Optimal TURBT: Do Skilled Urologists Really Need Photodynamic Diagnosis (PDD)? -Trinity Bivalacqua & Michael Cookson
May 2, 2023
The 2023 AUA annual meeting included the Bladder Cancer Forum, featuring a debate discussing whether skilled urologists need photodynamic diagnosis (PDD) to perform an optimal TURBT. Drs. Michael Cookson and Trinity Bivalacqua, who were participants in this debate, join Dr. Neal Shore to highlight the takeaways from the session. Cookson argued against the use of blue light due to the limitations and challenges with its adoption, while Bivalacqua highlighted the benefits of PDD, including its effectiveness in reducing recurrence rates and enhanced detection, especially in high-risk non-muscle invasive bladder cancers. They both agreed that PDD has practical real-world uses and benefits for patients, and it would be nice to see it utilized more often.
Biographies:
Michael Cookson, MD, FACS, Professor and Chairman, Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City, OK
Trinity Bivalacqua, MD, PhD, Director of Urologic Oncology, Co-Director of the Genitourinary Cancer Service Line, Abramson Cancer Center, Professor of Surgery at the Hospital of the University of Pennsylvania, Philadelphia, PA
Neal D. Shore, MD, FACS, Chief Medical Officer, Surgery/Urology, for GenesisCare, Medical Director, Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC
Biographies:
Michael Cookson, MD, FACS, Professor and Chairman, Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City, OK
Trinity Bivalacqua, MD, PhD, Director of Urologic Oncology, Co-Director of the Genitourinary Cancer Service Line, Abramson Cancer Center, Professor of Surgery at the Hospital of the University of Pennsylvania, Philadelphia, PA
Neal D. Shore, MD, FACS, Chief Medical Officer, Surgery/Urology, for GenesisCare, Medical Director, Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC
Read the Full Video Transcript
Neal Shore: Neal Shore here with my really great friends and colleagues, Mike Cookson and Trinity Bivalacqua. We were really fortunate to have a session at the IBCG Symposium at AUA 2023 this year. Thanks to the leadership of Doctors Kamat and Li, and their team. Our session was debating PDD, photodynamic diagnosis, the use of blue light and Cysview or Hexvix, depending on where you are in the world, and is it required for a skilled urologist? Dr. Cookson had the con side, Dr. Bivalacqua had the pro, so let me just turn it over to Dr. Cookson first and then we'll hear from Dr. Bivalacqua, the summary of how you felt the debate went and your thoughts really in a practical way on real world use of PDD.
Michael Cookson: Sure. Thank you, Neal. Well, the debate was set up intentionally to add a little color and controversy, and it gave us the opportunity to expose some of the real world limitations of blue light. And so my position started out really acknowledging the benefit of blue light to the reduction in recurrence rates and enhanced detection. However, it's always used in combination with white light. And then I really looked at one of these large studies that was published at the UK, a multi-center study where they randomized patients to PPD versus white light, and they had a three-year recurrence free outcome, where they really didn't see any difference.
So that was informative to at least some of the studies that have... Most of the studies that have been done today really showed benefit, this one really questioned that benefit, but what I was most surprised in kind of doing the homework for the debate was on the real world under utilization, and in the United States, really it's less than 2% of TURs are really being done with blue light. So what I could say is that I think there are barriers to adoption. There are financial barriers, cost of the equipment, there's reimbursement issues that still really need to be adjusted for, in order to really fully have patients benefit from that enhanced detection. But in the format of the debate, of course, we just take one side or the other. In the real world, I was involved in several of the initial studies that brought blue light forward in the United States, and I do use blue light in my practice. So we had fun with the debate. I tried to highlight some of the limitations and challenges, but that really was for the purpose of theater.
Neal Shore: Yeah. No, that's a great summary. Trinity, your thoughts?
Trinity Bivalacqua: Yeah, thanks Mike and Neal. This was a fun debate. It was, as you said, purposely put together to go back and forth, but all I did on my side, which was the pro for the utilization of PDD in clinical practice, was to highlight some of the limitations of the PHOTO trial, which is the large randomized control trial, which is a pragmatic RCT that was run in the UK. I think some of the important points from that trial, that I highlighted, was the fact that this was utilized upfront as the initial TURBT and mostly patients with intermediate risk, non muscle invasive bladder cancer. And what they found, as Dr. Cookson stated, was that at three years it really didn't have an effect. But when you look at the Kaplan-Meier curves, there's a clear separation of the curves at 12 months, which demonstrated that the blue light group or the PDD group had less recurrence.
And that's essentially what you see in clinical practice, as well as in the RCTs from the United States. So the endpoint may have been a negative trial, but when you really look at the differences in recurrence at 12 months, which is where we've always looked at our RCTs, there was a clear difference in improvement in those patients that had PDD. There are a number of limitations from the trial, which I won't speak to right now, but made the point that when we evaluate endpoints in any clinical trial, the devils in the details, and we have to make certain that we're truly looking at the patient population, that we see in clinical practice. And I would argue that the PHOTO trial was only in patients that had intermediate risk, up front TURBT.
I use the light in my practice. I know both of you do as well. And I think, I believe that the high risk non muscle invasive bladder cancers, with recurrent disease, is where we ultimately will probably see the most benefit. And that's what the RCTs have shown, at least in the United States. I'll only make... The other point that came up with Dr. Cookson is the inability or the inability for us as practitioners to see a cost-benefit from utilization of blue light. As we all know, it is a upfront capital cost, but there is some emerging data from Dr. Shore as well as from Lambros in Washington D.C., looking at Medicare that over time, because blue light reduces recurrences and reduces recurrences per patient, by five years you actually will see a benefit or cost reduction with the utilization of PDD and blue light cystoscopy. So I think in summary it was fun, but as I stated, the devils in the details and I think this clearly benefits our patients and I think it'd be nice to see it utilized more, as Dr. Cookson stated.
Neal Shore: Well, thanks gentlemen. That was great. Yeah, I think it's really not very controversial. It just makes you a bit of a better resectionist. White light is good, it's fine, it's relatively ubiquitous, but when you can add the blue light, with a caveat that you can get access to the equipment, you don't have a site of service differential, depending if you're doing it in your ambulatory surgery center versus an in-hospital. And that's the sort of a challenge in the US, it may be the same or less so in different countries, and I know we'll have an international audience. I don't think it's controversial to say that if economics are not part of it, if equipment limitations are not part of it, it just enhances your ability to detect disease and makes you potentially a better resectionist. And at the end of the day, that's what we all want to do. We want to cut down on recurrence, reduce the risk for progression. So I think this was a really great debate. IBCG symposium at the AUA, this was the second year. It was really a lot of fun. And anytime I could work with doctors Cookson and Bivalacqua, it's always a blast, because they reviewed the state-of-the-art data and did it in a way that was extremely thoughtful. So thanks gentlemen.
Michael Cookson: Yeah. And I just want to add, thank you, Neal. It was wonderful to work with both of you too. And I was really pleased to see Trinity overwhelmingly win in the audience participation vote, because even though I was sort of given the con proposal, as I said, I truly realized the value it is to our patients. So I'm glad that I didn't win.
Neal Shore: Neal Shore here with my really great friends and colleagues, Mike Cookson and Trinity Bivalacqua. We were really fortunate to have a session at the IBCG Symposium at AUA 2023 this year. Thanks to the leadership of Doctors Kamat and Li, and their team. Our session was debating PDD, photodynamic diagnosis, the use of blue light and Cysview or Hexvix, depending on where you are in the world, and is it required for a skilled urologist? Dr. Cookson had the con side, Dr. Bivalacqua had the pro, so let me just turn it over to Dr. Cookson first and then we'll hear from Dr. Bivalacqua, the summary of how you felt the debate went and your thoughts really in a practical way on real world use of PDD.
Michael Cookson: Sure. Thank you, Neal. Well, the debate was set up intentionally to add a little color and controversy, and it gave us the opportunity to expose some of the real world limitations of blue light. And so my position started out really acknowledging the benefit of blue light to the reduction in recurrence rates and enhanced detection. However, it's always used in combination with white light. And then I really looked at one of these large studies that was published at the UK, a multi-center study where they randomized patients to PPD versus white light, and they had a three-year recurrence free outcome, where they really didn't see any difference.
So that was informative to at least some of the studies that have... Most of the studies that have been done today really showed benefit, this one really questioned that benefit, but what I was most surprised in kind of doing the homework for the debate was on the real world under utilization, and in the United States, really it's less than 2% of TURs are really being done with blue light. So what I could say is that I think there are barriers to adoption. There are financial barriers, cost of the equipment, there's reimbursement issues that still really need to be adjusted for, in order to really fully have patients benefit from that enhanced detection. But in the format of the debate, of course, we just take one side or the other. In the real world, I was involved in several of the initial studies that brought blue light forward in the United States, and I do use blue light in my practice. So we had fun with the debate. I tried to highlight some of the limitations and challenges, but that really was for the purpose of theater.
Neal Shore: Yeah. No, that's a great summary. Trinity, your thoughts?
Trinity Bivalacqua: Yeah, thanks Mike and Neal. This was a fun debate. It was, as you said, purposely put together to go back and forth, but all I did on my side, which was the pro for the utilization of PDD in clinical practice, was to highlight some of the limitations of the PHOTO trial, which is the large randomized control trial, which is a pragmatic RCT that was run in the UK. I think some of the important points from that trial, that I highlighted, was the fact that this was utilized upfront as the initial TURBT and mostly patients with intermediate risk, non muscle invasive bladder cancer. And what they found, as Dr. Cookson stated, was that at three years it really didn't have an effect. But when you look at the Kaplan-Meier curves, there's a clear separation of the curves at 12 months, which demonstrated that the blue light group or the PDD group had less recurrence.
And that's essentially what you see in clinical practice, as well as in the RCTs from the United States. So the endpoint may have been a negative trial, but when you really look at the differences in recurrence at 12 months, which is where we've always looked at our RCTs, there was a clear difference in improvement in those patients that had PDD. There are a number of limitations from the trial, which I won't speak to right now, but made the point that when we evaluate endpoints in any clinical trial, the devils in the details, and we have to make certain that we're truly looking at the patient population, that we see in clinical practice. And I would argue that the PHOTO trial was only in patients that had intermediate risk, up front TURBT.
I use the light in my practice. I know both of you do as well. And I think, I believe that the high risk non muscle invasive bladder cancers, with recurrent disease, is where we ultimately will probably see the most benefit. And that's what the RCTs have shown, at least in the United States. I'll only make... The other point that came up with Dr. Cookson is the inability or the inability for us as practitioners to see a cost-benefit from utilization of blue light. As we all know, it is a upfront capital cost, but there is some emerging data from Dr. Shore as well as from Lambros in Washington D.C., looking at Medicare that over time, because blue light reduces recurrences and reduces recurrences per patient, by five years you actually will see a benefit or cost reduction with the utilization of PDD and blue light cystoscopy. So I think in summary it was fun, but as I stated, the devils in the details and I think this clearly benefits our patients and I think it'd be nice to see it utilized more, as Dr. Cookson stated.
Neal Shore: Well, thanks gentlemen. That was great. Yeah, I think it's really not very controversial. It just makes you a bit of a better resectionist. White light is good, it's fine, it's relatively ubiquitous, but when you can add the blue light, with a caveat that you can get access to the equipment, you don't have a site of service differential, depending if you're doing it in your ambulatory surgery center versus an in-hospital. And that's the sort of a challenge in the US, it may be the same or less so in different countries, and I know we'll have an international audience. I don't think it's controversial to say that if economics are not part of it, if equipment limitations are not part of it, it just enhances your ability to detect disease and makes you potentially a better resectionist. And at the end of the day, that's what we all want to do. We want to cut down on recurrence, reduce the risk for progression. So I think this was a really great debate. IBCG symposium at the AUA, this was the second year. It was really a lot of fun. And anytime I could work with doctors Cookson and Bivalacqua, it's always a blast, because they reviewed the state-of-the-art data and did it in a way that was extremely thoughtful. So thanks gentlemen.
Michael Cookson: Yeah. And I just want to add, thank you, Neal. It was wonderful to work with both of you too. And I was really pleased to see Trinity overwhelmingly win in the audience participation vote, because even though I was sort of given the con proposal, as I said, I truly realized the value it is to our patients. So I'm glad that I didn't win.