hardest for patients and me to deal with is that clinical trials sometimes have a lot of rules that make them more difficult to manage. Some of our clinical trials have what is called randomization, where the patient may have the opportunity to go on one, two, or three lines of therapy, and sometimes that line of therapy is standard of care. It is randomly chosen what arm they go into, and patients sometimes have a hard time being randomized to the standard of care. They are disappointed and upset that they did not get put in the fancy clinical trial arm, so there is that.
Sometimes people are on medications that work well for them, and they have to go off those medications and have to substitute for something else, something they may have been on for a long time. And because of the way the trial is set up or the medication is processed, they have to go off a drug that has worked for them to control their blood pressure, nausea, or anxiety. They have to stop those medicines and go on another one so that they can go in the clinical trial, which means some of their other symptoms may not be well managed.
There is also the schedule. The study lays out the schedule. For someone on standard therapy, we may see them only once a month. But if they are on a clinical trial, they have to be seen more frequently, which means they are at the clinic longer and more often if they travel. They are a lot more restricted in what they can and cannot do, and that sometimes makes it more difficult for patients to manage the process.
Tanios S. Bekaii-Saab, MD, FACP: Tim, I am going to take it back to you. You are certainly pretty knowledgeable about all the trials that you have been on. Why did you consider getting involved with clinical trials? What exactly is it? In that sense, what is the advice you would give others when they are thinking about their own treatment and the potential to consider clinical trials?
Timothy Willson: I definitely did not look at it as if I was at the end of the road and had nowhere else to go, because I was still having a pretty good response to previous treatments. When they started to wane, I was basically ready to start clinical trials. I have exhausted the standard of care at most institutions, so that is how I got involved in it. Additionally, after I had surgery and they could not resect it, they mentioned getting radiation and then clinical trials as the next step. I got a lot of encouragement from my health care team, and that gave me a lot of confidence going into a clinical trial. As Kelley mentioned, you do not know if you are going to get the Cadillac or if you are going to get the standard of care, so there is always that in the back of your mind. There is usually a crossover down the road on it, so you do get the study drug.
I looked at it as the next step, not as a failure of anything. Particularly in my area, this is something that is all over the world of clinical trials around colon cancer, so I thought I was in a pretty good spot because there are a lot of studies, and a lot of them are complex where you have to have all these biological markers and things like that. I just had the garden variety tumor that might be harder to treat than the others.
It definitely helped having someone to help see the ins and outs of the clinical trial and how it works. That is probably the best thing that patients could get to make sure that they understand how the clinical trial protocol works, and that if they do not get on a study drug, that would happen down the road a bit. That is where the team approach comes in, and Kelley has done an awesome job making me understand what the outcome of the trial will be and how to take care of those bumps in the road.
Tanios S. Bekaii-Saab, MD, FACP: You have been through different types of trials. You have been through three of them. Briefly describe what those trials were focused on and what your experience was with them, potentially including some of the side effects that you experienced and how long you were on them. For a couple of them, you went for a while.
Timothy Willson: Yeah. They did not call it the ReDOS trial when I started, but they changed it after they were done with that. I was on the highest dose of the nonstudy drug.
Tanios S. Bekaii-Saab, MD, FACP: You were on regorafenib.
Timothy Willson: Yeah.
Tanios S. Bekaii-Saab, MD, FACP: You started with the dose. There were two arms to the study: a dose-escalation arm and the arm that just started on the highest dose, and you were on the highest dose.
Timothy Willson: Yeah, it was for a good three or four months at least, but I accepted it and said, “Let’s do it.” We were having good results. I had some really positive scans, the blood work was good and I was tolerating it to my expectations. Then there were some of the side effects around the second or third month on the drug: I got the hands and the feet. That was the only thing I noticed, but the feet were the worst because I could not exercise. I had to buy new skates with a big toe in the front because of the pressure, and I had to have special tennis shoes made up. The hands and the feet were the biggest challenge on that. For someone who is active, all of a sudden, you cannot close your hands and your feet; it is painful to walk.
Tanios S. Bekaii-Saab, MD, FACP: You did relatively well after that. Did they adjust the dose of the treatment?
Timothy Willson: Yes.
Tanios S. Bekaii-Saab, MD, FACP: That seemed to have done well for you?
Timothy Willson: Yes, absolutely. They went from the highest dose to a medium dose. Then the trial completed, and I stayed on it for some extra time.
Tanios S. Bekaii-Saab, MD, FACP: You were on it for a bit more than a year, maybe a month more than a year.
Timothy Willson: Yeah.
Tanios S. Bekaii-Saab, MD, FACP: About 13 months.
Timothy Willson: Yeah.
Tanios S. Bekaii-Saab, MD, FACP: This trial is one example of a trial that changed practice. You ended up on what we call the standard-of-care arm, and the other arm, where you escalate the dose of the drug, was essentially meant to start low and go high vs. the standard, which was just high. It essentially ends up that, if you start low and go high with the same drug, you end up doing better with the toxicities and doing better with the capability of the patient to tolerate the treatment, and you are perhaps doing better on other fronts. Your participation helped complete the trial, and the study helped change the NCCN [National Comprehensive Cancer Network] Guidelines. There was even a suggestion that may change the label. That is an example of you participating in a trial that changed the standard of how we use this drug. Kelley, do you want to say something?
Timothy Willson: Yeah, sorry. I did not mean to interrupt you.
Tanios S. Bekaii-Saab, MD, FACP: No, you are good. I did not know if Kelley wanted to speak. I saw that she was ready to say something.
Kelley Rone, APRN, DNP: Tim never slowed down at all. He continued to do all the things he wanted to do. He is downplaying his activity level. He made me exhausted when I heard him come in and tell me what he was doing. He is a great study patient because he does everything you tell him to do and then some, but he was also good at telling us what was happening so that we could make adjustments, so that he could continue to do the things he wanted to do.
Tanios S. Bekaii-Saab, MD, FACP: These adjustments were done in rea -time to help him go through the trial. Is that right, Kelley?
Kelley Rone, APRN, DNP: Right. He did great. He was on that drug for a lot longer than most people.
Tanios S. Bekaii-Saab, MD, FACP: Yes. Go ahead.
Timothy Willson: The other point I was going to make before we move on is that I had so many things in the cancer center and everything with the infusion, and this was the first oral drug I was exposed to. That has challenges, but it also takes a lot of the burden off you from going in and with the whole routine of getting an infusion. That was new to me, and I know more drugs are going to be small molecules with an oral use for them. You feel as if you are a bit more in control of things, but you have to remember to take your medicine every day. It opened up a new front for me.
Tanios S. Bekaii-Saab, MD, FACP: Being on the oral drug was a perceived advantage, but it is importantto emphasize that these do not come without side effects. They are manageable as long as there is an open line of communication with the clinical team, with Kelley and me, and that certainly helps you navigate through some of the toxicities. Once things get adjusted around the drug, you could certainly continue with it as you did for a year plus, with a bit more of a normal life than carrying a pump around or going to the infusion center. That is what I heard from you, right?
Timothy Willson: Absolutely. I would even say that that was about embarrassment, even with just walking around. I used to drive my son to school every day and try to hide that box. It has gotten a lot smaller, so you can; it is not as big. You are exactly right: You’ve got that, and that is why the chemotherapy is so different from the emerging clinical trials.
Transcript Edited for Clarity
