European urology focus最新文献

{"title":"Outpatient Robotic Urological Surgery: An Evidence-based Analysis.","authors":"Angelo Orsini, Francesco Lasorsa, Gabriele Bignante, Michele Marchioni, Luigi Schips, Giuseppe Lucarelli, Francesco Porpiglia, Jihad H Kaouk, Simone Crivellaro, Riccardo Autorino","doi":"10.1016/j.euf.2024.10.003","DOIUrl":"https://doi.org/10.1016/j.euf.2024.10.003","url":null,"abstract":"<p><strong>Background and objective: </strong>One of the primary advantages of minimally invasive surgery is the shorter hospitalization time, which can potentially allow \"outpatient\" (OP) procedures. The recent advent of single-port (SP) robotics has further fueled the debate on this topic. We sought to provide an evidence-based analysis of the safety, feasibility, and advantages of robotic urological surgery in the OP setting.</p><p><strong>Methods: </strong>A literature search in PubMed was conducted in June 2024 to identify studies on the feasibility and safety of OP robotic urological surgery. Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria and the Population, Intervention, Comparator, Outcome model were used to select retrospective and prospective studies. Data collected included patient characteristics, operative outcomes, same-day discharge (SDD), and complication and readmission rates. Study quality was assessed using the Newcastle-Ottawa Scale. Data analysis and synthesis were performed using Review Manager and GraphPad Prism.</p><p><strong>Key findings and limitations: </strong>For 3291 patients in noncomparative studies, we found SDD rates of 46.17% for multiport (MP) robot-assisted radical prostatectomy (RARP), 77.35% for SP-RARP, 93.1% for robot-assisted radical or partial nephrectomy, and 93.3% for adrenalectomy. Among comparative studies involving 4130 patients, we found that the OP setting is feasible and safe. Comparison of overall complications between OP and inpatients (IP) settings revealed a relative risk (RR) of 0.66 (95% confidence interval [CI] 0.48-0.91; p = 0.01) favoring OP. The risk of readmission was lower risk for OP than for IP surgery (RR 0.53, 95% CI 0.33-0.85; p = 0.008). Comparison of MP-RARP and SP-RARP revealed that OP protocols are more easily achievable with SP-RARP (44.20% vs 79.59%; p < 0.001).</p><p><strong>Conclusions and clinical implications: </strong>OP robotic urological surgery is feasible and safe in selected patients and can enhance satisfaction and reduce costs. SP robotics could promote wider adoption of SDD protocols. Strict case selection minimizes complications. Differences in health care systems should be considered in future evaluations.</p><p><strong>Patient summary: </strong>We examined the feasibility and safety of same-day hospital discharge after robot-assisted surgery for urology operations. We found that this option can be safely offered and may be even more viable if the use of robots allowing surgery through a single keyhole incision becomes more widespread.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to Arun Joshi, Lazaros Tzelves, Zafer Tandogdu, Patrick Juliebø-Jones, and Bhaskar Somani's Letter to the Editor re: Christian Moro, Charlotte Phelps, Vineesha Veer, et al. Cranberry Juice, Cranberry Tablets, or Liquid Therapies for Urinary Tract Infection: A Systematic Review and Network Meta-analysis. Eur Urol Focus. In press. https://doi.org/10.1016/j.euf.2024.07.002.","authors":"Christian Moro, Charlotte Phelps, Vineesha Veer, Mark Jones, Paul Glasziou, Justin Clark, Kari A O Tikkinen, Anna Mae Scott","doi":"10.1016/j.euf.2024.09.014","DOIUrl":"10.1016/j.euf.2024.09.014","url":null,"abstract":"","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Survival Rates in Trimodal Therapy Versus Radiotherapy in Urothelial Carcinoma of Urinary Bladder.","authors":"Mario de Angelis, Carolin Siech, Francesco Di Bello, Natali Rodriguez Peñaranda, Jordan A Goyal, Zhe Tian, Nicola Longo, Felix K H Chun, Stefano Puliatti, Fred Saad, Shahrokh F Shariat, Giorgio Gandaglia, Marco Moschini, Armando Stabile, Francesco Montorsi, Alberto Briganti, Pierre I Karakiewicz","doi":"10.1016/j.euf.2024.09.013","DOIUrl":"10.1016/j.euf.2024.09.013","url":null,"abstract":"<p><strong>Background and objective: </strong>Trimodal therapy (TMT) provided significant survival advantage relative to external beam radiation therapy (EBRT) alone in prospective trials. However, the magnitude of survival benefit has not been validated in population-based studies. The objective of this study is to determine whether TMT is associated with lower cancer-specific mortality (CSM) rates relative to EBRT.</p><p><strong>Methods: </strong>Within the Surveillance, Epidemiology, and End Results database (2004-2020), we identified patients with cT2-T4aN0M0 urothelial carcinoma of urinary bladder (UCUB) treated with either TMT or EBRT. Cumulative incidence plots and multivariable competing risk regression (CRR) models addressed CSM after additional adjustment for other-cause mortality and standard covariates. The same methodology was repeated according to stage and age categories.</p><p><strong>Key findings and limitations: </strong>Of 4471 patients, 3391 (76%) underwent TMT versus 1080 (24%) EBRT. TMT rates increased over time in the overall cohort (estimated annual percent change [EAPC]: 1.8%, p < 0.001) as well as in organ-confined (OC) stage (EAPC: 1.7%, p < 0.001), but not in non-organ-confined (NOC) stage (p = 0.051). In the overall cohort, 5-yr CSM rates were 43.6% in TMT versus 52.7% in EBRT. In multivariable CRR models, TMT was an independent predictor of lower CSM (hazard ratio [HR]: 0.76, p < 0.001). In OC patients, 5-yr CSM rates were 42.0% in TMT versus 51.9% in EBRT (p < 0.001). In multivariable CRR models, TMT was an independent predictor of lower CSM (HR: 0.74, p < 0.001). Conversely, in NOC patients, TMT did not achieve independent predictor status (p = 0.3).</p><p><strong>Conclusions and clinical implications: </strong>In this population-based study, relative to EBRT, TMT is associated with lower CSM in OC stage, but not in NOC UCUB patients.</p><p><strong>Patient summary: </strong>In this report, we investigated the survival benefit of administering systemic chemotherapy in addition to radiotherapy in patients who are candidates for bladder-sparing strategies. We found that the combination of systemic chemotherapy and radiotherapy leads to improved cancer-specific survival compared with radiotherapy alone in patients with organ-confined urothelial carcinoma. We conclude that among patients who are candidates for bladder-sparing strategies, following transurethral resection, the combination of radiotherapy and chemotherapy (namely, trimodal therapy) should always be offered in those with organ-confined urothelial carcinoma.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review.","authors":"Anirban Dey, Georgios Georgiadis, Justin Umezurike, Yuhong Yuan, Fawzy Farag, James N'Dow, Muhammad Imran Omar, Charalampos Mamoulakis","doi":"10.1016/j.euf.2024.09.012","DOIUrl":"https://doi.org/10.1016/j.euf.2024.09.012","url":null,"abstract":"<p><strong>Background and objective: </strong>The prevalence of overactive bladder (OAB) increases with age. Mirabegron and other drugs are used for the management of patients with OAB. To evaluate mirabegron versus other treatments for overactive bladder syndrome (OAB).</p><p><strong>Methods: </strong>This randomised controlled trial (RCT)-based systematic review (CRD42020200394) was conducted following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-analyses statement, with standards reported in the Cochrane Handbook for Systematic Reviews of Interventions.</p><p><strong>Key findings and limitations: </strong>We included 28 RCTs (n = 27 481 adults), comparing the following: mirabegron 25 mg versus placebo (n = 8798; six RCTs): significant changes in urgency urinary incontinence (mean difference [MD] -0.41, 95% confidence interval [CI] -0.56 to -0.26), total incontinence (MD -0.47, 95% CI -0.63 to -0.30), and nocturia (MD -0.10, 95% CI -0.17 to -0.02), and mirabegron 50 mg versus placebo (n = 14 933; 12 RCTs): significant changes in urgency urinary incontinence (MD -0.41, 95% CI -0.52 to -0.31), urgency (MD -0.49, 95% CI -0.64 to -0.33), total incontinence (MD -0.44, 95% CI -0.55 to -0.33), favouring mirabegron 25/50 mg; mirabegron 50 mg versus tolterodine 4 mg (n = 8008; five RCTs): significant changes in micturition (MD -0.16, 95% CI -0.31 to -0.02) and overall adverse events (AEs; odds ratio [OR] 0.71, 95% CI 0.59-0.86), favouring mirabegron 50 mg; mirabegron 50 mg versus solifenacin 5 mg (n = 8911; four RCTs): significant changes in voided volume/micturition in millilitres (MD -7.77, 95% CI -12.93 to -2.61), favouring mirabegron 50 mg; and mirabegron 50 mg versus oxybutynin 73.5 mg (n = 302; one RCT): significant changes in overall AEs (OR 0.02, 95% CI 0.00-0.16), favouring mirabegron 50 mg.</p><p><strong>Conclusions and clinical implications: </strong>Mirabegron is effective, safe, and well tolerated. Coadministration with anticholinergics provides an advantageous additive effect without a higher occurrence of side effects.</p><p><strong>Patient summary: </strong>Mirabegron is effective, safe, and well tolerated for treating overactive bladder. When used in conjunction with anticholinergic medications, it provides extra benefits without causing more side effects.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Re: Christian Moro, Charlotte Phelps, Vineesha Veer, et al. Cranberry Juice, Cranberry Tablets, or Liquid Therapies for Urinary Tract Infection: A Systematic Review and Network Meta-analysis. Eur Urol Focus. In press. https://doi.org/10.1016/j.euf.2024.07.002.","authors":"Arun Joshi, Lazaros Tzelves, Zafer Tandogdu, Patrick Juliebø-Jones, Bhaskar Somani","doi":"10.1016/j.euf.2024.08.012","DOIUrl":"https://doi.org/10.1016/j.euf.2024.08.012","url":null,"abstract":"","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a Bladder Injury Classification System for Endoscopic Procedures: A Mixed-methods Study Involving Expert Consensus and Validation.","authors":"Burak Akgül, Atınc Tozsin, Theodoros Tokas, Salvatore Micali, Thomas Herrmann, Giampaolo Bianchi, Cristian Fiori, Nurullah Altınkaya, Gernot Ortner, Thomas Knoll, Karin Lehrich, Axel Böhme, Nariman Gadzhiev, Mohamed Omar, Ioannis Kartalas Goumas, Javier Romero Otero, Abdullatif Aydın, Lukas Lusuardi, Christopher Netsch, Azhar Khan, Francesco Greco, Prokar Dasgupta, Lütfi Tunc, Jans Rassweiler, Ali Serdar Gozen, Kamran Ahmed, Selçuk Güven","doi":"10.1016/j.euf.2024.09.004","DOIUrl":"https://doi.org/10.1016/j.euf.2024.09.004","url":null,"abstract":"<p><strong>Background and objective: </strong>The widespread adoption and rapid integration of new technologies and techniques in endoscopic and laser bladder interventions, particularly endoscopic enucleation, have led to new types of bladder injuries. This underscores the need for an intraoperative injury classification system. This study aims to develop and validate the Bladder Injury Classification System for Endoscopic Procedures (BICEP), which standardizes the classification of complications and intervention requirements.</p><p><strong>Methods: </strong>This mixed-methods study involved experts from the European Association of Urology Section of Urotechnology to standardize and validate the BICEP classification system. An iterative process involving focus groups, expert surveys, and revisions assessed clarity, relevance, comprehensiveness, and practicality. Validity was confirmed through expert surveys conducted in two rounds for face and content validity, using a 5-point Likert scale to correlate ratings with expected outcomes.</p><p><strong>Key findings and limitations: </strong>The novel BICEP classification system categorizes bladder injuries into ten subcategories with scores ranging from 0 to 4, reflecting injury severity and management requirements. Face validity was demonstrated by a 95% consensus on the system's clarity, relevance, and comprehensiveness. Content validity was supported by high acceptance rates in expert surveys, with average scores of 4.53 and 4.58 in the first and second rounds, respectively. This demonstrates strong support for its applicability in clinical practice. However, the primary limitation is the lack of external validation.</p><p><strong>Conclusions and clinical implications: </strong>Our study demonstrates that the BICEP system is a robust and comprehensive classification system, with strong support for its face and content validity. The BICEP system is a proposal based on expert opinion, and additional studies are necessary to ensure its widespread adoption and efficacy.</p><p><strong>Patient summary: </strong>Our study addressed the critical need for standardized classification in the increasingly widespread context of urology endoscopic technologies by focusing on intraoperative evaluation, reporting, and standardization of bladder injuries. This study provides a globally standardized basis for the classification and treatment of bladder injuries in urology endoscopic procedures.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preventing Infectious Complications Following Prostate Biopsy: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials of Alternative Approaches to Transrectal Biopsy with Empirical Antibiotic Prophylaxis Therapy.","authors":"Kumar Madhavan, Priyank Bhargava, Amrut Phonde, Sagar Yadav, Sonu Kumar Plash, Puneeth Kumar Kadlepla Mutt, Manupriya Madhavan, Devashish Kaushal, Rahul Jena","doi":"10.1016/j.euf.2024.09.011","DOIUrl":"https://doi.org/10.1016/j.euf.2024.09.011","url":null,"abstract":"<p><strong>Background and objective: </strong>Prostate biopsy, conducted frequently through the transrectal route, is associated with significant risks of infectious complications. This study aimed to compare the efficacy of various strategies to reduce these complications, using a network meta-analysis approach.</p><p><strong>Methods: </strong>Our study included randomized controlled trials (RCTs) identified from PubMed/MEDLINE, Embase, and the Cochrane database as of March 1, 2024. We included studies that involved adults undergoing transrectal or transperineal prostate biopsy with either standard empirical antibiotic prophylaxis or alternative interventions. The primary outcomes were assessment of sepsis, fever, urinary tract infections (UTIs), and readmissions. The study was registered with PROSPERO (CRD42024532225).</p><p><strong>Key findings and limitations: </strong>Our search yielded 28 RCTs eligible for analysis, encompassing a total of 10 179 participants. Rectal cleansing had the highest rankogram score to reduce infectious complications such as sepsis (odds ratio 0.40, 95% confidence interval [0.28-0.58]; rankogram, p score = 0.917), followed by transperineal biopsy (p score = 0.496). The overall analysis also highlighted a lower incidence of UTIs and readmissions with this method. Heterogeneity among studies was minimal (I² < 50% for all outcomes).</p><p><strong>Conclusions and clinical implications: </strong>Rectal cleansing might be the most effective strategy to reduce infectious complications following transrectal prostate biopsy and could be more effective than rectal culture-based antibiotic prophylaxis and transperineal biopsy. Given the indirect nature of our comparisons, further RCTs are needed to determine the safest approach for prostate biopsy, particularly between transperineal biopsy and transrectal biopsy with rectal cleansing or rectal culture-based antibiotic prophylaxis.</p><p><strong>Patient summary: </strong>In this review, we analyzed different techniques to reduce infectious complications after a prostate biopsy. We found that rectal cleansing prior to performing a transrectal prostate biopsy reduced infectious complications and might be the most effective strategy. We conclude that either transperineal or transrectal prostate biopsies are acceptable approaches, albeit with rectal cleansing or rectal culture-based antibiotic prophylaxis, respectively.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Towards a Reference Standard Definition of Urinary Tract Infection for Research.","authors":"Glenn T Werneburg, Florian Wagenlehner, J Quentin Clemens, Chris Harding, Marcus J Drake","doi":"10.1016/j.euf.2024.09.010","DOIUrl":"https://doi.org/10.1016/j.euf.2024.09.010","url":null,"abstract":"<p><p>Urinary tract infection (UTI) is among the most common human bacterial infections. In the context of increasing antibiotic resistance, there are many research efforts to improve the pathophysiological understanding, diagnosis, and treatment of UTI. Despite the high clinical relevance of UTI, there is high variability in definitions in the literature, making interpretation and comparison of research studies difficult, and even impossible in some cases. A recent Delphi consensus study generated a new reference standard definition for UTI that incorporates symptoms, pyuria, and urine culture results. This definition allows for designation of systemic involvement, and no longer categorizes UTIs as complicated or uncomplicated. The definition aligns with guidance from regulatory bodies for approval of UTI drugs. Implementation of a reference standard definition in the design and reporting of future investigations will allow better research design and interpretability within and outside the urology field. The new reference standard resolves some issues and offers a suitable way to unify methodology, and hence increase the potential strength of research in this area. There are some limitations and challenges for implementation, such as difficulties in establishing sensitivity and specificity values for the various settings in which the definition will be used. The inclusion of \"probable\" and \"possible\" UTI categories could be a problem in studies that require dichotomous outcomes. Nonetheless, the reference standard should be recommended until new developments become available, notably a more specific UTI biomarker than pyuria. Approaches to standardized diagnosis of catheter-associated UTIs remain unresolved. PATIENT SUMMARY: A new research definition for urinary tract infection (UTI) has been developed. Use of a single standardized definition in research will help in better design of research studies and comparison of results. Although the new definition will help in reducing the variability in UTI research reports, it has some limitations and there may be challenges to overcome before it is widely used.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to \"The Impact of Venous Thromboembolism on Upper Tract Urothelial Carcinomas Undergoing Open or Minimally Invasive Radical Nephroureterectomy in the USA: Perioperative Outcomes and Health Care Costs from Insurance Claims Data\".","authors":"Anas S Tresh, Francesco Del Giudice, Shufeng Li, Satvir Basran, Federico Belladelli, Ettore De Berardinis, Vincenzo Asero, Matteo Ferro, Sabin Tataru, Gian Maria Busetto, Ugo Falagario, Riccardo Autorino, Felice Crocetto, Biagio Barone, Benjamin Pradere, Marco Moschini, Andrea Mari, Wojciech Krajewski, Łukasz Nowak, Bartosz Małkiewicz, Tomasz Szydełko, Simone Crivellaro, Abhay Rane, Benjamin Challacombe, Rajesh Nair, Benjamin I Chung","doi":"10.1016/j.euf.2024.09.003","DOIUrl":"https://doi.org/10.1016/j.euf.2024.09.003","url":null,"abstract":"","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Belzutifan Efficacy and Tolerability in Patients with Sporadic Metastatic Clear Cell Renal Cell Carcinoma.","authors":"Emily Wang, Eric S Rupe, Sagar S Mukhida, Andrew C Johns, Matthew T Campbell, Amishi Y Shah, Amado J Zurita, Jianjun Gao, Sangeeta Goswami, Eric Jonasch, Pavlos Msaouel, Nizar M Tannir, Andrew W Hahn","doi":"10.1016/j.euf.2024.09.007","DOIUrl":"https://doi.org/10.1016/j.euf.2024.09.007","url":null,"abstract":"<p><strong>Background and objective: </strong>Belzutifan, a hypoxia-inducible factor 2 alpha inhibitor, was approved initially for patients with von Hippel-Lindau disease and more recently for sporadic, metastatic clear cell renal cell carcinoma (ccRCC) based on the results of LITESPARK-005. There is a paucity of data regarding real-world experience with belzutifan in patients with sporadic, metastatic ccRCC. This study aims to describe clinical outcomes with belzutifan in patients with sporadic, metastatic ccRCC.</p><p><strong>Methods: </strong>A retrospective study of 22 patients who received belzutifan at MD Anderson Cancer Center prior to the Food and Drug Administration approval was conducted. Progression-free survival (PFS) and objective response rate (ORR) were assessed by a blinded radiologist using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. PFS and overall survival (OS) were measured from belzutifan initiation.</p><p><strong>Key findings and limitations: </strong>The median follow-up time was 14.9 mo. Most patients had International Metastatic RCC Database Consortium intermediate-risk disease, more than three metastatic sites, and a median of five prior lines of treatment at initiation of belzutifan; all patients received prior immune checkpoint therapy (ICT) and vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs). The median PFS was 8.51 mo (95% confidence interval [CI] 0-18.4) and ORR was 36.4%. The median OS was 14.72 mo (95% CI 7.34-22.10). Of 22 patients, four (18.2%) patients required dose reductions and three (13.6%) patients discontinued belzutifan because of adverse drug events (ADEs). The most common ADEs were anemia (77.3%; 17/22) and hypoxia (36.4%; 8/22). There were no treatment-related deaths.</p><p><strong>Conclusions and clinical implications: </strong>In a heavily pretreated cohort of patients with sporadic, metastatic ccRCC, belzutifan had meaningful clinical activity and was well tolerated. These real-world results add to the results of LITESPARK-005 and support the use of belzutifan after progression on ICT and VEGFR-TKIs.</p><p><strong>Patient summary: </strong>Belzutifan is a new medicine used to treat a type of clear cell kidney cancer that has spread to other parts of the body (metastasized). A study at MD Anderson Cancer Center followed 22 patients who were treated with belzutifan, and found that it worked to control the cancer for almost 9 mo and caused the cancer to shrink in 36% of patients. This study confirms that belzutifan can be effective and safe, even after other treatments have not worked.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}