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Alicia Morgans: Hi, I'm thrilled to have here with me today Dr. Yair Lotan who's Professor and Chief of Urologic Oncology at UT Southwestern Medical Center at Dallas. Thank you so much for being here with me today. 

Yair Lotan: Absolutely. Good morning. 

Alicia Morgans: Wonderful. So, you gave a really exciting talk recently at EAU describing your experience and the benefits of using some new technology in the clinic that we've really only had access to, I think, in some ways in the OR, in terms of cystoscopy. And I'd love to hear your ... Give us the basics and the low-down on this new technology. 

Yair Lotan: Sure. So, for many years now we've been using blue light cystoscopy in the operating room. There's a lot of data that shows that you can improve detection of cancers, especially carcinoma in situ, and some randomized trials have shown reduction in recurrence rates. 

But up until last year, you could not do that in the clinic, and I think it's very important to note that all surveillance for bladder cancer typically happens in the clinic. You do a flexible cystoscopy every three to six months depending on the risk group of the patient, and you're looking in the office with a white light cystoscope, and trying to see if the patient is having a recurrence. 

We all know that detecting recurrence early is important, and also determining whether or not somebody is having a good response to therapies like BCG is important, and early detection probably will reduce the risk of progression. 

Last year, there was a large Phase 3 study in the US at 17 centers looking at the use of blue light flexible cystoscopy, the thought being that if it improves detection in the operating room, then it probably would improve detection in the clinic. And so, this was a study in about 304 patients, and the study was designed very nicely to try to keep people honest, right? So, everybody looked with a white light, and then you randomize patients to whether or not they continued on to blue light or not. 

And what happened was that study found about 63 cancers, but the blue light technology found close to 21% more cancers than the white light alone, and 34% more carcinoma in situ. And based on that, the FDA approved the technology for use in the clinic. Starting in May of last year, we started using the technology routinely in our clinic, and there was, in fact, a consensus panel convened at the last AUA to look at the best times to use it.

Most people agree that it was important to use a three-month time point after cystoscopy. That's the time when they're highest risk of residual cancer or recurrent cancers being detected, but also, at six months for patients who are undergoing intravesical BCG to try to determine if it's unresponsive, and then probably at some interval for high and intermediate risk disease. 

There's also a significant benefit when you're doing office biopsies and fulgurations for low-grade tumors because, in a Phase 3 trial, 46% of patients were found to have additional lesions. And if you think about a patient with recurrent low-grade cancers, part of the problem is that if you're missing them with white light then three months later, the tumor grows and now you see it again. It adds another procedure and also adds anxiety. 

We've been able to manage a lot of these tumors in the office with a biopsy and fulguration, and if you do it at the same time with blue light cystoscopy, then instead of seeing maybe one or two lesions, maybe you'll see three or four and you can fulgurate them all at the same time and avoid having recurrence down the road that both reduces the number of procedures patients have and reduces their anxiety. 

Alicia Morgans: Well, it's striking to me when you say that 20% or so additional cancers were detected. So, these were T1 lesions, or what? If they were ... CIS, you mentioned separately. Does this include potentially T2 lesions? 

Yair Lotan: That was pretty rare. 

Alicia Morgans: Okay. 

Yair Lotan: No, in this study, most of the patients had to have intermediate or high-risk disease, so they either had recurrent low-grade cancers or they had high-grade cancers. 202 out of the 304 had high-grade disease. 

Alicia Morgans: Okay. 

Yair Lotan: Most patients who have recurrences do have non-invasive recurrences, thankfully, but we do remove bladders for patients who have unresponsive and recurrent high-grade disease to try to reduce the chance for them to progress. 

Muscle invasive disease, thankfully, is usually visualizable but you can't usually see carcinoma in situ, but you also surprisingly miss a lot of small papillary tumors and sometimes it's the just the location in the bladder where they might be, or sometimes patients who have had intravesical therapies, they already have inflammation. It's harder to distinguish an inflammatory area from a cancerous area. So the increased risk of detection was 20.6%, to be exact, but it included carcinoma in situ, but also papillary tumors. 

Alicia Morgans: Okay. Well, can you tell me a little bit about how this is operationalized in your clinic? Because this is a new technology, I'm sure that people are trying to envision how do they incorporate this into their day-to-day where they hadn't used it before? 

Yair Lotan: Absolutely. There are some logistical issues. First of all, of course, you have to have a cystoscope that has blue light. In the U.S., the STORZ scope is the only one currently approved, and so you do have to have that equipment. I think the company is looking at different ways to try to facilitate that for people. We, fortunately, have a STORZ camera, so that made it a little easier. 

You do need to identify patients before the clinic because you can't just add on a clinic, they have to have installation. 

Alicia Morgans: Okay. 

Yair Lotan: Early on, we identified patients with high-risk. Right now I just have a routine. After I see a patient, after the resection, I go over the pathology report, talk to them about the implications of their cancer, whether or not they need additional therapies. And then, three months later, when they're gonna have their first cystoscopy, I already schedule it as a blue light. And so, my staff knows, the patient knows, what to expect and they come early. 

It's not that hard early on to look at your schedule in a week or two and have the patient show up a little bit earlier. I'd never change my actual schedule. I usually do a cystoscopy or a procedure on the hour, sometimes on the half hour, and I just designated patients that they're gonna have a blue light. 

And so, it doesn't really add time, so I never really modified my schedule to see less patients because I still have to see my full group of patients. 

Alicia Morgans: Of course. 

Yair Lotan: And you can't schedule just these procedures, and I know most urologists probably do six to eight or more procedures a day. So, they key is to have them do the same procedures, just designate the patient as a blue light or a regular cystoscopy. 

Alicia Morgans: So, just to make sure that the staff gets them in, takes care of the installation so that when you're ready, you can do the scope? 

Yair Lotan: Yeah. To be honest with you, urology staff are familiar with putting in catheters. It literally takes five additional minutes for my nurse to go in and put a catheter in and instill the Cysview®, and so, it's not particular disruptive for their day either. 

Alicia Morgans: Great, great. It sounds like this has been both beneficial in terms of identifying additional lesions, which is something that's really important, identifying them potentially earlier before they become a more intensive procedure, and potentially add to anxiety, certainly for the patient as well. And it's pretty easy for you to incorporate into your routine. 

So, it sounds like this has been a positive experience for you. What are your take-home messages to people trying to learn about this technology?

Yair Lotan: Sure. I think there are a few take-home messages. I think the guidelines currently recommend use of enhanced cystoscopy, especially with blue light in the operating room because of the definite benefits in detection and reducing recurrences. 

I think it's natural that if you wanna incorporate a technology in the operating room, that it's beneficial in the clinic as well, especially with a large study that supports that. I think that detecting disease early is what patients want. In fact, in that Phase 3 trial, we asked patients if they thought it was worthwhile. They did, overwhelmingly. There was no impact on pain. It actually decreased anxiety because patients felt like you did a more thorough evaluation for them. 

And the truth is, now, I've had some patients who have had the procedure four times. Every three months, they've had the procedure. And interestingly, because the technology is not available, I've had somebody fly to Dallas from New York, and somebody fly from Miami. So, there's clearly some patient desire to improve the performance of cystoscopy, and I think I have found it to be beneficial both in surveillance but also for the office biopsies. 

Alicia Morgans: Great. Well, thank you so much for sharing your expertise with us and your experience. And I really appreciate your time today. Thank you. 

Yair Lotan: Thank you very much for having me.