{"title":"Lymphovascular Invasion is Predictive for Adjuvant Platinum Therapy Benefit in Urothelial Bladder Cancer","authors":"Dániel Juhász MD , Anita Csizmarik PhD , Melinda Váradi PhD , Dániel Bacsó MD , András Kubik MD , Miklós Szűcs MD, PhD , Eszter Székely MD, PhD , Mulham Al-Nader MD , Osama Mahmoud MD , Ulrich Krafft MD, DSc , Boris Hadaschik MD, DSc , Péter Nyirády MD, DSc , Tibor Szarvas PhD, DSc","doi":"10.1016/j.clgc.2025.102421","DOIUrl":"10.1016/j.clgc.2025.102421","url":null,"abstract":"<div><h3>Introduction</h3><div>Perioperative platinum-based chemotherapy remains the standard systemic treatment for nonmetastatic muscle-invasive bladder cancer (MIBC). Adjuvant chemotherapy (AC) is recommended for patients with pT3/4 (stage IIIA) or lymph node-positive (LN+, stage IIIB) disease following radical cystectomy (RC). However, not all patients benefit equally, highlighting the need for predictive biomarkers. Lymphovascular invasion (LVI) is a known risk-factor in several cancers, including MIBC, but its predictive value for AC benefit remains unclear. Therefore, we aimed to assess whether LVI can predict response to platinum-based AC in MIBC.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study involving MIBC patients who underwent RC between 2005 and 2023 at two academic centers. Inclusion criteria were pT3/T4M0 or LN+ disease, with available LVI status and survival data. Patients were divided into a treatment (AC) and a control group (RC without AC). Overall survival (OS) was the primary endpoint; cancer-specific survival (CSS) was secondary. Statistical analysis was performed using Kaplan-Meier estimates, Cox proportional hazards models, and propensity score matching (PSM) to adjust for potential confounders.</div></div><div><h3>Results</h3><div>A total of 345 patients fulfilled the inclusion criteria of whom 92 (27%) received and 253 (73%) did not receive AC. LVI-positive patients demonstrated significantly improved OS and CSS when treated with AC (both <em>P</em> < .001), while no significant OS or CSS benefit was observed for AC-treated LVI-negative patients (<em>P</em> = .146 for OS, <em>P</em> = .975 for CSS). Results remained similar after PSM correction revealing survival benefit for AC treatment in LVI-positive but not in LVI-negative patients.</div></div><div><h3>Conclusions</h3><div>This study demonstrates, for the first time, LVI status as a predictor of treatment benefit from platinum-based AC. Our results suggest that LVI status is an easily assessable biomarker to identify those patients who derive greater benefit from the treatment, while LVI-negative patients might be spared unnecessary chemotherapy and its associated toxicity.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102421"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145133133","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}
Salvador Jaime-Casas , Miguel Zugman , Regina Barragan-Carrillo , Hedyeh Ebrahimi , Koral Shah , Wesley Yip , Cory M. Hugen , Kevin G. Chan , Clayton S. Lau , Bertram E. Yuh , Benjamin Mercier , Nicholas J. Salgia , Daniela V. Castro , Xiaochen Li , JoAnn Hsu , Charles B. Nguyen , Alexander Chehrazi-Raffle , Sumanta K Pal , Abhishek Tripathi
{"title":"Clinical and Pathological Predictors for Occult Lymph Node Involvement in Patients With Clinical Node-Negative Bladder Cancer Undergoing Radical Cystectomy","authors":"Salvador Jaime-Casas , Miguel Zugman , Regina Barragan-Carrillo , Hedyeh Ebrahimi , Koral Shah , Wesley Yip , Cory M. Hugen , Kevin G. Chan , Clayton S. Lau , Bertram E. Yuh , Benjamin Mercier , Nicholas J. Salgia , Daniela V. Castro , Xiaochen Li , JoAnn Hsu , Charles B. Nguyen , Alexander Chehrazi-Raffle , Sumanta K Pal , Abhishek Tripathi","doi":"10.1016/j.clgc.2025.102405","DOIUrl":"10.1016/j.clgc.2025.102405","url":null,"abstract":"<div><h3>Background</h3><div>Occult pathological lymph node involvement in patients with clinical node-negative (cN0) bladder cancer (BC) remains a diagnostic challenge. We evaluate predictors of lymph node positivity (pN+) in patients with cT1-4N0M0 BC undergoing radical cystectomy and pelvic lymph node dissection (RC-PLND).</div></div><div><h3>Methods</h3><div>We included patients with cT1-4N0M0 BC undergoing RC-PLND from February 2004 through October 2020. Patients were classified as pN+ vs. pN0. Baseline characteristics were summarized using descriptive statistics. Logistic regression models and multivariable analysis estimated odds ratios (OR) for pN+ status. Kaplan Meier analysis and multivariable Cox proportional hazards models analyzed recurrence-free survival (RFS) and overall survival (OS).</div></div><div><h3>Results</h3><div>440 patients were evaluated, of which 81% (<em>n</em> = 359) had pN0 and 17% (<em>n</em> = 74) had pN+ disease. Most were male (80%), white (88%), and had a median age of 71 years. Most had clinical T2 (55%) and T1 (25%) disease. Lymphovascular invasion (LVI) on TURBT (OR 2.62, <em>P</em> = .04), positive surgical margins (OR 16.77, <em>P</em> < .001), and ≥ cT2 disease (OR 1.89, <em>P</em> = .04) had higher odds of pN+ status. pN+ patients were more likely to suffer recurrence (HR 7.67, <em>P</em> < .001) or death (HR 3.26, <em>P</em> < .001) compared to pN0 patients. Preoperative hydronephrosis predicted worse RFS (HR 1.76, <em>P</em> = .011) and OS (HR 1.55, <em>P</em> = .007). Positive surgical margins (HR 2.34, <em>P</em> = .008) and preoperative renal function (HR 1.50, <em>P</em> = .004) predicted worse OS.</div></div><div><h3>Conclusion</h3><div>Positive surgical margins, LVI, and ≥ cT2 disease strongly predict pN+ findings in patients with cT1-4N0M0 BC. Preoperative variables can inform treatment for patients with a higher risk for positive lymph node findings at surgery.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102405"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144982428","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}
Giacomo Musso , Giuseppe Garofano , Mai Dabbas , Margaret F. Meagher , Kit L. Yuen , Natalie Birouty , Benjamin Baker , Cesare Saitta , Melis Guer , Francesco Montorsi , Alberto Briganti , Umberto Capitanio , Alessandro Larcher , Andrea Salonia , Ithaar H. Derweesh
{"title":"The Influence of Lymphovascular Invasion on T Stage Upstaging and Overall Survival in Renal Cell Carcinoma: A Population-Based Study","authors":"Giacomo Musso , Giuseppe Garofano , Mai Dabbas , Margaret F. Meagher , Kit L. Yuen , Natalie Birouty , Benjamin Baker , Cesare Saitta , Melis Guer , Francesco Montorsi , Alberto Briganti , Umberto Capitanio , Alessandro Larcher , Andrea Salonia , Ithaar H. Derweesh","doi":"10.1016/j.clgc.2025.102412","DOIUrl":"10.1016/j.clgc.2025.102412","url":null,"abstract":"<div><h3>Introduction</h3><div>Lymphovascular invasion (LVI) is a recognized adverse pathological feature in renal cell carcinoma (RCC). However, its impact on staging and prognosis remains poorly defined, especially across T-stage subcategories.</div></div><div><h3>Patients and Methods</h3><div>We analyzed surgically treated RCC patients from the National Cancer Database (NCDB), including clear cell, papillary and chromophobe RCCs. Data on pathological T-stage and LVI status were retrieved, with overall survival (OS) as the primary outcome. Kaplan-Meier curves (KMA) and log-rank test evaluated survival differences between T-stages with and without LVI. Univariable and multivariable Cox Proportional Hazard Model (CoxPH) were fitted to test the association between LVI and All-cause Mortality (ACM) and the interaction term between LVI and T-stage. Forest plots and regression lines from the CoxPH interaction hazard ratios (HR) illustrated the impact of LVI across T-stages.</div></div><div><h3>Results</h3><div>Among 159,387 RCC patients, 11.3% showed LVI. LVI was associated with larger and higher‐grade tumors, and increased rates of nodal and metastatic disease (<em>P</em> < .001). KMA showed significantly lower 5‐year OS among LVI‐positive versus LVI‐negative patients (61% vs. 85%; <em>P</em> < .001). Across T stages, LVI conferred a “functional upstaging” with survival of T1a+LVI approximating T1b, T1b+LVI resembling T2, T2+LVI approximating T3, and T3a+LVI mirroring T3b outcomes. At univariable and multivariable CoxPH, LVI was an independent predictor of ACM (<em>P</em> < .001), with forest plots indicating its highest relative impact in earlier T-stages.</div></div><div><h3>Conclusion</h3><div>LVI is an aggressive pathological feature in RCC that impairs survival, especially in lower‐stage tumors. Incorporating LVI status into RCC staging may refine risk stratification and guide more intensive surveillance and adjuvant management, particularly for patients with early T-stage disease.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102412"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144982379","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}
{"title":"Active Surveillance in Intermediate-Risk Prostate Cancer: A Contemporary Synthesis of Evidence","authors":"Fausto Petrelli , Lorenzo Dottorini , Giada Parsani , Francesca Ceresoli , Domenico Taglialatela , Margherita Pampado , Alessandro Serino , Agostina De Stefani , Francesca Trevisan , Valentina Riboldi , Lorenza Bruschieri , Ivano Vavassori","doi":"10.1016/j.clgc.2025.102407","DOIUrl":"10.1016/j.clgc.2025.102407","url":null,"abstract":"<div><div>Active surveillance (AS) is a widely accepted strategy for low-risk prostate cancer, but its application to intermediate-risk disease remains controversial. Given the potential to reduce overtreatment without compromising survival, this review evaluates the safety and clinical outcomes of AS in intermediate-risk prostate cancer (IR-PCa), with a focus on favorable intermediate-risk (FIR) subsets. The objective is to synthesize current evidence on AS utilization, selection criteria, oncologic outcomes, and predictors of disease progression.We conducted a narrative review of 85 studies published between 2009 and 2025 identified through PubMed, Embase, and Web of Science. Search terms included “AS,” “intermediate-risk prostate cancer,” “Gleason 3 + 4,” and “watchful waiting.” Eligible studies included prospective and retrospective cohorts, registry-based analyses, and comparative observational studies evaluating AS in IR-PCa. Data were extracted regarding inclusion criteria, follow-up protocols, progression rates, survival outcomes, and use of imaging and genomic tools for risk stratification. AS is increasingly used in FIR patients with low-volume Gleason 3 + 4 disease, low PSA density, and favorable imaging/genomic profiles. In these patients, 5-10 year metastasis-free survival exceeds 95%. However, AS in unfavorable IR disease is associated with higher risks of disease progression and prostate cancer–specific mortality. Limitations include heterogeneity in AS protocols, lack of randomized trials, and variable definitions of FIR. AS is a viable option for well-selected FIR-PCa patients. Incorporating PSA density, mpMRI, and genomic testing enhances risk stratification. Clinical guidelines should support tailored AS approaches with standardized follow-up and timely intervention triggers.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102407"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890035","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}
Adam A. Barsouk , Austin Yang , Jonathan H. Sussman , Omar Elghawy , Jessica Xu , Jason Xu , Lingbin Meng , Shunsuke Koga , Wei Du , Ronac Mamtani , Lin Mei
{"title":"Survival Disparities by Sex, Race, and Age in the Era of Contemporary Advanced Urothelial Carcinoma Therapy: A Real-World Analysis","authors":"Adam A. Barsouk , Austin Yang , Jonathan H. Sussman , Omar Elghawy , Jessica Xu , Jason Xu , Lingbin Meng , Shunsuke Koga , Wei Du , Ronac Mamtani , Lin Mei","doi":"10.1016/j.clgc.2025.102395","DOIUrl":"10.1016/j.clgc.2025.102395","url":null,"abstract":"<div><h3>Introduction</h3><div>Retrospective data suggest poorer survival for female, racial minority, and older advanced urothelial carcinoma (aUC) patients. However, data on survival disparities in the modern era remain limited.</div></div><div><h3>Methods</h3><div>This cohort study used Flatiron Health’s nationwide de-identified electronic health record (EHR)-derived database. Patients who initiated systemic therapy for aUC between January, 2017 and May, 2024 were included. Baseline characteristics, treatment history, and clinical outcomes were abstracted. PFS and OS were compared by sex (male vs. female), race (White, Black, vs. Asian/Pacific Islander [API]), and age at diagnosis (> 65 years [y] vs. ≤ 65 y), using Kaplan-Meier log-rank analysis and Cox proportional hazards models. Independent sample t-tests and chi-square analyses were used for univariate comparisons. <em>P</em>-values < <em>.</em>05 were considered statistically significant.</div></div><div><h3>Results</h3><div>A total of 5142 patients with aUC were identified. 1419 were (28%) female and 575 (11%) were > 65 y. Of those with recorded race (<em>n</em> = 3492), 1% were API, 5% Black, 14% categorized as “other,” and 80% White. There was no difference in PFS (8.7 vs. 9.0 months [m], HR1.03; <em>P</em> = <em>.</em>82) or OS (13.2 vs. 13.5 m; HR1.05, <em>P</em> = <em>.</em>31) between women and men. Women had shorter PFS to men on immune checkpoint inhibitors (ICI) (<em>P</em> = <em>.</em>002) but not with other first-line (1L) therapy. API patients had comparable PFS (9.6 vs. 8.9 m; HR0.91; <em>P</em> = <em>.</em>45) but longer OS (28.5 vs. 14.1 m; HR0.56; <em>P</em> = <em>.</em>008) compared to White patients. Black patients had comparable PFS (7.9 vs. 8.5; HR1.06; <em>P</em> = <em>.</em>81) and OS (11.5 vs. 14.1 m; HR1.32; <em>P</em> = <em>.</em>73) vs White patients. Patients > 65 y had shorter PFS to ≤ 65 y (7.6 vs. 9.0 m; HR1.14, <em>P</em> = <em>.</em>019); however, OS was longer in older patients (16.5 vs. 12.8 m; HR0.80, <em>P</em> < <em>.</em>001). Only on 1L ICI, OS was longer in those > 65 y compared to those ≤ 65 y (HR0.71; <em>P</em> = <em>.</em>021)</div></div><div><h3>Conclusion</h3><div>In this large real-world database, female aUC patients had comparable PFS and OS to males. API patients showed superior OS to White patients. Patients > 65 y had inferior PFS but superior OS to patients ≤ 65 y.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102395"},"PeriodicalIF":2.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144694712","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}
Cevat İlteriş Kıkılı , Maide Müreva , Caner Kapar , Bahadır Köylü , Fatih Kemik , Feyyaz Hazar Yağmur , Fatih Selçukbiricik , Ercan İnci , Deniz Tural
{"title":"Evaluation of the Effects of Enzalutamide and Abiraterone Acetate on Sarcopenia in Metastatic Castration-Sensitive Prostate Cancer","authors":"Cevat İlteriş Kıkılı , Maide Müreva , Caner Kapar , Bahadır Köylü , Fatih Kemik , Feyyaz Hazar Yağmur , Fatih Selçukbiricik , Ercan İnci , Deniz Tural","doi":"10.1016/j.clgc.2025.102388","DOIUrl":"10.1016/j.clgc.2025.102388","url":null,"abstract":"<div><h3>Background</h3><div>Sarcopenia is associated with worse prognosis and higher mortality in various solid tumors. We aim to evaluate the impact of enzalutamide and abiraterone acetate on sarcopenia in patients with metastatic castration-sensitive prostate cancer.</div></div><div><h3>Materials and Methods</h3><div>The skeletal muscle indexes (SMI, cm²/m²) were calculated from pre-treatment and 12th-month CT scans. Patients were categorized into sarcopenic and non-sarcopenic groups based on the predefined SMI and body mass index cut-off values. Baseline and 12th-month SMI values together with percentages of sarcopenic patients were compared between the enzalutamide and abiraterone acetate groups. Radiological progression-free survival (rPFS) and overall survival (OS) were also compared between sarcopenic and non-sarcopenic patients.</div></div><div><h3>Results</h3><div>We included 19 patients receiving enzalutamide and 30 patients receiving abiraterone acetate. In the enzalutamide group, SMI decreased significantly from pre-treatment to the 12th month (median ΔSMI: −3.1 cm<sup>2</sup>/m<sup>2</sup>, <em>P</em> = .004). In the abiraterone acetate group, SMI declined significantly over the same period (median ΔSMI: −4.1 cm<sup>2</sup>/m<sup>2</sup>, <em>P</em> = .001). There were no significant differences in SMI changes and sarcopenia rates between two groups. Median rPFS was 29 months in the pre-treatment sarcopenic group and 37 months in the non-sarcopenic group (HR = 2.38 [95% CI, 0.54-10.41], <em>P</em> = .24). Median OS was 33 months in the sarcopenic group and 47 months in the non-sarcopenic group (HR = 1.94 [95% CI, 0.42-9.03], <em>P</em> = .38).</div></div><div><h3>Conclusion</h3><div>Both enzalutamide and abiraterone acetate significantly reduces SMI values following a 12-month treatment period. Despite a trend toward shorter rPFS and OS in sarcopenic patients, the differences did not reach statistical significance.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102388"},"PeriodicalIF":2.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144663159","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}
Lian Hu , Jia-Wei Hu , Chang-Quan Wang , Rui-Ying Li , Song Li
{"title":"Neoadjuvant PD-1/PD-L1 Inhibitors for Muscle-Invasive Bladder Cancer: A Meta-Analysis","authors":"Lian Hu , Jia-Wei Hu , Chang-Quan Wang , Rui-Ying Li , Song Li","doi":"10.1016/j.clgc.2025.102408","DOIUrl":"10.1016/j.clgc.2025.102408","url":null,"abstract":"<div><div>Neoadjuvant immune checkpoint inhibitors have emerged as a potential treatment option for muscle-invasive bladder cancer (MIBC), but their comparative efficacy and safety remain unclear. This meta-analysis evaluated pathological outcomes and adverse events of neoadjuvant PD-(L)1 inhibitors across different therapeutic approaches. A systematic search was conducted across multiple databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, and Wanfang databases), from their inception to December 21, 2024, for studies investigating neoadjuvant PD-(L)1 inhibitors in patients with MIBC. Primary outcomes included pathological complete response (pCR), pathological partial response (pPR), downstaging (DS), and grade ≥3 immune-related adverse events (irAEs). Random-effects models were used to calculate pooled estimates, with subgroup analyses performed based on treatment strategy and inhibitor type. Twenty-nine studies were finally included, involving 33 treatment arms. The overall pooled pCR rate was 32.7% (95% confidence interval [CI]: 27.7%-37.7%), with PD-(L)1 inhibitors plus chemotherapy showing the highest rate (39.2%, 95% CI: 32.1%-46.3%), followed by dual checkpoint inhibition (27.6%, 95% CI: 15.5%-39.6%), and monotherapy (24.6%, 95% CI: 16.9%-32.3%). The overall pooled pPR was 45.3% (95% CI: 38.4%-52.2%), and DS rate was 62.9% (95% CI: 53.1%-72.8%). Grade ≥3 irAEs varied significantly by approach: 9.4% (95% CI: 6.0%-12.7%) for monotherapy, 24.9% (95% CI: 9.6%-40.2%) for dual checkpoint inhibition, and 14.2% (95% CI: 6.9%-21.5%) for combination with chemotherapy. Sensitivity analyses confirmed the robustness of these findings. Neoadjuvant PD-(L)1 inhibitors demonstrate promising efficacy in MIBC with acceptable toxicity profiles. Combination with chemotherapy provides the highest pathological response rates with moderate toxicity, while monotherapy offers a favorable safety profile that may benefit cisplatin-ineligible patients. These findings support the continued investigation of these approaches in ongoing Phase III trials.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102408"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144920357","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}
Neal D. Shore , K. Kent Chevli , Daniel Saltzstein , Yaron Ehrlich , Jay D. Raman , Boris Friedman , Alexander Sankin , Douglas Scherr , William C. Huang , Michael J. Louie , Sunil Raju , Brent Burger , Andrew Meads , Mark Schoenberg , OPTIMA II Study
{"title":"Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-Year Long-Term Extension Study of the Single-Arm, Phase 2b Optima II Study","authors":"Neal D. Shore , K. Kent Chevli , Daniel Saltzstein , Yaron Ehrlich , Jay D. Raman , Boris Friedman , Alexander Sankin , Douglas Scherr , William C. Huang , Michael J. Louie , Sunil Raju , Brent Burger , Andrew Meads , Mark Schoenberg , OPTIMA II Study","doi":"10.1016/j.clgc.2025.102392","DOIUrl":"10.1016/j.clgc.2025.102392","url":null,"abstract":"<div><h3>Introduction</h3><div>The OPTIMA II phase 2b study (NCT03558503) treated patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) with UGN-102, a reverse thermal hydrogel containing mitomycin. Efficacy and safety results have been reported for the 12-month parent study; here, we report 5-year follow-up data.</div></div><div><h3>Patients and Methods</h3><div>Patients who participated in the OPTIMA II study and achieved a complete response (CR) after 6 weekly doses of UGN-102 were followed for up to 9 months after initial CR. Those with CR at study completion were eligible to enroll in a further long-term follow-up (LTFU) study, during which there were no protocol-specified interventions/treatments, protocol-specified visits, or evaluations. Supervising physicians provided semiannual updates on patients’ disease status. Duration of response (DoR) was calculated using the Kaplan–Meier method.</div></div><div><h3>Results</h3><div>Of the 41 patients achieving a CR at 3 months, 25 remained in CR at 12 months and 17 entered LTFU. For the 41 patients achieving a CR at 3 months the median Kaplan–Meier estimate of DoR was 24.2 months (95% confidence interval [CI], 9.72-42.09), with a median follow-up time of 35.8 months (95% CI, 10.78-60.98). For the 17 patients in the LTFU study the median DoR was 42.1 months (95% CI, 24.18-not estimable [NE]), with a median follow-up of 50.40 months (95% CI, 26.97-NE),</div></div><div><h3>Conclusion</h3><div>These results demonstrate that treatment with UGN-102 results in clinically meaningful, and highly durable response in patients with LG-IR-NMIBC. UGN-102 may offer a promising non-surgical alternative to transurethral resection of bladder cancer (TURBT) for LG-IR-NMIBC patients.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102392"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144762681","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}
Tian Han , Honglei Cui , Gan Du , Youyan Guan , Xingang Bi , Lei Guo , Hongzhe Shi , Jianzhong Shou
{"title":"Expression and Prognostic Significance of Different Antibody-Drug Conjugate Target Proteins in Urachal Carcinoma","authors":"Tian Han , Honglei Cui , Gan Du , Youyan Guan , Xingang Bi , Lei Guo , Hongzhe Shi , Jianzhong Shou","doi":"10.1016/j.clgc.2025.102403","DOIUrl":"10.1016/j.clgc.2025.102403","url":null,"abstract":"<div><h3>Background</h3><div>Urachal carcinoma (UrC), a rare malignancy originating from urachal remnants, currently lacks standardized therapeutic options for advanced stages. While antibody-drug conjugate (ADC) therapy has emerged as a transformative approach in oncology, its clinical application in UrC remains investigational due to the paucity of data regarding target antigen expression profiles. This study systematically characterized the immunohistochemical landscape of UrC through the lens of established ADC targets and evaluated their prognostic implications, thereby informing future therapeutic development.</div></div><div><h3>Patients and Methods</h3><div>We retrospectively analyzed 41 histologically confirmed UrC specimens with complete clinical information. Immunohistochemical evaluation was performed for 6 therapeutic targets: HER2, Nectin-4, Claudin18.2, Trop2, Mesothelin, and PD-L1. Standardized scoring system was used to quantify the level of target expression and to determine the rate of high expression for each target. Survival outcomes were assessed through Kaplan–Meier method and Cox proportional hazards modeling.</div></div><div><h3>Results</h3><div>With a median follow-up of 99 months, the cohort exhibited a 5-year overall survival (OS) rate of 62.4% (95% CI, 48.5%-80.3%). Analysis of ADC target protein expression showed that Trop2 had the highest rate of high expression (58.5%), followed by Mesothelin (43.9%), Claudin18.2 (34.1%), Nectin-4 (24.4%), HER2 (9.8%), and PD-L1 (4.9%). Survival analysis demonstrated significantly reduced 5-year overall survival (OS) in the Trop2-high group (47.1% vs. 87.5%, <em>P</em> = 0.01). Multivariate Cox regression analysis identified both Trop2 and Sheldon stage as independent prognostic determinants.</div></div><div><h3>Conclusion</h3><div>Our findings confirm that UrC has the potential to be treated by ADC. Trop2 has the highest high expression rate in UrC and is associated with a worse prognosis, which may be a potential target for ADC therapy for UrC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102403"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144851892","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}
Cristina Suárez , Òscar Reig Torras , Rafael Morales Barrera , Ángel Rodríguez Sánchez , Georgia Anguera Palacios , André Miguel Branco Manshino , Natalia Fernández Núñez , María José Méndez Vidal , Icíar García Carbonero , Ovidio Fernández Calvo , Regina Gironés Sarrió , Guillermo Crespo Herrero , Javier Afonso Afonso , María José Juan Fita , Josep Gumà Padró , Martín Lázaro Quintela , Alejo Rodriguez-Vida , Carolina Hernández Pérez , Ana Medina Colmenero , Ricardo Collado Martín , Enrique Gallardo
{"title":"Effectiveness and Safety of Cabozantinib Treatment in Patients with Advanced Renal Cell Carcinoma in Spanish and Portuguese Real-world Practice: The SOGUG-SPRWEC Study","authors":"Cristina Suárez , Òscar Reig Torras , Rafael Morales Barrera , Ángel Rodríguez Sánchez , Georgia Anguera Palacios , André Miguel Branco Manshino , Natalia Fernández Núñez , María José Méndez Vidal , Icíar García Carbonero , Ovidio Fernández Calvo , Regina Gironés Sarrió , Guillermo Crespo Herrero , Javier Afonso Afonso , María José Juan Fita , Josep Gumà Padró , Martín Lázaro Quintela , Alejo Rodriguez-Vida , Carolina Hernández Pérez , Ana Medina Colmenero , Ricardo Collado Martín , Enrique Gallardo","doi":"10.1016/j.clgc.2025.102402","DOIUrl":"10.1016/j.clgc.2025.102402","url":null,"abstract":"<div><h3>Background</h3><div>The SPRWEC study investigated cabozantinib effectiveness and safety in patients with advanced renal cell carcinoma (RCC) in real-world Spanish and Portuguese settings.</div></div><div><h3>Patients and methods</h3><div>Observational, ambispective, multicenter study including adult patients with advanced RCC receiving cabozantinib between October 2016 and May 2020 as second or subsequent treatment line. Primary endpoint was progression-free survival (PFS).</div></div><div><h3>Results</h3><div>About 258 patients (mean [SD] age 62.5 [11.0] years, 75.6% male) were included, 55.8% with prior immunotherapy. Median follow-up was 34.3 months. Median PFS was 7.63 months (95% CI, 6.64-8.72). Median overall survival (OS) was 15.36 months (95% CI, 11.58-19.11); objective response rate (ORR), 29.5% (95% CI, 24.0-35.4); median time to first response, 3.27 months (95% CI, 3.03-3.68); median duration of response, 9.77 months (95% CI, 7.24-12.63); median time to discontinuation, 6.97 months (95% CI, 5.79-8.42). Prior immunotherapy increased ORR (OR 2.132) and decreased OS (HR 1.529). ECOG 0-1 and dose reductions were associated with increased PFS (HR 0.470 and 0.558); poor and intermediate MSKCC (HR 3.861 and 1.681) and IMDC risks (HR 2.558 and 1.537) with decreased PFS. Most common AEs were diarrhea (41.9%), asthenia (34.9%), and anorexia (18.2%).</div></div><div><h3>Conclusion</h3><div>Cabozantinib’s effectiveness and safety as second or subsequent treatment line for advanced RCC in real-world settings are similar to those observed in clinical trials. This treatment after prior immunotherapy, the front-line standard of care, resulted in increased ORR and decreased OS, without changes in PFS.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 5","pages":"Article 102402"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144884456","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}