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Ashish Kamat: A warm welcome to all of you from the UroToday Studios. I'm Ashish Kamat, Urologic Oncologist at MD Anderson Cancer Center. We're live in San Francisco at GU ASCO 2025. It's a pleasure to welcome Professor Sia Daneshmand and Alireza Ghoreifi to the studios. Thank you for taking the time to join us today.

Siamak Daneshmand: Thank you.

Alireza Ghoreifi: Thank you.

Ashish Kamat: So we're all excited to see and hear what you're going to present on the blue light registry. So Sia, what are you going to be talking about?

Siamak Daneshmand: Yeah. So let me give you a little background on this registry. It's been around for almost 10 years, I think. We started with a few groups, and now we have about 14, 15 sites that contribute to this registry.

It's become a pretty powerful database. We have over 3,000 patients in this database—non-muscle invasive. It's a blue light registry of, obviously, patients undergoing blue light cystoscopy for non-muscle invasive bladder cancer, both in the operating room and some surveillance in the office, with a Flex Blue as well.

So over the years, we've contributed a lot to the patient population. And now we're beginning to look back. We have follow-up on many of these patients, and we're beginning to look back to see—the recurrence rates, progression rates. Many of those things we've known in the past, but now we have a larger database.

Ashish Kamat: Yeah. And this database, is there a cutoff date for the database as for which patients have stopped enrolling? Or is it an ongoing database?

Siamak Daneshmand: It’s an ongoing database. And we constantly are trying to do the follow-ups on the patients. That’s, I think, the most powerful sort of data that we can get—is the follow-up, right? We all want to know about progression rates.

Recurrence we’ve known for years from the previous studies that were done in the phase III's, looking at the improvement in recurrence rates. But now trying to concentrate and see whether we can see any difference in progression rates. So that requires the follow-up. But it’s ongoing, yeah.

Ashish Kamat: Yeah. And that’s critical because it’s real-world data. It’s patients actually in the real world getting the blue light cystoscopy.

Siamak Daneshmand: Very few contraindications of not getting into it. It’s a registry, like you said. It’s real world. So almost all the patients coming on—it’s just non-muscle invasive. It’s all non-muscle invasive.

Ashish Kamat: All right. Great.

Siamak Daneshmand: It’s a moving target, right? So different treatment. We have newer options for non-muscle invasive bladder cancer. So we’re constantly updating the database to include those treatments in there.

Ashish Kamat: Right. Exactly. And then speaking of data, Ali, what’s the data you’re going to be presenting?

Alireza Ghoreifi: Yeah. So in this project, actually, we looked at the effect of blue light cystoscopy on the risk stratification of the patients with non-muscle invasive bladder cancer. We know that blue light cystoscopy is an established technology for the diagnosis and also surveillance of patients with non-muscle invasive bladder cancer. But most of the prior prospective and retrospective studies on this topic mainly focused on the detection rate, and the progression, and the recurrence rates. And we don't have any data on the effect of this technology on the risk stratification.

And we already know that, in daily practice, risk stratification is an integral part of the patient's management. And we need some information about the number of the lesions, the size of the lesions, any prior treatment—like intravesical therapy or surgical management prior—or the presence of additional lesions, like CIS. And all these together contribute to the risk stratification of the patients. And we actually make the decision based on this.

So we looked at the database in a period between 2014 and 2024. And we included 2,854 patients who had TURBT with blue light cystoscopy. And our aim actually was to find patients who experienced risk group migration, i.e., using blue light cystoscopy changed the risk group compared to just doing white light cystoscopy.

And after reviewing all these patients, we found out that 9.3% of these patients experienced risk group migration. And 6% of these risk migrations was going to high risk, and 2.1% to intermediate risk, and 1.2% to low risk. So—

Ashish Kamat: So let me stop you there for a quick second. Because when you say “risk migration,” the way we use blue light, we usually think we’re going to pick up a greater number of lesions; we’re going to pick up CIS; we’re going to pick up tumors that may not otherwise have been visible. And you might get some low grade, high grade.

So I understand the migration to high risk or the up-risk, upstaging of the risk category. I understand going from low to intermediate, because you probably pick up more tumors, et cetera. But you also said that they became lower risk. How did that happen?

Alireza Ghoreifi: So the low risk means that the patient—if with the white light cystoscopy, we didn’t appreciate any lesions, but they had lesions with blue light cystoscopy that was finally positive on the final pathology—

Ashish Kamat: Oh, I see. So they went from negative to being some category.

Alireza Ghoreifi: Yes.

Ashish Kamat: They didn’t migrate to a lower-risk category.

Alireza Ghoreifi: Yeah. Actually, we put these two groups together—the patients who went from 0, like normal, to positive, and also the patients who had low or intermediate risk to the higher-risk group.

Siamak Daneshmand: Migration from no risk to low risk.

Ashish Kamat: The way it came across—I just want our audience to understand—it’s not like a patient went from a higher-risk category to a lower-risk category, right? It was not a reverse migration.

Alireza Ghoreifi: No. Yeah.

Ashish Kamat: Continue.

Alireza Ghoreifi: Yeah. And actually, from the clinical implication of our data, our aim was that we know that, for example, when a patient goes from low risk to high risk, or low risk to intermediate risk, this might change the management plan of these patients.

For example, if the patient was not initially planned to receive intravesical therapy, then they would be eligible for that. Or they might have an extension for the duration of intravesical therapy. Or some of these patients would be eligible to proceed with radical cystectomy, which we think is going to impact our daily practice.

Ashish Kamat: No, absolutely. I mean, again, the use of optical-enhanced technology—and, in this case, we’re talking about blue light—clearly helps us to understand which patients need certain therapies that might not have previously needed it, right?

Did you also look at, or do you plan to look at how, hypothetically, if everybody—all the physicians—were practicing guideline-based medicine, pick your guideline, EAU or AUA, have you also thought about looking to see, would the management of the patient have changed?

Siamak Daneshmand: Yeah, that’s a great question. It’s probably an area we need to look at in the future. We haven’t yet looked at what happens to those patients who are risk-migrated and whether that changed their management ultimately. But it’s a very good point.

We’re just kind of rebuilding the database right now to include some of the additional treatment options that are available. So we’ll be looking at that in the future. Yeah.

Ashish Kamat: And, Ali, again, I’ll ask you a little bit more about the data. So when you said patients migrated up to the high-risk category, what was the driving force? Was it the CIS? What drove them to go to that?

Alireza Ghoreifi: Yeah. So the main contributor for that was finding the CIS. There have been some other factors, but the main factor was CIS.

When you look at the raw data, for example, for patients who upstaged from 0 to positive, as far as I remember, more than 40% of those patients had CIS. So this actually shows the benefit of blue light cystoscopy to find those lesions, the CIS lesions, which cannot be appreciated by white light cystoscopy.

Ashish Kamat: Yeah. And then again, Sia, you know I use blue light, you use blue light. But how do you counter the argument from folks that say, well, now I have the higher-definition equipment, I have the Chroma, Clara, whatever you want to call it, and I also do random biopsies. So why do I need to use blue light? What would you say to that?

Siamak Daneshmand: Yeah. I think, first of all, these flat lesions are invisible that we see with blue light as being CIS. So I don’t think random biopsies necessarily pick up those areas. Random biopsies are just that—they’re random. I’m not so keen on these random biopsies.

The argument has always been, finding additional lesions—and what does it matter? I’m going to treat the patient—if you miss a small lesion, I’m going to treat the patient with BCG. So really the impetus for this study was to show it’s not just finding additional lesions, but it’s actually a risk migration, like Alireza said, that will alter your management, whether it’s duration of maintenance therapy from one year to three years, from intermediate to high risk, or the finding of CIS putting you in the high-risk category.

Different guidelines are different. Obviously, you’re a big proponent of saying any high grade is high risk. But still, at the AUA, it’s intermediate risk. And that has implications also on trial inclusion, where intermediate-risk patients—if you have a high-grade small lesion—are included in the intermediate-risk cohort. It now can get on trial A or B. But if now you find CIS elsewhere…

So your original question was about the enhanced cystoscopies and HD and Chroma and Clara. I think those are fantastic. They’re great in clarity of these lesions, of seeing them. But many of these lesions, as you’ve seen many times yourself, are not visible to the naked eye. And it really points it out, unlike the other enhanced cystoscopy. So that’s what we mainly use it for.

Also, another advantage is you do a resection of a larger tumor—4 or 5 centimeters. You think you’re done. You cauterize all the edges. Then you use your blue light, and you go, wow, I missed this whole region here. Those are recurrences in three months or an extended period of time.

So I think that’s one of the other advantages that we don’t see in databases. It’s really hard to capture that in a database: did it help you resect better? That we have to see in recurrence rates and progression rates.

Ashish Kamat: Yeah. And I think that’s extremely critical when we are looking at all these single-arm studies that are looking at BCG-unresponsive patient populations. And nothing against single-arm studies—that’s the paradigm that we actually pushed the FDA, so I’m glad they allowed us initially. But it’s hard to know what happens with patients if you use white light and you don’t see anything, and you use blue light and you see something—what’s the CR rate, what’s the response rate, all of those things?

Gentlemen, it’s always a pleasure to chat with you. But in closing, any closing thoughts for the audience, Ali? Sia?

Siamak Daneshmand: Thanks. No, I think I’m super excited about this registry because now we’re having more extended follow-up on the patients. And I think we’re going to be able to glean a lot more information on these patients and the treatment options. So be on the lookout for more studies to come.

Ashish Kamat: Absolutely. You’re going to be here again next year, is that what you’re saying?

Siamak Daneshmand: Yes.

Ashish Kamat: Thank you for taking the time.

Alireza Ghoreifi: Thank you so much.

Siamak Daneshmand: Thanks so much.