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Clinical Focus

Oncology Decoded Live! Revolutionizing GU Cancer Care: Applying Cutting-Edge Evidence to 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 three-year durability data from this study further validate the potential of JELMYTO in providing long-term disease control for patients with low-grade upper tract urothelial cancer,” says Solomon L. Woldu, MD.

UGN-101 offers durable RFS in low-grade upper tract urothelial carcinoma

The accuracy of PLND was 93.41% in the ICG injection arm compared with 75.91% in the control arm. 

ICG-guided technique improves surgical time, accuracy of PLND

“If patients are not experiencing a clear clinical benefit for chemotherapy prior to surgery, we need to be really thoughtful about how we use it,” says Fed Ghali, MD. 

Challenges in plasmacytoid urothelial carcinoma underscore need for novel treatment options

The planned sBLA will seek approval of Anktiva for patients with BCG-unresponsive NMIBC in the papillary indication.

Anktiva targets expanded indication in US and global approvals in EU and UK 

The NDA is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

New Drug Application initiated with FDA for TAR-200 for NMIBC

, Timothy D. Lyon, MD, gives an overview of his Desai Sethi Urology Institute Urology on the Beach presentation “In-Home Therapy for Bladder Cancer.” 

Timothy D. Lyon, MD, outlines trial of in-home intravesical therapy for bladder cancer

 gives an overview of his Desai Sethi Urology Institute Urology on the Beach presentation “In-Home Therapy for Bladder Cancer.” Lyon is an associate professor of urology and Urology Residency Program Director at Mayo Clinic in Jacksonville, Florida.

At Mayo Clinic, we think that delivering intravesical therapy for non muscle invasive bladder cancer in patients' homes has the potential to reduce treatment burden, improve the patient experience, as well as increase access to care. And we're currently conducting a clinical trial called the INVITE trial for in-home intravesical therapy to test that hypothesis. The background of this study, as anyone who treats bladder cancer knows, receiving intravesical therapy for non muscle invasive bladder cancer can be an incredibly burdensome care process, with frequent weekly visits for treatments, periodic cystoscopic surveillance. In fact, if you were to precisely follow the SWOG treatment protocol for the first year of induction and maintenance BCG, that's 19 visits in the first year to the urologist, not to mention any other unscheduled visits, urinalyses, urine cultures, and this is in a patient population that's generally older and has multiple comorbidities, so they've got other doctors to see. So really, it's a lot that we're asking of our patients, and some of the survey data that we've done with bladder cancer survivors has indicated that helping bring the treatments to where they are and delivering it in their homes may help reduce the treatment burden. So that's what we're excited about doing. At present, we're performing the INVITE trial, as I mentioned before, which is enrolling patients who are beginning induction intravesical therapy with one of a few eligible regimens: BCG, gemcitabine, mitomycin, or gemcitabine/docetaxel. They come to the office and receive the first dose in the clinic to make sure that they can tolerate it, and then doses 2 through 6 are delivered in their homes by a network of contracted home care nursing providers. Co-primary end points of this study are safety, so frequency, nature and severity of adverse events, as well as feasibility, which we're defining as the ability to deliver at least 5 of 6 planned treatments over a 12-week period of time. Key secondary outcomes include patient satisfaction, health-related quality life, etc. So we're very excited to be generating some data to test this hypothesis.

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

Videos

"At Mayo Clinic, we think that delivering intravesical therapy for non-muscle invasive bladder cancer in patients' homes has the potential to reduce treatment burden, improve the patient experience, as well as increase access to care," says Timothy D. Lyon, MD.

Ilaha Isali, MD, MSc, and Laura Bukavina, MD, MPH, MSc, discuss how they hope findings from their recent Urologic Oncology paper “State-of-the-Art review: The Microbiome in Bladder Cancer” could help influence the development of microbiome-based inventions for bladder cancer. 

Experts discuss review of the microbiome and bladder cancer

 discuss how they hope findings from their recent 

paper “State-of-the-Art review: The Microbiome in Bladder Cancer” could help influence the development of microbiome-based inventions for bladder cancer. Isali is a urology resident at Weill Cornell Medicine in New York, New York, and 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.

How do you see the findings from your review influencing the development of microbiome-based interventions or contributing to personalized medicine approaches for patients with bladder cancer in the future?

I think our review mainly highlighted the potential for microbiome-based interventions to revolutionize bladder cancer care. By leveraging microbiome biomarkers for risk stratification, I think we can identify high-risk patients and customize therapeutic strategies. I will say, for example, microbiome composition has been shown to predict response to therapies such as pembrolizumab [Keytruda] or microbiome modulation. Potential probiotics or prebiotic interventions could restore microbiome balance and potentially mitigate immunotherapy-related toxicities or enhancing therapeutic efficacy.

There is always a lot to do in terms of implications for personalized medicine. I will say integration of microbiome insights into clinical workflow will potentially advance precision oncology and potentially offer tailored treatments that improve survival and also quality of life for patients with bladder cancer, not only for bladder cancer, basically, implications for personalized medicine can be applicable for all cancer types.

My biggest hope for people reading this review is to understand that there are some golden opportunities for research. The second thing I would love for readers to understand is that there are certain guidelines when you're doing microbiome research. If you're doing urine-based research, it's important to understand that urine does not have the same amount of bacteria that stool has. So this bio burden, the amount of bacteria that's in the urine, is more likely to be contaminated. In order to reduce that contamination, we have to be able to collect sterilely, so sometimes catheterization is necessary. We have to also understand that we need to have very strict decontamination protocols when we're running the analysis.

And the same thing for gut; when we're talking about the gut microbiome, we have to standardize how we're collecting samples, how we are freezing the samples, how we're analyzing it. In the past, people have used the cheapest possible method just to get the genus of a bug, but not really getting the species. It's a bit like comparing you to a zebra. You're both animals, but it doesn't necessarily mean that you're part of the same group. I don't expect you or the zebra to be very similar. That's how the previous microbiome research has been done. It's been very high in terms of order and family and really not getting down to the species level, because it's more costly. It's better to analyze fewer samples, but on a species level, clean samples that are not contaminated, than being able to collect 300 samples and being able to do the analysis much cheaper. And I hope the readers understand that is more important in microbiome studies than the sheer volume of patients.

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

"My biggest hope for people reading this review is to understand that there are some golden opportunities for research," says Laura Bukavina, MD, MPH, MSc.

Advancements, Unmet Needs, and Future Trends in the Treatment of NMIBC

What are some unmet needs in the treatment landscape of NMIBC that investigational and approved agents still haven’t addressed?

What advancements and future trends are you looking forward to in the field, considering the various MOAs of investigational agents?

A panelist discusses how significant unmet needs in NMIBC treatment persist around BCG supply shortages, optimal treatment sequencing, biomarker development for patient selection, and reducing treatment toxicity, while expressing optimism about emerging trends in combination therapies, novel delivery systems, and personalized medicine approaches based on molecular profiling.

Video Series

Ilaha Isali, MD, MSc, and Laura Bukavina, MD, MPH, MSc, discuss bridging the gap between microbiome research and therapeutic applications

Ilaha Isali, MD, and Laura Bukavina, MD, on the microbiome and bladder cancer

 discuss bridging the gap between microbiome research and therapeutic applications. They are authors of the recent 

paper “State-of-the-Art review: The Microbiome in Bladder Cancer.” Isali is a urology resident at Weill Cornell Medicine in New York, New York, and 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.

The abstract suggests that microbiome surveillance, metagenomic sequencing, and metabolomics could be integrated into clinical trials. What specific methodologies or technologies do you envision being most impactful in bridging the gap between microbiome research and therapeutic applications?

I think integrating microbiome surveillance into clinical trials can bridge the gap between research and also therapeutic applications. Metagenomic sequencing and metabolomics are poised to make significant impacts. I will say, for metagenomic sequencing, which provides a high-resolution analysis of microbiome populations and enabling the identification of potential biomarkers for disease progression and also treatment response. When it comes to metabolomics, I will say we know it captures functional data, such as microbiome metabolics such as short chain fatty acids and bile acids, which influence tumor biology and immune responses that there is a research going on, and, of course, advanced analytics, because machine learning models trained on microbiome and also clinical data, I think, can further enhance predictions of treatment efficacy, which was demonstrated in recent studies exploring neoadjuvant chemotherapy responses. I think such tools will facilitate personalized medicine by tailoring therapies based on patients' unique microbiome profile.

Just to give some background about how I think about the microbiome, is that the microbiome is just 1 little tab in a full-page summary. If you're studying stool microbiome in patients who are receiving cancer therapy, whether it's chemotherapy or immunotherapy, just knowing what bugs are different and associating that to a better response; we don't know the mechanism. We don't understand what exactly is going on with those bugs. Are those bugs priming your immune system? Is it an immunogenic effect? Are those bacteria changing the drug itself? Is it metabolizing the drug? Is it releasing it back into circulation, and if it's releasing it back to circulation, is it actually helping or harming? So if you just know the bacteria without understanding the effect or the mechanism by studying the metagenomics and the metabolites that are produced by that bacteria, you really are just getting part of the picture, and you're seeing an association and not seeing the mechanism, because the hope is down the line, if you're able to understand the mechanism, potentially altering that mechanism, without even involving big studies with fecal microbiota transplant or even involving gut depletion of that specific bacteria could be done if we just hone in on what exactly is happening.

"I think integrating microbiome surveillance into clinical trials can bridge the gap between research and also therapeutic applications," says Ilaha Isali, MD, MSc.

Fed Ghali, MD, highlights key findings from the study, “Evaluating Clinical Outcomes and the Role of Neoadjuvant Chemotherapy in Plasmacytoid Urothelial Carcinoma: Insights from a Combined National and Institutional Series.” 

Fed Ghali, MD, on clinical outcomes in plasmacytoid urothelial carcinoma

, highlights key findings from the study, “Evaluating Clinical Outcomes and the Role of Neoadjuvant Chemotherapy in Plasmacytoid Urothelial Carcinoma: Insights from a Combined National and Institutional Series,” which was presented at the 

Society of Urologic Oncology 25th Annual Meeting

 in Dallas, Texas. Ghali is an assistant professor of urology in the division of urologic oncology at the Yale School of Medicine and the Yale Cancer Center in New Haven, Connecticut.

We found a couple of key things that stand out. Most of these things add to what we anticipated ahead of time based on some of these other studies that I'd mentioned, the MD Anderson experience, which was recently reported, and other institutional series. The first thing to say is that this disease is very rare. In the National Cancer Database over the years that this has been collected, we found 123 individual cases reported across the country over several years. When we add our patients, that goes up to just under 150 patients. These are not large numbers, so we're still in the position of studying quite a rare disease.

Our data reiterated the fact that this is quite an aggressive disease. The median survival across the stages of bladder cancer, including both non-muscle invasive and more advanced disease, median survival was between 2 and 3 years, depending on the details of the cohort. In other words, these patients do face quite a challenge. It's an aggressive disease.

An additional thing that we identified—and this is has been reported, but we found this across a broad population—is that our staging of the disease, our understanding of the extent of disease, tends to underestimate the extent of disease quite a bit. One way you can look at this is by looking at the clinical T stage, for example, and the clinical nodal status. Meaning, how deep do we think the tumor goes in the bladder? Do we think that there's cancer in the lymph nodes? Then [you look at] how that changes after the patient undergoes a radical cystectomy, for example, where we maybe have the closest thing to a true standard when a pathologist gets to look at the tissue under the microscope. What you see is there's a large discrepancy. For example, around 8% or 9% of patients are thought to have cancer in their lymph nodes prior to surgery. When patients with plasmacytoid cancer undergo radical cystectomy and actually have their lymph nodes evaluated under the microscope, that number goes up to 25% to 30% depending on the cohort. What that suggests is that our clinical understanding of the extent of disease tends to underplay how extensive the disease actually is. Those of us who take care of patients with plasmacytoid urothelial cancer know this implicitly. I don't think anyone will be shocked by this, but I think it's helpful to have specific numbers to evaluate it. So, that was reiterated through the data was how aggressive this cancer is.

Another key finding from our study was that the role of neoadjuvant chemotherapy, giving chemotherapy prior to surgery, is not well established in variant histologies, variant subtype bladder cancer, and specifically plasmacytoid. All of the evidence that supports early neoadjuvant chemotherapy, the really high-quality evidence from clinical trials, is in classic urothelial carcinoma. What we found is that there's a large discrepancy between how frequently neoadjuvant chemotherapy is used. In the prior reports that I mentioned, and including our experience at Yale, somewhere between 65% and 75% of patients with plasmacytoid get chemotherapy prior to surgery. We are quite active about using chemotherapy in academic centers. If you compare that to the National Cancer Database, so looking at the experience from a broader collection of hospitals including community practice and other academic centers, the use of neoadjuvant chemotherapy drops to around 21%. So, the community is using chemotherapy prior to surgery much less frequently than we do at academic centers is what our data suggests.

Then finally, I think the ultimate question is do we think chemotherapy helps? In other words, is there evidence to suggest that chemotherapy is improving survival for patients? What we find is that if you compare the patients who have received chemotherapy and those who did not receive neoadjuvant chemotherapy, we can detect a difference in how long those patients live. In other words, neoadjuvant chemotherapy was associated with a longer survival.

But when we ran some statistical tests to account for differences in which types of patients get chemo and which don’t, so when we do an analysis that accounts for the patient's age, the clinical T stage—in other words, how advanced the tumor is locally in the bladder—and the primary treatment modality, what [we found] is that the benefit from neoadjuvant chemotherapy washes away. It’s not maintained. It's hard for us, based on our evidence here, to say that neoadjuvant chemotherapy is causal in any way or is resulting in prolonged survival. It's at least possible, if not likely, that there's a different type of patient—maybe a younger, healthier patient, for example—that receives chemotherapy, and that's really what's associated with survival.

“It's hard for us, based on our evidence here, to say that neoadjuvant chemotherapy is causal in any way or is resulting in prolonged survival,” says Fed Ghali, MD.

Emerging Treatments for Patients with NMIBC

Please give an overview and your overall impressions about selected investigational agents to treat patients with NMIBC.

A panelist discusses how emerging investigational agents for NMIBC show promise through diverse mechanisms, including oncolytic viruses (CG0070), immune checkpoint inhibitors (durvalumab, sasanlimab), targeted drug delivery systems (TAR-200), mitomycin-containing gels (UGN-102/103), immunotherapies (TARA-002), gene therapies (EG-70), and FGFR inhibitors (erdafitinib), representing a robust pipeline of potential treatment options.

Ilaha Isali, MD, MSc, and Laura Bukavina, MD, MPH, MSc, discuss gaps in the literature relating to the microbiome and bladder cancer

Research points to gaps in literature for bladder cancer and the microbiome

 discuss gaps in the literature relating to the microbiome and bladder cancer. They are authors of the recent 

You noted gaps in the literature, particularly regarding the impact of bladder cancer treatments on the microbiome and immunotherapy-related toxicities. What do you see as the biggest challenges or limitations in studying these aspects, and how might they be addressed in future research?

 We recently published on paper with Dr Laura Bukavina. She is the leader of this research. We also highlighted several limitations [with] microbiome research. In this review article, we specifically focused on challenges in researching the microbiome in bladder cancer. I will highlight those several limitations that currently hinder our understanding of how bladder cancer treatments, particularly immunotherapies, affect the microbiome. [The] first thing is methodological variability. Studies often lack standardized methods for sample collection, DNA extraction, and sequencing, leading to inconsistent findings. Second, [there are] contamination risks. Low biomass samples, such as those from bladder tissue or urine samples, are very prone to contamination, which complicates the interpretation of microbiome signatures. And of course, dynamic microbiome changes, I would say, treatments, specifically chemotherapies or intravesical therapies, can induce rapid changes in the microbiome, which requires longitudinal studies for comprehensive insights. Future research should focus on standardizing methodologies, incorporating multi-omics approach and utilizing preclinical models that closely mimic the patient's specific conditions. This hopefully will help delineate the links between microbiome dysbiosis and cancer progression and also the treatment outcomes.

There are significant gaps. The majority of the studies in the microbiome within the concept of bladder cancer have been done in terms of characterization studies. Those are the studies that you're looking at potential differences between your healthy controls or the patients with bladder cancer. Those are sort of the baseline grade studies to have, but I really see that we haven't made much of a leap compared with lung cancer or melanoma trials in understanding above just beyond the baseline differences in microbiome. Patients who are receiving treatment for their bladder cancer, whether it's localized or systemic treatment, how do those baseline differences alter their response to therapy? I think the biggest challenge is we haven't figured out what specifically we should be doing in bladder and the microbiome. Should we be doing urine? Should we be doing gut? Should we be doing a combination of both? Studying the microbiome overall is challenging because it's dirty science. You have to be incredibly careful with contamination, and it becomes challenging to understand what's real and what's not. Just because we find an association, it doesn't necessarily mean it translates to a clinical effect.

"Studying the microbiome overall is challenging because it's dirty science. You have to be incredibly careful with contamination," says Ilaha Isali, MD, MSc, and Laura Bukavina, MD, MPH, MSc.

Ilaha Isali, MD, MSc, and Laura Bukavina, MD, MPH, MSc, discuss their recent Urologic Oncology paper “State-of-the-Art review: The Microbiome in Bladder Cancer.”

Experts discuss microbial-tumor interactions in bladder cancer

Can you elaborate on the intricate microbial-tumor interactions mentioned in your abstract? How do these dynamics influence the tumor microenvironment and potentially affect cancer progression or treatment outcomes?

The interplay between the microbiome and bladder cancer is very complex. There is still more research going on in this area, and we still need to get to know more information. Specific microbiome populations such as physio bacterium and campylobacter hominis have been associated with bladder cancer carcinogenesis, potentially through mechanisms such as chronic inflammation, immune modulation, and also epithelial barrier disruption...Furthermore, I would say the altered microbiome diversity observed in bladder cancer tissue and urine samples suggest that microbiome ecosystems can influence the tumor progression and also treatment response. I think understanding these dynamics could potentially provide novel therapeutic targets and also biomarkers to improve patient outcomes, specifically in patients with bladder cancer.

Within the tumor, we know for a fact that there are microbes, just like multiple tissues in your body, there are microbes within it, and we know that the cancer itself is what's called a hypoxic environment, meaning that oxygen at the core of cancer is low. There are certain bacteria that dwell on this environment, and certain bacteria that live on the outside. The tumor microenvironment is very dense in different immune cells, and having different bacteria can be beneficial or can be detrimental to the tumor. So part of what I would call a gap in bladder cancer is that, yes, we know that the bacteria exist. Think about bladder, right? It's completely open to the environment. There's urine; there's always bacteria in there. We know that there's bacteria within the tumors, but we don't really know how to modulate those bacteria. We don't really know what they're doing. We don't know how they're responding with the immune cells in the environment. And it's funny to think that even within urology, we use bacteria to treat bladder cancer, and there are still many people who think that bacteria have no effect on bladder cancer, even though we're using BCG, which is a bacteria, to treat bladder cancer. So especially within bladder cancer, I think it's important to understand that we need to keep going forward and understanding the tumor, the micro environment, and the microbial composition of that whole picture.

"The interplay between the microbiome and bladder cancer is very complex," says Ilaha Isali, MD, MSc.

Vikram M. Narayan, MD, highlights the challenges and opportunities associated with the array of new treatment options in bladder cancer, specifically focusing on nadofaragene firadenovec-vncg .

Vikram Narayan, MD, on weighing treatment options in NMIBC

, highlights the challenges and opportunities associated with the array of new treatment options in bladder cancer, specifically focusing on nadofaragene firadenovec-vncg (Adstiladrin). Nadofaragene was approved in December 2022 for the treatment of patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Narayan is an assistant professor of urology at Emory University and the director of urological oncology at Grady Memorial Hospital in Atlanta, Georgia.

In my practice, I provide patients with a menu of treatment options. When a patient comes in with BCG unresponsive, obviously we talk about cystectomy, we talk about nadofaragene, there's also nogapendekin alfa inbakicept-pmln or Anktiva together with BCG as an option, gemcitabine/docetaxel, which of course, is being used off label, but widely used and considered very effective. There's some trials underway that we're interested in seeing the results for, including the BRIDGE study. I think that you have to present the pros and cons of each treatment option to the patient. I do enroll a lot of patients in clinical trials as well.

As it relates to challenges. I think challenges that patients face include things like having to decide between the menu of options. It's a good problem to have, because we're thinking about a previous era in which we didn't have many options besides more BCG vs cystectomy, and now patients have the ability to choose from options. But I think it's fair to say that we haven't been as excited about the durability of a lot of these agents. We want to see better durability.

As far as convenience for the patient, the things that I talk about are cost, how easy it is to get it, what are the adverse events for these drugs. Nadofaragene tends to be relatively well tolerated. There are some issues that people can have as it relates to bladder spasm, things of that sort, which in my practice, we manage by giving patients anticholinergics prior to treatment. That seems to work relatively well for them. Another challenge, of course, is storage and handling. This drug does arrive frozen. It does need to be thawed. The company has provided some additional guidance on how to make that piece easier, but I think in a lot of urology practices, being able to do that in an efficient way in a busy clinical practice remains a challenge.

The other thing that is convenient for the patient with this is that you can dose it once every 3 months as opposed to once a week like a lot of the other treatments that are available. But I let my patients choose after presenting the pros and cons of each of the options for them.

“It's a good problem to have, because we're thinking about a previous era in which we didn't have many options besides more BCG vs cystectomy,” says Vikram M. Narayan, MD. 

Shreyas S. Joshi, MD, MPH, highlights early findings from the ongoing phase 2 LEGEND trial (NCT04752722) of detalimogene voraplasmid (EG-70) for patients with high-risk NMIBC.

Shreyas Joshi, MD, highlights initial promise from pivotal trial of EG-70

, highlights early findings from the ongoing phase 2 LEGEND trial (NCT04752722) of detalimogene voraplasmid (EG-70) for patients with high-risk non–muscle-invasive bladder cancer (NMIBC). Joshi is an assistant professor of urology at Emory University School of Medicine in Atlanta, Georgia.

The FDA had a real desire to have treatments available for BCG-unresponsive patients, so those patients who have gotten at least 5 doses of an induction and at least 2 doses of another induction or maintenance BCG. If they continue to have persistent disease, and there's definitions around that, then they are applicable to get a salvage therapy. In that salvage setting, we've had multiple drugs in the past. Pembrolizumab has been approved, which is an IV infusion. We now have Adstiladrin, which is nadofaragene, which is intravesical. We now also have Anktiva, which is in combination with BCG. All of these drugs are trying to hit this space where patients who otherwise would go to cystectomy after not responding to BCG. Can we spare their bladders?

We were involved in the phase 1/2 part of this study. Now we're also involved in the pivotal phase 2, which is equivalent to the phase 3 part of the study. It's an international study, and we're looking at patients who are BCG-unresponsive and trying to prove efficacy. The outcomes would be complete response at any time, and then complete response at different time points, 3 months, 6 months, and 1 year. The initial data was very promising for the initial 3-month complete response rates, being well above 60%. Now, that's really promising, but we always want to see durability, especially for those patients who initially responded. We're very much looking forward to the new data that'll be presented, hopefully, within the next year, to see where this falls in the grand scheme of the all the new drugs coming into play here. If it's showing good efficacy, hopefully we can see this get FDA approval and have this as an option for the rest of our patients, too.

"We're very much looking forward to the new data that'll be presented, hopefully, within the next year, to see where this falls in the grand scheme of the all the new drugs coming into play here," says Shreyas S. Joshi, MD, MPH. 

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

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