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Perioperative RCC Treatment: Immunotherapy and Urology

Panelists: Daniel George, MD, Duke Cancer Institute; Neeraj Agarwal, MD, Huntsman Cancer Institute; Robert Alter, MD, Hackensack University Medical Center; Bradley McGregor, MD, Dana-Farber Cancer Institute; Nicholas J. Vogelzang, MD, FASCO, FACP, Comprehensive Cancer Centers of Nevada
Published: Wednesday, Mar 14, 2018



Transcript: 

Daniel George, MD: I think it’s really important to recognize that although this is maybe an advancement in the field, it’s not maybe where we want to be ultimately, right? Immunotherapy offers some exciting results in terms of duration of effect and maybe some complete responses in patients. What are the adjuvant therapies that we’re seeing right now? Brad, can you comment a little bit on the current adjuvant studies that are going on, the industry studies? Nick, I’ll ask you to talk about the neoadjuvant study that’s a cooperative group-led study.

Bradley McGregor, MD: I think when you look at the purely adjuvant studies, there are 2 trials ongoing that have a very similar design. One trial’s looking at pembrolizumab versus placebo, the other one is looking at atezolizumab. Both trials are looking at those with high-risk disease who are T2, grade 4; T3; and T4. I know the pembrolizumab trial has an arm that has M1 NED. So, if you’ve had surgery from metastasectomy within a year of the nephrectomy, you also go on it. Those patients are obviously at very high risk for distant recurrence. And so, it’s comparing immunotherapy with either agent versus placebo.

Daniel George, MD: There are a couple of immunotherapy options, single-agent checkpoint strategies. What about the neoadjuvant setting? How is that different, Nick?

Nicholas J. Vogelzang, MD, FASCO, FACP: Lauren Harshman’s got a nice trial. It took a lot of time getting through the GU Steering Committee, and there was a lot of controversy. But basically, it’s neoadjuvant. You biopsy the tumor. You don’t, by the way, have to have histology; you just have to prove that you’ve done the biopsy. My first patient got his biopsy but it was negative, and I thought I couldn’t get him on trial. But you then give them 2 cycles of nivolumab, nephrectomy, and they’re randomized to either no additional nivolumab or a year of nivolumab. It’s a little easier because nivolumab is given every 4 weeks. And so, it’s a bit easier trial. It’s not so stark where it’s says, “Well, you’re not getting it and you are.” Everybody gets a shot at nivolumab in that trial. So, I think it’s a good trial. I think it’ll fly.

Daniel George, MD: Yes, I think the key thing with studies like this is the multidisciplinary coordination with urology. Can you guys talk a little bit about how that’s working in your center? Do you have any advice for groups out there on how to set this up? I think up to this point in time, there hasn’t necessarily been multidisciplinary care with urology in renal cell carcinoma because we just haven’t had that many treatment options to share in this setting. Bob, are there any thoughts on that from Hackensack?

Robert Alter, MD: Sure. I think the first thing is that you have to have a good rapport with your department of urology. In private practice, as well as the faculty practice, you really need to be able to recognize this is outpatient care. With the ability of now having, even as we look at it, adjuvant data, we have to allow our urologist partners to let us know that these patients are out there. We should be seeing these patients who are at risk even when you look at the PROTECT clinical trial, which has patients at T2 disease, or even at the ASSURE trial, which had T1b patients. It just allows them to recognize that all patients at a higher risk of concern of recurrence should be referred to a medical oncologist just for an assessment. I think the surveillance scans that we do should be done properly, based upon NCCN guidelines. The fact is that they still maintain their care under the urologist as well as the medical oncologists. It gives us the ability to make sure the patients will be monitored and managed appropriately with laboratories as well as scans.

The ability of having neoadjuvant clinical trials definitely includes our urologist, because it allows us to offer them an option of therapy while they’re still going for the cytoreductive nephrectomies, or nephrectomies, with a curative intent. I think the allowance of the urologists to let us partake in their patients is quite important, and it gives patients the ability to be overseen by 2 multidisciplinary professionals who really are looking for their overall survival.

Daniel George, MD: Great advice. I think, with the coordination of care, recognizing the importance of bringing in that medical oncologist—even before nephrectomy, to open up some of these neoadjuvant options—and recognizing both the standard of care and immunotherapy clinical trial options that are out there today, this is an exciting time right now for adjuvant therapy. I don’t think we’ve ever had this kind of diversity of trials with standard options before. I really look forward to seeing how the community adopts all of this in their practice.

Transcript Edited for Clarity 

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Transcript: 

Daniel George, MD: I think it’s really important to recognize that although this is maybe an advancement in the field, it’s not maybe where we want to be ultimately, right? Immunotherapy offers some exciting results in terms of duration of effect and maybe some complete responses in patients. What are the adjuvant therapies that we’re seeing right now? Brad, can you comment a little bit on the current adjuvant studies that are going on, the industry studies? Nick, I’ll ask you to talk about the neoadjuvant study that’s a cooperative group-led study.

Bradley McGregor, MD: I think when you look at the purely adjuvant studies, there are 2 trials ongoing that have a very similar design. One trial’s looking at pembrolizumab versus placebo, the other one is looking at atezolizumab. Both trials are looking at those with high-risk disease who are T2, grade 4; T3; and T4. I know the pembrolizumab trial has an arm that has M1 NED. So, if you’ve had surgery from metastasectomy within a year of the nephrectomy, you also go on it. Those patients are obviously at very high risk for distant recurrence. And so, it’s comparing immunotherapy with either agent versus placebo.

Daniel George, MD: There are a couple of immunotherapy options, single-agent checkpoint strategies. What about the neoadjuvant setting? How is that different, Nick?

Nicholas J. Vogelzang, MD, FASCO, FACP: Lauren Harshman’s got a nice trial. It took a lot of time getting through the GU Steering Committee, and there was a lot of controversy. But basically, it’s neoadjuvant. You biopsy the tumor. You don’t, by the way, have to have histology; you just have to prove that you’ve done the biopsy. My first patient got his biopsy but it was negative, and I thought I couldn’t get him on trial. But you then give them 2 cycles of nivolumab, nephrectomy, and they’re randomized to either no additional nivolumab or a year of nivolumab. It’s a little easier because nivolumab is given every 4 weeks. And so, it’s a bit easier trial. It’s not so stark where it’s says, “Well, you’re not getting it and you are.” Everybody gets a shot at nivolumab in that trial. So, I think it’s a good trial. I think it’ll fly.

Daniel George, MD: Yes, I think the key thing with studies like this is the multidisciplinary coordination with urology. Can you guys talk a little bit about how that’s working in your center? Do you have any advice for groups out there on how to set this up? I think up to this point in time, there hasn’t necessarily been multidisciplinary care with urology in renal cell carcinoma because we just haven’t had that many treatment options to share in this setting. Bob, are there any thoughts on that from Hackensack?

Robert Alter, MD: Sure. I think the first thing is that you have to have a good rapport with your department of urology. In private practice, as well as the faculty practice, you really need to be able to recognize this is outpatient care. With the ability of now having, even as we look at it, adjuvant data, we have to allow our urologist partners to let us know that these patients are out there. We should be seeing these patients who are at risk even when you look at the PROTECT clinical trial, which has patients at T2 disease, or even at the ASSURE trial, which had T1b patients. It just allows them to recognize that all patients at a higher risk of concern of recurrence should be referred to a medical oncologist just for an assessment. I think the surveillance scans that we do should be done properly, based upon NCCN guidelines. The fact is that they still maintain their care under the urologist as well as the medical oncologists. It gives us the ability to make sure the patients will be monitored and managed appropriately with laboratories as well as scans.

The ability of having neoadjuvant clinical trials definitely includes our urologist, because it allows us to offer them an option of therapy while they’re still going for the cytoreductive nephrectomies, or nephrectomies, with a curative intent. I think the allowance of the urologists to let us partake in their patients is quite important, and it gives patients the ability to be overseen by 2 multidisciplinary professionals who really are looking for their overall survival.

Daniel George, MD: Great advice. I think, with the coordination of care, recognizing the importance of bringing in that medical oncologist—even before nephrectomy, to open up some of these neoadjuvant options—and recognizing both the standard of care and immunotherapy clinical trial options that are out there today, this is an exciting time right now for adjuvant therapy. I don’t think we’ve ever had this kind of diversity of trials with standard options before. I really look forward to seeing how the community adopts all of this in their practice.

Transcript Edited for Clarity 
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