Benign Conditions

Benign Prostatic Hyperplasia

Bladder Cancer

Female Urology

Genitourinary Cancers

Genomic Testing

Hormone Therapy

Kidney Cancer

Challenging Anatomy

Innovative Techniques

Laser Lithotripsy

PCNL Tech & Devices

Ureteroscopy Tech & Devices

Kidney Stones

Men's Health

Next-Generation Imaging

Voiding Dysfunction

OAB and Incontinence

Pediatrics

Controveries in Urologic Cancer

Drug Therapy

Prostate Cancer

Sexual Dysfunction

UTUC

Cosmetic Surgery

Urologic Surgery

Business

Practice Management

Malpractice Consult

Health Law & Policy

Media

Case-Based Peer Perspectives

Investigator Perspectives 

Medical World News

Podcasts

Urology Medical Perspectives

UTv Videos

Peer Exchange

News Network

Virtual Tumor Board

Insights

Peers & Perspectives

Conferences

Conference Listing

Conference Previews 

Conference Recaps

Publications

Urology Times Journal

Editorial Advisory Board

Urologists in Cancer Care

Supplements and Featured Publications

CME/CE

Resources

Begin Your Journey: Tackling Burnout

Live Events

Interactive Tools

Job Board

Partners

Subscribe

The bladder cancer section is a comprehensive resource for urology news and expert insights. Read more at Urology Times.

Bladder Cancer | Urology News & Expert Insights | Urology Times

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do not sell my Personnal Information

Urology Times | News & Insights for Urologists & Health Professionals

Facebook

LinkedIn

Spotlight

Peers and Perspectives

Clinical

1rem

Clinical Focus

Howard I. Scher, MD; Scott T. Tagawa, MD, MS, FACP; Mary-Ellen Taplin, MD

Medical Crossfire®: How Does Recent Evidence on PARP Inhibitors and Combinations Inform Treatment Planning for Prostate Cancer Now and In the Future?

 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 target action date for the application is June 13, 2025.

FDA accepts new drug application for UGN-102 in NMIBC

"On-going innovation will continue to drive UTUC management forward, and with it will come on-going challenges of how to best study a relatively rare disease," write the authors.

Upper tract urothelial carcinoma: An in-depth review for urologists

"The biomarker is better at predicting presence of disease than absence, and the reason that that's important is that's how we can think about the biomarker aiding in careful clinical assessment of patients," says Elizabeth R. Plimack, MD, MS, FASCO.

Biomarker may predict MIBC status following neoadjuvant chemo

"Overall, TAR-200 is being tested with the aim of changing the therapeutic paradigm of patients with an early bladder cancer diagnosis, including non–muscle-invasive disease and muscle-invasive disease," says Andrea Necchi, MD. 

Andrea Necchi, MD, on promising SunRISe-4 data of TAR-200 in MIBC

In total, the phase 3 UTOPIA trial plans to enroll 87 patients with LG-IR-NMIBC to assess the safety and efficacy of UGN-103.

Phase 3 trial launches of UGN-103 in low-grade, intermediate-risk NMIBC

Geoffrey N. Sklar, MD, FACS, recaps the session, “Incorporating New Tech & Treatments,” which was presented at the 2024 Stronger United Conference 

Geoffrey Sklar, MD, on considerations for implementing new therapies and tech in urology

, recaps the session, “Incorporating New Tech & Treatments,” which was presented at the 2024 Stronger United Conference in Phoenix, Arizona. Sklar is the chief medical officer for Chesapeake Urology and United Urology Group.

That discussion was focused on 3 of our bigger service lines: bladder cancer, kidney stone disease, and overactive bladder. And how there are new technologies that are entering these fields and how to deploy that. In urology, we have a lot of toys. We have a lot of new drugs; we have a lot of new therapies. Just like any new shiny thing, there's downsides to all those things. Most of the downsides are cost. A lot of things that come out are not covered by insurance, they may cost an extravagant amount of money, but they do have patient value. The goal is, how do we get these therapies?

Particularly [in] bladder cancer, there's 2 new drugs on the market that are exceptionally expensive, but they do provide benefit to patients. That's what it's really all about. How do we get those new technologies, those new drugs, those new therapies to these patients without putting them financially at risk, without putting us financially at risk, and taking great care of patients. That's what we looked at there.

With kidney stones, we're one of the very few programs in the country where one of our affiliate group practices, Chesapeake, has an advanced kidney stone program for the treatment of large stones, where we're doing ambulatory percutaneous stone surgery. We're closing in on 5000 of these surgeries. We've done more than anybody else in the country, and we have our own fellowship. The goal of this was how do we spread that across our other group practices to give those patients that additional line of service to take better care of their kidney stones? And how do we unroll that so it looks similar to Maryland, but it's always different. That's one of the things that we have to be keenly aware of. Each of these environments, different types of patients, different obstacles, and different ways to deploy things. That's where we need the input from our docs, our APPs, and support staff.

The last group was the OAB, or female incontinence groups, where there's new technologies coming out where there are implantable devices to take away urgency incontinence. How do we deploy those, again, in a way where we don't put the patient at risk for a big bill, we don't lose money for ourselves, but we provide the services that keep them from getting additional or much more rigorous therapies. That was a really insightful discussion that we had. I think those discussions need to be had all the time when we're rolling out new technology and new devices.

This transcription has been edited for clarity.

Videos

The session at the 2024 Stronger United Conference focused on integrating new technologies and treatments in urology, specifically for bladder cancer, kidney stone disease, and overactive bladder. Challenges include high costs and insurance coverage issues, despite the potential patient benefits. The discussion highlighted Chesapeake Urology's advanced kidney stone program and the need to expand it across other practices. Additionally, the session addressed deploying new implantable devices for overactive bladder without imposing financial burdens on patients or providers, emphasizing the importance of continuous dialogue when introducing new medical technologies.

“Particularly [in] bladder cancer, there's 2 new drugs on the market that are exceptionally expensive, but they do provide benefit to patients,” says Geoffrey N. Sklar, MD, FACS.

Data from the phase 3 BART trial shows adjuvant radiotherapy is notably safe for patients with MIBC following radical cystectomy and chemotherapy.

Interpreting BART toxicity and tolerability for bladder cancer, with Vedang Murthy, MD

Adjuvant radiotherapy (ART) was not associated with a significantly greater risk of acute and late toxicity following radical cystectomy (RC) and chemotherapy in patients with 

, according to new findings from a phase 3 trial.

New data from the BART trial, presented in a late-breaking abstract session at the 

American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting 

in Washington, DC, last week, showed that despite mild bowel toxicity occurring more frequently among patients receiving post-RC ART, the treatment method may be generally safe and tolerable for patients with MIBC. The trial is continuing to assess for oncological efficacy outcomes beyond the ASTRO 2024 data presentation, according to investigators.

 during ASTRO 2024, study author Vedang Murthy, MD, professor of GU-Radiation Oncology at Tata Memorial Centre in Mumbai, India, discussed the significance of the BART trial findings, beginning with the fact that post-operative radiotherapy is not a highly common practice for MIBC.

“I think it comes from...a hardwired fear that radiation oncologists have, to treat the cystectomy bed, because there's a whole lot of bowel that is floating around there, and we are trained to not treat the bowel,” Murthy said. “So, when one looks at the bowel, one gets worried, and that's not just the (radiation oncologists).”

Much of this concern stems from education 10-20 years ago—a time when oncologists did not have adequate technology to safely treat the cystectomy bed, Murthy said. His team wanted to validate the modern safety of ART in post-cystectomy patients with MIBC in the trial. And indeed, the team reported that only up to 8% of patients reported toxicity after 2 years of follow-up with ART.

However, toxicity safety was a secondary outcome measure; Murthy and colleagues are continuing to assess BART patients for the primary outcome of improved disease control with ART.

“And that remains to be seen,” Murthy said. “There are some data coming from Egypt that it would be a good idea to (use adjunct) radiation, but I think over the next year or two, we will have enough events to show whether it helps outcomes or not.”

Murthy additionally discussed further analyses planned with the BART cohort, as well as the validation of safety and efficacy outcomes with consideration to patient-reported domains of bodily function after treatment and outcomes pertinent to quality of life.

Murthy V, Maitre P, Pal M, Sharma R, et al. LBA04 - Bladder Adjuvant RadioTherapy (BART): Acute and Late Toxicity from a Phase III Multicenter Randomized Controlled Trial. Session presented at: American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting. Washington, DC. September 29 – October 2, 2024.

Adjuvant radiotherapy (ART) following radical cystectomy (RC) and chemotherapy in muscle-invasive bladder cancer (MIBC) patients does not significantly increase acute or late toxicity, according to phase 3 BART trial findings. Despite mild bowel toxicity, ART is generally safe and tolerable. Historically, radiation oncologists have been cautious due to concerns about bowel exposure, but modern technology has improved safety. The trial continues to evaluate ART's oncological efficacy, with preliminary data suggesting potential benefits. Future analyses will focus on safety, efficacy, and patient-reported quality of life outcomes.

News

Interpreting ART toxicity and tolerability for bladder cancer, with Vedang Murthy, MD

Guru P. Sonpavde, MD, highlights the background and key findings from the trial, “Alliance A031501: AMBASSADOR study of adjuvant pembrolizumab (Pembro) in muscle-invasive urothelial carcinoma (MIUC) vs observation (Obs): Extended follow-up disease-free survival (DFS) results and metastatic (met) disease recurrence distribution,” 

Guru Sonpavde, MD, on phase 3 AMBASSADOR data in urothelial carcinoma

, highlights the background and key findings from the trial, “Alliance A031501: AMBASSADOR study of adjuvant pembrolizumab (Pembro) in muscle-invasive urothelial carcinoma (MIUC) vs observation (Obs): Extended follow-up disease-free survival (DFS) results and metastatic (met) disease recurrence distribution,” which was presented at the 

 in Barcelona, Spain. Sonpavde in the Medical Director of Genitourinary Oncology, Assistant Director of the Clinical Research Unit, and Christopher K. Glanz Chair for Bladder Cancer Research at AdventHealth Cancer Institute in Orlando, Florida.

AMBASSADOR is a phase 3 trial that evaluated adjuvant pembrolizumab in patients with high-risk muscle-invasive urothelial carcinoma. These are patients with either upper tract or bladder or urethral carcinoma, with predominantly urothelial carcinoma. These were patients who had neoadjuvant chemo, or they may have been cisplatin-ineligible and not had neoadjuvant cisplatin-based chemo. The trial has been already reported as positive at the GU ASCO symposium earlier this year in 2024, and essentially, there was an improvement in disease free survival. There's an update at ESMO 2024 here, which shows that the improvement in DFS is maintained after a longer follow-up. Now survival has not been met, but survival is a secondary end point, and the DFS improvement was with a hazard ratio of approximately 0.7, which is what was reported at the GU ASCO Symposium.

I think that these data in this approximately 700 patient trial consolidates and makes a strong case for the role of pembrolizumab in the adjuvant setting. As we know, nivolumab is already approved in this adjuvant setting, high-risk muscle invasive disease in all-comers in the US and in P-L1 high patients only in Europe. So, with this AMBASSADOR trial, we expect pembrolizumab might also be available at some point in the future in the clinic, so we need to wait for regulatory agencies to look at the data and tell us.

Now, one of the interesting findings in this trial, which has been reported before, was there was not a trend for improved outcomes in the PD-L1 high population. So, that did not fall out. That was not a primary end point, to look at PD-L1 alone; it was a secondary end point. There does seem to be a trend for improved outcomes in the bladder primary as opposed to upper tract, especially renal pelvis. That was seen actually across both those [readouts]. But those are hypothesis generating. So, at the end of the day, adjuvant pembrolizumab, we think, could be added to the therapeutic armamentarium for the adjuvant therapy of patients with high-risk muscle-invasive urothelial carcinoma.

“I think that these data in this approximately 700 patient trial consolidates and makes a strong case for the role of pembrolizumab in the adjuvant setting,” says Guru P. Sonpavde, MD. 

Guru Sonpavde, MD, on phase 3 AMBASSADOR trial data in urothelial carcinoma

Yair Lotan, MD, highlights the development and validation of an AI algorithm designed to predict recurrence in patients with non–muscle-invasive bladder cancer

Yair Lotan, MD, on the development of an AI algorithm to predict BCG response in NMIBC

, highlights the development and validation of an AI algorithm designed to predict response to BCG in patients with non–muscle-invasive bladder cancer. Lotan is the chief of urologic oncology and a professor of urology at UT Southwestern Medical Center in Dallas, Texas.

There is a company that I work with, Valar [Labs], that is helping develop an AI technology for predicting outcomes in patients with non–muscle-invasive bladder cancer, specifically patients who are getting BCG for high-risk disease. They're also working on algorithms for intermediate risk disease as well, but for now, they're this initial research was looking at patients who are BCG naive, with high-risk features.

Whenever you are developing an AI algorithm based on pathology, there are several steps. First of all, you have to teach the AI program what they're looking at. So, for example, what does a cancer cell look like? What does an immune cell look like? What's a blood vessel? What's a fibroblast? What's a stroma? You have to make sure that you test that over and over to make sure that the AI program recognizes the cells with a very high rate of accuracy. The next step is, if you're looking at scan slides, you don't want to necessarily specify which platform is used to scan the slide. You want to test the accuracy of this identification across different slide scanning platforms. Those 2 steps were done. The good news is that any given slide from a bladder cancer patient has thousands of cells, so you can quickly take a small number of patients and give information to the AI program for hundreds of thousands of cells, so you can make sure that the algorithm works in a robust way. Those were the first steps: Can the AI program identify what cancer looks like vs benign elements, and can you use different platforms?

The next step was putting together a cohort of almost 1000 patients who had high-risk bladder cancer and were getting BCG, and then taking 300 or so patients and telling the program what the outcomes were. And [we] said, "Okay, look at these slides. We taught you what cancer looks like. We taught you what the other cells look like. We're telling you who recurred or progressed, and we told you who didn't. Identify a pattern." We also looked at clinical features, since you already know if a patient has multifocality, carcinoma in situ, a large tumor, a small tumor, etc. We found that certain clinical features matter. Multifocality, for example, increases your risk for recurrence, and invasion to the lamina propria, T1 disease, increases your risk for progression. We took those clinical features and added them to our AI algorithm. Then we said, "Okay, this is locked now. This is what the program is going to use."

Then we took over 600 patients, and we didn't tell the AI program what happened with them. We asked it to predict based on this algorithm. We were able to identify a group of patients who are at high risk for progression, 3 times higher risk for progression and 3 times higher risk for recurrence, compared to other patients using this algorithm. Then we compared it to some of the known algorithms from the EORTC, or the European Association of Urology, which just uses clinical features. We found that this artificial intelligence program actually performed better than either of those algorithms did just using clinical features. We think that this is a potentially useful algorithm, because if you know a patient is at higher risk, it [may] help you select more intensive treatments or more intensive surveillance.

There are several trials right now looking at BCG plus checkpoint inhibitors. Those combination trials haven't been published yet; they may show an increased efficacy, but they definitely will show an increased cost and toxicity of adding a checkpoint inhibitor. So, maybe you don't want to use it for everybody, but if you could identify a patient who is 3 times more likely to progress, maybe that's a good patient to consider. There are other treatment options, like intravesical gemcitabine/docetaxel, that you could theoretically use. There's a bridge trial comparing gemcitabine/docetaxel to BCG. If you knew a patient wasn't going to respond to BCG, maybe they would do better off using a different combination treatment.

It's still relatively early, but this study in close to 1000 patients validated this algorithm, and it's now being studied prospectively as well. Hopefully these tools, which have some advantages of not using up tissue and potentially not being as expensive as genetic tests, might actually be easy tools for a pathologist to incorporate into their standard practice when they give you your results and they say, "You have a high-risk patient, and by the way, this algorithm says they're at a higher than average risk for recurrence of progression."

“It's still relatively early, but this study in close to 1000 patients validated this algorithm, and it's now being studied prospectively as well,” says Yair Lotan, MD.

Managing BCG-Unresponsive NMIBC: Cretostimogene Monotherapy vs. Combination Therapy

Video content above is prompted by the following questions:

What are your thoughts regarding cretostimogene as monotherapy versus a combination therapy? Could you comment on how you would use this in your clinical practice either as a monotherapy or combination therapy and which patients may benefit from either approach?

Why is it important that urologists stay informed about advances in managing BCG-unresponsive NMIBC now that we have multiple therapeutic agents approved in this disease state?

Please share any closing thoughts regarding the unmet needs that remain in the management of BCG-unresponsive NMIBC, along with the impact cretostimogene plus pembrolizumab combination therapy could have on the overall care of patients with NMIBC. 

Panelists discuss their views on using cretostimogene as monotherapy versus combination therapy, the importance for urologists to stay updated on advances for managing BCG-unresponsive NMIBC, and the potential impact of combining cretostimogene with pembrolizumab on addressing unmet needs in NMIBC care.

Evaluating Cretostimogene: BOND-003 and PIVOT-006 Trial Results

Do you think the results of this trial support the investigation of cretostimogene in combination with other checkpoint inhibitors?

Can you briefly discuss other notable trials that are investigating cretostimogene for intermediate- or high-risk NMIBC?

Panelists discuss whether the trial results support investigating cretostimogene with other checkpoint inhibitors and provide insights into notable ongoing trials exploring cretostimogene for intermediate- or high-risk NMIBC, such as BOND-003 and PIVOT-006.

Laura Bukavina, MD, MPH, MSc, discusses some of the challenges that women face following a diagnosis of bladder cancer. 

Laura Bukavina, MD, on challenges faced by women with bladder cancer

, discusses some of the challenges that women face following a diagnosis of bladder cancer. Bukavina is an assistant professor of urologic oncology at Cleveland Clinic Glickman Urologic Institute and the translational science lead in GU oncology at Cleveland Clinic Lerner College of Medicine in Cleveland, Ohio.

Just thinking about anatomy overall, a lot of female cystectomy patients, we do what's called an anterior exenteration, which means we take the bladder, the vagina, the uterus, [and] we can put patients in early menopause. Even if they're postmenopausal, we remove the ovaries, which puts them at a higher risk for other complications such as osteopenia.

Mental health is a real challenge because females are typically thought of and think of themselves as providers, as caregivers. They're in that age where they're taking care of their husband, their grandkids, perhaps even their elderly parents. However, they can no longer be the caregiver. They have to be able to be the patient. And a lot of times, a lot of our female patients have such a difficulty transitioning from that role and always thinking about [themselves] as the caregiver. The first question a lot of times is, "who's going to help my husband?" Or "who's going to help my kids? How am I going to help with my grandkids?" That happens all the time, and that's something that mental health and being able to adjust with the help of behavioral health specialists is very important for them to continue their treatment.

“Even if they're postmenopausal, we remove the ovaries, which puts them at a higher risk for other complications such as osteopenia,” says Laura Bukavina, MD, MPH, MSc. 

, Laura Bukavina, MD, MPH, MS, discusses the need to improve female representation in bladder cancer clinical trials 

Dr. Bukavina on the need to improve female representation in bladder cancer clinical trials

 discusses the need to improve female representation in bladder cancer clinical trials, building on the recent 

, “Why it’s essential to study sex and gender, even as tensions rise.” Bukavina is an assistant professor of urologic oncology at Cleveland Clinic Glickman Urologic Institute and the translational science lead in GU oncology at Cleveland Clinic Lerner College of Medicine in Cleveland, Ohio.

. They had a whole collection about sex and gender as being important within research. I found that article to be incredibly interesting because if we look at bladder cancer, for example, females represent only 1 in 4, [about] 20% to 30% of all our patients. So, if you look at all of the trials within immunotherapy [and] chemotherapy, females are particularly underrepresented; not on purpose, it's just part of the natural population –– less females. So, when we start looking at the hazard ratio to see if the drug is helping or not, we often find that immunotherapy particularly does not work very well in females. This is not unique to bladder cancer; this has been published over and over in lung, in melanoma, and in a lot of the gynecological malignancies. What we find that works really well in our male patients, either it's adjuvant or metastatic treatment with our immunotherapy, females just don't get the same benefit.
A lot of these drugs get approved based on the data for males because they represent the majority of patients, and it's showing good response and durable response. But when you actually start to dissect and look at the female population, we see that even in clinical practice, they just don't get the benefit. They get the side effects; they get the toxicity. The FDA approval is there because it's a great medication, but the females just don't get the same results. One way to think about it, and it becomes challenging in clinical trials, is to really make it a more balanced cohort of patients. So, while the natural epidemiological prevalence of disease is only 20% to 30%, we really should aim for studies where we can oversample the females to make sure that that medication truly is doing what it's doing in both males and females.

“So, while the natural epidemiological prevalence of disease is only 20% to 30%, we really should aim for studies where we can oversample the females to make sure that that medication truly is doing what it's doing in both males and females,” says Laura Bukavina, MD, MPH, MS. 

Armine K. Smith, MD, recaps a 2024 a Bladder Cancer Advocacy Network (BCAN) Think Tank session on oligometastatic bladder cancer

Armine K. Smith, MD, recaps BCAN session on oligometastatic bladder cancer

, recaps a 2024 Bladder Cancer Think Tank session on oligometastatic bladder cancer. Smith is an assistant professor of urology at Johns Hopkins University as well as the co-director of the Women’s Bladder Cancer Program at Sibley Memorial Hospital.

Thanks for having me. My name is Armine Smith. I am an assistant professor of urology at Johns Hopkins University. I'm also a co-director of Bladder Cancer Program for Women at Sibley Memorial Hospital, which is also part of the program with the Greenberg Bladder Cancer Institute [at Johns Hopkins Medicine]. I wanted to tell you about our breakout session that happened at the Bladder Cancer Advocacy Network Think Tank in 2024, just recently. Our breakout session was dedicated to [the] oligometastatic state in bladder cancer. We had a really nice faculty. Along with Dr. Randy Sweis [from] University of Chicago, and presenters Dr. [Sean P.] Pitroda from University of Chicago and Dr. [Phouc T.] Tran from University of Maryland, we collectively decided to focus on the current state of treatments in this stage of disease and to analyze the experience in the treatment of oligometastatic cancers from other cancer states. The reason we wanted to think about this and talk about this is because traditionally, metastatic bladder cancer was a lethal disease, and hence consolidative treatments are [not really] offered to patients unless it's for very severe palliation of symptoms.
However, we are living in a new era of treatments. We have new treatment combinations for metastatic disease. Earlier this year we had data presented at the oncology meeting that looked at a few different combinations. One was enfortumab [vedotin] and pembrolizumab, and that had a great response rate in patients––about a 70% response rate in patients. Another combination was nivolumab with cisplatin and gemcitabine, and that produced about a 60% response rate. Now, compare [that] to prior chemotherapy regimens that only produced about 44% overall response in metastatic bladder cancer patients. With this exciting development, we rethought a lot of the paradigms in this cancer.

Additionally, we have experience with the clinical trials in prostate, colorectal, breast, and lung cancers in the oligometastatic state. We also have treatment in oligometastatic kidney cancers. Building on our experience from these other disease states, we have also experienced a paradigm change in metastatic cancers.
In the past, again, any sort of metastatic cancer [was] felt to be incurable, so there was not a huge reason to target those metastatic spots. However, we have now realized that in some patients with a low number of metastatic sites, providing systemic treatment and providing some site-targeted treatment will provide lasting benefit or at least a temporary benefit that will help ameliorate the need for the systemic treatments or very intense systemic treatments.

So, the question is, is oligometastatic disease curable? It depends on the number of metastatic sites [and] the sites of metastatic deposits in the human body. We know that indolent clinical metastatic disease is the one that has [a] low number of lesions, about 1 to 5––again, extrapolating from other disease states––metachronous presentation, meaning that these arise in sequential fashion, and usually there is no involvement of lymph nodes, there's a slow rate of progression, and there are limited organ sites. We also have to look at the biology of the cancer. Favorable histological presentations can also give us a hint whether this disease may be amenable to cure. Some other things that we have to consider are what is the purpose of treatment for these patients? Is it the cure? Is it improvement of quality of life? And what is the optimal treatment type? Is it radiation therapy vs surgery? We had a very interesting discussion from all the presenters and all the attendees, and we all felt that the time is right for trials in the bladder cancer space just because I think we have really nice systemic treatments now. They're not 100% effective, but they're not really lacking in efficacy. It would be very nice to have a more organized plan to try to treat this disease both systemically and with targeted therapy, which may be provided by multiple disciplines. We know that bladder cancer is a multidisciplinary disease, especially in the advanced state.

"We have now realized that in some patients with a low number of metastatic sites, providing systemic treatment and providing some site-targeted treatment will provide lasting benefit or at least a temporary benefit that will help ameliorate the need for the systemic treatments or very intense systemic treatments," says Armine K. Smith, MD. 

Evaluating the Benefits of Cretostimogene Plus Pembrolizumab for BCG-Unresponsive NMIBC Management

In your opinion, what does cretostimogene plus pembrolizumab combination therapy offer to the management of BCG-unresponsive NMIBC? 

Cretostimogene plus pembrolizumab received an FDA Breakthrough Therapy Designation in May 2023. What is important for physicians to know or understand about this designation?

Panelists discuss how the combination therapy of cretostimogene plus pembrolizumab offers a promising new approach for managing BCG-unresponsive non-muscle-invasive bladder cancer, highlighting its potential benefits and the implications of its FDA Breakthrough Therapy Designation for clinical practice.

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.

Viewpoints

Promising Developments in NMIBC

Experts on non–muscle invasive bladder cancer discuss promising developments in the overall treatment landscape, highlighting potentially practice-changing clinical research.

Patient Monitoring Strategies in BCG-Unresponsive NMIBC

Bladder cancer specialists discuss their strategies for monitoring patients with BCG-unresponsive non–muscle invasive bladder cancer.

Selecting Optimal Treatment in BCG-Unresponsive NMIBC

A panel of experts provide clinical insights on factors that inform how they select treatments for patients with BCG-unresponsive non–muscle invasive bladder cancer.

Bladder Cancer

Latest News