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Clinical Implications of the ReDOS Findings

Insights From:Tanios Bekaii-Saab, MD, FACP, Mayo Clinic; Andrea Cercek, MD, Memorial Sloan Kettering Cancer Center; Zev A. Wainberg, MD, David Geffen School of Medicine at UCLA
Published: Tuesday, Mar 06, 2018



Transcript: 

Tanios Bekaii-Saab, MD, FACP: The most important element to be understood from the study is that we weren’t looking at a low-dose versus a high-dose strategy. We were looking at optimizing the dose. The goal remains the same—to try to get to the highest dose tolerated by the patient. But, there are different ways to do it.

So, the standard dose was 160 mg. This dose would be adjusted closer to 120 mg, for many patients, so they could continue on trial. Our dose optimization strategy went the other way. We’d start with the low dose. Every week, the intent was to go up on the dose, to try to reach the goal. So, there’s the intent and the goal. The intent is essentially to optimize the dose. The goal is to reach the maximal dose—160 mg.

The dose optimization strategy is designed to try to reach the maximal dose that we think the patient will tolerate. It may end up being 120 mg, for most patients. But, there are a few patients, or more than a few, about 20%. We’re going to look a little bit more at those numbers that do reach 160 mg and stay at 160 mg, through their lifetime exposure to regorafenib.

So, again, for community oncologists, it’s very important to remember that this was not a low-dose versus a high-dose strategy. This was a start point of a low dose with a goal to reach 160 mg, if the patient could tolerate it, versus starting at 160 mg from the get-go.

Andrea Cercek, MD: In my personal experience, I’ve used regorafenib at a lower dose for some time. I have noticed the difficulty of patients tolerating standard dosing, which is why I’m so happy to see the ReDOS data. The efficacy was not compromised with a lower dose. We’ve also started to be very proactive with the management of toxicity—including dermatology referrals, early on, and referrals to podiatrists for foot care—because that was one of the main issues that patients had. They did not have proper foot care prior to starting the treatment. We know that looser shoes are better than tighter shoes, so those are the types of things that we’ve incorporated into clinic. I think that this is actually making a difference, in terms of tolerability, in my personal experience.

Zev A. Wainberg, MD: Many of us who treat a lot of colon cancer patients with this drug have been doing so for some time. One of the important values of the ReDOS study is that it reaffirmed what oncologists have been doing in practice—starting at the lowest dose, 80 mg, which is half of the starting dose of the drug. Then, we increase it in a very thoughtful fashion, week by week. And, if possible, we get to 160 mg. But, if not, stopping a biologically active dose is felt to be in the 80-mg to 120-mg dose range. It’s much more important to keep the patient on an 80-mg to 120-mg dose range at a continuous point, rather than stopping and starting at an intolerable dose level. With the ReDOS study, I think we have affirmation of how to best dose escalate and keep patients there.

Transcript Edited for Clarity 
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Transcript: 

Tanios Bekaii-Saab, MD, FACP: The most important element to be understood from the study is that we weren’t looking at a low-dose versus a high-dose strategy. We were looking at optimizing the dose. The goal remains the same—to try to get to the highest dose tolerated by the patient. But, there are different ways to do it.

So, the standard dose was 160 mg. This dose would be adjusted closer to 120 mg, for many patients, so they could continue on trial. Our dose optimization strategy went the other way. We’d start with the low dose. Every week, the intent was to go up on the dose, to try to reach the goal. So, there’s the intent and the goal. The intent is essentially to optimize the dose. The goal is to reach the maximal dose—160 mg.

The dose optimization strategy is designed to try to reach the maximal dose that we think the patient will tolerate. It may end up being 120 mg, for most patients. But, there are a few patients, or more than a few, about 20%. We’re going to look a little bit more at those numbers that do reach 160 mg and stay at 160 mg, through their lifetime exposure to regorafenib.

So, again, for community oncologists, it’s very important to remember that this was not a low-dose versus a high-dose strategy. This was a start point of a low dose with a goal to reach 160 mg, if the patient could tolerate it, versus starting at 160 mg from the get-go.

Andrea Cercek, MD: In my personal experience, I’ve used regorafenib at a lower dose for some time. I have noticed the difficulty of patients tolerating standard dosing, which is why I’m so happy to see the ReDOS data. The efficacy was not compromised with a lower dose. We’ve also started to be very proactive with the management of toxicity—including dermatology referrals, early on, and referrals to podiatrists for foot care—because that was one of the main issues that patients had. They did not have proper foot care prior to starting the treatment. We know that looser shoes are better than tighter shoes, so those are the types of things that we’ve incorporated into clinic. I think that this is actually making a difference, in terms of tolerability, in my personal experience.

Zev A. Wainberg, MD: Many of us who treat a lot of colon cancer patients with this drug have been doing so for some time. One of the important values of the ReDOS study is that it reaffirmed what oncologists have been doing in practice—starting at the lowest dose, 80 mg, which is half of the starting dose of the drug. Then, we increase it in a very thoughtful fashion, week by week. And, if possible, we get to 160 mg. But, if not, stopping a biologically active dose is felt to be in the 80-mg to 120-mg dose range. It’s much more important to keep the patient on an 80-mg to 120-mg dose range at a continuous point, rather than stopping and starting at an intolerable dose level. With the ReDOS study, I think we have affirmation of how to best dose escalate and keep patients there.

Transcript Edited for Clarity 
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