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Patient Communication About Adjuvant Therapy for RCC

Panelists: Robert A. Figlin, MD, Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center; Eric Jonasch, MD, University of Texas MD Anderson Cancer Center; Toni K. Choueiri, MD, Dana-Farber Cancer Institute; Michael R. Harrison, MD, Duke Cancer Institute; David I. Quinn, MBBS, PhD, USC Norris Cancer Hospital
Published Online: Thursday, Apr 27, 2017



Transcript:

Robert A. Figlin, MD:
David, at the end of the day, if a patient comes in to your office and they haven’t read all the data that the 4 of you have, they don’t know the pluses and minuses and the subtleties. They do know that you’ve told them that they have a risk of recurrence. At some point, the FDA will decide on the S-TRAC data and decide what to do with that information, and no predilection on what that’s going to be. There are clearly other trials in the world that have continued observation as the control arm. What’s the conversation with the patient like? What do you tell Mrs. Jones, for example? Because you are the gatekeeper for that information and share that with your patient and help them make a decision.

David I. Quinn, MBBS, PhD: I think there’s evidence for some benefit for a disease-free or progression delay that occurs with a year of sunitinib, based on S-TRAC, but it’s a very defined population and there does seem to be a larger effect in poorer-risk patients. Now, I would really like to see that confirmed by another study, in that group of patients. It would have been nice if in a subset analysis of ASSURE, a larger number of patients, we had seen that, but that’s not the case.

I actually think the FDA may approve sunitinib in this setting, and that will open up the conversation with clinicians and patients, which is going to be actually a difficult one. There’s a year of side effects with sunitinib with us trying to maintain the dose during that time, which we know, from having done ASSURE and the other studies, is not easier. It does seem, in my opinion, to be easier with the later generations of drugs, with pazopanib and axitinib, but that’s just my feeling. From that perspective, there’s a balance with a year of side effects, which are well documented in ASSURE with both sunitinib and sorafenib, where you want to get a distinct benefit. The patient may decide that delaying recurrence by a year is worth a year of those side effects, and if they do and they want to go forward with it, I’d say, “Okay, I’ll take you through this and we’ll manage it together.”

I would rather continue to accrue to the clinical trials that we’re doing, which are now with immuno-oncology agents. And so, we’re focused on doing that. We have the PROSPER study coming through the Cooperative Groups, where we’re going to give nivolumab or observe. Interestingly, we’re going to be challenged by that because we have to randomize the patients before they get nephrectomy.

Getting in the way of a urologist who is intent on doing a nephrectomy on that patient, getting them to do a biopsy and pausing for 2 doses of nivolumab, will be a significant challenge. Now, in the Cooperative Groups, we’re up for that. We’ve got Dr. Harshman from Dana-Farber Cancer Institute leading that, and I think she’s up for that. We’re going to have to really work on getting that accrued. There are another couple of studies with other checkpoint inhibitors, atezolizumab and pembrolizumab, which are more pure adjuvant studies where you put the patient on after they’ve had nephrectomy. So, there’s a bit of competition there.

Now, if you talk to the pure immunologists or those that do laboratory work in this area, there may be an argument for priming with a couple doses of a checkpoint inhibitor or even more before you take the kidney out to get optimal immunotherapy. We’re about to have a test of that and also our accrual ability. So, I would offer a patient a year of sunitinib, but I’d be talking to them about the clinical trials. That’s where I’d rather take them.

Transcript Edited for Clarity

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Transcript:

Robert A. Figlin, MD:
David, at the end of the day, if a patient comes in to your office and they haven’t read all the data that the 4 of you have, they don’t know the pluses and minuses and the subtleties. They do know that you’ve told them that they have a risk of recurrence. At some point, the FDA will decide on the S-TRAC data and decide what to do with that information, and no predilection on what that’s going to be. There are clearly other trials in the world that have continued observation as the control arm. What’s the conversation with the patient like? What do you tell Mrs. Jones, for example? Because you are the gatekeeper for that information and share that with your patient and help them make a decision.

David I. Quinn, MBBS, PhD: I think there’s evidence for some benefit for a disease-free or progression delay that occurs with a year of sunitinib, based on S-TRAC, but it’s a very defined population and there does seem to be a larger effect in poorer-risk patients. Now, I would really like to see that confirmed by another study, in that group of patients. It would have been nice if in a subset analysis of ASSURE, a larger number of patients, we had seen that, but that’s not the case.

I actually think the FDA may approve sunitinib in this setting, and that will open up the conversation with clinicians and patients, which is going to be actually a difficult one. There’s a year of side effects with sunitinib with us trying to maintain the dose during that time, which we know, from having done ASSURE and the other studies, is not easier. It does seem, in my opinion, to be easier with the later generations of drugs, with pazopanib and axitinib, but that’s just my feeling. From that perspective, there’s a balance with a year of side effects, which are well documented in ASSURE with both sunitinib and sorafenib, where you want to get a distinct benefit. The patient may decide that delaying recurrence by a year is worth a year of those side effects, and if they do and they want to go forward with it, I’d say, “Okay, I’ll take you through this and we’ll manage it together.”

I would rather continue to accrue to the clinical trials that we’re doing, which are now with immuno-oncology agents. And so, we’re focused on doing that. We have the PROSPER study coming through the Cooperative Groups, where we’re going to give nivolumab or observe. Interestingly, we’re going to be challenged by that because we have to randomize the patients before they get nephrectomy.

Getting in the way of a urologist who is intent on doing a nephrectomy on that patient, getting them to do a biopsy and pausing for 2 doses of nivolumab, will be a significant challenge. Now, in the Cooperative Groups, we’re up for that. We’ve got Dr. Harshman from Dana-Farber Cancer Institute leading that, and I think she’s up for that. We’re going to have to really work on getting that accrued. There are another couple of studies with other checkpoint inhibitors, atezolizumab and pembrolizumab, which are more pure adjuvant studies where you put the patient on after they’ve had nephrectomy. So, there’s a bit of competition there.

Now, if you talk to the pure immunologists or those that do laboratory work in this area, there may be an argument for priming with a couple doses of a checkpoint inhibitor or even more before you take the kidney out to get optimal immunotherapy. We’re about to have a test of that and also our accrual ability. So, I would offer a patient a year of sunitinib, but I’d be talking to them about the clinical trials. That’s where I’d rather take them.

Transcript Edited for Clarity
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