European urology oncology最新文献

{"title":"Unmet Need in Non-muscle-invasive Bladder Cancer Failing Bacillus Calmette-Guérin Therapy: A Systematic Review and Cost-effectiveness Analyses from the International Bladder Cancer Group.","authors":"David D'Andrea, Hugh Mostafid, Paolo Gontero, Shahrokh Shariat, Ashish Kamat, Alexandra Masson-Lecomte, Maximilian Burger, Morgan Rouprêt","doi":"10.1016/j.euo.2024.10.012","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.012","url":null,"abstract":"<p><strong>Background and objective: </strong>Non-muscle-invasive bladder cancer (NMIBC) poses a significant clinical challenge, particularly when failing bacillus Calmette-Guérin (BCG) therapy, necessitating alternative treatments. Despite radical cystectomy being the recommended treatment, many patients are unfit or unwilling to undergo this invasive procedure, highlighting the need for effective bladder-sparing therapies. This review aims to summarize and report the evidence on the efficacy and to estimate the costs of bladder-preserving strategies used in NMIBC recurrence after failure of intravesical BCG therapy.</p><p><strong>Methods: </strong>We systematically searched online databases for prospective studies investigating intravesical therapy, systemic therapy, or combination of both in patients treated previously with BCG. Owing to significant heterogeneity across the studies, a meta-analysis was inappropriate. A sensitivity analysis was performed in an exploratory manner. We used a decision-analytic Markov model to compare novel U.S. Food and Drug Administration-approved treatments with a 2-yr time horizon.</p><p><strong>Key findings and limitations: </strong>A total of 57 studies published between 1998 and 2024, with 68 unique study arms and consisting of 2589 patients, were identified. The 3-mo overall response rate (ORR) across all studies, complete response rate (CRR) in concomitant carcinoma in situ (CIS) or CIS only disease, and recurrence-free rate (RFR) in papillary disease were estimated to be 52.4% (95% confidence interval [CI]: 45.4-59.2), 52.8% (95% CI: 42.9-62.6), and 26.4% (95% CI: 13.3-45.6), respectively. The 12-mo ORR, CRR, and RFR were estimated to be 78% (95% CI: 52.9-91.8), 27.8% (95% CI: 21.3-35.4), and 25.4% (95% CI: 18.2-34.2), respectively. The progression rate was estimated to be 13% (95% CI: 9-18.2). The mean proportion of patients treated with radical cystectomy was estimated to be 24.7 (range 0-85.7). The reported toxicity grades were overall mild, with a median of 3.4% (range 0-33.3%) participants experiencing a dose limiting toxicity. Compared with using radical cystectomy to treat patients failing BCG therapy, at a willingness-to-pay threshold of 100 000 USD, nadofaragene firadenovec was cost effective, with an incremental cost-effectiveness ratio (ICER) of 10 014 USD per quality-adjusted life year (QALY), while nogapendekin alfa inbakicept was less cost effective than nadofaragene firadenovec (ICER of 44 602 USD per QALY). Pembrolizumab, which dominated, was both less costly and more effective than the other strategies.</p><p><strong>Conclusions and clinical implications: </strong>Salvage bladder-sparing therapies show a response rate of around 50% at 3 mo in patients with NMIBC failing BCG. However, long-term data are heterogeneous. Nevertheless, recently developed agents show promising tumor control activity. In the rapidly evolving landscape of urothelial cancer, some of these treatment strategies migh","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correlation of Body Mass Index with Overall Survival Among Patients with Metastatic Hormone-sensitive Prostate Cancer: Analysis of Patient-level Data from SWOG-1216.","authors":"Umang Swami, Yeonjung Jo, Arshit Narang, Melissa Plets, Chadi Hage Chehade, Georges Gebrael, Shilpa Gupta, Zin Myint, Catherine Tangen, Primo N Lara, Ian M Thompson, Maha H A Hussain, Tanya B Dorff, Seth P Lerner, Neeraj Agarwal","doi":"10.1016/j.euo.2024.10.013","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.013","url":null,"abstract":"<p><p>Although obesity has been associated with better overall survival (OS) among patients with metastatic castration-resistant prostate cancer, its association with OS has not been extensively explored in metastatic hormone-sensitive prostate cancer (mHSPC). We conducted a post hoc exploratory analysis of patient-level data from the SWOG-1216 trial to determine whether baseline body mass index (BMI) is associated with better OS among patients with mHSPC. SWOG-1216 was an open-label, phase 3 trial that randomized patients newly diagnosed with mHSPC 1:1 to either androgen deprivation therapy (ADT) with orteronel (experimental arm) or ADT with bicalutamide (control arm). Of 1279 patients included in the analysis, 12 (0.9%) were underweight, 252 (19.7%) had normal BMI, 958 (74.9%) were overweight, and 57 (4.5%) were obese. Age, Gleason score, extent of disease burden, the incidence of visceral metastases, and treatment allocation were similar among the groups (p > 0.05), while differences in baseline prostate-specific antigen and Zubrod performance status were observed (p < 0.05). Median OS was 2.4, 5.5, 6.6, and 6.8 yr in the underweight, normal, overweight, and obese groups, respectively. After adjusting for prognostic variables, high BMI was associated with better OS (HR for each increment in BMI category: 0.829, 5% CI 0.68-0.98; p = 0.029). These findings need to be validated in other phase 3 trials. PATIENT SUMMARY: We analyzed data from a clinical trial to evaluate the association between body mass index (BMI) and overall survival among patients with metastatic hormone-sensitive prostate cancer. We found that in this group of patients, the risk of death was lower for patients with higher BMI.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142617580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Response Assessment According to Updated PROMISE Criteria in Patients with Metastatic Prostate Cancer Using an Automated Imaging Platform for Identification, Measurement, and Temporal Tracking of Disease.","authors":"Cecil M Benitez, Hannicka Sahlstedt, Ida Sonni, Johan Brynolfsson, Gholam Reza Berenji, Jesus Eduardo Juarez, Nathanael Kane, Sonny Tsai, Matthew Rettig, Nicholas George Nickols, Sai Duriseti","doi":"10.1016/j.euo.2024.10.011","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.011","url":null,"abstract":"<p><strong>Background and objective: </strong>Prostate-specific membrane antigen (PSMA) molecular imaging is widely used for disease assessment in prostate cancer (PC). Artificial intelligence (AI) platforms such as automated Prostate Cancer Molecular Imaging Standardized Evaluation (aPROMISE) identify and quantify locoregional and distant disease, thereby expediting lesion identification and standardizing reporting. Our aim was to evaluate the ability of the updated aPROMISE platform to assess treatment responses based on integration of the RECIP (Response Evaluation Criteria in PSMA positron emission tomography-computed tomography [PET/CT]) 1.0 classification.</p><p><strong>Methods: </strong>The study included 33 patients with castration-sensitive PC (CSPC) and 34 with castration-resistant PC (CRPC) who underwent PSMA-targeted molecular imaging before and ≥2 mo after completion of treatment. Tracer-avid lesions were identified using aPROMISE for pretreatment and post-treatment PET/CT scans. Detected lesions were manually approved by an experienced nuclear medicine physician, and total tumor volume (TTV) was calculated. Response was assessed according to RECIP 1.0 as CR (complete response), PR (partial response), PD (progressive disease), or SD (stable disease). KEY FINDINGS AND LIMITATIONS: aPROMISE identified 1576 lesions on baseline scans and 1631 lesions on follow-up imaging, 618 (35%) of which were new. Of the 67 patients, aPROMISE classified four as CR, 16 as PR, 34 as SD, and 13 as PD; five cases were misclassified. The agreement between aPROMISE and clinician validation was 89.6% (κ = 0.79).</p><p><strong>Conclusions and clinical implications: </strong>aPROMISE may serve as a novel assessment tool for treatment response that integrates PSMA PET/CT results and RECIP imaging criteria. The precision and accuracy of this automated process should be validated in prospective clinical studies.</p><p><strong>Patient summary: </strong>We used an artificial intelligence (AI) tool to analyze scans for prostate cancer before and after treatment to see if we could track how cancer spots respond to treatment. We found that the AI approach was successful in tracking individual tumor changes, showing which tumors disappeared, and identifying new tumors in response to prostate cancer treatment.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142617582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Value of Whole-body Magnetic Resonance Imaging Using the MET-RADS-P Criteria for Assessing the Response to Intensified Androgen Deprivation Therapy in Metastatic Hormone-naïve and Castration-resistant Prostate Cancer.","authors":"Julien Van Damme, Bertrand Tombal, Nicolas Michoux, Sandy Van Nieuwenhove, Vassiliki Pasoglou, Perrine Triqueneaux, Anwar R Padhani, Frederic E Lecouvet","doi":"10.1016/j.euo.2024.10.009","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.009","url":null,"abstract":"<p><strong>Background and objectives: </strong>We assessed the agreement between prostate-specific antigen (PSA) and imaging responses using whole-body magnetic resonance imaging (wbMRI). Our aim was to explore the potential prognostic value of PSA and wbMRI responses in metastatic hormone-naïve prostate cancer (mHNPC) and castration-resistant PC (mCRPC).</p><p><strong>Methods: </strong>wbMRI was prospectively performed in 37 patients with mHNPC and 51 with mCRPC before and after 6-12 mo of androgen deprivation therapy and an androgen receptor pathway inhibitor (ARPI). Imaging responses were defined according to the Metastasis Reporting and Data System for PC (MET-RADS-P) criteria. A PSA response was defined as PSA ≤0.2 ng/ml in mHNPC and a ≥50% decrease from the pretreatment level in mCRPC. Agreement between PSA and wbMRI responses was assessed using Cohen's κ. The association between time to subsequent treatment and overall survival (OS) was analyzed using Cox regression analysis.</p><p><strong>Key findings and limitations: </strong>Agreement between PSA and wbMRI responses was fair in mHNPC (κ = 0.30) but none to slight in mCRPC (κ = 0.15). In mHNPC, patients with a PSA or wbMRI response were less likely to receive subsequent treatments; wbMRI progression was associated with a significantly higher risk of death (hazard ratio 8.59; p = 0.002). In mCRPC, two-thirds of patients with a PSA response showed progression on wbMRI; neither PSA nor wbMRI progression changed the likelihood of starting a subsequent treatment or the risk of death.</p><p><strong>Conclusions and clinical implications: </strong>In mHNPC, wbMRI progression was associated with a higher risk of needing subsequent treatment and shorter OS.</p><p><strong>Patient summary: </strong>We evaluated the agreement between routine PSA (prostate-specific antigen) test results and whole-body MRI (magnetic resonance imaging) scans for assessing the response of metastatic prostate cancer to treatment. There was disagreement between the PSA and MRI results, mainly for patients with cancer that was resistant to hormone-based treatment. Combining PSA with whole-body MRI might provide a more accurate picture of the response of advanced prostate cancer to treatment.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of Small Testicular Masses: A Delphi Consensus Study.","authors":"Karl H Pang, Giuseppe Fallara, João Lobo, Hussain M Alnajjar, Vijay Sangar, Conrad von Stempel, Dean Y Huang, Arie Parnham, Walter Cazzaniga, Francesco Giganti, Aiman Haider, Ashwin Sachdeva, Maarten Albersen, Costi Alifrangis, Marco Bandini, Fabio Castiglione, Hielke-Martijn De Vries, Christian Fankhauser, Daniel Heffernan Ho, David Nicol, Jonathan Shamash, Anita Thomas, Miles Walkden, Alex Freeman, Asif Muneer","doi":"10.1016/j.euo.2024.10.010","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.010","url":null,"abstract":"<p><strong>Background and objective: </strong>The majority of small testicular masses (STMs) are benign and therefore radical orchidectomy (RO) may represent overtreatment. In appropriately selected patients, surveillance or testis-sparing surgery (TSS) is an alternative option to preserve testicular function. Since there are no clear guidelines, we aimed to develop consensus recommendations on the management of STMs.</p><p><strong>Methods: </strong>A four-round Delphi study was conducted by 24 experts representing multiple subspecialties to reach consensus. Consensus was defined as ≥75% of the participants scoring within the same 3-point grouping (1-3, disagree; 4-6, uncertain; 7-9, agree.). The first two rounds were survey based, the third round was an online meeting to discuss uncertainties from the first two rounds, and the fourth round was a review of the final consensus statements from rounds 1-3.</p><p><strong>Key findings and limitations: </strong>The initial survey consisted of 126 statements. Following the four rounds of assessment, a list of 96 statements were produced, which focused on clinical and biochemical assessment, colour Doppler ultrasound (CDUS) characteristics, and management options including surveillance, RO, and TSS. Management should be personalised according to risk factors for testicular cancer, fertility status, uni- or bilateral tumours, status of the contralateral testis, and CDUS characteristics, with solid lesions displaying vascularity and hypoechogenicity being more suspicious for malignancy. The consensus statements are prone to a bias, and some may not reflect robust, randomised evidence.</p><p><strong>Conclusions and clinical implications: </strong>The expert panel has produced consensus recommendations on the management of STMs, and TSS should be considered in patients with an STM. The recommendations could aid in the dissemination of best practice.</p><p><strong>Patient summary: </strong>There are no clear guidelines on the management of small testicular masses. Excising the whole testicle (radical orchidectomy) with a small or an indeterminate mass may affect fertility and hormonal function. A panel of experts was formed, and consensus recommendations were developed on how to deal with small and indeterminate testicular masses, which include surveillance or testis-sparing surgery.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regional Versus Systematic Biopsy in Addition to Targeted Biopsy: Results from a Systematic Review and Meta-analysis.","authors":"Francesco Sanguedolce, Carol Nancy Gianna Lauwers, Alessandro Tedde, Giuseppe Basile, Daria Chernysheva, Alessandro Uleri, Michael Baboudjian, Gianluca Giannarini, Valeria Panebianco, Massimo Madonia, Lars Budeaus, Morgan Roupret, Joan Palou, Alberto Breda, Ivo Schoots, Anwar R Padhani","doi":"10.1016/j.euo.2024.10.006","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.006","url":null,"abstract":"<p><strong>Background and objective: </strong>Intensification of targeted biopsy (TBx) around a magnetic resonance imaging (MRI)-visible lesion with regional biopsy (RBx) could obviate the need for systematic biopsy (SBx). We aimed to compare the detection yields of clinically significant prostate cancer (csPCa)-defined as International Society of Urological Pathology (ISUP) grade group ≥2-between TBx + RBx and the reference standard (TBx + SBx).</p><p><strong>Methods: </strong>RBx was defined as perilesional or ipsilateral biopsy. A literature search was conducted up to September 2023 using PubMed, Embase, and Web of Science databases. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. Included studies were eligible when presenting data from SBx, TBx, and TBx + RBx cores and their detection yields. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) criteria were used to assess the risk of bias of the included studies.</p><p><strong>Key findings and limitations: </strong>Twenty-one studies were included for a meta-analysis. The overall detection yield of csPCa was not statistically different between TBx + SBX and TBx + RBx (46.1% vs 44.2%; odds ratio [OR] 1.07, 95% confidence interval [CI] 0.99-1.16, p = 0.07); similar findings were found also for ISUP grade group ≥3 prostate cancer (PCa; OR 1.06, 95% CI 0.92-1.22, p = 0.43) and in different subgroup analyses. TBx + SBx was associated with higher cancer detection of ISUP grade group 1 PCa (OR 1.16, 95% CI 1.04-1.30, p = 0.008). The main limitations include the retrospective nature of most of the selected studies, heterogeneity of RBx definition, and template.</p><p><strong>Conclusions and clinical implications: </strong>Our study supports the use of the TBx + RBx template in the early detection pathway for the detection of csPCa. SBx can be omitted when targeting lesions visible on MRI.</p><p><strong>Patient summary: </strong>A prostate biopsy strategy consisting of taking biopsy in and around an magnetic resonance imaging-visible lesion reduces the risk of detecting indolent prostate cancers without affecting the detection of aggressive tumours.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oncological Outcomes of Active Surveillance versus Surgery or Ablation for Patients with Small Renal Masses: A Systematic Review and Quantitative Analysis.","authors":"Ichiro Tsuboi, Pawel Rajwa, Riccardo Campi, Marcin Miszczyk, Tamás Fazekas, Akihiro Matsukawa, Mehdi Kardoust Parizi, Robert J Schulz, Stefano Mancon, Anna Cadenar, Ekaterina Laukhtina, Tatsushi Kawada, Satoshi Katayama, Takehiro Iwata, Kensuke Bekku, Koichiro Wada, Pierre I Karakiewicz, Mesut Remzi, Motoo Araki, Shahrokh F Shariat","doi":"10.1016/j.euo.2024.10.008","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.008","url":null,"abstract":"<p><strong>Background and objective: </strong>While active surveillance (AS) is an alternative to surgical interventions in patients with small renal masses (SRMs), evidence regarding its oncological efficacy is still debated. We aimed to evaluate oncological outcomes for patients with SRMs who underwent AS in comparison to surgical interventions.</p><p><strong>Methods: </strong>In April 2024, PubMed, Scopus, and Web of Science were queried for comparative studies evaluating AS in patients with SRMs (PROSPERO: CRD42024530299). The primary outcomes were overall (OS) and cancer-specific survival (CSS). A random-effects model was used for quantitative analysis.</p><p><strong>Key findings and limitations: </strong>We identified eight eligible studies (three prospective, four retrospective, and one study based on Surveillance, Epidemiology and End Results [SEER] data) involving 4947 patients. Pooling of data with the SEER data set revealed significantly higher OS rates for patients receiving surgical interventions (hazard ratio [HR] 0.73; p = 0.007), especially partial nephrectomy (PN; HR 0.62; p < 0.001). However, in a sensitivity analysis excluding the SEER data set there was no significant difference in OS between AS and surgical interventions overall (HR 0.84; p = 0.3), but the PN subgroup had longer OS than the AS group (HR 0.6; p = 0.002). Only the study based on the SEER data set showed a significant difference in CSS. The main limitations include selection bias in retrospective studies, and classification of interventions in the SEER database study.</p><p><strong>Conclusions and clinical implications: </strong>Patients treated with AS had similar OS to those who underwent surgery or ablation, although caution is needed in interpreting the data owing to the potential for selection bias and variability in AS protocols. Our review reinforces the need for personalized shared decision-making to identify patients with SRMs who are most likely to benefit from AS.</p><p><strong>Patient summary: </strong>For well-selected patients with a small kidney mass suspicious for cancer, active surveillance seems to be a safe alternative to surgery, with similar overall survival. However, the evidence is still limited and more studies are needed to help in identifying the best candidates for active surveillance.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world Study of Avelumab First-line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma in France: Overall Results from the Noninterventional AVENANCE Study and Analysis of Outcomes by Second-line Treatment.","authors":"Philippe Barthélémy, Constance Thibault, Aude Fléchon, Marine Gross-Goupil, Eric Voog, Jean-Christophe Eymard, Christine Abraham, Matthieu Chasseray, Véronique Lorgis, Werner Hilgers, Aurélien Gobert, Sylvestre Le Moulec, Camille Simon, Emanuel Nicolas, Anne Escande, Damien Pouessel, Guillaume Mouillet, Constant Josse, Marie-Noelle Solbes, Prisca Lambert, Yohann Loriot","doi":"10.1016/j.euo.2024.09.014","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.014","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Avelumab first-line maintenance treatment was approved for patients with advanced urothelial carcinoma (aUC) without progression following platinum-based chemotherapy (PBC), based on the results from the JAVELIN Bladder 100 phase 3 trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To report the results from AVENANCE, a real-world study of avelumab first-line maintenance treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This is a retrospective and prospective, noninterventional study (NCT04822350). Eligible patients with aUC without progression on first-line PBC were enrolled at 82 centers in France between July 2021 and May 2022. The effectiveness population included 595 patients. The median follow-up was 26.3 mo.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Intervention: &lt;/strong&gt;Previous, ongoing, or planned avelumab first-line maintenance treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Outcome measurements and statistical analysis: &lt;/strong&gt;Overall survival (OS) from avelumab initiation (primary endpoint) and safety were evaluated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results and limitations: &lt;/strong&gt;The median age was 73.0 yr, and performance status was 0/1 in 91% of patients and ≥2 in 9.3%. The most common prior first-line chemotherapy regimen was carboplatin plus gemcitabine (61%). At data cutoff (December 7, 2023), the median duration of avelumab treatment was 5.6 mo, 125 patients remained on avelumab, and 55% had received second-line treatment. The median OS from avelumab initiation was 21.3 mo (95% confidence interval [CI], 17.6-24.6), and the median progression-free survival was 5.7 mo (95% CI, 5.2-6.5). In exploratory analyses of this population without disease progression on PBC, the median OS from the start of first-line PBC was 26.5 mo overall, and in subgroups that received second-line enfortumab vedotin (n = 55) or PBC (n = 79), it was 41.5 and 24.5 mo, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Real-world data from AVENANCE confirm the effectiveness and safety of avelumab first-line maintenance treatment in a heterogeneous population, supporting its recommendation for cisplatin-eligible and cisplatin-ineligible patients with aUC who are progression free after first-line PBC. In an exploratory analysis, a small subgroup that received a treatment sequence of first-line PBC without disease progression followed by avelumab first-line maintenance and second-line enfortumab vedotin had a median OS of &gt;3 yr.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Patient summary: &lt;/strong&gt;A French real-world study, called AVENANCE, looked at avelumab maintenance treatment in people with advanced urothelial cancer whose tumor disappeared, shrank, or stopped growing with chemotherapy. Overall, results were consistent with those seen in a previous clinical trial, and on average, people treated with avelumab maintenance lived for 26.5 mo from the start of chemotherapy. Analyses of different groups of people found that survival varied, with people living for an average of 18-42 mo depending on what treatment ","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex Disparity in Non-muscle-invasive Bladder Cancer: Pitfalls of Large Population-based Data Sets and Lessons from an Integrated Analysis.","authors":"Niyati Lobo, Zhigang Duan, Akshay Sood, Hui Zhao, Sia V Lindskrog, Lars Dyrskjot, Sharon H Giordano, Stephen B Williams, Kelly K Bree, Ashish M Kamat","doi":"10.1016/j.euo.2024.10.001","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.001","url":null,"abstract":"<p><p>The impact of sex on non-muscle-invasive bladder cancer (NMIBC) remains uncertain and current evidence is conflicting. To address this uncertainty, we conducted an integrative analysis using Surveillance, Epidemiology and End Results (SEER)-Medicare and UROMOL data sets to explore sex disparities in NMIBC oncological outcomes. In the SEER-Medicare cohort, females had lower risks of recurrence and progression in comparison to males, but no significant difference in BC-specific mortality was observed. Analysis of the UROMOL cohort revealed no sex-specific differences in tumour biology across genomic, transcriptomic, and spatial proteomic domains. These findings highlight the limitations of relying on just SEER-Medicare data for NMIBC, for which identification of the true incidence of recurrence and progression is challenging, and emphasise the importance of combining population-based data and molecular biology results to gain a comprehensive understanding of NMIBC. PATIENT SUMMARY: The impact of sex on non-muscle-invasive bladder cancer (NMIBC) outcomes is unclear. Our analysis of a large population-based data set showed that the risks of recurrence and progression were lower for females. However, analysis of a separate molecular dataset showed no sex-specific differences. The results highlight the importance of combining population-based data and molecular biology results for a better understanding of NMIBC.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital Twins in Urological Oncology: Precise Treatment Planning via Complex Modeling.","authors":"Enrico Checcucci, Christoph Oing, Daniele Amparore, Francesco Porpiglia, Pasquale Rescigno","doi":"10.1016/j.euo.2024.10.005","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.005","url":null,"abstract":"<p><p>Digital twins can revolutionize personalized medicine by providing virtual simulations for optimized treatment planning and patient care. Digital twins can enhance precision in oncology and surgery, although challenges regarding data and model complexity necessitate ongoing multidisciplinary collaboration for effective implementation.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}