Urologic Oncology-seminars and Original Investigations最新文献

{"title":"Assessment of synergistic vs. independent drug activity for enfortumab vedotin and pembrolizumab in untreated advanced urothelial carcinoma","authors":"Ryan D. Chow M.D., Ph.D.,&nbsp;Ronac Mamtani M.D., M.S.C.E.","doi":"10.1016/j.urolonc.2025.07.003","DOIUrl":"10.1016/j.urolonc.2025.07.003","url":null,"abstract":"<div><h3>Background</h3><div>The combination of enfortumab vedotin (EV) and pembrolizumab (EV+P) was recently approved as a first-line (1L) therapy for patients with advanced urothelial cancer (aUC). Preclinical studies have suggested that these 2 drugs synergize with one another to drive anti-tumor responses. However, it remains unknown whether EV and pembrolizumab demonstrate synergistic activity in a clinical setting.</div></div><div><h3>Methods</h3><div>We analyzed progression-free survival (PFS) from the pivotal clinical trials evaluating EV and/or pembrolizumab as 1L therapy for aUC, focusing on cisplatin-ineligible patients. We computed predicted PFS for combination EV+P under a statistical model of independent drug action. We then compared predicted PFS to observed PFS to ascertain whether EV+P demonstrates synergistic vs. independent drug activity.</div></div><div><h3>Results</h3><div>Predicted PFS for EV+P combination therapy, assuming independent action of EV and pembrolizumab, was clinically and statistically indistinguishable from observed PFS for EV+P in the EV-302 trial (HR = 1.04 [0.79–1.37], <em>P</em> = 0.76).</div></div><div><h3>Conclusions</h3><div>Among cisplatin-ineligible patients with untreated aUC, the observed clinical efficacy of combination EV+P is supported by a model of independent drug action. These findings suggest that distinct patient subgroups respond to EV and/or pembrolizumab. Identifying predictive biomarkers of response for each drug could reduce unnecessary toxicity arising from universal combination therapy, as patients could instead be selectively treated with whichever therapy is more likely to be effective.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 10","pages":"Pages 597.e1-597.e4"},"PeriodicalIF":2.3,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144769107","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":"An RMST-based analysis of systemic therapy in muscle-invasive bladder cancer","authors":"Arjun Venkatesh M.S. ,&nbsp;Yudai Ishiyama M.D., Ph.D. ,&nbsp;Reynier D. Rodriguez Rosales B.S. ,&nbsp;Jean-Pierre Kanumuambidi M.P.H. ,&nbsp;Mohammed Al-Toubat M.D. ,&nbsp;Hunter Sceats M.D., Ph.D. ,&nbsp;Shelby Sparks M.S. ,&nbsp;Nicole Murray M.D. ,&nbsp;Mark Bandyk M.D., M.P.H. ,&nbsp;K.C. Balaji M.D.","doi":"10.1016/j.urolonc.2025.07.002","DOIUrl":"10.1016/j.urolonc.2025.07.002","url":null,"abstract":"<div><h3>Introduction</h3><div>Recent Phase III trials using immunotherapy agents in perioperative setting for muscle-invasive bladder cancer (MIBC) have reshaped treatment paradigms. Traditional hazard ratios, while statistically robust, may mask modest absolute survival gains, complicating informed decision-making for clinicians and patients alike. This study aims to utilize restricted mean survival time (RMST) analysis to provide more intuitive interpretations of survival benefits and facilitate development of a framework for comparing efficacy, toxicity, and costs across three pivotal trials.</div></div><div><h3>Methods</h3><div>Overall survival (OS), disease free survival (DFS) and adverse effects (AE) data were extracted from recently published Phase III MIBC trials reporting results by HR: NIAGARA (perioperative durvalumab), CheckMate-274 (adjuvant nivolumab) and AMBASSADOR (adjuvant pembrolizumab). Using reconstructed individual patient data, RMST was calculated at a 42-month truncation. Costs were sourced from U.S. Medicare prices and calculated using each study’s median treatment duration.</div></div><div><h3>Results</h3><div>DFS-RMST differences at 42 months were: 3.39 months (95% CI: 1.4–5.39) for NIAGARA, 4.05 months (95% CI: 1.33–6.78) for CheckMate-274, and 3.97 months (95% CI: 1.3–6.65) for AMBASSADOR. OS-RMST differences were: 1.84 months (95% CI: 0.37–3.37) for NIAGARA, 2.56 months (95% CI: 0.54–4.58) for CheckMate-274, and 0.95 months (95% CI: –1.21 to 3.15) for AMBASSADOR. Cost per month of survival gained ranged from $43,460 to $49,832 for DFS and $52,387 to $207,374 for OS across trials.</div></div><div><h3>Conclusion</h3><div>Our RMST-based analysis highlights the minimal real-world survival benefits and provides more intuitive and clinically relevant interpretations than traditional hazard ratios. Our visualization framework offers an intuitive approach to assist clinicians and patients in making informed decisions.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 10","pages":"Pages 596.e15-596.e21"},"PeriodicalIF":2.3,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765542","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":"Comparison of real-world outcomes between nivolumab plus ipilimumab and lenvatinib plus pembrolizumab or nivolumab plus cabozantinib combination therapies for previously untreated advanced renal cell carcinoma","authors":"Hiroki Ishihara ,&nbsp;Kenji Omae ,&nbsp;Yuki Nemoto ,&nbsp;Shinsuke Mizoguchi ,&nbsp;Nanaka Katsurayama ,&nbsp;Takayuki Nakayama ,&nbsp;Hironori Fukuda ,&nbsp;Kazuhiko Yoshida ,&nbsp;Hiroaki Shimmura ,&nbsp;Yasunobu Hashimoto ,&nbsp;Junpei Iizuka ,&nbsp;Tsunenori Kondo ,&nbsp;Toshio Takagi","doi":"10.1016/j.urolonc.2025.06.019","DOIUrl":"10.1016/j.urolonc.2025.06.019","url":null,"abstract":"<div><h3>Background</h3><div>Data regarding a direct comparison of outcomes between nivolumab plus ipilimumab (N-I) and lenvatinib plus pembrolizumab (L-P) or nivolumab plus cabozantinib (N<img>C) combination therapies for advanced renal cell carcinoma (RCC) are limited. We compared treatment outcomes between N-I and <span>L-P</span><em>/N</em><img>C in previously untreated advanced RCC.</div></div><div><h3>Methods</h3><div>The clinical data of 194 patients receiving N-I (<em>n</em> = 109) and <span>L-P</span>/N<img>C (<em>n</em> = 85) as first-line therapies for advanced RCC were retrospectively assessed.</div></div><div><h3>Results</h3><div>According to the inverse probability of treatment weighting analysis, progression-free survival (PFS) was longer (median: 26.0 vs. 9.0 months, <em>P</em> = 0.0024) and the objective response rate (ORR) was higher (61.4% vs. 45.6%, <em>P</em> = 0.031) in the <span>L-P</span>/N<img>C group than in the N-I group, whereas no significant difference was observed in overall survival between the groups (median: not reached vs. 56.0 months, <em>P</em> = 0.193). The rates of adverse events (AEs) (97.4% vs. 78.8%, <em>P</em> &lt; 0.0001) and treatment interruption (70.5% vs. 51.1%, <em>P</em> = 0.007) were higher in the <span>L-P</span>/N<img>C group than in the N-I group. The rate of glucocorticoid requirement was higher in the N-I group than in the <span>L-P</span>/N<img>C group (43.8% vs. 27.5%, <em>P</em> = 0.023).</div></div><div><h3>Conclusion</h3><div><span>L-P</span>/N<img>C exhibited superior PFS and ORR compared with N-I in patients with advanced RCC. The <span>L-P</span>/N<img>C group harbored a higher risk of AEs and treatment withdrawal, whereas the rate of glucocorticoid requirement was higher in the N-I group. Understanding the outcome characteristics of each immuno-oncology combination therapy will help to provide optimal and individualized treatment strategies.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 10","pages":"Pages 598.e1-598.e10"},"PeriodicalIF":2.3,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144776271","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":"Prostate cancer deaths in 2050-quo vadimus?","authors":"Kevin R Loughlin","doi":"10.1016/j.urolonc.2025.06.014","DOIUrl":"https://doi.org/10.1016/j.urolonc.2025.06.014","url":null,"abstract":"","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144769108","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":"Exosome: The hidden messengers in cancer detection and immunotherapy","authors":"Fahmida Sultana M.Sc.,&nbsp;Ajit Ghosh Ph.D.","doi":"10.1016/j.urolonc.2025.07.006","DOIUrl":"10.1016/j.urolonc.2025.07.006","url":null,"abstract":"<div><div>Cancer continues to pose a significant global health challenge, driving the need for innovative approaches in early detection and treatment management. Exosomes, small extracellular vesicles secreted by various cell types, play a pivotal role in intercellular communication by transferring molecular cargo between donor and recipient cells. They have emerged as key players in cancer progression and therapy. Exosomes contribute to tumor growth by mediating immune suppression, drug resistance, and metastasis. Yet, their distinctive properties also present them as valuable tools for cancer diagnosis. Tumor-derived exosomes, abundant in body fluids, are promising candidates for liquid biopsies, offering non-invasive biomarkers that can aid in cancer detection, prognosis, and real-time monitoring of disease progression. Beyond diagnostics, exosomes are at the forefront of cancer immunotherapy, particularly in developing exosome-based vaccines and targeted therapies. Their capacity to deliver molecular cargo directly to cancer or immune cells allows personalized and highly effective cancer treatments. This review explores the current understanding of exosomes in cancer biology, underscores their emerging diagnostic potential, and examines their transformative role in advancing future cancer immunotherapy strategies.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 11","pages":"Pages 609-627"},"PeriodicalIF":2.3,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765544","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":"Assessing oncological outcomes of bladder-sparing treatments in patients with BCG-unresponsive and BCG-exposed non-muscle-invasive bladder cancer","authors":"Andrea Piccolini M.D. ,&nbsp;Roberto Contieri M.D. ,&nbsp;Alessandro Uleri M.D. ,&nbsp;Stefano Moretto M.D. ,&nbsp;Alessio Finocchiaro M.D. ,&nbsp;Muhannad Aljoulani M.D. ,&nbsp;Pietro Brin M.D. ,&nbsp;Stefano Mancon M.D. ,&nbsp;Filippo Dagnino M.D. ,&nbsp;Ludovica Cella M.D. ,&nbsp;Pier Paolo Avolio M.D. ,&nbsp;Marco Paciotti M.D. ,&nbsp;Vittorio Fasulo M.D., Ph.D. ,&nbsp;Alberto Saita M.D. ,&nbsp;Paolo Casale M.D. ,&nbsp;Nicolò Maria Buffi M.D. ,&nbsp;Giovanni Lughezzani M.D. ,&nbsp;Massimo Lazzeri M.D., Ph.D. ,&nbsp;Rodolfo Hurle M.D.","doi":"10.1016/j.urolonc.2025.07.004","DOIUrl":"10.1016/j.urolonc.2025.07.004","url":null,"abstract":"<div><h3>Background</h3><div>A subset of non-muscle invasive bladder cancer (NMIBC) patients falls between BCG-naïve and BCG-unresponsive, leading to the introduction of the ‘BCG-exposed’ category. We assessed oncological outcomes in BCG-unresponsive and BCG-exposed patients undergoing bladder-sparing treatments (BST).</div></div><div><h3>Methods</h3><div>This retrospective study included BCG-unresponsive and BCG-exposed patients who underwent BST with BCG or a shift to different intravesical chemotherapy. Patients undergoing early RC after BCG failure (<em>N</em> = 14) were excluded. Kaplan-Meier (KM) curves estimated HG recurrence-free survival (HG-RFS) and progression-free survival (PFS).</div></div><div><h3>Results</h3><div>Among 541 patients treated with BCG from January 2005 to September 2022, 102 (19%) met inclusion criteria: 66 (65%) were classified as BCG-exposed according to IBCG criteria, 36 (35%) as BCG-unresponsive. Median follow-up from BCG-failure was 43 months (Interquartile range: 21–70). Forty-nine patients had a second HG-recurrence after BST. Of these, 8 patients progressed. No difference in KM curves was observed between the 2 groups for HG-RFS (<em>P</em> = 0.47) and PFS (<em>P</em> = 0.77). The 3-year HG-RFS after BCG treatment was 57% (95% CI: 43%–69%) for BCG-exposed and 39% (95% CI: 21%–57%) for BCG-unresponsive (HR: 1.24; 95% CI: 0.69–2.21, <em>P</em> = 0.47).</div></div><div><h3>Conclusion</h3><div>Our analysis revealed no significant differences in HG-recurrence or progression rates between BCG-exposed and BCG-unresponsive patients. Stage at the time of BCG failure recurrence, rather than the interval since the last BCG treatment, emerged as the primary factor in determining subsequent management strategies. Validation through larger-scale studies is warranted.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 11","pages":"Pages 661.e1-661.e8"},"PeriodicalIF":2.3,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765543","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":"Assessing the uptake of core outcome sets in randomized controlled trials for localized prostate cancer: A cross-sectional study","authors":"Carson L. Wright B.S. ,&nbsp;Joseph Case B.S. ,&nbsp;Trevor Magee B.S. ,&nbsp;Kimberly Magana M.Ed. ,&nbsp;Kyle Fitzgerald B.S. ,&nbsp;Garrett Jones B.S. ,&nbsp;Jay Modi B.S. ,&nbsp;Shaelyn Ward B.S. ,&nbsp;Griffin Hughes B.A., B.S. ,&nbsp;Alicia Ito-Ford Ph.D. ,&nbsp;Matt Vassar Ph.D.","doi":"10.1016/j.urolonc.2025.07.008","DOIUrl":"10.1016/j.urolonc.2025.07.008","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate core outcome set (COS) completion recommended in localized prostate cancer (LPC) randomized controlled trials (RCTs).</div></div><div><h3>Methods</h3><div>We identified the original LPC COS from 2017 established by the Core Outcome Measures in Effectiveness Trials Initiative. We conducted a search of LPC RCT registries between 2013 and 2023 from databases on ClinicalTrials.gov and International Clinical Trials Registry Platform (ICTRP) via who.int. We screened RCTs from our search in a masked, duplicate fashion. We extracted trial characteristics and specific COS outcomes for survival, bodily functions, quality of life, and treatment-specific outcomes again in a masked, duplicate fashion. COS uptake results were analyzed using an interrupted time series analysis.</div></div><div><h3>Results</h3><div>Our initial search of ClinicalTrials.gov and ICTRP yielded 13,909 trials. After exclusions, we extracted data from 82 clinical trials. \"Disease Progression\" (76/82; 92.68%) was the most commonly measured outcome while \"Need for Salvage Therapy\" (27/82; 32.93%) was the least. Limitations include lack of generalization for other COSs and inability to confirm systematic search returned all pertinent trials.</div></div><div><h3>Conclusion</h3><div>A nonsignificant decrease in COS adherence prior to the publication of a COS for LPC in 2017 occurred, then a subsequent nonsignificant increase in COS adherence after. We recommend LPC clinical trialists adhere to the COS outlined in our study and that further uptake studies be done to assess future LPC COS adherence.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 10","pages":"Pages 598.e17-598.e24"},"PeriodicalIF":2.3,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144761469","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":"Leveraging DNA repair deficiency to personalize radiopharmaceutical therapy in prostate cancer","authors":"Panagiotis J. Vlachostergios M.D., Ph.D.","doi":"10.1016/j.urolonc.2025.07.001","DOIUrl":"10.1016/j.urolonc.2025.07.001","url":null,"abstract":"<div><div>Radiopharmaceutical therapies targeting prostate-specific membrane antigen (PSMA) have transformed the management of metastatic prostate cancer, yet inter-patient variability in therapeutic response remains a critical challenge. Emerging evidence indicates that defects in DNA repair pathways, including homologous recombination deficiency (HRD) and mismatch repair deficiency (MMRd), sensitize tumor cells to ionizing radiation by impairing damage resolution. Ongoing research explores the potential of integrating genomic profiling of DNA repair defects to optimize patient selection and personalize radiopharmaceutical strategies such as 177Lu-PSMA and alpha-emitting conjugates. Clinical efforts to combine targeted radiation with synthetic lethality approaches are ongoing. Tailoring radiopharmaceutical therapy to individual tumor DNA repair profiles offers a promising paradigm to improve outcomes and expand therapeutic windows in advanced prostate cancer.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 11","pages":"Pages 654-656"},"PeriodicalIF":2.3,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144745138","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":"Characterizing obesity: Its’ time we address the elephant in the room!","authors":"Rohan Magoon D.M., M.D.","doi":"10.1016/j.urolonc.2025.06.016","DOIUrl":"10.1016/j.urolonc.2025.06.016","url":null,"abstract":"","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 11","pages":"Page 659"},"PeriodicalIF":2.3,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733477","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":"Early real-world utilization of avelumab switch maintenance among patients with advanced urothelial carcinoma without progression following treatment with first-line platinum-based chemotherapy","authors":"Helen H. Moon MD ,&nbsp;Jeanny B. Aragon-Ching MD ,&nbsp;Allison Thompson PharmD, MBA ,&nbsp;Anup Abraham MPH ,&nbsp;Anna Vlahiotis MA ,&nbsp;Chiemeka Ike PharmD, MPH ,&nbsp;Darrin Benjumea MPH ,&nbsp;Anran Shao MPH ,&nbsp;Haiyan Sun MS ,&nbsp;Mairead Kearney MB, BCh, MBA, MSc, MPH ,&nbsp;Norbek Gharibian PharmD ,&nbsp;Sarah Hanson MD, PhD ,&nbsp;Benjamin Li PhD ,&nbsp;Melissa Kirker PharmD, MPH ,&nbsp;Petros Grivas MD, PhD","doi":"10.1016/j.urolonc.2025.05.014","DOIUrl":"10.1016/j.urolonc.2025.05.014","url":null,"abstract":"<div><h3>Background</h3><div>A standard treatment option for patients with locally advanced/metastatic urothelial carcinoma (la/mUC) is first-line platinum-based chemotherapy (1L PBC) followed by avelumab 1L switch maintenance (1LM) in patients without progression. This study aimed to evaluate the real-world treatment patterns and outcomes in patients with la/mUC in the US treated with 1L PBC and characterize the early adoption of avelumab 1LM following FDA approval in June 2020.</div></div><div><h3>Methods</h3><div>This retrospective cohort study identified adults diagnosed with la/mUC between January 2017 and September 2021 using electronic health records from the Flatiron Health database. Patients were grouped based on real-world response to 1L PBC: complete or partial response (rwCR/PR) or stable disease (rwSD). Baseline characteristics and treatment patterns were described. Clinical outcomes, including real-world overall survival (rwOS) and progression-free survival (rwPFS), were analyzed using the Kaplan-Meier method.</div></div><div><h3>Results</h3><div>Of 1,703 identified patients with la/mUC treated with 1L PBC, 1,245 (73%) had response data available during the study period, with 998 (80%) having a best response of rwCR/PR (60%) or rwSD (20%). Demographic and clinical characteristics were similar between patients with rwCR/PR and rwSD. Patients with rwCR/PR had longer median rwOS and rwPFS from 1L PBC initiation vs patients with rwSD. Of patients evaluated after FDA approval of avelumab 1LM on June 30, 2020, 435 discontinued 1L PBC. Of these patients, 339 had response data, and 138 of those without progression were considered avelumab 1LM eligible. Of these, 97 (70%) initiated avelumab 1LM within 180 days following last administration of 1L PBC, with 40 patients receiving second-line (2L) treatment, most commonly enfortumab vedotin (60%).</div></div><div><h3>Conclusion</h3><div>In the post–FDA approval period, uptake of avelumab 1LM was high (70%) in patients with rwSD or rwCR/PR following 1L PBC, and 41% of these patients received 2L treatment, most commonly with enfortumab vedotin.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 10","pages":"Pages 594.e19-594.e29"},"PeriodicalIF":2.3,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144660391","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}