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Clinical Focus

Oncology Decoded Live! Advancing Peri-Operative Bladder Cancer Care: Integration of Emerging Evidence into Clinical Practice

 highlights the state of bladder cancer care in recognition of Bladder Cancer Awareness Month this May. During the discussion he touches on his own clinical practice, recent advances in the field, data on bladder cancer presented at the recent AUA meeting, including his own study, "Mental health illness in patients with non-muscle invasive bladder cancer. Does BCG play a role?", and more. 

Kamat is a professor of urologic oncology at University of Texas MD Anderson Cancer Center in Houston. 

Don’t forget to subscribe to Speaking of Urology® on 

, or anywhere that podcasts are available.

In this episode, Ashish M. Kamat, MD, MBBS, highlights the state of bladder cancer care in recognition of Bladder Cancer Awareness Month. 

Bladder Cancer Awareness Month: Dr. Kamat highlights the state of bladder cancer care

® Assistant Editor Janelle Hart spoke with 

They give an overview of the app they co-created, BlaTUR, which was designed to help clinicians risk stratify their patients and manage their practices more efficiently. Ritch is an associate professor of urology and associate director of UHealth International, and Katz is a PGY5 resident at the Miller School of Medicine, University of Miami, Florida.

“It's not a replacement for clinical judgment, obviously. But at the end of the day, the idea is that it shows you what your next steps are based on what the American Urological Association and [Society of Urologic Oncology] guidelines are for non-muscle invasive bladder cancer,” Chad R. Ritch, MD, MBA, FACS.

Speaking of Urology Podcast: Dr. Ritch and Dr. Katz discuss new bladder cancer management app

He discusses the current state of the BCG shortage, what is being done to resolve it, and what the future holds for patients with non–muscle-invasive bladder cancer who are seeking treatment. Chang is a Patricia and Rodes Hart professor of urology and oncology at the Vanderbilt University Medical Center and chief surgical officer at the Vanderbilt Ingram Cancer Center, Vanderbilt University, Nashville, Tennessee.

“I wouldn't be surprised if we have spotty distribution areas of concern for the next several years,” says Sam S. Chang MD, MBA, on the latest episode of the UT podcast Speaking of Urology. 

What does the BCG shortage look like in 2021?

 paper, “A 30-Year Review of Cystectomy Litigation,” for which she served as senior author. The paper, Malik says, “is a snapshot into what we can find about malpractice associated with cystectomy.” Malik is an assistant professor and director of female pelvic medicine and reconstructive surgery at the University of Maryland Medical System, Baltimore.

A search of a legal database found 42 cases related to cystectomy over a 30-year period.

Dr. Rena Malik on cystectomy-related litigation

 discusses findings from a paper published in Urology titled, Comparing Costs of Radical Versus Partial Cystectomy for Patients Diagnosed With Localized Muscle-Invasive Bladder Cancer: Understanding the Value of Surgical Care, for which he served as a study author. Williams is chief of urology and professor of urology and radiology at the University of Texas Medical Branch at Galveston.

Williams discusses a study comparing costs for radical versus partial cystectomy.

Dr. Stephen Williams on costs of surgical treatments for bladder cancer

In this episode, Angela B. Smith, MD, MS, of UNC Lineberger Comprehensive Cancer Center, discusses the recent FDA approval of Jelmyto, which is the first therapy for the treatment of low-grade upper tract urothelial cancer.

Speaking of Urology podcast: Dr. Angela Smith discusses Jelmyto for low-grade UTUC

The priority review decision is based on results of the phase 3 NIAGARA study (NCT03732677).

FDA grants priority review to durvalumab for muscle-invasive bladder cancer

Ferring has announced the opening of the first clinical trial sites for 2 studies within the ABLE clinical trial program as well as the launch of the phase 1/2 LUNAR trial. 

Trials launch of nadofaragene firadenovec in bladder cancer

“The combination of pembrolizumab and chemotherapy presents a promising new treatment approach for these challenging-to-treat, rare cancers and could be a major breakthrough for patient care,” says Arnold I. Chin, MD, PhD.

Pembro/chemo combo shows promise in small cell/neuroendocrine bladder and prostate cancer

“The median DOR of 47.8 months in patients who achieved complete response with JELMYTO provides evidence of robust durability in maintaining control of low-grade UTUC over an extended period,” says Phillip Pierorazio, MD. 

UGN-101 demonstrates long-term durability in low-grade UTUC

At the time of data cutoff, 71% of patients achieved a complete response following treatment. 

QUILT 3.032 trial: Anktiva achieves high response rate in BCG-unresponsive NMIBC

Treatment Strategies for Patients with NMIBC: Importance of Risk Stratification

Please share where the field of Non-muscle Invasive Bladder Cancer (NMIBC) is right now. Consider the following topics, which will be discussed in depth later on:

Please provide a brief overview of risk stratification for patients with NMIBC and treatment strategy for each group.

What are the FDA-approved agents for treating patients with NMIBC, and what treatment options are available for BCG-naïve and BCG-unresponsive patients?

How do intravesical therapies compare to intravenous therapies in this context?

Videos

A panelist discusses how Non-muscle Invasive Bladder Cancer (NMIBC) treatment varies by risk stratification (low, intermediate, and high-risk), with BCG immunotherapy being standard for high-risk patients, while newer options like pembrolizumab and gene therapies are emerging for BCG-unresponsive cases, and treatment decisions between intravesical versus systemic therapy depend on risk level and previous treatment response.

Video Series

Ava Saidian, MD, highlights the importance of preventing pelvic prolapse in female patients following bladder cancer surgery

Ava Saidian, MD, on preserving pelvic floor health after cystectomy

, highlights the importance of preventing pelvic prolapse in female patients following bladder cancer surgery. Saidian is a urologic oncologist and assistant professor of urology at the University of Tennessee Health Science Center in Memphis, Tennessee.

Something that's a little bit more specific to women who have undergone radical surgery for bladder cancer is their overall pelvic floor health. A big issue after women who have gotten cystectomies with or without vaginectomies or hysterectomies is pelvic prolapse. We really need to know [did] they have prolapse beforehand? Do they have risk factors for prolapse? And what can we do to preserve that? I think as urologists, we need to become more comfortable with the female pelvic floor and operating there in terms of preserving the ligaments that can help keep their pelvic floor suspended and help prevent prolapse and even dehiscence, which can be a catastrophic outcome from these surgeries. That can significantly affect their quality of life after these surgeries that we do.

This transcript was AI generated and edited by human editors for clarity.

“I think as urologists, we need to become more comfortable with the female pelvic floor,” says Ava Saidian, MD. 

Ava Saidian, MD, reflects on the psychosocial challenges that women with bladder cancer face, as well as how urologists can better support their needs.

Ava Saidian, MD, on the need for sexual health assessments in female patients 

, reflects on the psychosocial challenges that women with bladder cancer face, as well as how urologists can better support their needs. Saidian is a urologic oncologist and assistant professor of urology at the University of Tennessee Health Science Center in Memphis, Tennessee.

That's a really good question. I think we as urologists need to be better at evaluating the female patient. We're taught the basics of a pelvic floor exam, but we're not really good at talking to female patients about their sexual health. We're very much used to talking to men about that as urologists. I think we have those tools to speak to our female patients about their sexual health and their overall well-being just as well. I've tried to make it part of my routine that as I'm asking my female patients about all their other health care issues, their review of system, I get a baseline on their sexual health. Are they sexually active? If not, are they interested in being sexually active? Are they not active because it hurts to have sex, or simply because they don't have a partner right now? Are they interested in being sexually active after their cancer treatment? What are things we can do to work on their sexual health before, during, and after cancer treatment? I think as urologists, there's lots of tools out there, and it's very much changing our education on highlighting the importance of these topics with our female patients. So, I think that's one way we can support the psychosocial health of these female patients, is making their sexual health a priority and showing them that it's not a taboo topic, and they can open up to us about it.

And also, I think, as urologists, we need to better understand the effects on body image that this has. Whether they're having a neobladder continent diversion or an ileal conduit, what is the impact on their body image in the future, and is that going to weigh heavily on them, and just talking to our patients about it, as well as using a lot of other resources. We only have so much time with our patients, but we want to show them that we support them. So, whether that's just asking them, do they want someone to talk to, a therapist, even a sexual health therapist. Are there financial burdens that they're undergoing that we can potentially help them with. Treating our patients as a person and not just someone with bladder cancer, and trying to help find all their needs is very important, especially in our female patients.

Women with bladder cancer face unique psychosocial challenges, including issues related to sexual health and body image. Urologists can better support these patients by prioritizing discussions about sexual health, understanding the impact of treatments on body image, and addressing financial and emotional needs. By treating patients holistically and utilizing available resources, urologists can help improve the overall well-being of female bladder cancer patients. This approach emphasizes the importance of open communication and personalized care to address the comprehensive needs of these patients.

"We only have so much time with our patients, but we want to show them that we support them," says Ava Saidian, MD.

Gary D. Steinberg, MD, discusses the potential for exploration of novel combinations with bel-sar

Gary Steinberg, MD, on exploring novel combinations with bel-sar in NMIBC

, discusses the potential for exploration of novel combinations with belzupacap sarotalocan (bel-sar), a virus-drug conjugate currently in phase 1 development for non–muscle-invasive bladder cancer (NMIBC). Steinberg is a professor of urology at Rush University Medical Center in Chicago, Illinois.

What's most important with immunotherapy is to identify single immunologic agents and single therapies. But certainly, at some point, we will need to explore potential combinations. Will you get additional efficacy from combinations of immunologic agents? One of the things that we're seeing in non–muscle-invasive bladder cancer, with other products, we're looking at things that are chemoablative, so that we can avoid taking patients to the operating room, TURBTs, which require general anesthesia, patients [and] family members taking a day off of work, recovery, and so forth.

Can we identify bel-sar as an ideal immunoablative agent to avoid TURBTs? Can we use it as an adjuvant treatment, if you've had a TURBT? Then, inject various areas in the bladder to help prevent tumors from coming back. Are there novel combinations that makes sense, potentially with cytokine therapy, such as with IL-15 or IL-12 plus bel-sar, to rev up the immune system to become a complete immune-ablation effect, or even immune-preventive effects? There are a lot of other ways to look at bel-sar with other immunotherapy agents, other combinations, to truly help prevent patients needing to go to the operating room. This is a treatment all done in the office. More importantly, what patients want not only is having a therapy cure their tumor; they want it to be durable. They don't want the tumor to come back. One of the things that's most frustrating for the patients with non–muscle-invasive bladder cancer is the frequent recurrences. If we can decrease the recurrences, enhance the immune protective effect, potentially create T-cell memory so that they have durable disease-free responses, they've avoided the operating room, I think that would be a great move forward.

Belzupacap sarotalocan (bel-sar), a virus-drug conjugate, is being explored for its potential in treating non–muscle-invasive bladder cancer (NMIBC). The focus is on its use as an immunoablative agent to avoid transurethral resection of bladder tumors (TURBTs) and as an adjuvant therapy to prevent tumor recurrence. Combining bel-sar with cytokine therapies like IL-15 or IL-12 may enhance immune responses, offering durable, office-based treatment options. The goal is to reduce recurrence rates and improve patient outcomes by fostering T-cell memory and durable disease-free responses.

“There are a lot of other ways to look at bel-sar with other immunotherapy agents, other combinations, to truly help prevent patients needing to go to the operating room,” says Gary D. Steinberg, MD. 

Ava Saidian, MD, highlights differences in the way that she counsels male vs female patients with bladder cancer

Ava Saidian, MD, on unique considerations for female patients with bladder cancer

, highlights differences in the way that she counsels male vs female patients with bladder cancer. Saidian is a urologic oncologist and assistant professor of urology at the University of Tennessee Health Science Center in Memphis, Tennessee.

When considering treatment for bladder cancer, specifically in women, I have 2 schools of thought in terms of their disease. In non–muscle-invasive bladder cancer, which is what most people present with––about 70% of patients present with non-muscle-invasive [disease]––the actual treatment itself doesn't really differ between men and women for me. However, how I counsel them about the treatment is different. For example, most of the time we're using intravesical chemotherapy. In women, I counsel them on the importance of, for example, after getting intravesical chemotherapy, on cleaning and prepping the skin, because they can have skin irritation or toxicity vs in men, they tend to be more continent. It's easier to hold the chemotherapy in compared to women who might have some leakage and stuff like that. I think some institutions even use barrier creams around the vulva and urethra to help protect the skin when they're getting intravesical chemotherapy.

The other thing is, I am a huge proponent of topical hormone therapy in and around the vagina, vulva, and urethra, so vaginal estrogen and DHEA. Anecdotally, it helps decrease a lot of the symptoms, the irritability, that comes with treating non–muscle-invasive bladder cancer.

Now for muscle-invasive [disease], how I counsel patients on surgery when they're a man vs a woman is almost completely different, because their anatomy is very different. For women, if they are going to undergo a radical cystectomy, historically, we used to take everything––the vagina, the uterus, the ovaries––but that is very much changing. We have lots of good data showing us that we can safely preserve these organs in women if it's oncologically sound. I tell all my female patients at the end of the day, we're treating your cancer, so I'm going to do what's best for your cancer. But after that, I want to talk to you about what you want your functional outcomes to be in terms of urinary function and sexual function. That starts by doing a good pelvic exam and examin[ing] their bladder to stage their disease. If they're a good candidate, I will attempt to spare their vagina [and] their uterus, at the very least. In almost all patients, we have good data showing us that we can spare their ovaries, especially in women under the age of 75. That has a lot of impact in the future on their sexual health, even cognitive function, muscle preservation, all of that stuff that will lend to them having a better quality of life afterwards.

Ava Saidian, MD, discusses her approach to counseling male and female bladder cancer patients, emphasizing differences in treatment guidance. For non-muscle-invasive bladder cancer, she highlights the importance of skin care for women undergoing intravesical chemotherapy due to potential skin irritation. She advocates for topical hormone therapy to alleviate symptoms. In muscle-invasive cases, she stresses the importance of preserving female reproductive organs during radical cystectomy when oncologically feasible, to enhance post-treatment quality of life, including sexual and cognitive health, especially in women under 75.

“Now for muscle-invasive [disease], how I counsel patients on surgery when they're a man vs a woman is almost completely different, because their anatomy is very different,” says Ava Saidian, MD. 

Gary D. Steinberg, MD, discusses remaining questions on bel-sar, a virus-drug conjugate currently in phase 1 development for non–muscle-invasive bladder cancer 

Gary Steinberg, MD, on next steps for clinical development of bel-sar in NMIBC 

, discusses remaining questions on bel-sar, a virus-drug conjugate (VDC) currently in phase 1 development for non–muscle-invasive bladder cancer (NMIBC). Steinberg is a professor of urology at Rush University Medical Center in Chicago, Illinois.

I think that there's a couple of things. Number 1 is I think that we have to nail down the dose. I think that we've been using a relatively low dose. As we know, these VDCs can be used in other cancers. They've been very effectively used in choroidal uveal melanoma with be-sar. So, we really have to nail down the dosage. I would suspect that larger papillary, non-invasive tumors would potentially require a larger dose. We also have to assess: can we do it all at one time? Can we do the VDC intravesical installation and then light activate the same day? How much time do you have to wait? Is there a benefit to waiting 24 hours? 48 hours? More importantly, can we re-dose? Would it be more effective, especially if we have a larger papillary tumor, to dose multiple times? Once a week? Once every other week? Would we see even more immunologic infiltrate if we waited 3 to 4 weeks after the treatment? Would we see more complete resolution of the tumors visually just by waiting longer and letting the immune system work longer? There are a number of different things that we need to iron out.

But more importantly, I think that we need to identify a patient population, most likely the intermediate risk, non–muscle-invasive bladder cancer patients that have low-grade disease. Ideally, I'd like to see us also treat some patients with papillary Ta high grade disease. With the mechanism of action the way it is, there's no reason to think that there would be any difference between results with low-grade vs high-grade. High-grade may need a larger dose, more treatments, or more time to allow the immune system to see efficacy.

I think that most importantly, we need to continue to make sure that it's safe and that there are no untoward adverse events or immune-related adverse events [and] that it is a local treatment. It does not cause systemic toxicity. I think that we need to nail down the treatment algorithm. How much of the dose? How many injections? When we talk about bladder cancer, non-muscle-invasive bladder cancer, we talk about an individual tumor, but as we know, many times there's a field change effect within the bladder. Even though we only may see 1 tumor, there may be a number of smaller tumors throughout the bladder that we can't visually see. We know that the cells may all have cancer, but just set in a different time clock. The other thing that we believe will be important to see is it not only effective where we inject a tumor and turn the light on in the tumor, but will there be abscopal effects throughout the bladder? In other words, tumors that are not where we injected, but say 2 or 3 centimeters away, are they being affected? Can we treat those tumors as well? And I suspect that we will, but we probably need a longer interval from treatment to resection to allow the immune system to work throughout the bladder. Those are other things that that we have to investigate. How much to treat? How often? Can you re-treat? How much time can we give to allow the VDCs in the immune system to work?

This transcription was AI generated and edited by human editors for clarity.

Bel-sar, a virus-drug conjugate (VDC), is in phase 1 development for non–muscle-invasive bladder cancer (NMIBC). Key considerations include determining optimal dosage, timing, and frequency of administration. The potential for re-dosing and the impact of waiting periods on immune response are under investigation. Identifying suitable patient populations, particularly those with intermediate-risk, low-grade disease, is crucial. Ensuring safety and local treatment efficacy without systemic toxicity is paramount. The possibility of abscopal effects and the need for a comprehensive treatment algorithm are also being explored.

“The other thing that we believe will be important to see is it not only effective where we inject a tumor and turn the light on in the tumor, but will there be abscopal effects throughout the bladder?” says Gary D. Steinberg, MD. 

Ava Saidian, MD, sheds light on the challenges that women face in the diagnosis of bladder cancer.

Ava Saidian, MD, on delayed diagnosis of bladder cancer in women

, sheds light on the challenges that women face in the diagnosis of bladder cancer. Saidian is a urologic oncologist and assistant professor of urology at the University of Tennessee Health Science Center in Memphis, Tennessee.

I think one of the biggest challenges women have in general in terms of diagnosis of bladder cancer is that it tends to be delayed. When they are diagnosed, it is usually at a more advanced stage compared to their male counterparts. There are lots of theories behind why their diagnosis is delayed. The most common reason is that the symptoms and signs can often mimic other things that are seen commonly in women. For example, bladder cancer can mimic the signs of a urinary tract infection. Blood in the urine, which is the most common sign, whether you see it grossly or microscopically, can be attributed to other things, such as menstrual bleeding, post-menopausal bleeding, or a UTI. That can often delay things. In fact, when compared to men, women are less likely to get a cystoscopy when they present with blood in the urine than men are, I think for aforementioned reasons, that it's often attributed by physicians to be caused by something else that's non-cancerous.

Women face significant challenges in the timely diagnosis of bladder cancer, often being diagnosed at more advanced stages than men. This delay is primarily due to symptoms mimicking other common conditions in women, such as urinary tract infections or menstrual bleeding. Blood in the urine, a key symptom, is frequently misattributed to non-cancerous causes, leading to fewer cystoscopies being performed on women compared to men. This misattribution by physicians contributes to the delayed diagnosis and subsequent advanced stage at which women are often diagnosed.

“I think one of the biggest challenges women have in general in terms of diagnosis of bladder cancer is that it tends to be delayed,” says Ava Saidian, MD. 

Gary D. Steinberg, MD, discusses the background and initial findings from an ongoing phase 1 study of bel-sar in patients with non–muscle-invasive bladder cancer 

Gary Steinberg, MD, shares initial phase 1 data on bel-sar in NMIBC 

, discusses the background and initial findings from an ongoing phase 1 study of bel-sar in patients with non–muscle-invasive bladder cancer (NMIBC).

Aura, the developer of the investigational drug, recently reported that 4 of 5 patients with low-grade disease who received bel-sar with light activation demonstrated a complete clinical response. Additionally, 2 of 3 patients with high-grade disease demonstrated visual tumor shrinkage on cystoscopy. Regarding safety, bel-sar appeared to be well-tolerated among trial participants.

Steinberg is a professor of urology at Rush University Medical Center in Chicago, Illinois.

All too often when we do clinical trials, people want to see phase 3 results from phase 1 trials, but we have to remind ourselves that phase is a safety trial. What we do in pre-clinical work changes once we start putting it into humans. We have to make sure that what we're doing is safe. First and foremost, the initial part of the trial was just using the VDCs in the bladder to make sure that that was safe. Then the second phase was using the VDCs with the light activation.

Number 1, first and foremost, we have to look at the safety profile. Do patients tolerate this procedure well? The initial trial was to use a cystoscopic needle to inject the VDC, the drug, around the tumor. We're still working out how much drug to use. How many injections do you inject the tumor? Do you inject around the tumor? [Do you use] light activation? More importantly, how long do you wait? This trial was designed to show safety. Put the drug in, the next day, [use] light activation, and then 7 to 10 days later, perform a TURBT. They’re assessing immune-related adverse events; they're assessing for urinary symptoms, and so forth. Then looking at histologic findings from the TURBT, what do we see on the microscope? Do we see tumors still there? Do we see tumors gone? Do we see immune cell infiltrate, which is a key signal of turning on the adaptive immune system. Again, first and foremost is safety. But also, you do want to look at the efficacy, because the efficacy is going to give you a signal to inform you [if you] can go forward and potentially design a phase 2 and ultimately a phase 3 trial.

The patients that were treated were non–muscle-invasive, bladder cancer patients, most [of whom had] low-grade [disease], but some [had] high-grade. When we look at bladder cancer, 75% of all patients newly diagnosed with bladder cancer in the United States have non–muscle-invasive bladder cancer. There's an equal split between low-grade and high-grade, about 50% to 60% are low-grade, and the rest are high-grade. So, there's a huge prevalence of this disease in the US population. Quite frankly, it is a worldwide disease. We see large amounts of bladder cancer all over the world.

Initially, the majority of the patients were low-grade. We did have some high-grade patients that were treated. The preliminary findings were quite favorable in that we saw, especially in the low-grade population, complete elimination of tumor cells on the biopsies, on the transurethral resection of bladder tumors. We were [also] excited to see a fair amount of immune cell infiltrate, increased CD8+ T-cells, CD4+ T-cells. These are parts of the adaptive immune system. There also was some suggestion of some other immune cell infiltrates, again, which is very important to demonstrate. More importantly, we only waited 7 to 10 days after the treatment to see this. As we know, the immune system can take longer in different patients. Many times you might not see the immune system revved up for 3, 4, even 6 weeks, if not longer, after a treatment. So, this was a very important signal and finding that in humans, what we saw preclinical is happening in real-time in humans.

This transcription has been edited for clarity.

1. Multiple clinical complete responses demonstrated following single low dose administration of bel-sar in patients with non-muscle-invasive bladder cancer (NMIBC) in ongoing phase 1 trial. News release. Aura. October 17, 2024. Accessed October 24, 2024. https://ir.aurabiosciences.com/news-releases/news-release-details/multiple-clinical-complete-responses-demonstrated-following

The ongoing phase 1 study of bel-sar in non–muscle-invasive bladder cancer (NMIBC) patients shows promising initial results. The investigational drug, developed by Aura, demonstrated a complete clinical response in 4 of 5 patients with low-grade disease and visual tumor shrinkage in 2 of 3 patients with high-grade disease. The study primarily focuses on safety, with bel-sar appearing well-tolerated. The trial design involves drug injection and light activation, followed by TURBT to assess immune response and histologic findings, providing insights for future trial phases.

“The preliminary findings were quite favorable in that we saw, especially in the low-grade population, complete elimination of tumor cells on the biopsies, on the transurethral resection of bladder tumors,” says Gary D. Steinberg, MD. 

Talia A. Helman, MD, shares the key findings from the study, “Exploring Female Bladder Cancer Survivorship: Patient Perspectives on Sexual Health Challenges and Resilience When Receiving Bladder Sparing Therapies,”

Talia Helman, MD, on sexual quality of life in female patients with bladder cancer

, shares the key findings from the study, “Exploring Female Bladder Cancer Survivorship: Patient Perspectives on Sexual Health Challenges and Resilience When Receiving Bladder Sparing Therapies,” which she presented at the 

25th Annual Fall Scientific Meeting of the Sexual Society of North America

. Helman is a fourth-year resident at Emory University School of Medicine in Atlanta, Georgia.

This study was a pilot study. We had 18 participants that we were able to get ahold of and interview. I personally called women in our database that have had non–muscle-invasive or muscle-invasive bladder cancer that have not received a cystectomy. After informed consent, we went over the interview questions with them. I wanted to make sure that it was an actual interview vs a survey design, because I wanted to hear what these women had experienced and how many years they had been experiencing these symptoms. For a lot of women, they've been dealing with this bladder cancer diagnosis for years, and I wanted to hear their feedback and listen to them. Although our n is low, we only had 18 participants, it was still extremely informative.

From this, we interviewed the patients. We gave the female sexual function index survey for those that were sexually active. Then we also [included] their baseline characteristics, demographic information, tumor characteristics, stuff like that. The data that I am going to focus on is the interview data. There's not a lot of profound statistical data that we can gather from this, because our n is so low at 18.

Of the patients that we interviewed, only 5 of them were sexually active. For the sexual function index, you need to be sexually active in order to qualify to take the survey. One of the first questions it asks is, “Have you been sexually active in the last 4 weeks?” Only 5 women were sexually active, which, if you think about the diagnosis of bladder cancer, it's going to be older women. The main takeaway from those 5 women is that only 1 of the women had sexual dysfunction. It's hard to say [if it was due to] her bladder cancer or other factors such as depression or anxiety. We [did] ask about [these,] but with only 1 woman having dysfunction, you can't [attribute] blame to anything.

After doing a literature review about cystectomy patients and how devastating it is for female sexual function after having a cystectomy, [my main takeaway from this study is that] it seems that women tolerate the intravesical treatments well. They don't [seem to] cause too much disruption to their sexual health. Some of the quotes that we got from women were that at first they were scared or they didn't know what to expect, but then afterwards they realized that it didn’t have as much effect as they thought it was going to, especially on their sexual function.

Some women talked about the urinary symptoms. They had increased urinary incontinence or urinary urgency, which made them a little bit embarrassed when they were having sexual intercourse. One woman said that she just pees before she starts, and that's all she needs to do. [There were] stories like that of female resilience as they're going through a cancer diagnosis, and how to navigate that to have the quality of life that they wanted.

A lot of women talked about vaginal estrogen. Even among the women that were not sexually active or those that [said] bladder cancer didn't affect them at all as far as their sexual activity, many of them touched on the benefits of vaginal estrogen on lubrication and pain. We've seen this with our non-bladder cancer patients in the perimenopausal stage as well.

Some other interesting things that women talked about were this fear of everyone being down there. One woman said, “There’s a lot of people down there; everyone's always in your business.” I really felt that as someone who's had to do these procedures on women. If you have fear of it, or you maybe had a bad experience 1 time, I can see how that affects people as they're getting their treatments.

One woman who it really affected said, "You get afraid of having sexual intercourse. You don't want to disrupt what's going on there. Your partner is nervous too. Everything is too close going down there." One woman said, "It did at the beginning, and then it was okay. It was a shock when you have cancer, no symptoms. That made me not want to have sex, though. But after the surgeries, I take some breaks. I need some time." That was a common theme as well is that women have their cystoscopies for surveillance of their bladder cancer, and then they usually took a day or 2 off of any kind of sexual activity afterwards, just for their own reasons. They couldn't really describe it; they just wanted a break. They felt that their partners were receptive of that as well.

For the other cohort of patients, the ones that were not sexually active, it was [pretty] black and white. [We'd ask], "Are you sexually active currently? Do you wish to be in the future? Do you have any interest in this?" For the women that weren't sexually active, they said, "Bladder cancer does not affect my sexual activity. I'm just not sexually active for X, Y, and Z." Maybe they lost their partner, maybe they're dealing with some health issues. They felt like it was a non-issue for them; out of all things in their life, bladder cancer was not the reason that they were not sexually active.

The study explored female bladder cancer survivors' perspectives on sexual health challenges and resilience when receiving bladder-sparing therapies. Conducted with 18 participants, it highlighted that only a minority were sexually active, with minimal sexual dysfunction reported. The findings suggest that intravesical treatments are generally well-tolerated, with limited impact on sexual health. Participants shared experiences of resilience, managing urinary symptoms, and the benefits of vaginal estrogen. The study also revealed emotional challenges related to medical procedures and the importance of partner support during recovery.

“After doing a literature review about cystectomy patients and how devastating it is for female sexual function after having a cystectomy, [my main takeaway from this study is that] it seems that women tolerate the intravesical treatments well,” says Talia A. Helman, MD. 

Gary D. Steinberg, MD, explains the mechanism of action for bel-sar, an investigational therapy currently under phase 1 development for non–muscle-invasive bladder cancer 

Gary Steinberg, MD, on the mechanism of action for bel-sar in NMIBC

, explains the mechanism of action for bel-sar, an investigational therapy currently under phase 1 development for non–muscle-invasive bladder cancer (NMIBC). Steinberg is a professor of urology at Rush University Medical Center in Chicago, Illinois.

As you know, we're in a new era of treatment for patients with non-muscle-invasive bladder cancer. Many of the therapies are intravesical, or inside the bladder, as well as a wealth of newer, innovative immunologic therapies. Bladder cancer is the cancer that responds well to immunologic treatments. Bel-sar is another novel concept in therapeutic innovation, in that it is a virus drug conjugate, so VDC. We've got a lot of antibody drug conjugates already available in all cancers, especially in bladder cancer. This is a virus drug conjugate. There are virus particles from the HPV virus, which is relatively ubiquitous in mankind, but it's a virus-like particle conjugated to a cytotoxic drug.

These virus-like particles are heavily packed with a lot of this drug, and they bind to heparan sulfate proteoglycans, which are on the cell surface of specifically, cancer cells. We have a lot of glycans on the surface of cells, but heparan sulfate proteoglycans seem to be upregulated or increased in many different types of cancers, and urothelial cancer is one of them. So, this virus drug conjugate binds very strongly to the heparan sulfate proteoglycans on the surface of the cancer cells in the urothelium, and they bind them by using light to activate this binding in this conjugation that sets off the process for the delivery of the drug and the activation of the drug to kill, specifically the cancer cells.

In addition to the viral-like killing, we also have immune cell death. The cancer cells die. They release a significant number of what we call neoantigens, or proteins that are recognized specifically as cancers that are recognized by the immune system. These are delivered with dendritic type cells and energy presenting cells to the T cells or the immune system to turn on the adaptive immune system. So, you've got a double pronged killing of these cancer cells, the virus-like particles delivering their cytotoxic payload, creating neoantigens that are recognized as abnormal by the immune system. You've got cancer killing in addition to immune adaptive system killing. You've got a double pronged attack to kill cancer cells, which is in line with our concepts of immunologic care and immunologic treatment in a variety of cancers, especially cancers such as bladder cancer.

Bel-sar, an investigational therapy for non-muscle-invasive bladder cancer, represents a novel virus drug conjugate (VDC) approach. It utilizes virus-like particles from the HPV virus conjugated to a cytotoxic drug, targeting heparan sulfate proteoglycans on cancer cell surfaces. This binding is activated by light, facilitating drug delivery and cancer cell destruction. Additionally, the therapy induces immune cell death by releasing neoantigens, which activate the adaptive immune system. This dual mechanism aligns with current immunologic treatment strategies, offering a promising approach for bladder cancer management.

"You've got a double pronged attack to kill cancer cells, which is in line with our concepts of immunologic care and immunologic treatment in a variety of cancers, especially cancers such as bladder cancer," says Gary D. Steinberg, MD.

Key Takeaways on the Evolving NMIBC Treatment Landscape

The panel concludes by offering key takeaways on the evolving treatment landscape for BCG-unresponsive non–muscle invasive bladder cancer.

Bladder Cancer

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