Clinical genitourinary cancer最新文献

{"title":"Mesothelioma of the Tunica Vaginalis Testis","authors":"Alon Lazarovich ,&nbsp;Gregory Raster ,&nbsp;Samuel Tremblay ,&nbsp;Aaron S. Dahmen ,&nbsp;Jung Woo Kwon ,&nbsp;Gladell P. Paner ,&nbsp;Owen Mitchell ,&nbsp;Hedy L. Kindler ,&nbsp;Scott Eggener","doi":"10.1016/j.clgc.2025.102409","DOIUrl":"10.1016/j.clgc.2025.102409","url":null,"abstract":"<div><div><ul><li><span>•</span><span><div>Mesothelioma of the tunica vaginalis testis is a rare and aggressive malignancy with highly variable clinical presentation, most commonly appearing as hydrocele or testicular mass.</div></span></li><li><span>•</span><span><div>Radical surgery with negative margins is a cornerstone of treatment and may improve outcomes.</div></span></li><li><span>•</span><span><div>Systemic therapies, including chemotherapy and immunotherapy, are adapted from pleural mesothelioma treatment protocols. Their role in mesothelioma of the tunica vaginalis testis remains investigational and warrants further prospective study.</div></span></li></ul></div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102409"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144996986","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":"Sarcopenia in mCSPC: Beyond Radiological Metrics—The Need for Functional and Supportive Assessments","authors":"Parth Aphale,&nbsp;Himanshu Shekhar,&nbsp;Shashank Dokania","doi":"10.1016/j.clgc.2025.102439","DOIUrl":"10.1016/j.clgc.2025.102439","url":null,"abstract":"","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102439"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145304952","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":"Pathogenic Germline Variant Prevalence and Genetic Testing Outcomes in Patients With Urothelial Carcinoma","authors":"Eugene Oh ,&nbsp;Ye Chua ,&nbsp;Piroz Bahar ,&nbsp;Marie-Louise Accardo ,&nbsp;Xiaochen Li ,&nbsp;Erika Koeppe ,&nbsp;Steven Monda ,&nbsp;Phillip L. Palmbos ,&nbsp;Irene Tsung ,&nbsp;Zachery R. Reichert ,&nbsp;Ulka N Vaishampayan ,&nbsp;Udit Singhal ,&nbsp;Tobias Else ,&nbsp;Charles B. Nguyen","doi":"10.1016/j.clgc.2025.102451","DOIUrl":"10.1016/j.clgc.2025.102451","url":null,"abstract":"<div><h3>Introduction</h3><div>Urothelial carcinoma (UC) is rarely attributed to hereditary causes, but recent studies suggest inherited factors may play a larger role. Current guidelines recommend genetic evaluation in patients with UC diagnosed at &lt; 50 years old or features associated with Lynch syndrome. However, the full pathogenic germline variant landscape and optimal genetic evaluation criteria in UC remain poorly understood.</div></div><div><h3>Patients and Methods</h3><div>A retrospective analysis of all patients with UC referred for genetic evaluation between 2002 and 2024 was performed. Genetic testing outcomes, variant prevalence and characterization, and associated clinicopathologic features were recorded. Fisher’s Exact test was used to compare factors between patients with pathogenic or likely pathogenic (P/LP) variant versus those with negative testing.</div></div><div><h3>Results</h3><div>Overall, 128 patients underwent genetic evaluation. Median age at diagnosis was 59 (IQR: 48-68). Most (58.6%) had non-muscle invasive disease at initial diagnosis; 8.6% had metastatic disease. Pure urothelial histology was most frequent (71%). Upper tract disease was present at 14.8%. Among the cohort, 34 (26.6%) had a confirmed P/LP variant. The most common P/LP variants were Lynch syndrome-associated genes (9.4%) and DNA damage repair genes (9.4%). Having a history of ≥ 2 additional cancers was associated with a positive genetic test (<em>P</em> = .010). Otherwise, there were no statistically significant differences in testing outcomes based on age at diagnosis, primary tumor location, or initial stage at diagnosis.</div></div><div><h3>Conclusion</h3><div>Among patients with UC referred for genetic evaluation, 26.6% had a confirmed P/LP variant, although this cohort was a selected population. Age and traditional clinicopathologic features were not associated with testing results, though history of ≥ 2 additional cancers was associated. These findings may suggest a broader use of genetic evaluation in UC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102451"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145440336","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":"A Multi-Center Comparative Analysis of the G8-Score and Charlson Comorbidity Index as General Health Assessment Tools in Older Patients With Prostate Cancer","authors":"Brecht Chys ,&nbsp;Philip R. Debruyne ,&nbsp;Lore Decoster ,&nbsp;Cindy Kenis ,&nbsp;Hans Wildiers ,&nbsp;Diederik Ponette ,&nbsp;Steven Joniau","doi":"10.1016/j.clgc.2025.102454","DOIUrl":"10.1016/j.clgc.2025.102454","url":null,"abstract":"<div><h3>Introduction</h3><div>Frail and older patients who develop prostate cancer (PCa), are at risk of overtreatment. Multiple general health assessment (GHA) tools have been validated in oncology. we aim to validate and compare the performance of the G8 screening tool, age and Charlson Comorbidity Index (CCI) as a predictor of overall survival (OS) in men older than 70 years with a newly diagnosed prostate cancer. Is it possible to identify a CCI cut-off indicative for frailty?</div></div><div><h3>Patients and methods</h3><div>Between 2009 and 2015, a national multicenter initiative on geriatric screening and GHA’s took place in Belgium. Baseline characteristics were collected on the date of inclusion on which a specialist nurse completed multiple GHA questionnaires for each patient. We performed a sub analysis on the prostate cancer (<em>n</em> = 182) cohort, ≥ 70 years old. GHA’s were compared through multivariate-, Kaplan-Meier- and sensitivity analysis. If indicated, Case-control matching was applied to reduce variate heterogeneity. Ten-year OS is the primary endpoint.</div></div><div><h3>Results</h3><div>Men with a G8-score of ≤14 points had a significantly worse OS both in the unmatched: 86.8 months (95% CI: 70.5-103.1) vs. 137.9 months (95% CI: 129.4-146.4) (<em>P</em> &lt; .001) and matched population: 99.3 months (95% CI 81.9-116.73) vs. 136.0 months (95% CI: 121.8-150.2) (<em>P</em> &lt; .05). Defining frailty as the presence of comorbidities (CCI ≥ 1 point) shows inferior (HR:1.3, 95% CI: 0.8-2.1—AUC: 0.583) accuracy compared to the G8-score (HR 2.9, 95% CI 1.8-4.5—AUC: 0.715). If the frailty threshold of the CCI is raised to ≥ 2 points, accuracy is matched (HR 4.9, 95% CI 2.8-8.4—AUC 0.735).</div></div><div><h3>Conclusion</h3><div>This multicenter analysis validates the predictive value of the G8-score and CCI on OS in newly diagnosed PCa in the older patient. Both GHA’s appear more accurate than age. A CCI ≥ 2 points approximates the sensitivity of G8 defined frailty. External validation of these findings is needed.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102454"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145454263","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":"Rising Trends of Aggressive Renal Cell Carcinoma Among Younger Adults: Insights From the National Cancer Database","authors":"Giuseppe Garofano ,&nbsp;Cesare Saitta ,&nbsp;Giacomo Musso ,&nbsp;Margaret F. Meagher ,&nbsp;Umberto Capitanio ,&nbsp;Dhruv Puri ,&nbsp;Mai Dabbas ,&nbsp;Natalie Birouty ,&nbsp;Sanjana Karamcheti ,&nbsp;Breanna Kim ,&nbsp;Kit L. Yuen ,&nbsp;Alessandro Larcher ,&nbsp;Benjamin Baker ,&nbsp;Riccardo Autorino ,&nbsp;Savio D. Pandolfo ,&nbsp;Francesco Montorsi ,&nbsp;Alberto Saita ,&nbsp;Massimo Lazzeri ,&nbsp;Giovanni Lughezzani ,&nbsp;Paolo Casale ,&nbsp;Ithaar H. Derweesh","doi":"10.1016/j.clgc.2025.102425","DOIUrl":"10.1016/j.clgc.2025.102425","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate trends, and characteristics of renal cell carcinoma (RCC) in younger adults, as its rise has been primarily attributed to increasing incidental discovery of small renal masses in older adults.</div></div><div><h3>Methods</h3><div>We utilized the National Cancer Database to examine RCC patients aged 20-39 years between 2004 and 2021. Annual Average Percent Change (AAPC) was estimated via negative binomial regression. Aggressive RCC was defined as pT3+, high-grade (G3/G4), pN1, or metastatic disease. Logistic regression identified risk factors for aggressive RCC. Kaplan-Meier and Cox models assessed survival impact.</div></div><div><h3>Results</h3><div>Among 30,849 RCC cases, 8,465 (27.45%) were classified as aggressive RCC. The number of diagnosed cases increased over time (AAPC: 3.53%, <em>P</em> &lt; .001), with aggressive RCC increasing at a similar rate (AAPC: 3.58%, <em>P</em> &lt; .001). Compared to clear cell RCC, papillary (OR = 1.49, <em>P</em> &lt; .001), chromophobe (OR = 1.14, <em>P</em> = .006), collecting duct (OR = 35.68, <em>P</em> &lt; .001), and RCC NOS (OR = 1.51, <em>P</em> &lt; .001) had higher odds of aggressive RCC. Black (OR = 1.53, <em>P</em> &lt; .001) and Asian/Pacific Islander patients (OR = 1.51, <em>P</em> &lt; .001) were more likely to present with aggressive RCC compared to White patients. Uninsured (OR = 1.18, <em>P</em> = .001) and unknown insurance status patients (OR = 1.49, <em>P</em> &lt; .001) had significantly higher odds of aggressive RCC compared to privately insured patients. At 120 months, survival was significantly lower for aggressive vs nonaggressive RCC (65.0% vs. 91.7%, <em>P</em> &lt; .001). The negative impact of aggressive RCC on survival was attenuated in patients aged ≥ 35 years (HR = 0.78, <em>P</em> = .001)</div></div><div><h3>Conclusion</h3><div>Rising RCC cases in younger adults are accompanied by an increase in aggressive disease, not attributable to stage migration. The drivers for this rise are unclear and demand more investigation.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102425"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145139791","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":"Nationwide Real-World Outcomes of Trial Eligible and Trial Ineligible Patients With Metastatic Renal Cell Carcinoma Treated With Nivolumab Plus Ipilimumab","authors":"Mette Syberg Jespersen ,&nbsp;Jesper Andreas Evers Palshof ,&nbsp;Niels Fristrup ,&nbsp;Niels Viggo Jensen ,&nbsp;Jon Røikjær Henriksen ,&nbsp;Ane Bundsbæk Bøndergaard Iversen ,&nbsp;Sarah Grønbech Steen ,&nbsp;Morten Andersen ,&nbsp;Kasper Madsen ,&nbsp;Inge Marie Svane ,&nbsp;Anne Kirstine Møller Darras","doi":"10.1016/j.clgc.2025.102450","DOIUrl":"10.1016/j.clgc.2025.102450","url":null,"abstract":"<div><h3>Introduction</h3><div>Clinical trials have demonstrated efficacy and safety of immune checkpoint inhibitor-based combination therapy in metastatic renal cell carcinoma (mRCC). However, patients who do not meet trial eligibility criteria constitute a large proportion of the real-world population, and their outcomes remain poorly described.</div></div><div><h3>Patients and Methods</h3><div>This nationwide, retrospective cohort study included all Danish patients with mRCC who initiated nivolumab plus ipilimumab (NIVO/IPI) by May 5, 2022. Clinical data were obtained from electronic patient records. Outcomes included median progression-free survival (mPFS), median overall survival (mOS), and objective response rate (ORR), assessed by treating physicians. Patients were classified as trial-eligible or ineligible according to CheckMate 214 (CM214) key criteria. Survival was estimated using Kaplan–Meier methods, and subgroups were explored.</div></div><div><h3>Results</h3><div>A total of 464 patients were included, with a median follow-up of 33 months. In the total cohort, mPFS was 9 months, mOS 41 months, and ORR 43%, including 13% complete responses. Among 282 trial-eligible patients, outcomes were comparable to CM214 with mPFS 12 months and mOS 49 month, while 182 ineligible patients had inferior outcomes, with mPFS 6 months and mOS 26 months (both <em>P</em> &lt; .001). The presence of brain metastases did not adversely affect OS, while patients with autoimmune disease demonstrated unexpectedly favorable outcomes. Severe treatment-related toxicity (≥ grade 3) occurred in 44% in the total cohort, comparable to CM214.</div></div><div><h3>Conclusion</h3><div>This is the first nationwide real-world study evaluating NIVO/IPI outcomes in unselected mRCC. Trial-eligible patients achieved survival outcomes comparable to clinical trial results. Although ineligible patients derived less benefit, they still experienced meaningful clinical outcomes. These findings provide benchmark data for treatment of real-world mRCC populations in routine clinical practice.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102450"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145427213","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":"Sarcomatoid Differentiation as a Predictor of Recurrence in Intermediate- and High-Risk RCC: Implications for Adjuvant Immunotherapy Selection","authors":"Francisco Tomás Rodriguez-Covarrubias,&nbsp;Horst Emanuel Lagos-Beitz,&nbsp;Jorge Augusto Alcacio-Mendoza,&nbsp;Betsabé Petra Carreño-Hinojosa,&nbsp;Yoztinn Bernal-Benitez,&nbsp;Guillermo Martínez-Delgado,&nbsp;Guillermo Trujillo-Martínez","doi":"10.1016/j.clgc.2025.102430","DOIUrl":"10.1016/j.clgc.2025.102430","url":null,"abstract":"<div><h3>Background</h3><div>Adjuvant pembrolizumab improves survival in clear cell renal cell carcinoma (ccRCC) at elevated recurrence risk. However, broad application may lead to overtreatment. Sarcomatoid differentiation, a histologic feature associated with poor prognosis, is not currently used to guide adjuvant decisions.</div></div><div><h3>Objective</h3><div>To evaluate whether sarcomatoid differentiation can refine patient selection for adjuvant immunotherapy in intermediate- and high-risk ccRCC.</div></div><div><h3>Methods</h3><div>Retrospective analysis of 136 patients with localized/locally advanced ccRCC who underwent nephrectomy (2000-2023) meeting modified KEYNOTE-564 criteria. Recurrence-free survival (RFS) and predictive factors were analyzed using Kaplan-Meier estimates, logistic regression, and Cox models. Clinical utility was assessed via the number needed to treat (NNT) and cost-effectiveness modeling.</div></div><div><h3>Results</h3><div>At median follow-up of 55 months, recurrence occurred in 26 patients (19.1%). Sarcomatoid differentiation was significantly associated with recurrence (HR = 2.31; 95% CI, 1.03-5.18; <em>P</em> = .042). Among intermediate-risk patients, those with sarcomatoid features had 50.0% recurrence versus 16.7% without (<em>P</em> = .007). number needed to treat (NNT) improved from 5 (treating all) to 2 (treating sarcomatoid-positive only). Combining sarcomatoid status and ECOG 0 allowed 39.1% of patients to avoid therapy with 7.0% recurrence rate. This strategy could theoretically save $11.4 million USD.</div></div><div><h3>Conclusions</h3><div>Sarcomatoid differentiation was independently associated with recurrence and may help inform adjuvant therapy decisions. Selective immunotherapy based on histologic features may optimize outcomes while avoiding overtreatment.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102430"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145208859","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":"Impact of Systemic Therapy for Renal Cell Carcinoma With a Tumor Thrombus: Results From the Intercontinental Collaboration on Renal Cell Carcinoma Database","authors":"Maxwell Sandberg ,&nbsp;Gregory Russell ,&nbsp;Dana Feldman ,&nbsp;Mitchell Hayes ,&nbsp;Reuben Ben David ,&nbsp;Justin Miller ,&nbsp;Kartik Patel ,&nbsp;Brejjette Aljabi ,&nbsp;Seok-Soon Byun ,&nbsp;Oscar Rodriguez Faba ,&nbsp;Donato Cannoletta ,&nbsp;Tatiana Letowski ,&nbsp;Gustavo Villoldo ,&nbsp;Patricio Garcia Marchinena ,&nbsp;Thiago Mourao ,&nbsp;Gaetano Ciancio ,&nbsp;Charles C. Peyton ,&nbsp;Rafael Zanotti ,&nbsp;Steven Chang ,&nbsp;Philippe E. Spiess ,&nbsp;Alejandro Rodriguez","doi":"10.1016/j.clgc.2025.102442","DOIUrl":"10.1016/j.clgc.2025.102442","url":null,"abstract":"<div><h3>Purpose</h3><div>The primary objective of this study was to assess the utility of using systemic therapy for patients with renal cell carcinoma with tumor thrombus (RCC-TT) in the setting of both metastatic (mRCC-TT) and non-mRCC-TT disease.</div></div><div><h3>Methods</h3><div>This was a multi-institutional retrospective analysis from 1999-present, and every patient underwent radical nephrectomy with tumor thrombectomy (RN-TT) plus/minus systemic therapy. Systemic therapy was defined as chemotherapy, immunotherapy, targeted therapy, or any combination administered ≤12 months from RN-TT. Overall survival (OS), cancer-specific survival (CSS), and metastasis-free survival (MFS) were studied. We examined the effect of preoperative systemic therapy before RN-TT for non-mRCC-TT, preoperative systemic therapy before RN-TT for mRCC-TT, and postoperative systemic therapy after RN-TT.</div></div><div><h3>Results</h3><div>A total of 206 patients were nonmetastatic before RN-TT, and 146 (70.9%) did not receive systemic therapy and 60 (29.1%) did. There was no difference in OS and CSS (<em>p</em> &gt; .05), but MFS was significantly better in the no systemic therapy group (Median not reached; 80 months 50.6% of the cohort did not experience metastatic event vs. 13 months; <em>p</em> &lt; .0001). 117 patients had mRCC-TT before RN-TT, and of these, 84 (71.2%) received preoperative systemic therapy and 33 (28.2%) did not receive systemic therapy before surgery. Median OS was 24 months in the systemic therapy group and 5.7 months in the non-systemic therapy group (<em>p</em> = .0007). Median CSS was 27.6 months in the systemic therapy grouping and 6 months in the non-systemic therapy grouping (<em>p</em> = .0007). 315 patients were in the last analysis, and of these, 119 (37.8%) received systemic therapy after RN-TT and 196 (62.2%) did not. OS, CSS, and MFS did not differ (<em>p</em> &gt; .05).</div></div><div><h3>Conclusion</h3><div>There appears to be an OS and CSS benefit to preoperative systemic therapy for mRCC-TT. Further analysis is required to elucidate the best therapy regimens and ideal timing.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102442"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145350479","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":"Study Endpoint Fulfillment and FDA Approval Success in Phase III Clinical Trials of Genitourinary Malignancies","authors":"Matthew Steidle ,&nbsp;Kamil Malshy ,&nbsp;Trevor C. Hunt ,&nbsp;Zijing Cheng ,&nbsp;Ashley Li ,&nbsp;Karen Doersch ,&nbsp;Jathin Bandari","doi":"10.1016/j.clgc.2025.102436","DOIUrl":"10.1016/j.clgc.2025.102436","url":null,"abstract":"<div><h3>Introduction</h3><div>This study investigates the impact of Phase-III genitourinary oncology trial endpoint fulfillment (EF+) on FDA approval probability over the past 15 years.</div></div><div><h3>Methods</h3><div>We identified urothelial/bladder cancer (UCa), renal cancer (RCa), and prostate cancer (PCa) trials from ClinicalTrials.gov. The primary analysis compared the time from primary completion to FDA approval between trials with overall survival EF+ (OS+) and those without (OS−). Secondary analyses assessed the impact of OS+ versus non-OS primary EF (PE+) studies on FDA approval, considering disease site, disease status, and treatment line.</div></div><div><h3>Results</h3><div>Of 183 trials screened, 78 (42.6%) met inclusion criteria: 41 (52.6%) PCa, 23 (29.5%) RCa, and 14 (17.9%) UCa. FDA approval was granted in 40/78 trials. OS+ (<em>n</em> = 31 [39.7%]) significantly increased approval likelihood (HR 8.38, 95% CI, 4.1-17.1, <em>P</em> &lt; 0.001) compared to OS− trials. The median time to approval was 348 days (95% CI, 294-380) in the OS+ group and was not reached in the OS− group. One- and two-year approval rates were 63.3% and 8.5%, and 86.6% and 19.2%, respectively. Among trials with PE+, 39/50 received approval. Trials with both OS and non-OS PE+ had higher approval rates (HR 2.3, 95% CI, 1.04-5.3, <em>P</em> = 0.041), particularly in PCa studies (Log HR 0.51, 95% CI, 0.29-1.06, <em>P</em> &lt; 0.001) and metastatic disease (HR 0.74, 95% CI, 0.30-1.17, <em>P</em> = 0.001).</div></div><div><h3>Conclusions</h3><div>OS EF+ remains a strong predictor of FDA approval. Non-OS PE+ benefit trials gain better success when accompanied by OS+. These findings can guide future trial designs to optimize regulatory success in GU oncology.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102436"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145263070","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":"Impact of Bisphosphonates in Hormone-sensitive Metastatic Prostate Cancer A Systematic Review and Meta-Analysis","authors":"Gabriel Berlingieri Polho ,&nbsp;Adler Araujo Ribeiro Melo ,&nbsp;Laerte Canedo Ornelas-Filho ,&nbsp;Paulo Siqueira Amaral ,&nbsp;Felippe Lazar Neto ,&nbsp;Gabriella Fernandes Soares ,&nbsp;Andre Silva Franco ,&nbsp;Diogo Assed Bastos","doi":"10.1016/j.clgc.2025.102438","DOIUrl":"10.1016/j.clgc.2025.102438","url":null,"abstract":"<div><h3>Introduction</h3><div>Bone modifying agents (BMA) are part of the management of metastatic hormone-refractory prostate cancer, however its use in hormone-sensitive scenario is controversial. The objective of this meta-analysis is to determine whether the addition of BMA on standard of care (SoC) in metastatic hormone sensitive prostate cancer (mHSPC) improves OS or time to first skeletal related event (SRE).</div></div><div><h3>Patients and Methods</h3><div>A literature search of Web of Science, Pubmed and references lists of relevant articles was conducted. Eligible studies were prospective randomized trials comparing SoC to SoC plus BMA in mHSPC. We extracted data on: SoC option; type, dosing and duration of BMA; adverse events; hazard ratio and confidence interval for time to SRE and OS. Hazard radios were pooled using random-effects model. The main outcomes were OS and time to SRE. Secondary outcomes were the relative risk of grade 3-5 adverse events, osteonecrosis and renal dysfunction.</div></div><div><h3>Results</h3><div>Among 4949 studies identified, we selected 7 for the meta-analysis. Pooled results showed favorable OS (HR 0.87 [95% CI, 0.79-0.96], <em>P</em> = .007) and time to SRE (HR 0.74 [95% CI, 0.57-0.98], <em>P</em> = .003) for patients treated with bisphosphonates (BP). However, only 1 trial used androgen receptor pathway inhibitors (ARPI) and no trial included anti-RANK-L inhibitors. There was a significant increase in the risk of jaw osteonecrosis (RR 9.6 [95% CI, 1.98-46.82]).</div></div><div><h3>Conclusion</h3><div>BP may be beneficial in mHSPC, although there is scarcity of data on anti-RANKL agents and association with ARPI.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102438"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145276966","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}