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

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

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

Contact Us

Terms and Conditions

Privacy

Do not sell my Personnal Information

Urology Times | News & Insights for Urologists & Health Professionals

Facebook

Twitter

LinkedIn

Spotlight

Peers and Perspectives

Clinical

1rem

Clinical Focus

Robert Dreicer, MD, MS, MACP, FASCO; Neal Shore, MD, FACS; Michael Morris, MD; Alicia K. Morgans, MD, MPH

Medical Crossfire®: How Will Emerging Data Inform Treatment Planning for Patients With Prostate Cancer in the Community?

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

"I think the fact that we're having these conversations, that they are being talked about at national meetings, and that we are bringing the patient voice into this is hugely important," says Mary W. Dunn, MSN, NP-C, OCN, RN.

Advancing bladder cancer care: The importance of integrating mental health support

“Our study highlights critical gaps in health care equity when it comes to treatments that have been shown effective in prolonging survival,” says Solomon Woldu, MD.

Study reveals disparities in immunotherapy use for patients with kidney, bladder cancer

The approval is based on findings from the first interim analysis of the phase 3 EV-302 trial.

Enfortumab vedotin plus pembrolizumab approved in Europe for urothelial carcinoma

The phase 3 trial will assess the anti-tumor activity of 9MW2821 plus toripalimab vs chemotherapy in patients with locally advanced or metastatic urothelial carcinoma. 

Phase 3 trial launches of 9MW2821 plus toripalimab for urothelial carcinoma

The approval is supported by data from cohort 1 of the phase 3 THOR trial.

Erdafitinib approved in Europe for FGFR3-positive 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."

This transcription has been edited for clarity.

Videos

“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.

Safety Outcomes and Duration of Response in Combination Therapy vs. Monotherapy for BCG UR CIS +/- Papillary Disease

Did safety outcomes with combination therapy vary from those observed with monotherapy cretostimogene or pembrolizumab?

Can you please talk about the duration of response and how this compares to other agents that have been tested in BCG UR CIS +/- papillary disease?

Key opinion leaders examine the comparative safety profiles and response durations of combination therapy versus monotherapy in the treatment of BCG-unresponsive carcinoma in situ with or without papillary disease.

Experts discuss the results of the CORE-001 Trial

Results of the CORE-001 Trial: 24-Month Complete Response Rate and Duration of Response

In the CORE-001 trial, what were the results for the primary endpoint of complete response at 24 months as well as the secondary endpoint of duration of response? What is notable about these results?

How do these results compare to those associated with other FDA-approved therapies and other investigational drugs?

What was the overall cystectomy-free survival rate, and what was this rate among patients who experienced a complete response?

Were there other notable efficacy outcomes?

Experts discuss the results of the CORE-001 Trial. 

Experts compare Cretostimogene and BCG Administration Methods

Comparing Cretostimogene and BCG Administration Methods

Can you describe the therapy dose, mode of administration, and duration? 

How does the administration method of cretostimogene compare to that of BCG?

What were the primary and secondary endpoints of this trial?

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.

Experts on bladder cancer discusses strategies to minimize adverse effects and the role of immunotherapy in BCG-unresponsive NMIBC treatment paradigms.

Adverse Effect Management and the Role of Immunotherapy in NMIBC

Bladder cancer experts discuss quality of life and progression considerations and their impact on treatment decisions for patients with BCG-unresponsive NMIBC.

Quality of Life and Progression Considerations in BCG-Unresponsive NMIBC

Overview of the QUILT Trial in BCG-Unresponsive NMIBC

Jason Hafron, MD, CMO, provides an overview of the QUILT trial investigating N-803 in patients with BCG-unresponsive high-grade non–muscle invasive bladder cancer.

Efficacy and Safety Data from SunRISe-1

The panel reviews data from the SunRISe-1 trial investigating TAR-200 and offers its impressions on the efficacy and safety findings.

Bladder cancer experts discuss the evolving treatment landscape in BCG-unresponsive NMIBC and give an overview of TAR-200, an emerging therapy.

The Evolving Treatment Landscape in BCG-Unresponsive NMIBC

A panel of experts on NMIBC discuss challenges associated with BCG shortages and the impact on treatment options and patients’ quality of life.

Navigating BCG Shortages in NMIBC

A panel of experts on non–muscle invasive bladder cancer (NMIBC) discuss challenges associated with BCG shortages and the impact on treatment options and patients’ quality of life.

Bladder Cancer

Latest News