Pub Date : 2025-10-31DOI: 10.1016/j.urolonc.2025.10.007
Nico C. Grossmann M.D. , Luca Funk M.Med. (UZH) , Christian D. Fankhauser M.D., M.P.H. , Jörg Beyer M.D. , Anja Lorch M.D. , Thomas Hermanns M.D.
Introduction
Adherence to clinical guidelines in the management of testicular germ-cell cancer ensures optimal oncological outcomes, minimizes the risk of overtreatment and undertreatment, and reduces unnecessary investigations including radiographic imaging. An interdisciplinary testis cancer clinic (ITCC) in the Department of urology of the University Hospital Zürich was therefore established in 2016 led by a urologist and medical oncologist, who had both specialized in germ-cell cancer. Aside from treatment decision visits, structured follow-up schedules were integrated to guarantee guideline-conformant therapy and follow-up. We aimed to evaluate the impact of the ITCC on guideline adherence and follow-up.
Materials and Methods
A retrospective analysis was conducted on all testicular germ-cell cancer patients treated from 2012 to 2020 in our hospital. Patients were categorized into 2 groups: those followed prior to the establishment of the ITCC and those thereafter. We compared patient characteristics, follow-up protocols, and the compliance with guideline-recommended follow-up schedules.
Results
We included 143 patients, with 77 in the pre-ITCC group and 66 in the ITCC group. Adherence to clinical follow-up guidelines over a 5-year period was significantly higher in the ITCC group, with 89% completeness of the recommended consultations and diagnostics compared to only 21% in the pre-ITCC group. Additionally, the median number of computed tomography scans was significantly lower in the ITCC group during each of the 5 years of follow-up. The time between orchiectomy and start of further therapies was significantly shorter in the ITCC group (median 24 days versus 32 days, P < 0.01) and significantly less patients were lost to follow-up (11% versus 36%, P < 0.001).
Conclusions
A well-structured ITCC can improve the quality of care of testis cancer patients by optimizing adherence to follow-up schedules and therefore expediting further therapies, reducing unnecessary diagnostics and minimizing loss to follow-up.
{"title":"Improved quality of care for testicular germ cell cancer patients by the implementation of an interdisciplinary testis cancer clinic","authors":"Nico C. Grossmann M.D. , Luca Funk M.Med. (UZH) , Christian D. Fankhauser M.D., M.P.H. , Jörg Beyer M.D. , Anja Lorch M.D. , Thomas Hermanns M.D.","doi":"10.1016/j.urolonc.2025.10.007","DOIUrl":"10.1016/j.urolonc.2025.10.007","url":null,"abstract":"<div><h3>Introduction</h3><div>Adherence to clinical guidelines in the management of testicular germ-cell cancer ensures optimal oncological outcomes, minimizes the risk of overtreatment and undertreatment, and reduces unnecessary investigations including radiographic imaging. An interdisciplinary testis cancer clinic (ITCC) in the Department of urology of the University Hospital Zürich was therefore established in 2016 led by a urologist and medical oncologist, who had both specialized in germ-cell cancer. Aside from treatment decision visits, structured follow-up schedules were integrated to guarantee guideline-conformant therapy and follow-up. We aimed to evaluate the impact of the ITCC on guideline adherence and follow-up.</div></div><div><h3>Materials and Methods</h3><div>A retrospective analysis was conducted on all testicular germ-cell cancer patients treated from 2012 to 2020 in our hospital. Patients were categorized into 2 groups: those followed prior to the establishment of the ITCC and those thereafter. We compared patient characteristics, follow-up protocols, and the compliance with guideline-recommended follow-up schedules.</div></div><div><h3>Results</h3><div>We included 143 patients, with 77 in the pre-ITCC group and 66 in the ITCC group. Adherence to clinical follow-up guidelines over a 5-year period was significantly higher in the ITCC group, with 89% completeness of the recommended consultations and diagnostics compared to only 21% in the pre-ITCC group. Additionally, the median number of computed tomography scans was significantly lower in the ITCC group during each of the 5 years of follow-up. The time between orchiectomy and start of further therapies was significantly shorter in the ITCC group (median 24 days versus 32 days, <em>P</em> < 0.01) and significantly less patients were lost to follow-up (11% versus 36%, <em>P</em> < 0.001).</div></div><div><h3>Conclusions</h3><div>A well-structured ITCC can improve the quality of care of testis cancer patients by optimizing adherence to follow-up schedules and therefore expediting further therapies, reducing unnecessary diagnostics and minimizing loss to follow-up.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 72.e9-72.e14"},"PeriodicalIF":2.3,"publicationDate":"2025-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145427076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-30DOI: 10.1016/j.urolonc.2025.08.023
Zijing Cheng Ph.D. , Timothy Campbell M.D. , Trevor C. Hunt M.D. , Ashley Li M.D. , Carl Ceraolo M.D. , Karen Doersch M.D., Ph.D. , Jathin Bandari M.D.
Purpose
Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in pediatric patients. Due to rarity, treatment advancements are infrequent and randomized controlled trials (RCTs) are challenging to conduct and interpret. Surrogate endpoints are particularly useful in RCTs for rare diseases; however, they are not always accurate or effective. Event-free survival (EFS) is a common surrogate endpoint for overall survival (OS), but has never been validated in genitourinary (GU) RMS.
Methods
Data from three clinical trials were pooled, including 111 subjects with GU primary sites across low-, intermediate-, and high-risk RMS. These trials employed various chemotherapy regimens ± radiation, based on risk-group. The definitive endpoint was OS and the surrogate endpoint was EFS. A 2-stage meta-analytic copula modeling approach was selected to assess surrogacy. The Plackett model was chosen to estimate treatment effects. Sensitivity analyses included convergence testing, goodness-of-fit, and leave-one-out cross-validation.
Results
Of 111 subjects, 56 (50.5%) were randomized into control and 55 (49.5%) into treatment arms. Surrogacy analysis revealed a moderate to strong association between EFS and OS, with trial-level associations ( of 1.0) showing a stronger correlation than individual-level associations (Kendall’s τ of 0.67). The surrogate threshold effect was 0.44. Robustness was limited by sample size due to disease and trial rarity.
Conclusions
In GU RMS, EFS is a moderate to strong surrogate endpoint for OS. These findings support its use as a surrogate endpoint, and the strength of this surrogacy may enable future clinical trial design to utilize EFS with greater emphasis than in prior studies.
{"title":"Evaluation of event-free survival as a surrogate for overall survival in genitourinary rhabdomyosarcoma","authors":"Zijing Cheng Ph.D. , Timothy Campbell M.D. , Trevor C. Hunt M.D. , Ashley Li M.D. , Carl Ceraolo M.D. , Karen Doersch M.D., Ph.D. , Jathin Bandari M.D.","doi":"10.1016/j.urolonc.2025.08.023","DOIUrl":"10.1016/j.urolonc.2025.08.023","url":null,"abstract":"<div><h3>Purpose</h3><div>Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in pediatric patients. Due to rarity, treatment advancements are infrequent and randomized controlled trials (RCTs) are challenging to conduct and interpret. Surrogate endpoints are particularly useful in RCTs for rare diseases; however, they are not always accurate or effective. Event-free survival (EFS) is a common surrogate endpoint for overall survival (OS), but has never been validated in genitourinary (GU) RMS.</div></div><div><h3>Methods</h3><div>Data from three clinical trials were pooled, including 111 subjects with GU primary sites across low-, intermediate-, and high-risk RMS. These trials employed various chemotherapy regimens ± radiation, based on risk-group. The definitive endpoint was OS and the surrogate endpoint was EFS. A 2-stage meta-analytic copula modeling approach was selected to assess surrogacy. The Plackett model was chosen to estimate treatment effects. Sensitivity analyses included convergence testing, goodness-of-fit, and leave-one-out cross-validation.</div></div><div><h3>Results</h3><div>Of 111 subjects, 56 (50.5%) were randomized into control and 55 (49.5%) into treatment arms. Surrogacy analysis revealed a moderate to strong association between EFS and OS, with trial-level associations (<span><math><msubsup><mi>R</mi><mrow><mi>t</mi><mi>r</mi><mi>i</mi><mi>a</mi><mi>l</mi></mrow><mn>2</mn></msubsup></math></span> of 1.0) showing a stronger correlation than individual-level associations (Kendall’s τ of 0.67). The surrogate threshold effect was 0.44. Robustness was limited by sample size due to disease and trial rarity.</div></div><div><h3>Conclusions</h3><div>In GU RMS, EFS is a moderate to strong surrogate endpoint for OS. These findings support its use as a surrogate endpoint, and the strength of this surrogacy may enable future clinical trial design to utilize EFS with greater emphasis than in prior studies.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 49-54"},"PeriodicalIF":2.3,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145698196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-30DOI: 10.1016/j.urolonc.2025.10.004
Kathryn E. Fink , Mitchell M. Huang M.D. , Eric V. Li M.D. , Mohammad R. Siddiqui M.D. , Nicole Handa M.D. , Austin Drysch , Ridwan Alam M.D., M.P.H. , Anugayathri Jawahar M.D. , Edward M. Schaeffer M.D., Ph.D. , Ashley E. Ross M.D., Ph.D. , Hiten D. Patel M.D., M.P.H.
Introduction
To evaluate the diagnostic performance of version 2.1 of the prostate imaging reporting and data system (PI-RADS v2.1) compared to version 2.0 (PI-RADS v2.0) for detecting clinically significant prostate cancer (csPCa), we analyzed a cohort using multiparametric MRI (mpMRI). PI-RADS was developed to standardize mpMRI acquisition and interpretation, with version 2.1 introducing revisions to the assessment of transition zone (TZ) lesions aimed at improving detection of prostate cancer (PCa).
Methods
We conducted a retrospective study of biopsy-naive men who underwent mpMRI between 2018 and 2022. Patients were grouped by interpretation under PI-RADS v2.0 or v2.1. The primary outcome was detection of csPCa, defined as Grade Group ≥2 on subsequent biopsy. Analyses were performed for the cohort and stratified by the region of the index lesion.
Results
Of 1,427 patients, 1,144 (80.2%) underwent mpMRI evaluated under v2.1 and 283 (19.8%) under v2.0. Compared to v2.0, the v2.1 group had more PI-RADS 5 lesions (21% vs. 16%) and fewer PI-RADS 1 to 2 lesions (8% vs. 14%) (P = 0.004). csPCa detection per patient was higher in the v2.1 group (50% vs. 43%, P = 0.04), driven by improved detection in the TZ (55.1% vs. 39.3%, P = 0.04). No significant difference was seen in the peripheral zone (PZ). Multivariable analysis showed higher csPCa detection for TZ lesions with v2.1 (OR: 1.34, 95% CI: 1.02–1.76, P = 0.03).
Conclusions
PI-RADS v2.1 was associated with csPCa detection in TZ lesions compared to v2.0.
{"title":"Evaluation of PI-RADS version 2.1 vs. 2.0 for detecting clinically significant prostate cancer in biopsy-naïve men","authors":"Kathryn E. Fink , Mitchell M. Huang M.D. , Eric V. Li M.D. , Mohammad R. Siddiqui M.D. , Nicole Handa M.D. , Austin Drysch , Ridwan Alam M.D., M.P.H. , Anugayathri Jawahar M.D. , Edward M. Schaeffer M.D., Ph.D. , Ashley E. Ross M.D., Ph.D. , Hiten D. Patel M.D., M.P.H.","doi":"10.1016/j.urolonc.2025.10.004","DOIUrl":"10.1016/j.urolonc.2025.10.004","url":null,"abstract":"<div><h3>Introduction</h3><div>To evaluate the diagnostic performance of version 2.1 of the prostate imaging reporting and data system (PI-RADS v2.1) compared to version 2.0 (PI-RADS v2.0) for detecting clinically significant prostate cancer (csPCa), we analyzed a cohort using multiparametric MRI (mpMRI). PI-RADS was developed to standardize mpMRI acquisition and interpretation, with version 2.1 introducing revisions to the assessment of transition zone (TZ) lesions aimed at improving detection of prostate cancer (PCa).</div></div><div><h3>Methods</h3><div>We conducted a retrospective study of biopsy-naive men who underwent mpMRI between 2018 and 2022. Patients were grouped by interpretation under PI-RADS v2.0 or v2.1. The primary outcome was detection of csPCa, defined as Grade Group ≥2 on subsequent biopsy. Analyses were performed for the cohort and stratified by the region of the index lesion.</div></div><div><h3>Results</h3><div>Of 1,427 patients, 1,144 (80.2%) underwent mpMRI evaluated under v2.1 and 283 (19.8%) under v2.0. Compared to v2.0, the v2.1 group had more PI-RADS 5 lesions (21% vs. 16%) and fewer PI-RADS 1 to 2 lesions (8% vs. 14%) (<em>P</em> = 0.004). csPCa detection per patient was higher in the v2.1 group (50% vs. 43%, <em>P</em> = 0.04), driven by improved detection in the TZ (55.1% vs. 39.3%, <em>P</em> = 0.04). No significant difference was seen in the peripheral zone (PZ). Multivariable analysis showed higher csPCa detection for TZ lesions with v2.1 (OR: 1.34, 95% CI: 1.02–1.76, <em>P</em> = 0.03).</div></div><div><h3>Conclusions</h3><div>PI-RADS v2.1 was associated with csPCa detection in TZ lesions compared to v2.0.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 72.e1-72.e7"},"PeriodicalIF":2.3,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145422163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Open radical cystectomy with urinary diversion is associated with high morbidity, partly due to perioperative opioid use and delayed return of bowel function. We designed a prospective, randomized controlled trial to compare 4 common perioperative analgesic techniques.
Methods
A total of 160 patients between 2019 and 2021 were prospectively enrolled and randomized into 4 groups – thoracic epidural anesthesia (TEA), rectus sheath block (RSB), surgeon infiltration (SI) with either liposomal bupivacaine (LB) or standard bupivacaine (SB). The primary outcome was Visual Analog Scale (VAS) scores at different time points. Secondary outcomes including opioid use, incidence of treatment related side effects, and length of stay (LOS) were measured.
Results
There was no statistical difference regarding VAS scores among 4 groups at 24-, 48, or 96-hour marks. At 72-hour, both TEA and SI with SB had lower VAS scores compared to SI with LB at rest. Compared to SI with SB, TEA had lower cumulative opioid use in first 72 hours postoperatively. The opioid use at individual timepoint, treated related side effects and LOS were similar across groups. TEA was not associated with increased incidence of hypotension, AKI, or delayed ambulation. The ileus rates were higher in SI groups than in TEA and RSB groups (not statistically significant). Limitations include variability in analgesic techniques and timing to transition to PO opioids.
Conclusions
Four analgesic methods perform similarly regarding pain control, opioid use, treatment related side effects and LOS in radical cystectomy.
{"title":"Comparison of 4 local anesthetic techniques for open radical cystectomy: A prospective, randomized controlled trial","authors":"Jiping Zeng MD , Isamu Tachibana MD , Josh Sadowski , Yar Yeap MD , Amy McCutchan MD , Elisa Sarmiento MPH , Pengyue Zhang PhD , Adam Lemmon MD , Brendon Burke MD , Clint Cary MD, MPH, MBA , Hristos Z. Kaimakliotis MD , Timothy A. Masterson MD","doi":"10.1016/j.urolonc.2025.09.019","DOIUrl":"10.1016/j.urolonc.2025.09.019","url":null,"abstract":"<div><h3>Background and Objective</h3><div>Open radical cystectomy with urinary diversion is associated with high morbidity, partly due to perioperative opioid use and delayed return of bowel function. We designed a prospective, randomized controlled trial to compare 4 common perioperative analgesic techniques.</div></div><div><h3>Methods</h3><div>A total of 160 patients between 2019 and 2021 were prospectively enrolled and randomized into 4 groups – thoracic epidural anesthesia (TEA), rectus sheath block (RSB), surgeon infiltration (SI) with either liposomal bupivacaine (LB) or standard bupivacaine (SB). The primary outcome was Visual Analog Scale (VAS) scores at different time points. Secondary outcomes including opioid use, incidence of treatment related side effects, and length of stay (LOS) were measured.</div></div><div><h3>Results</h3><div>There was no statistical difference regarding VAS scores among 4 groups at 24-, 48, or 96-hour marks. At 72-hour, both TEA and SI with SB had lower VAS scores compared to SI with LB at rest. Compared to SI with SB, TEA had lower cumulative opioid use in first 72 hours postoperatively. The opioid use at individual timepoint, treated related side effects and LOS were similar across groups. TEA was not associated with increased incidence of hypotension, AKI, or delayed ambulation. The ileus rates were higher in SI groups than in TEA and RSB groups (not statistically significant). Limitations include variability in analgesic techniques and timing to transition to PO opioids.</div></div><div><h3>Conclusions</h3><div>Four analgesic methods perform similarly regarding pain control, opioid use, treatment related side effects and LOS in radical cystectomy.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 64.e7-64.e14"},"PeriodicalIF":2.3,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145422002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-30DOI: 10.1016/j.urolonc.2025.08.019
Huseyin Besiroglu, Mustafa Kadihasanoglu
{"title":"Letter to the editor regarding the article “Enhanced diagnostic accuracy of micro-ultrasound in prostate cancer detection: An updated series from a single-center prospective study”","authors":"Huseyin Besiroglu, Mustafa Kadihasanoglu","doi":"10.1016/j.urolonc.2025.08.019","DOIUrl":"10.1016/j.urolonc.2025.08.019","url":null,"abstract":"","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Page 59"},"PeriodicalIF":2.3,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145697733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-29DOI: 10.1016/j.urolonc.2025.09.027
Alberto Artiles Medina , César Mínguez Ojeda , José Daniel Subiela , David López Curtis , Ana Domínguez Gutiérrez , Sandra Chamorro Tojeiro , Irene De La Parra Sánchez , Miguel Ángel Jiménez Cidre , Victoria Gómez Dos Santos , Francisco Javier Burgos Revilla
We aimed to evaluate the incidence, microbiological patterns and risk factors of UTIs following radical cystectomy (RC). The study was registered with PROSPERO (CRD42024586612). We searched the PubMed/MEDLINE and Embase databases for articles published until December 2024. The selected records consisted of observational studies with at least two of the following main outcomes: UTI incidence, urosepsis rate, positive urine culture rate, isolated pathogens in urine culture and UTI-associated factors in the 90-day period after RC. Risk of bias was assessed for single-arm and nonrandomised comparative studies. We identified 1845 records and included 17 studies, comprising 18,976 patients who underwent RC. Overall, the pooled 90-day UTI incidence after RC was 21% (95% CI, 17%–25%). Among patients who develop UTI, pooled incidence of urosepsis was 25% (95% CI, 19%–32%). Pooled urine culture positivity reached 79% (95% CI, 74%–84%), with a 25% (95% CI, 17%–34%) and 11% (95% CI, 6%–18%) rate of polymicrobial and fungal infections, respectively.
Pooled prevalence of common bacterial isolates obtained from urine cultures was 26% (95% CI, 18%–35%) for Escherichia coli, 26% (95% CI, 17%–35%) for Enterococcus spp. and 12% (95% CI, 8%–16%) for Klebsiella pneumoniae. Risk factors for 90-day UTI after RC included estimated glomerular filtration rate <60 ml/min/1.73 m2 (RR 1.75, 95% CI, 1.44–2.12), orthotopic neobladder (RR 2.02, 95% CI, 1.17–3.48), postoperative hydronephrosis (RR 1.73, 95% CI, 1.28–2.34) and ureterointestinal stricture (RR 1.98, 95% CI, 1.65–2.38). UTIs are common after RC and clinically present as urosepsis in nearly 25% of cases. A high rate of mixed infections is observed, and the rate of fungal infection can reach 10%. These findings are important for patient counselling and may be utilised to guide empirical antibiotic treatment in everyday clinical practice.
{"title":"A systematic review and meta-analysis evaluating the incidence, microbiological profile and risk factors associated with urinary tract infection after radical cystectomy","authors":"Alberto Artiles Medina , César Mínguez Ojeda , José Daniel Subiela , David López Curtis , Ana Domínguez Gutiérrez , Sandra Chamorro Tojeiro , Irene De La Parra Sánchez , Miguel Ángel Jiménez Cidre , Victoria Gómez Dos Santos , Francisco Javier Burgos Revilla","doi":"10.1016/j.urolonc.2025.09.027","DOIUrl":"10.1016/j.urolonc.2025.09.027","url":null,"abstract":"<div><div>We aimed to evaluate the incidence, microbiological patterns and risk factors of UTIs following radical cystectomy (RC). The study was registered with PROSPERO (CRD42024586612). We searched the PubMed/MEDLINE and Embase databases for articles published until December 2024. The selected records consisted of observational studies with at least two of the following main outcomes: UTI incidence, urosepsis rate, positive urine culture rate, isolated pathogens in urine culture and UTI-associated factors in the 90-day period after RC. Risk of bias was assessed for single-arm and nonrandomised comparative studies. We identified 1845 records and included 17 studies, comprising 18,976 patients who underwent RC. Overall, the pooled 90-day UTI incidence after RC was 21% (95% CI, 17%–25%). Among patients who develop UTI, pooled incidence of urosepsis was 25% (95% CI, 19%–32%). Pooled urine culture positivity reached 79% (95% CI, 74%–84%), with a 25% (95% CI, 17%–34%) and 11% (95% CI, 6%–18%) rate of polymicrobial and fungal infections, respectively.</div><div>Pooled prevalence of common bacterial isolates obtained from urine cultures was 26% (95% CI, 18%–35%) for <em>Escherichia coli</em>, 26% (95% CI, 17%–35%) for <em>Enterococcus</em> spp. and 12% (95% CI, 8%–16%) for <em>Klebsiella pneumoniae</em>. Risk factors for 90-day UTI after RC included estimated glomerular filtration rate <60 ml/min/1.73 m<sup>2</sup> (RR 1.75, 95% CI, 1.44–2.12), orthotopic neobladder (RR 2.02, 95% CI, 1.17–3.48), postoperative hydronephrosis (RR 1.73, 95% CI, 1.28–2.34) and ureterointestinal stricture (RR 1.98, 95% CI, 1.65–2.38). UTIs are common after RC and clinically present as urosepsis in nearly 25% of cases. A high rate of mixed infections is observed, and the rate of fungal infection can reach 10%. These findings are important for patient counselling and may be utilised to guide empirical antibiotic treatment in everyday clinical practice.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 12-26"},"PeriodicalIF":2.3,"publicationDate":"2025-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145402105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-27DOI: 10.1016/j.urolonc.2025.09.023
Bastiaan J. Viergever M.Sc. , Alba C. Zuidema Ph.D. , Trudy Jonges M.D. , Susanne J. Van Schelven B.Sc. , Denise Westland B.Sc. , Eric Kalkhoven Ph.D. , Onno Kranenburg Ph.D. , Richard P. Meijer M.D., Ph.D.
Background
Bladder cancer is among the top ten most common cancers globally and one of the most expensive to treat, primarily due to high recurrence rates stemming from significant heterogeneity and mutational rates. The standard treatment, cisplatin-based combination chemotherapy, yields only 40–56% clinical responses, highlighting the need for improved patient stratification to enable precision treatments. Currently, in general practice patient stratification is based on physical fitness and immunohistopathological characterization. While molecular subtyping has traditionally relied on RNA-sequencing, this method is clinically impractical due to cost and often lacking direct sensitivity correlation. Therefore, we aim to develop an immunohistochemistry-based classification system for the major bladder cancer subtypes.
Methods and Patient Summary
We used the log10 IHC ratios of 3 markers to classify major bladder cancer subtypes.
We applied this subtyping in 3 patient cohorts. First on a tissue microarray cohort (n = 53) from cystectomy treated MIBC patients. Furthermore, a cisplatin-based neoadjuvant chemotherapy cohort with pre- and post-treatment tissues (n = 18). Finally, patient derived bladder cancer organoid cohort (n = 8) for direct subtype specific drug sensitivity testing.
Key Findings and Limitations
Our findings reveal that the classification system offers a valuable approach for subtyping patients individually, in cohorts and in patient-derived organoids (n = 8 distinct organoid lines). Second, this classification system allows detection of subtype changing in patients undergoing neoadjuvant chemotherapy. Furthermore, the classification system effectively distinguishes between significantly (P = 4.07e−10) cisplatin-sensitive (basal-like) and cisplatin-resistant (luminal-like) subtypes in bladder cancer organoids and is hypothesis generating.
Conclusions and Clinical Implications
Our findings suggest that our 3-marker classification system could be valuable as method in future BC patient subtyping for clinical stratification of patients undergoing cisplatin-based treatment.
{"title":"Molecular subtyping of advanced bladder cancer patients and patient-derived organoids based on a 3-marker immunohistochemistry approach to evaluate chemotherapy sensitivity","authors":"Bastiaan J. Viergever M.Sc. , Alba C. Zuidema Ph.D. , Trudy Jonges M.D. , Susanne J. Van Schelven B.Sc. , Denise Westland B.Sc. , Eric Kalkhoven Ph.D. , Onno Kranenburg Ph.D. , Richard P. Meijer M.D., Ph.D.","doi":"10.1016/j.urolonc.2025.09.023","DOIUrl":"10.1016/j.urolonc.2025.09.023","url":null,"abstract":"<div><h3>Background</h3><div>Bladder cancer is among the top ten most common cancers globally and one of the most expensive to treat, primarily due to high recurrence rates stemming from significant heterogeneity and mutational rates. The standard treatment, cisplatin-based combination chemotherapy, yields only 40–56% clinical responses, highlighting the need for improved patient stratification to enable precision treatments. Currently, in general practice patient stratification is based on physical fitness and immunohistopathological characterization. While molecular subtyping has traditionally relied on RNA-sequencing, this method is clinically impractical due to cost and often lacking direct sensitivity correlation. Therefore, we aim to develop an immunohistochemistry-based classification system for the major bladder cancer subtypes.</div></div><div><h3>Methods and Patient Summary</h3><div>We used the log10 IHC ratios of 3 markers to classify major bladder cancer subtypes.</div><div>We applied this subtyping in 3 patient cohorts. First on a tissue microarray cohort (<em>n</em> = 53) from cystectomy treated MIBC patients. Furthermore, a cisplatin-based neoadjuvant chemotherapy cohort with pre- and post-treatment tissues (<em>n</em> = 18). Finally, patient derived bladder cancer organoid cohort (<em>n</em> = 8) for direct subtype specific drug sensitivity testing.</div></div><div><h3>Key Findings and Limitations</h3><div>Our findings reveal that the classification system offers a valuable approach for subtyping patients individually, in cohorts and in patient-derived organoids (<em>n</em> = 8 distinct organoid lines). Second, this classification system allows detection of subtype changing in patients undergoing neoadjuvant chemotherapy. Furthermore, the classification system effectively distinguishes between significantly (<em>P</em> = 4.07e−10) cisplatin-sensitive (basal-like) and cisplatin-resistant (luminal-like) subtypes in bladder cancer organoids and is hypothesis generating.</div></div><div><h3>Conclusions and Clinical Implications</h3><div>Our findings suggest that our 3-marker classification system could be valuable as method in future BC patient subtyping for clinical stratification of patients undergoing cisplatin-based treatment.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 64.e15-64.e25"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-27DOI: 10.1016/j.urolonc.2025.09.025
Tanya Jindal B.S., B.A. , Cindy Y. Jiang M.D. , Omar Alhalabi M.D. , Matthew Davidsohn B.S. , Dory Freeman B.S., B.S.N. , Ilana Y. Epstein B.S. , Dimitra Rafailia Bakaloudi M.D. , Rafee Talukder M.D. , Amanda Nizam M.D. , Charles B. Nguyen M.D. , Eugene Oh B.A. , Irene Tsung M.D. , Michael J. Glover M.D. , Ali Raza Khaki M.D. , Amy K. Taylor M.D. , Salvador Jaime-Casas M.D. , Albert Jang M.D. , Emily Lemke D.N.P. , Cameron Pywell M.D. , Sean T. Evans M.D. , Vadim S. Koshkin M.D.
Background
Sacituzumab govitecan (SG) is an antibody-drug conjugate used for advanced urothelial carcinoma (aUC) refractory to platinum-based chemotherapy and immune checkpoint inhibitors (ICI). Real-world data are needed to better define SG outcomes, particularly following treatment with enfortumab vedotin (EV). In this analysis, we aim to evaluate efficacy of SG after EV and assess putative biomarkers associated with outcomes.
Methods
In the UNITE retrospective study, we identified patients who received ≥1 SG cycle after therapy with EV. Observed response rate (ORR) was assessed in evaluable patients and correlated with baseline clinical characteristics and biomarkers. ORRs were compared using logistic regression, while progression free survival (PFS) and overall survival (OS) from SG start were estimated via Kaplan-Meier and Cox proportional hazard (PH) model. Biomarkers of response were evaluated in multivariate Cox PH models after accounting for relevant clinical variables.
Results
Among 107 patients treated with SG after EV, 97 (91%) had NGS data. Median age was 69 years, 73% were male, 33% had ≥4 prior lines of therapy, and 42% received G-CSF. ORR was 18% (95% CI: 10%–26%), median PFS 3.2 months, and median OS 6.0 months. In patients with disease control on EV, ORR was 22% compared to 8% in primary progressors on EV. No significant associations were found between molecular biomarkers and SG outcomes in the multivariate analysis.
Conclusion
SG showed modest activity after EV in heavily pretreated patients with aUC. ORR with SG after EV was lower than reported in phase 2 and phase 3 clinical trials for SG in the postplatinum/ICI setting.
{"title":"Efficacy of sacituzumab govitecan after enfortumab vedotin in advanced urothelial carcinoma: Analysis of the UNITE study","authors":"Tanya Jindal B.S., B.A. , Cindy Y. Jiang M.D. , Omar Alhalabi M.D. , Matthew Davidsohn B.S. , Dory Freeman B.S., B.S.N. , Ilana Y. Epstein B.S. , Dimitra Rafailia Bakaloudi M.D. , Rafee Talukder M.D. , Amanda Nizam M.D. , Charles B. Nguyen M.D. , Eugene Oh B.A. , Irene Tsung M.D. , Michael J. Glover M.D. , Ali Raza Khaki M.D. , Amy K. Taylor M.D. , Salvador Jaime-Casas M.D. , Albert Jang M.D. , Emily Lemke D.N.P. , Cameron Pywell M.D. , Sean T. Evans M.D. , Vadim S. Koshkin M.D.","doi":"10.1016/j.urolonc.2025.09.025","DOIUrl":"10.1016/j.urolonc.2025.09.025","url":null,"abstract":"<div><h3>Background</h3><div>Sacituzumab govitecan (SG) is an antibody-drug conjugate used for advanced urothelial carcinoma (aUC) refractory to platinum-based chemotherapy and immune checkpoint inhibitors (ICI). Real-world data are needed to better define SG outcomes, particularly following treatment with enfortumab vedotin (EV). In this analysis, we aim to evaluate efficacy of SG after EV and assess putative biomarkers associated with outcomes.</div></div><div><h3>Methods</h3><div>In the UNITE retrospective study, we identified patients who received ≥1 SG cycle after therapy with EV. Observed response rate (ORR) was assessed in evaluable patients and correlated with baseline clinical characteristics and biomarkers. ORRs were compared using logistic regression, while progression free survival (PFS) and overall survival (OS) from SG start were estimated via Kaplan-Meier and Cox proportional hazard (PH) model. Biomarkers of response were evaluated in multivariate Cox PH models after accounting for relevant clinical variables.</div></div><div><h3>Results</h3><div>Among 107 patients treated with SG after EV, 97 (91%) had NGS data. Median age was 69 years, 73% were male, 33% had ≥4 prior lines of therapy, and 42% received G-CSF. ORR was 18% (95% CI: 10%–26%), median PFS 3.2 months, and median OS 6.0 months. In patients with disease control on EV, ORR was 22% compared to 8% in primary progressors on EV. No significant associations were found between molecular biomarkers and SG outcomes in the multivariate analysis.</div></div><div><h3>Conclusion</h3><div>SG showed modest activity after EV in heavily pretreated patients with aUC. ORR with SG after EV was lower than reported in phase 2 and phase 3 clinical trials for SG in the postplatinum/ICI setting.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 65.e1-65.e11"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To evaluate time-dependent changes in pathological risk factors for recurrence in patients with renal cell carcinoma (RCC) after surgery, we assessed the impact of prolonged recurrence-free survival (RFS) on subsequent recurrence rates and pathological risk factors using conditional survival (CS) analysis.
Patients and Methods
This retrospective multicenter study included 994 patients who underwent radical or partial nephrectomy for localized RCC between 2010 and 2019. Conditional RFS (C-RFS) and conditional cumulative incidence of cancer-specific mortality (CCSM) were calculated to assess the time-dependent recurrence risk. The impact of pathological factors on recurrence was evaluated using multivariable Cox regression and hazard function analyses.
Results
The 5-year C-RFS and CCSM remained stable over time, with no significant improvement even as the postoperative duration increased. Although pathological tumor stage and World Health Organization/International Society of Urological Pathology grade were significant predictors of recurrence at baseline, their prognostic values declined over time. In contrast, lymphovascular invasion (LVI) consistently remained a significant risk factor for recurrence throughout the follow-up period, as demonstrated by the CS analysis (baseline: LVI-positive, 64.3%; LVI-negative, 92.5%; 5-year LVI-positive, 74.1%; LVI-negative, 92.3%), multivariate Cox regression analyses (baseline hazard ratio [HR], 3.03; 3-year HR, 4.33), and hazard curves.
Conclusion
Even with longer event-free time after surgery, improvements in subsequent C-RFS and CCSM were limited. Although the influence of most pathological risk factors diminished over time, LVI remained a consistent predictor of recurrence. These findings underscore the importance of postoperative strategies that account for the dynamic changes in pathological risk factors in RCC.
{"title":"Time-dependent changes in pathological risk factors of recurrence after renal cell carcinoma surgery","authors":"Hiroyuki Shikuma MD , Yuki Kohada MD , Keisuke Goto MD, PhD , Masanobu Shigeta MD, PhD , Mitsuru Kajiwara MD, PhD , Akira Yano MD, PhD , Yuichi Kadonishi MD , Shuntaro Koda MD, PhD , Kohei Kobatake MD, PhD , Yohei Sekino MD, PhD , Hiroyuki Kitano MD, PhD , Akihiro Goriki MD, PhD , Keisuke Hieda MD, PhD , Nobuyuki Hinata MD, PhD","doi":"10.1016/j.urolonc.2025.10.003","DOIUrl":"10.1016/j.urolonc.2025.10.003","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate time-dependent changes in pathological risk factors for recurrence in patients with renal cell carcinoma (RCC) after surgery, we assessed the impact of prolonged recurrence-free survival (RFS) on subsequent recurrence rates and pathological risk factors using conditional survival (CS) analysis.</div></div><div><h3>Patients and Methods</h3><div>This retrospective multicenter study included 994 patients who underwent radical or partial nephrectomy for localized RCC between 2010 and 2019. Conditional RFS (C-RFS) and conditional cumulative incidence of cancer-specific mortality (C<img>CSM) were calculated to assess the time-dependent recurrence risk. The impact of pathological factors on recurrence was evaluated using multivariable Cox regression and hazard function analyses.</div></div><div><h3>Results</h3><div>The 5-year C-RFS and C<img>CSM remained stable over time, with no significant improvement even as the postoperative duration increased. Although pathological tumor stage and World Health Organization/International Society of Urological Pathology grade were significant predictors of recurrence at baseline, their prognostic values declined over time. In contrast, lymphovascular invasion (LVI) consistently remained a significant risk factor for recurrence throughout the follow-up period, as demonstrated by the CS analysis (baseline: LVI-positive, 64.3%; LVI-negative, 92.5%; 5-year LVI-positive, 74.1%; LVI-negative, 92.3%), multivariate Cox regression analyses (baseline hazard ratio [HR], 3.03; 3-year HR, 4.33), and hazard curves.</div></div><div><h3>Conclusion</h3><div>Even with longer event-free time after surgery, improvements in subsequent C-RFS and C<img>CSM were limited. Although the influence of most pathological risk factors diminished over time, LVI remained a consistent predictor of recurrence. These findings underscore the importance of postoperative strategies that account for the dynamic changes in pathological risk factors in RCC.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 69.e1-69.e9"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A systematic literature review (SLR) was conducted to evaluate patient-reported outcome (PRO) instruments used in clinical trials and real-world evidence (RWE) studies of locally advanced/metastatic urothelial cancer (la/mUC) therapies.
Methods
Five databases were used to identify publications up to May 29, 2024 and recent conference abstracts of phase 2/3 clinical trials and RWE studies. We reviewed reported adverse events and qualitative research to evaluate PRO instrument reporting quality using the CONSORT-PRO and ESMO-MCBS checklists.
Results
The SLR identified 37 trials and 12 RWE studies. High heterogeneity in PRO instrument choice was observed (11/18 different instruments were used in 1 study each). The most common instrument was the EORTC QLQ-C30 (36 studies). Minimal clinically important difference thresholds were not consistently used (9/36 studies reporting EORTC QLQ-C30 used a 10-point threshold). Based on qualitative research findings, assessed PRO instruments did not comprehensively capture patient concerns, with symptom coverage ranging from 27% to 82%. Unexpectedly, baseline EORTC QLQ-C30 and Short Form-36 scores indicated that patients with la/mUC have a similar quality of life to the general population. In 18/37 clinical trials, PRO timepoints preceded the median clinical follow-up, with differences ranging from 0.96 to 59.4 months.
Conclusions
PROs can assist in the tailoring of treatment strategies to improve outcomes and can aid in enhancing communication between patients and healthcare professionals about treatment choice. Our evaluation of PRO reporting quality identified room for improvement in most studies, indicating a need for robust, consistent reporting of PRO data to adequately capture the experiences of patients with la/mUC.
{"title":"Measuring what matters to patients: Systematic literature review of patient-reported outcomes assessment and reporting in locally advanced or metastatic urothelial cancer real-world and clinical studies","authors":"Mairead Kearney MB, BCh, MPH, MBA, MSc , Thomas Macmillan MSc , Julia Poritz PhD , Sherrie Schreiber-Gosche MSc , Mihaela Georgiana Musat PhD","doi":"10.1016/j.urolonc.2025.09.016","DOIUrl":"10.1016/j.urolonc.2025.09.016","url":null,"abstract":"<div><h3>Introduction</h3><div>A systematic literature review (SLR) was conducted to evaluate patient-reported outcome (PRO) instruments used in clinical trials and real-world evidence (RWE) studies of locally advanced/metastatic urothelial cancer (la/mUC) therapies.</div></div><div><h3>Methods</h3><div>Five databases were used to identify publications up to May 29, 2024 and recent conference abstracts of phase 2/3 clinical trials and RWE studies. We reviewed reported adverse events and qualitative research to evaluate PRO instrument reporting quality using the CONSORT-PRO and ESMO-MCBS checklists.</div></div><div><h3>Results</h3><div>The SLR identified 37 trials and 12 RWE studies. High heterogeneity in PRO instrument choice was observed (11/18 different instruments were used in 1 study each). The most common instrument was the EORTC QLQ-C30 (36 studies). Minimal clinically important difference thresholds were not consistently used (9/36 studies reporting EORTC QLQ-C30 used a 10-point threshold). Based on qualitative research findings, assessed PRO instruments did not comprehensively capture patient concerns, with symptom coverage ranging from 27% to 82%. Unexpectedly, baseline EORTC QLQ-C30 and Short Form-36 scores indicated that patients with la/mUC have a similar quality of life to the general population. In 18/37 clinical trials, PRO timepoints preceded the median clinical follow-up, with differences ranging from 0.96 to 59.4 months.</div></div><div><h3>Conclusions</h3><div>PROs can assist in the tailoring of treatment strategies to improve outcomes and can aid in enhancing communication between patients and healthcare professionals about treatment choice. Our evaluation of PRO reporting quality identified room for improvement in most studies, indicating a need for robust, consistent reporting of PRO data to adequately capture the experiences of patients with la/mUC.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 63.e21-63.e33"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}