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

Special Report

Virtual Tumor Board

Insights

Medcast

Peers & Perspectives

Conferences

Conference Listing

Conference Previews 

Conference Recaps

Publications

Urology Times Journal

Editorial Advisory Board

Urologists in Cancer Care

Supplements and Featured Publications

Clinical Forums Recaps

CME/CE

Resources

Begin Your Journey: Tackling Burnout

Live Events

Interactive Tools

Job Board

Partners

Treatment Landscape Evolutions

Subscribe

Articles

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

The approvals are supported by findings from the phase 3 CheckMate-67T trial.

Subcutaneous nivolumab approved in EU, Canada for solid tumors

These data are intended to support a new drug application to the FDA in the second half of 2025.

Phase 3 trial of tebipenem HBr for cUTI stopped early for efficacy

The single-use test can deliver diagnostic results for chlamydia and gonorrhea in approximately 30 minutes. 

Application submitted to FDA for 510(k) clearance of Men’s Sexual Health Test

However, the data did not show any benefit of a docetaxel doublet vs an ARPI doublet.

Combination therapy linked to longer OS vs ADT in veterans with mHSPC

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

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do not sell my Personnal Information

Urology Times – News & Insights for Urologists & Health Professionals

Facebook

LinkedIn

Spotlight

Peers and Perspectives

Clinical

1rem

Authors

Chung is a resident at NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York.

Growing evidence supports the existence of an intermediate metastatic disease state.

Management of hormone-naïve oligometastatic prostate cancer

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

 suggest that the use of combination therapy in veterans with de novo metastatic-hormone sensitive prostate cancer (mHSPC) has increased over time and is associated with significantly longer overall survival (OS) vs androgen-deprivation therapy (ADT) monotherapy.

“The increased use of combination therapy over time is expected, as implementation of novel therapies typically occurs over several years,” the authors noted. “To our knowledge, there is no large randomized clinical trial of [androgen receptor pathway inhibitors] (ARPIs) vs docetaxel doublet combinations in mHSPC, and it is unlikely that such a trial of 2 drug combinations will be performed with OS as the primary end point.”

In total, the retrospective cross-sectional study assessed 6216 veterans who received a diagnosis of de novo mHSPC from January 2013 to December 2022. The mean age of patients was 73.9 years (SD, 9.7). Among the 6216 patients included in the analysis, 3839 (61.8%) received ADT monotherapy, 1719 (27.7%) received an ARPI combination, and 658 (10.6%) received a docetaxel combination.

Overall, data showed an increase in the use of combination therapy over time, with combination treatment with either an ARPI or docetaxel becoming the majority of treatment in 2020. In 2020, combination therapy was used in 54% of patients (344 of 637), which rose to 63.1% of patients (465 of 737) in 2022.

Combination therapy was also associated with a significantly longer OS vs ADT monotherapy. Specifically, the mean OS was 40.3 months with combination therapy compared with 33 months with ADT monotherapy (HR, 0.80; 95% CI, 0.74 to 0.87).

There was no difference in OS between ARPI-based and docetaxel-based combination regimens. The mean OS was 40.4 months with ARPI combination therapy vs 40.2 months with docetaxel combination therapy (HR, 1.06; 95% CI, 0.92 to 1.22).

The study also assessed outcomes among 1540 patients who received combination therapy and had imaging reports for volume of disease. Those with high-volume disease demonstrated a significantly shorter survival; the mean OS was 33.3 months among those with high-volume disease compared with 62.5 months among those with low-volume disease (HR, 0.51; 95% CI, 0.43 to 0.60; 

Patients with high-volume disease were also more likely to receive combination therapy with docetaxel. Overall, 33.8% of patients with high-volume disease received docetaxel combination therapy vs 22.1% of patients with low-volume disease (

In patients with high-volume disease, data showed no difference in OS between those who received an ARPI combination vs those who received a docetaxel combination. Specifically, OS was 32.2 months among those who received an ARPI combination vs 34.7 months among those who received a docetaxel combination (HR, 1.06; 95% CI, 0.91 to 1.23).

However, in those with high-volume disease, combination therapy with an ARPI was associated with a longer progression-free survival (PFS) vs combination therapy with docetaxel. The mean PFS was 18.7 months with an ARPI combination vs 16.0 months with a docetaxel combination (HR, 0.80; 95% CI, 0.70 to 0.91).

Trends were similar in patients with low-volume disease. Data showed no difference in OS between those who received an ARPI vs docetaxel regimen (68.4 months vs 55.3 months; HR, 0.81; 95% CI, 0.58 to 1.13), but PFS was significantly longer among those who received an ARPI regimen. Specifically, the mean PFS was 39.7 months in those who received an ARPI combination vs 24.0 months in those who received a docetaxel regimen (HR, 0.57; 95% CI, 0.43 to 0.76).

“The data presented here suggest that an ARPI doublet combination treatment that avoids chemotherapy is a standard of care, and there is little evidence of benefit associated with a docetaxel doublet compared with an ARPI doublet,” the authors concluded.

They also noted, “Future research into the role of docetaxel in triple combination is needed to elucidate the benefit of chemotherapy in mHSPC.”

1. Schoen MW, Doherty J, Eaton D, et al. Treatment patterns and survival among veterans with de novo metastatic hormone-sensitive prostate cancer. 

. 2025;8(5):e259433. doi:10.1001/jamanetworkopen.2025.9433

2. Treatment patterns, survival among veterans with de novo metastatic hormone-sensitive prostate cancer. News release. Saint Louis University. May 7, 2025. Accessed May 27, 2025. https://www.newswise.com/articles/treatment-patterns-survival-among-veterans-with-de-novo-metastatic-hormone-sensitive-prostate-cancer

Combination therapy for veterans with de novo metastatic hormone-sensitive prostate cancer (mHSPC) has increased over time, leading to significantly longer overall survival (OS) compared to androgen-deprivation therapy (ADT) monotherapy. The study analyzed 6216 veterans, revealing that combination therapy became predominant by 2020. No OS difference was found between androgen receptor pathway inhibitors (ARPI) and docetaxel combinations, but ARPI showed longer progression-free survival (PFS). High-volume disease patients had shorter OS, with docetaxel more frequently used. Future research is needed to explore docetaxel's role in triple combination therapies.

The Ibex Prostate AI-powered solution demonstrated the ability to accurately identify and grade prostate cancer in the primary diagnosis of prostate needle biopsy (PNB) specimens, according to data presented at the United States and Canadian Academy of Pathology (USCAP) annual meeting in Baltimore, Maryland.

The study was conducted through a collaboration between Ibex Medical Analytics and the University of Pittsburgh Medical Center in Pennsylvania.

In addition to Ibex Prostate, Ibex Medical Analytics offers 2 other AI-based solutions with indications in breast cancer and gastric cancer. Data on those tools were also presented at the USCAP meeting.

"[Ibex] offers an unparalleled breadth of detection capabilities going well beyond cancer and becoming an integral part of everyday clinical practice in laboratories, hospitals, and health systems globally. With these outstanding outcomes achieved in leading US health care institutions across various tissue types, amplified by very positive user feedback, our technology continues to set the standard for AI solutions in pathology, helping clinicians improve patient outcomes,” said Chaim Linhart, PhD, in a news release on the data.

 Linhart is the chief technology officer and co-founder of Ibex Medical Analytics.

Overall, data from the Ibex Prostate study showed that in pre-classifying parts with the likelihood to be benign or malignant, Ibex Prostate demonstrated an area under the curve of 0.994 (95% CI, 0.99-0.998), a negative predictive value of 97.5% (95% CI, 95.1%-98.9%), and a positive predictive value of 99.2% (95% CI, 97.8%-99.8%). In total, the AI solution marked 17.9% of parts as suspicious (medium likelihood), with 78% of those being classified as benign and 22% as malignant per the pathologist.

Further, agreement between the AI tool and the pathologists in regard to Gleason group (GG) grading was high at 90% (defined as a complete agreement or a difference of 1 GG).

The user feedback from pathologists was also positive, with a satisfaction mark of 95% in regard to Gleason scoring, 90% in perineural invasion detection, and 95% in tissue and tumor length automated measurements. Overall, participating pathologists felt that there is potential to increase diagnostic efficiency by using the AI-powered tool in a clinical setting.

In total, the investigators in the study assessed 206 cases, which were composed of 860 parts and 1159 hematoxylin and eosin (H&E)-stained slides. The H&E-stained slides were scanned at 40x magnification. PNB specimens were collected from October 2022 to February 2023 and selected at random for AI analysis and subsequent review by genitourinary (GU) pathologists.

The AI solution was used for the prospective primary diagnosis of PNBs by 4 trained GU pathologists. The slides were also reviewed by pathologists via microscopic examination. Final diagnoses were either categorized as malignant, atypical small acinar proliferation, or benign.

The investigators concluded, “We report the successful implementation of a multi-feature AI solution that automatically imparts clinically relevant diagnostic parameters regarding prostate cancer, grading, measurements, and other pathologic features. The solution demonstrated its capability to accurately detect cancer and contribute to diagnostic quality and can serve as a valuable tool for pathologists in clinical decision-making in routine pathology practice.”

1. Korentzelos D, Deebajah MM, Quiroga-Garza GM, et al. Routine use of an artificial intelligence solution for primary diagnosis of prostate biopsies in clinical practice. Presented at: United States and Canadian Academy of Pathology Annual Meeting. March 23-28, 2024. Baltimore, Maryland. Poster 110

2. Ibex presents new data from multiple studies showcasing accuracy of AI in prostate, breast and gastric cancer diagnosis. News release. Ibex Medical Analytics. March 21, 2024. Accessed March 26, 2024. https://www.prnewswire.com/news-releases/ibex-presents-new-data-from-multiple-studies-showcasing-accuracy-of-ai-in-prostate-breast-and-gastric-cancer-diagnosis-302095787.html

Ibex Prostate, an AI-powered solution, demonstrated high accuracy in identifying and grading prostate cancer in needle biopsy specimens, as presented at the USCAP annual meeting. The study, conducted with the University of Pittsburgh Medical Center, showed an area under the curve of 0.994, with high predictive values. The AI tool achieved a 90% agreement with pathologists on Gleason grading. User feedback was positive, indicating potential for increased diagnostic efficiency. The study assessed 206 cases, highlighting the AI's capability to enhance diagnostic quality in routine pathology practice.

Overall, participating pathologists felt that there is potential to increase diagnostic efficiency by using Ibex Prostate in a clinical setting. 

Ibex Prostate demonstrates diagnostic value in prostate cancer

How common is a diagnosis of de novo metastatic prostate cancer? In an interview with 

, breaks down the answer to this question and more in the wake of former President Joe Biden’s recent cancer diagnosis.

According to Weiner, while it’s uncommon for men in the US to be diagnosed at this late stage of disease, it can happen in those who have stopped screening.

He explained, “For someone who is the former president's age range, he would certainly be above the typical age range that we might recommend screening, and certainly might be above the age range where we would say someone who was screening might want to consider stopping screening. While it's not common this day and age in the US to be diagnosed with metastatic prostate cancer, it still does happen.”
Weiner is a urologist at Cedars-Sinai Medical Center in Los Angeles, California.

Adam B. Weiner, MD, discusses prognosis and treatment options for men with metastatic prostate cancer in light of President Biden's recent cancer diagnosis.

De novo metastatic prostate cancer: Understanding Biden’s prognosis and treatment

Weiner also added, “President Biden was diagnosed with de novo metastatic prostate cancer. There are a number of great options for him at this point in terms of treatment.”

Depending on a number of factors, overall survival for patients in this disease state ranges from 5 to 10 years, according to Weiner. Ultimately, though, the decision for what treatment to pursue will be made with a few considerations in mind, including the disease volume, other medical issues, and more.

1. Biden diagnosed with ‘aggressive form’ of prostate cancer. CNN. May 19, 2025. Accessed May 22, 2025. https://edition.cnn.com/2025/05/18/politics/joe-biden-prostate-cancer

A prostate cancer expert breaks down likelihood of a diagnosis of metastatic prostate cancer and touches on available treatment options.  

De novo metastatic prostate cancer: Understanding Biden’s prognosis and treatment options

 recently hosted a pair of roundtable discussions on upper tract urothelial carcinoma (UTUC). The programs, moderated by 

 professor in the Department of Urology at NYU Grossman School of Medicine and chief of the Urology Service at Bellevue Hospital Center in New York, New York, encompassed a range of topics related to UTUC, including clinical guidelines, treatment considerations, and patient cases.

This summary was generated by artificial intelligence and edited by humans for clarity.

At the outset, Murray set the stage by outlining the prevalence of UTUC, noting that it affects 1 to 2 individuals per 100,000 people in the United States, representing about 6% of all urothelial carcinoma cases. Symptoms such as hematuria and urinary obstruction were discussed, underscoring the necessity for regular risk stratification to inform treatment decisions, particularly as one-third of patients are diagnosed with low-grade tumors. The association between upper tract tumors and concurrent bladder cancer was also emphasized, revealing that up to 13% of patients may have concomitant bladder carcinoma.

The Importance of Tumor Grade and Location

The conversation touched upon the American Urological Association (AUA) guidelines for the treatment of UTUC, which categorize tumors as low or high risk. Factors influencing this stratification include tumor size, urinary cytology results, biopsy findings, and imaging characteristics from CT scans. The further subcategorization of low-risk and high-risk variations guides therapeutic options tailored to individual patient profiles. Participants noted that their clinical practices varied significantly, reflecting their interpretations and experiences regarding the incidence of low-grade disease. Many indicated that they see approximately 20% to 30% of patients diagnosed with isolated low-grade upper tract disease.

Murray emphasized that treatment choices for low-grade UTUC depend fundamentally on tumor grade and location. Traditionally, the gold standard treatment has been radical nephroureterectomy with bladder cuff excision; however, alternatives such as segmental ureterectomy, endoscopic treatments, antegrade or retrograde ablation techniques, and adjuvant intracavitary therapies are increasingly common. The roundtable attendees shared their perspectives on how the location of a tumor—whether in the renal pelvis or ureter—plays a crucial role in treatment decisions. The importance of individualized approaches was underscored, taking into account not only the tumor’s characteristics but also the patient's overall health and preferences.

In exploring treatment innovations, the conversation highlighted the approval of a reverse thermal gel formulation of mitomycin (Jelmyto), stemming from trial data such as the OLYMPUS trial. This product is indicated for patients with unifocal tumors less than 1.5 cm, demonstrating a 59% complete response rate for low-grade disease when applied after surgical interventions aimed at debulking the tumor. Murray posited using adjuvant therapies like this to "mop up" residual disease after extensive attempts at clearance, emphasizing the collaborative nature of modern oncology where clinical trials inform treatment practices.

Special attention was also given to the complexities of endoscopic management in upper tract disease. Although ureteroscopy is commonly performed, the inherent challenges of high recurrence rates necessitated frank discussions about the potential for stricture formation and the complications tied to nephroureterectomy, which include significant impacts on renal function and associated risks, such as surgical infections and blood transfusions.

During the roundtable, several patient cases were presented that illuminate the complexities of managing low-grade UTUC. The participants shared their clinical experiences and strategies in relation to these cases, sparking a thoughtful dialogue about treatment options and decision-making processes.

One case involved a patient with high-volume, low-grade disease. The presenting physician raised concerns about the potential for undetected high-grade tumors despite biopsy results indicating low-grade pathology. This scenario ignited conversations regarding the appropriateness of nephroureterectomy, with some participating advocating for immediate surgical intervention based on the patient's symptomatic presentation, including issues such as bleeding. The uncertainty inherent in low-grade diagnoses led to different opinions on whether to proceed with radical surgery or to adopt a more conservative, kidney-sparing approach, particularly in patients with solitary kidneys.

Another case included discussions about patients who were deemed too high-risk for nephroureterectomy. Here, the focus turned to endoscopic techniques and kidney-sparing methodologies, exploring the possibility of managing high-grade tumors endoscopically. Attendees highlighted the need for individualized discussions with patients about treatment options, weighing the chance of disease progression against the quality-of-life implications of more invasive procedures. Options such as segmental ureterectomy and emerging treatments, including intraluminal therapies, were raised as alternatives worth considering for select patients.

A notable case involved the use of adjuvant treatments for patients who demonstrated residual low-grade disease after an initial resection. The introduction of therapies like mitomycin gel was discussed, particularly for patients who would not be candidates for aggressive surgical approaches. This allowed for a more conservative management strategy, circumventing major surgeries while still aiming to manage the disease effectively.

Participants underscored the importance of follow-up strategies, particularly in cases where residual disease or multifocality raised concerns about recurrence. The consensus was that rigorous surveillance protocols, including regular ureteroscopy, were vital for ensuring ongoing tumor management. Timelines for follow-up and patient education on the likely frequency of procedures were emphasized as essential components of care.

As in the first program, Murray and the participants discussed the prevalence of UTUC, the role of the AUA guidelines, and the importance of risk stratification. A significant portion of the discussion was devoted to treatment modalities, where participants shared their approaches to managing patients with low-grade UTUC. The consensus emphasized the role of endoscopic resection, often utilized as the primary treatment for low-grade tumors. In certain cases, this may be followed by perioperative intravesical therapy with chemotherapeutics like BCG or mitomycin C. The discussion also touched on the feasibility and implications of kidney-sparing surgeries, emphasizing the need to carefully evaluate patients based on tumor characteristics and individual health factors.

One participant introduced a critical point regarding the rate of undergrading in biopsies, noting findings from a recent systematic review that indicated an undergrading rate of approximately 30%. This highlighted the inherent challenges in diagnosing UTUC accurately and how these ambiguities could affect treatment decisions significantly. The group acknowledged that this undergrading could lead to either overly conservative management or more aggressive treatment than necessary, stressing the importance of comprehensive evaluation and shared decision-making with patients.

Participants discussed their experiences with recurrent cases and tailored their treatment strategies accordingly. For instance, the discussion referenced specific patient cases where clinicians had to decide between nephroureterectomy and kidney-sparing approaches based on tumor location, grade, and patient comorbidities. They acknowledged the importance of weighing risks, such as potential surgical complications and renal insufficiency, especially in patients with solitary kidneys or chronic health issues.

During the discussion, the application and benefits of mitomycin gel in treating low-grade UTUC were central themes. The discussion highlighted that although traditional treatment often involves nephroureterectomy or intraluminal therapies, the introduction of mitomycin gel presents an additional, lower-risk option to manage low-grade cases without necessitating more invasive surgical interventions.

Participants noted that the National Comprehensive Cancer Network guidelines suggest the use of mitomycin as an adjuvant therapy following endoscopic tumor ablation. This recommendation stems from its effectiveness in achieving near or complete ablation of low-grade tumors and is supported by some clinical trial data. This gel can be administered intravesically after tumor resection, allowing for a localized treatment that minimizes systemic exposure and potentially reduces adverse events.

The conversation also addressed the risk of adverse events associated with mitomycin gel, including ureteral stenosis, which was noted to be around 29% in some patients. The participants discussed managing these risks through careful monitoring and consideration of individual patient factors when recommending this treatment option.

The methods of administering mitomycin gel were also discussed. The participants shared their experiences regarding the logistical aspects, such as whether to administer the gel using a retrograde or antegrade approach, and how these methods might differ based on institutional practices. Notably, there was a focus on the crucial role of ureteral access sheaths during the procedure, which facilitated the effective delivery of the gel while allowing for thorough tumor ablation.

As in the previous program, several patient cases were discussed, including a female patient who was a longstanding smoker and had low-grade upper tract disease treated with endoscopic resection. Post-treatment, she initially achieved a complete response while using mitomycin gel, remaining in remission for approximately 2 years.

However, upon follow-up, imaging revealed a new renal pelvic mass approximately 1 cm in size, which was subsequently confirmed to be low-grade urothelial cancer. This case exemplified the high risk of recurrence associated with endoscopic treatments, with the recurrence rate estimated at approximately 60% to 70%.

Another case involved a patient with a solitary kidney and chronic renal insufficiency, which raised considerations about potential nephron loss if nephroureterectomy were performed. The discussion highlighted the challenges of predicting future complications in the contralateral kidney, especially in patients with risk factors such as diabetes and hypertension. This case underscored the importance of individualized patient assessment, considering the overall health, risk factors, and preferences related to treatment strategies.

Upper tract urothelial carcinoma (UTUC) affects 1-2 per 100,000 people in the U.S., representing 6% of urothelial carcinoma cases. Discussions emphasized the importance of tumor grade, location, and individualized treatment strategies, including radical nephroureterectomy and emerging therapies like mitomycin gel. The challenges of accurate diagnosis, risk stratification, and managing recurrence were highlighted. Case discussions underscored the complexities of treatment decisions, particularly in patients with solitary kidneys or chronic health issues, emphasizing the need for personalized approaches and rigorous follow-up protocols.

A pair of roundtable discussions encompassed a range of topics related to UTUC, including clinical guidelines, treatment considerations, and patient cases.

Rainjade Chung, MD

Articles

Latest Updated Articles