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Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

Articles

PSMA staging did not appear to have a significant impact on radiation therapy utilization.

PSMA staging is linked with higher rates of ADT, ARPI utilization in prostate cancer

The conditional approval of belzutifan is valid for 1 year, with the opportunity for yearly renewal pending forthcoming data.

Belzutifan approved in EU for renal cell carcinoma

“Among active surveillance patients, 82% are metastases free, and 60% were metastases free and had an intact, un-radiated bladder,” said Pooja Ghatalia, MD.

RETAIN-2 interim data promising for dose-dense MVAC plus nivolumab in MIBC

However, the triplet regimen did not lead to an improvement in overall survival. 

Adding cabozantinib to nivolumab/ipilimumab confers PFS benefit in aRCC

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"I think this is a very important trial, just to bring some importance about patients' worries about being sexually active with urinary incontinence," says LeRoy Jones, MD.

Sexual QOL improved at 12 months following AUS placement

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

Additional follow-up data from the phase 3 EV-302 trial (also known as KEYNOTE-A39; NCT04223856) continued to show that the combination of enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda; EV+P) provides benefit in median overall survival (OS) and progression-free survival (PFS) vs chemotherapy in patients with locally advanced or metastatic urothelial carcinoma (la/mUC).

These results, conducted at a median follow-up of 29.1 months, are consistent with the OS and PFS benefits that were seen at the primary analysis of the trial, presented in October 2023.

The updated analysis was presented by primary investigator Thomas Powles, MD, PhD, at the 

2025 American Society of Clinical Oncology Genitourinary Cancers Symposium

“These latest findings from the EV-302 trial reaffirm the primary results, which demonstrated survival improvements for patients treated with enfortumab vedotin and pembrolizumab that were previously unprecedented in locally advanced or metastatic urothelial cancer,” said Powles, a professor of genitourinary oncology at Queen Mary University of London and director of the Barts Cancer Center in London, in a news release on the findings.

 “These data show that the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care.”

Overall, the combination of EV+P reduced the risk of death by 49% vs chemotherapy, with a median OS of 33.8 months (95% CI, 26.1-39.3) with the combination vs 15.9 months (95% CI, 13.6-18.3) with chemotherapy (HR, 0.51; 95% CI, 0.43-0.61). Additionally, the median PFS was 12.5 months (95% CI,10.4-16.6) for EV+P vs 6.3 months (95% CI, 6.2-6.5) for chemotherapy, translating to a 52% reduction in the risk of disease progression or death (HR, 0.48; 95% CI, 0.41-0.57).

Powles noted during the presentation, “The forest plot analysis for progression-free survival and overall survival shows benefit irrespective of upper tract disease, liver metastases, PD-L1 expression, platinum eligibility, presence of metastatic disease, and renal function.”

The data also showed an OS benefit with EV+P regardless of cisplatin eligibility. Among the cisplatin eligible patients, the median OS was 36.7 months (95% CI, 31.5-not estimable) with EV+P compared with 18.7 months (95% CI, 16.6-22.1) with chemotherapy (HR, 0.54; 95% CI, 0.42-0.70). Among those who were cisplatin ineligible, the median OS was 25.6 months (95% CI, 22.7-36.1) and 12.7 months (95% CI, 11.0-14.7), respectively (HR, 0.50; 95% CI, 0.39-0.64).

Regarding the trial’s secondary end points, the confirmed objective response rate (cORR) was 67.5% in the combination arm compared with 44.2% in the chemotherapy arm. The median duration of response was 23.3 months (95% CI, 17.8-not estimable) and 7.0 months (95% CI, 6.2-9.0), respectively.

Further, 30.4% of patients in the combination arm and 14.5% of patients in the chemotherapy arm achieved a confirmed complete response (cCR). The median duration of cCR was not reached in the EV+P arm and was 15.2 months (95% CI, 10.3-not estimable) in the chemotherapy arm.

The safety profile was consistent with the primary analysis from the EV-302 trial, and no new safety signals emerged. In total, 57.3% of patients in the combination arm and 69.5% of patients in the chemotherapy arm experienced a grade 3 or higher treatment-related adverse event (TRAE). In the cCR subgroup, TRAEs of grade 3 or higher occurred in 61.7% and 71.9% of patients, respectively.

Treatment-related deaths occurred in 1.1% of patients treated with the combination vs 0.9% treated with chemotherapy. No treatment-related deaths occurred in the cCR subgroup.

In total, the EV-302 trial enrolled 886 patients with la/mUC who were randomly assigned 1:1 to receive EV+P (n = 442) or chemotherapy (n = 444). In the treatment arm, patients received 1.25 mg/kg of IV EV on days 1 and 8 plus 200 mg of IV pembrolizumab on day 1. In the chemotherapy arm, patients received either gemcitabine with cisplatin or carboplatin every 3 weeks.

The co-primary end points were OS and PFS per blinded independent central review. Secondary end points including cORR, duration of response, and safety. According to the authors, “An exploratory analysis evaluated treatment outcomes and safety in [patients] with cCR.”

The combination of EV+P was approved in the US in April 2023 for the treatment of patients with la/mUC. The combination also has approvals in this indication in the European Union, Japan, and other countries around the world.

“In conclusion, after 2.5 years of median follow-up, we continue to show a compelling benefit for EV+P over chemotherapy. [The] median overall survival of 34 months [is] unprecedented compared to what we saw before,” Powles concluded in his presentation. “These data reinforce enfortumab vedotin and pembrolizumab as the new standard of care in frontline urothelial cancer.”

1. Powles T, Van Der Heijden M, Loriot Y, et al. EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). 

. 43, 2025 (suppl 5; abstr 664). doi:10.1200/JCO.2025.43.5_suppl.664

2. Pfizer and Astellas’ PADCEV (enfortumab vedotin-ejfv) plus KEYTRUDA (pembrolizumab) shows long-term efficacy in first-line treatment of locally advanced or metastatic urothelial cancer (la/mUC). News release. Pfizer. February 10, 2025. Accessed February 15, 2025. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-astellas-padcevr-enfortumab-vedotin-ejfv-plus-0

“These data reinforce enfortumab vedotin and pembrolizumab as the new standard of care in frontline urothelial cancer," says Thomas Powles, MD, PhD.

EV/pembrolizumab continues to show OS, PFS benefit vs chemotherapy in la/mUC

Signati Medical recently filed an application with the FDA for de novo market clearance of its Separo vessel sealing system for vasectomy procedures.

The safety of the device was first demonstrated through the collection of Good Laboratory Practice (GLP) data, in which the device met the safety end points of sealing, no thermal spread, and clinically documented wound healing.

 The safety and effectiveness were further assessed in an Investigational Device Exemption (IDE) study (NCT06402773), which was first initiated in April 2024 and enrolled 8 patients.

, discussed the use of the Separo sealing system for the sealed vasectomy procedure as well as the data supporting its FDA submission. Mutter is the principal investigator of the safety profile study and a general urologist in New Orleans, Louisiana.

Signati recently filed for FDA approval of its Separo sealing system. Could you highlight that achievement in more depth?

Let me qualify the statement by letting you know that my answer is not going to do [justice to] all of the hard work and dedication that the entire Signati team put into this. Essentially, [this] was the culmination of 4 years of hard work, working with the FDA and the entirety of the team, from fundraising to the engineering that went into the device, as well as [adhering to] the FDA regulations and compliance. Suffice it to say that this was the culmination of a long 4 years of work.

For me, it's been very exciting to see something new and different. The advent of the no-scalpel vasectomy back in the late '70s was such a revolutionary technique for vasectomies, [and] it really transformed the world of vasectomy. It allowed many more men to have this [procedure] with very little downtime. As such, because it's been such a good procedure, there's been very little innovation over these 40 years, up until Signati came to market. As urologists, we're usually on the forefront of cutting-edge technology and surgery and all kinds of different types of procedures that we can do. I thought this fit in perfectly with urologists doing vasectomies because, again, there hasn't been any innovation over the past 40 years. This was quite exciting to be a part of, strictly for that reason. Then, the fact that I can do this by myself, without an assistant, and it frees up my assistants to do a multitude of other clinic tasks, is also fairly revolutionary.

It's a bipolar instrument, and there are sets of jaws that go around the vas deferens. This can either be done in the vasal sheath or out of the vasal sheath. The first part of the study was a safety profile. Ultimately, what Signati wants to do is a transdermal vasectomy. In other words, do the vasectomy through the skin. For this portion of the FDA safety study, this was all done outside of the skin. So, I would deliver the vas through the skin, as in a traditional no-scalpel vasectomy, and then just apply the Signati bipolar instrument to the vas deferens, in which time it seals and you're able to remove a segment all with 1 energy delivery of the device.

The device was also explored in an IDE trial––how was that study designed? What were the key findings?

This was [completed per] request by the FDA. This was a single-arm trial, and the end point was what it would be for a vasectomy, and that's to make a man azoospermic after the procedure. In the 8 patients [in whom] we [performed this procedure], all of them at 6 months either reached azoospermia or [had] rare, nonmodal sperm, which is perfectly acceptable within the [American Urological Association] guidelines for a successful vasectomy. So, our end point was reached.

I want to add that the safety profile was impeccable for this. No one experienced a [device-related] adverse event. As far as pain scores were recorded, there was only 1 pain score above a 0 throughout the duration of the study.

What were your initial reactions to the device?

The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant. I don't need my nurse in the room to help me with the procedure. Once I'm set up and I'm going, that frees up all the other staff in the office to [see] patients or do other clinic duties. That was the first thing that I thought was fantastic about it.

Another added benefit that I found is that it's a quick procedure. So, not only am I able to do it by myself without the need of an assistant, but it was really quick. It allowed me to knock out the procedure without other issues and get the patient out the door.

1. Signati Medical successfully completes IDE trial for Separo Vessel Sealing System and initiates FDA market clearance process. News release. Signati Medical. December 24, 2024. Accessed January 28, 2025. https://signatimed.com/signati-medical-successfully-completes-ide-trial-for-separo-vessel-sealing-system-and-initiates-fda-market-clearance-process/

2. Signati Medical files IDE study with FDA. News release. October 3, 2023. Accessed January 28, 2025. https://signatimed.com/signati-medical-files-ide-study-with-fda/

Signati Medical has filed for FDA de novo market clearance for its Separo vessel sealing system, designed for vasectomy procedures. The device's safety was initially demonstrated through GLP data, meeting key safety endpoints. An IDE study further assessed its safety and effectiveness, achieving successful outcomes in all eight patients. The Separo system allows for a transdermal vasectomy, offering a quick, assistant-free procedure. The trial showed no device-related adverse events, and the system's efficiency and independence were highlighted as significant advantages for urologists.

"The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant," says Matthew J. Mutter, MD. 

FDA market clearance sought for Separo sealing system for vasectomy 

Adding multiparametric MRI (mpMRI) into the initial staging pathway for muscle-invasive bladder cancer (MIBC) can expedite the time to definitive treatment, according to findings from the BladderPath trial, which were published in the 

“Bladder cancer is a common cancer, and we know that with any cancer, and especially muscle-invasive bladder cancer, speed is of the essence when treating. Any way to improve the time from initially suspecting cancer to getting the right treatment gives patients the best chance of responding well,” explained lead author Richard T. Bryan, PhD, professor in urothelial cancer research and director of the Bladder Cancer Research Centre at the University of Birmingham, in a news release on the findings.

 “However, this aspect of the bladder cancer care pathway has remained essentially unchanged worldwide for over 100 years, whilst the rest of medicine and health care has innovated around it. We wanted to evaluate whether the 21st-century approaches that have benefited the diagnosis and treatment of all other cancer patients would also benefit bladder cancer patients. The BladderPath trial looked at whether adding in some extra or alternative diagnostic testing, mpMRI first [and then] biopsy or TURBT [transurethral resection of bladder tumor], could speed up the time taken to receive the correct treatment for the most concerning form of bladder cancer.”

In total, the trial included 143 participants with suspected new bladder cancer across 17 hospitals in the UK. Participants were randomly assigned 1:1 to undergo initial TURBT (pathway 1; n = 72) or initial mpMRI (pathway 2; n = 71). Those in pathway 2 underwent TURBT if they were determined, per visual assessment, to have probable non–muscle invasive bladder cancer (NMIBC) or to undergo mpMRI for possible MIBC.

According to the authors, “If the proportion of participants with possible MIBC randomly assigned to pathway 2 who correctly followed pathway protocol exceeded 80%, pathway 2 would be considered feasible in clinical practice.”

Overall, 92% of patients (36 of 39) with possible MIBC in pathway 2 underwent mpMRI. Of those, 92% (n = 33) were fully compliant with the VI-RADS protocol and 94% (n = 34) demonstrated optimal bladder filling. Across both arms, the proportion of patients who correctly followed their respective protocol was 96%.

At the time of data report, 91% of patients received the correct treatment. This included 50 patients in the TURBT arm and 53 patients in the mpMRI arm who were found to have NMIBC, and 15 patients in the TURBT arm and 14 patients in the mpMRI arm who were found to have MIBC. Among those who did not receive the correct treatment, 2 participants with probable NMIBC were diagnosed with MIBC after TURBT and 4 participants with probable NMIBC were unconfirmed as MIBC/NMIBC.

In total, there were 26 patients assessed as possible MIBC who were confirmed to have MIBC, comprised of 14 patients in the TURBT arm and 12 in the mpMRI arm. Of those, 25 received the correct treatment. The median time to correct treatment (TTCT) for these patients was 77 days across both arms.

When stratified by pathway, the median TTCT was 98 days (95% CI, 72 to 125) among those who underwent initial TURBT and 53 days (95% CI, 20 to 89) among those who underwent initial mpMRI. The mpMRI pathway demonstrated a favorable TTCT on a model adjusting for sex and age and with the study center as a random effect (HR, 2.9; 95% CI, 1.0 to 8.1; 

The investigators also assessed TTCT among the 58 participants with probable NMIBC who were confirmed to have NMIBC. This included 28 patients in the TURBT arm and 30 patients in the mpMRI arm who all received TURBT as the correct treatment. The median TTCT among all participants was 16 days (95% CI, 11 to 23).

There was no difference in TTCT between the 2 study arms. The median TTCT was 14 days (95% CI, 10 to 29) among participants in the TURBT arm and 17 days (95% CI, 8 to 25) among patients in the mpMRI arm (HR, 0.8; 95% CI, 0.5 to 1.5).

According to the authors, this finding provides “no evidence that shorter TTCT for participants with MIBC was achieved to the detriment of TTCT for participants with NMIBC.”

They added, "This is impressive, given some participants with mpMRI-staged MIBC still underwent TURBT for histologic clarification."

When looking at all participants in the study, the median TTCT was 31 days (95% CI, 22 to 37). The mpMRI pathway was shown to have a faster TTCT, with a median TTCT of 25 days (95% CI, 18 to 35) compared with 37 days (95% CI, 22 to 37) among patients in the TURBT arm (

 = .03). When adjusting for age and sex, the model favored pathway 2 (HR, 1.4; 95% CI, 0.9 to 2.0).

“This research shows that by adding an MRI pre-biopsy we can cut the time taken to correct treatment for the worst bladder tumors—those that invade the bladder muscle wall—by almost half, from 98 days down to 53 days,” concluded chief investigator of the trial, Nicholas D. James, PhD, in the news release.

 “We’ve also shown that around 1 in 7 of these patients with problematic tumors can avoid the surgical procedure used to diagnose bladder cancer. As an MRI is considerably cheaper than this surgery, we estimate that this new diagnostic pathway will save money, as well as saving surgical theatre space and preventing patients from undergoing unnecessary procedures. The next step for this research is to assess whether this impacts the survival of these patients.”

1. Bryan RT, Liu W, Pirrie SJ, et al. Randomized comparison of magnetic resonance imaging versus transurethral resection for staging new bladder cancers: results from the prospective BladderPath trial. 

. 2025:JCO2302398. doi:10.1200/JCO.23.02398

2. MRI scanning and biopsy could reduce delays in the correct treatment for bladder cancer by more than six weeks. News release. University of Birmingham. January 15, 2025. Accessed January 21, 2025. https://www.birmingham.ac.uk/news/2025/mri-scanning-and-biopsy-could-cut-time-to-correct-bladder-cancer-for-by-more-than-six-weeks

Incorporating multiparametric MRI (mpMRI) into the initial staging of muscle-invasive bladder cancer (MIBC) significantly reduces the time to definitive treatment, as demonstrated by the BladderPath trial. The trial involved 143 participants and compared traditional transurethral resection of the bladder tumor (TURBT) with an mpMRI-first approach. Results showed that the mpMRI pathway halved the median time to correct treatment for MIBC from 98 to 53 days. This approach not only expedites treatment but also reduces unnecessary surgical procedures, potentially saving costs and resources.

The median time to correct treatment was 98 days with initial TURBT compared with 53 days with initial mpMRI. 

Incorporating mpMRI in bladder cancer staging may improve time to treatment

In 2 recent expert roundtable discussions, urologists convened to discuss the management of patients with low-grade upper tract urothelial carcinoma (UTUC). The gatherings focused on the challenges and evolving treatment strategies in this disease. The discussions were moderated by 

 professor of urology at New York University Grossman School of Medicine chief of the Urology Service at Bellevue Hospital Center, New York, New York. What follows is a summary of these discussions.

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

Utilization of American Urological Association (AUA) guidelines.

 The discussion began with a focus on AUA guidelines for UTUC. Participants expressed varying degrees of adherence to the guidelines, particularly regarding risk stratification for low-risk and high-risk disease. One participant noted the importance of identifying patients who may benefit from topical treatments for low-grade tumors, whereas another emphasized differentiating patients based on their disease's aggressiveness.

One participant said that patient context, including kidney function and overall health, plays a crucial role in decision-making. The consensus was that although guidelines are valuable, clinical judgment remains vital in managing patients with upper tract disease.

 The group addressed the inherent challenges in diagnosing and treating upper tract tumors. With a low incidence of these tumors, urologists often face difficulties in obtaining adequate biopsies. One participant highlighted the importance of ensuring that kidneys are functioning well before deciding on aggressive treatment options.

A significant concern raised was the potential for upgrading low-grade tumors during treatment, prompting the group to advocate for thorough sampling and consideration of alternative diagnostic approaches, including percutaneous biopsies.

Adjuvant therapies and new treatment options.

 As the discussion progressed, the panel explored adjuvant therapies, particularly the use of intracavitary treatments like mitomycin reverse thermal hydrogel (Jelmyto). Participants shared their experiences with the drug, noting its potential benefits in preserving kidney function while managing low-grade tumors. One participant emphasized the importance of treatment adherence and patient education regarding the risks of disease progression.

The panel also acknowledged the challenges associated with traditional chemotherapeutics like BCG and mitomycin C. One participant pointed out that although BCG has been used in upper tract management, data supporting its efficacy remain limited.

 As part of the roundtable, the panel discussed 2 patient cases. The first involved a 61-year-old woman who presented with intermittent painless gross hematuria. A CT scan revealed a 1.5-cm filling defect in the lower pole of the left kidney, which was confirmed to be low-grade upon biopsy. The cystoscopy was negative, and the urine cytology was also negative. The panelists discussed treatment options, with some suggesting endoscopic resection followed by intracavitary chemotherapy like mitomycin reverse thermal hydrogel, whereas others felt that endoscopic resection alone was sufficient due to the solitary tumor and low-risk category. The general consensus leaned toward endoscopic treatment first, with the possibility of adjuvant therapy if recurrence occurred, particularly due to the potential for multifocality in low-grade tumors.

The second case revolved around a 71-year-old man with a history of low-grade non-muscle invasive bladder cancer who presented with hematuria and was found to have multiple small papillary tumors in the ureter and renal pelvis. A diagnostic ureteroscopy confirmed these tumors as low-grade. The panel debated whether to proceed with adjuvant chemotherapy given the multifocal nature of the disease and the patient's renal function (GFR of 52). Although some advocated for a nephroureterectomy due to the multifocality and risk of recurrence, others argued for surveillance after ablation, emphasizing the patient’s history and renal preservation

The roundtable underscored the complexities of managing low-grade UTUC, highlighting the need for individualized treatment plans that consider patient history, tumor characteristics, and functional kidney status. As the field continues to evolve, ongoing collaboration and sharing of insights among experts will be essential in improving patient outcomes.

This roundtable began by highlighting that although UTUC constitutes only about 6% of all urothelial cancers, it presents unique challenges in diagnosis and treatment. Participants noted that only 25% to 30% of patients present with low-grade disease, making it imperative for clinicians to accurately identify these cases. Risk stratification plays a critical role in managing UTUC, with Murray emphasizing the importance of thorough patient evaluations, including urine cytology and imaging studies.

 Several treatment options were explored during the roundtable. One participant discussed the benefits of nephron-sparing techniques, including endoscopic approaches and laser ablation, particularly in patients with smaller tumors. The consensus among the group was that endoscopic resection should be considered for low-grade tumors, with many opting to combine this with adjuvant therapies such as mitomycin gel, particularly following ablation.

One discussant raised an important point regarding the challenges of managing multifocal tumors and the potential for under-staging. He noted that although low-grade tumors can be managed conservatively, the risk of high-grade disease necessitates careful monitoring and sometimes aggressive treatment, particularly in younger patients or those with significant comorbidities.

 The roundtable also highlighted recent advancements in the field, particularly the introduction of like mitomycin reverse thermal hydrogel. This formulation has shown promise in providing a minimally invasive option for patients with low-grade UTUC. Murray emphasized the importance of knowing the renal pelvis volume to ensure effective administration of the treatment, as dosage is contingent on this measurement.

Urologists recently convened to discuss the management of low-grade upper tract urothelial carcinoma (UTUC), focusing on challenges and evolving treatment strategies. The discussions highlighted the importance of American Urological Association guidelines, patient context, and clinical judgment in decision-making. Key topics included the challenges in diagnosis and treatment, the role of adjuvant therapies like mitomycin reverse thermal hydrogel, and the complexities of managing multifocal tumors. The roundtables emphasized individualized treatment plans, the potential of emerging therapies, and the necessity of ongoing collaboration and education to improve patient outcomes.

Two recent roundtable discussions focused on the challenges and evolving treatment strategies in upper tract urothelial carcinoma.

LeRoy Jones, MD

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