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Safety of Low-Dose Steroids with Abiraterone in Prostate Cancer

Panelists:Raoul S. Concepcion, MD, FACS, Urology Associates; Michael S. Cookson, MD, MMHC, University of Oklahoma Health Sciences Center; Daniel P. Petrylak, MD, Yale School of Medicine; Daniel I. Quinn, MBBS, PhD, FRACP, FACP, University of Southern California; Neal D. Shore, MD, FACS, Carolina Urologic Research Center; Charles J. Ryan, MD, UCSF Helen Diller Family Comprehensive Cancer Center
Published: Thursday, Jul 14, 2016


Transcript:

Raoul S. Concepcion, MD:
In terms of our mCRPC patients, I think that urologists are becoming a little bit more comfortable, but there continues to be a little bit of resistance to prescribe abiraterone because of mechanistically how abiraterone works, and you do need concomitant prednisone administration. It seems to be a big fear. It seems to hold back urology more so than medical oncology. Dan, for our urology viewers, are there any data? Has anything been recently published that addresses the potential adverse long-term effects to the use of long-term prednisone?

Daniel P. Petrylak, MD: Interestingly, there was a paper that came out by Fizazi in European Urology, where he looked at more than 2200 patients who were treated with abiraterone, and found that only 0.5% of those patients discontinued abiraterone due to a prednisone-related side effect. So, it’s really not a significant problem.

Raoul S. Concepcion, MD: I think most of us that have used the drug extensively realize that it’s not a big problem. We do know that there is some monitoring but I’m of the belief that these patients are sick and they need to be monitored. And I think this is not like giving an anticholinergic for overactive bladder. These patients need to be monitored not only for the side effect profile, understand how these drugs are metabolized, but also to keep continuous track on how their cancer is or is not progressing.

You see these patients. I personally think urologists shouldn’t be scared about the use of prednisone, especially because we know mechanistically how abiraterone acetate works and is required. Thoughts? Anything that you can tell the urology audience about why we shouldn’t be so frightful and fearful of the use of prednisone.

Michael S. Cookson, MD, MMHC: Yes, I would agree that any additional complexity to the regimen of the oral medication is sometimes a barrier to its uptake. First, it was kind of the secondary pharmacy. Everyone was comfortable with writing for a pill, but then it required a little more logistics from your office and making sure the patient qualified. That was one thing. Then there’s the side effect profiles, and we have to be comfortable with that. Of course, if you add two medications—a steroid and an oral agent—then you have to watch for the side effects of both of those. I think good data that are pulled out of some of these large trials show that relatively speaking, the side effect component of the steroid is pretty minor. You do have to watch things like blood sugars and monitor patients when you use abiraterone with prednisone. You’re watching for hypertension, fluid build-up, and edema. You check liver function studies and potassium levels periodically, but I don’t think that’s beyond the scope of practice for urologists. And I think that these drugs seem to be very well tolerated by most. And I think for the urologist or the most capable, maybe not the most comfortable, person managing that part of the practice in that multidisciplinary mode, I think it can be done quite easily.

Raoul S. Concepcion, MD: I think clearly this world is becoming more complex and there’s going to be more and more drugs. Like David had mentioned, we’ve got galeterone, and you’ve got all these other new agents. I’m sure there’s going to be more coming as we get more comfortable looking at some of these drivers, BRCA1, BRCA2, PARP inhibitors, immunotherapies. It’s just exploding. Dan, comments?

Daniel P. Petrylak, MD: One comment. I agree with Mike that steroids are not that difficult to give in this situation. The problem I have is getting patients off steroids. Generally, if we’re putting patients on another clinical trial, I like to reduce the prednisone. Even if it’s a small amount of prednisone, I have difficulty with fatigue in tapering that and stopping it. Managing it is not a difficult situation once they’re on it, but getting them off for the next treatment is a little bit difficult.

Neal D. Shore, MD: I think one of the other things about that article—Karim Fizazi is first author, I think I’m one of the guys in the et al group on that—and one of the long-term findings that we had is that in terms of significant glycemic issues and/or bone demineralization issues, it was very, very low single digits. So, it’s not a long-term challenge to manage patients with long-term use of steroids. And to your point, Dan, I think for urologists who want to take care of advanced prostate cancer patients—which it’s a serious disease and it’s not to be dabbled with—there needs to be a subspecialization within one’s practice to want to do this and do it well. Picking up and being able to take on a new medication, such as low-dose prednisone, actually is not difficult. And some of your patients later on you’ll bring it on to help stimulate energy, sometimes even occasionally improve appetite.

Transcript Edited for Clarity
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Transcript:

Raoul S. Concepcion, MD:
In terms of our mCRPC patients, I think that urologists are becoming a little bit more comfortable, but there continues to be a little bit of resistance to prescribe abiraterone because of mechanistically how abiraterone works, and you do need concomitant prednisone administration. It seems to be a big fear. It seems to hold back urology more so than medical oncology. Dan, for our urology viewers, are there any data? Has anything been recently published that addresses the potential adverse long-term effects to the use of long-term prednisone?

Daniel P. Petrylak, MD: Interestingly, there was a paper that came out by Fizazi in European Urology, where he looked at more than 2200 patients who were treated with abiraterone, and found that only 0.5% of those patients discontinued abiraterone due to a prednisone-related side effect. So, it’s really not a significant problem.

Raoul S. Concepcion, MD: I think most of us that have used the drug extensively realize that it’s not a big problem. We do know that there is some monitoring but I’m of the belief that these patients are sick and they need to be monitored. And I think this is not like giving an anticholinergic for overactive bladder. These patients need to be monitored not only for the side effect profile, understand how these drugs are metabolized, but also to keep continuous track on how their cancer is or is not progressing.

You see these patients. I personally think urologists shouldn’t be scared about the use of prednisone, especially because we know mechanistically how abiraterone acetate works and is required. Thoughts? Anything that you can tell the urology audience about why we shouldn’t be so frightful and fearful of the use of prednisone.

Michael S. Cookson, MD, MMHC: Yes, I would agree that any additional complexity to the regimen of the oral medication is sometimes a barrier to its uptake. First, it was kind of the secondary pharmacy. Everyone was comfortable with writing for a pill, but then it required a little more logistics from your office and making sure the patient qualified. That was one thing. Then there’s the side effect profiles, and we have to be comfortable with that. Of course, if you add two medications—a steroid and an oral agent—then you have to watch for the side effects of both of those. I think good data that are pulled out of some of these large trials show that relatively speaking, the side effect component of the steroid is pretty minor. You do have to watch things like blood sugars and monitor patients when you use abiraterone with prednisone. You’re watching for hypertension, fluid build-up, and edema. You check liver function studies and potassium levels periodically, but I don’t think that’s beyond the scope of practice for urologists. And I think that these drugs seem to be very well tolerated by most. And I think for the urologist or the most capable, maybe not the most comfortable, person managing that part of the practice in that multidisciplinary mode, I think it can be done quite easily.

Raoul S. Concepcion, MD: I think clearly this world is becoming more complex and there’s going to be more and more drugs. Like David had mentioned, we’ve got galeterone, and you’ve got all these other new agents. I’m sure there’s going to be more coming as we get more comfortable looking at some of these drivers, BRCA1, BRCA2, PARP inhibitors, immunotherapies. It’s just exploding. Dan, comments?

Daniel P. Petrylak, MD: One comment. I agree with Mike that steroids are not that difficult to give in this situation. The problem I have is getting patients off steroids. Generally, if we’re putting patients on another clinical trial, I like to reduce the prednisone. Even if it’s a small amount of prednisone, I have difficulty with fatigue in tapering that and stopping it. Managing it is not a difficult situation once they’re on it, but getting them off for the next treatment is a little bit difficult.

Neal D. Shore, MD: I think one of the other things about that article—Karim Fizazi is first author, I think I’m one of the guys in the et al group on that—and one of the long-term findings that we had is that in terms of significant glycemic issues and/or bone demineralization issues, it was very, very low single digits. So, it’s not a long-term challenge to manage patients with long-term use of steroids. And to your point, Dan, I think for urologists who want to take care of advanced prostate cancer patients—which it’s a serious disease and it’s not to be dabbled with—there needs to be a subspecialization within one’s practice to want to do this and do it well. Picking up and being able to take on a new medication, such as low-dose prednisone, actually is not difficult. And some of your patients later on you’ll bring it on to help stimulate energy, sometimes even occasionally improve appetite.

Transcript Edited for Clarity
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