Pub Date : 2024-11-05DOI: 10.1016/j.euo.2024.10.009
Julien Van Damme, Bertrand Tombal, Nicolas Michoux, Sandy Van Nieuwenhove, Vassiliki Pasoglou, Perrine Triqueneaux, Anwar R Padhani, Frederic E Lecouvet
Background and objectives: 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).
Methods: 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.
Key findings and limitations: 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.
Conclusions and clinical implications: In mHNPC, wbMRI progression was associated with a higher risk of needing subsequent treatment and shorter OS.
Patient summary: 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.
{"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":null,"pages":null},"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}
Pub Date : 2024-11-04DOI: 10.1016/j.euo.2024.10.010
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
Background and objective: 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.
Methods: 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.
Key findings and limitations: 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.
Conclusions and clinical implications: 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.
Patient summary: 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.
{"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":null,"pages":null},"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}
Pub Date : 2024-10-24DOI: 10.1016/j.euo.2024.10.006
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
Background and objective: 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).
Methods: 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.
Key findings and limitations: 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.
Conclusions and clinical implications: 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.
Patient summary: 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.
背景和目的:在磁共振成像(MRI)可见病灶周围加强靶向活检(TBx)并进行区域活检(RBx)可避免系统性活检(SBx)的需要。我们的目的是比较 TBx + RBx 和参考标准(TBx + SBx)对有临床意义的前列腺癌(csPCa)(定义为国际泌尿病理学会(ISUP)分级组≥2)的检出率:RBx定义为周围或同侧活检。使用PubMed、Embase和Web of Science数据库对截至2023年9月的文献进行了检索。研究遵循了系统综述和荟萃分析首选报告项目(PRISMA)指南。如果纳入的研究提供的数据来自 SBx、TBx 和 TBx + RBx 核心及其检测率,则符合条件。诊断准确性研究质量评估(QUADAS-2)标准用于评估纳入研究的偏倚风险:荟萃分析共纳入了 21 项研究。TBx+SBX和TBx+RBx对csPCa的总体检出率没有统计学差异(46.1% vs 44.2%;几率比[OR]1.07,95%置信区间[CI]0.99-1.16,p = 0.07);对于ISUP分级≥3级的前列腺癌(PCa;OR 1.06,95% CI 0.92-1.22,p = 0.43),在不同的亚组分析中也发现了类似的结果。TBx+SBx与更高的ISUP分级1组PCa癌症检出率相关(OR 1.16,95% CI 1.04-1.30,p = 0.008)。主要的局限性包括大多数所选研究的回顾性、RBx定义和模板的异质性:我们的研究支持在检测 csPCa 的早期检测路径中使用 TBx + RBx 模板。患者小结:前列腺活检策略包括在磁共振成像可见病灶及其周围进行活检,这种策略可降低检测出懒惰性前列腺癌的风险,同时不会影响侵袭性肿瘤的检测。
{"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":null,"pages":null},"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}
Pub Date : 2024-10-24DOI: 10.1016/j.euo.2024.10.008
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
Background and objective: 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.
Methods: 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.
Key findings and limitations: 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.
Conclusions and clinical implications: 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.
Patient summary: 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.
{"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":null,"pages":null},"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}
Pub Date : 2024-10-23DOI: 10.1016/j.euo.2024.09.014
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
<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To report the results from AVENANCE, a real-world study of avelumab first-line maintenance treatment.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Intervention: </strong>Previous, ongoing, or planned avelumab first-line maintenance treatment.</p><p><strong>Outcome measurements and statistical analysis: </strong>Overall survival (OS) from avelumab initiation (primary endpoint) and safety were evaluated.</p><p><strong>Results and limitations: </strong>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.</p><p><strong>Conclusions: </strong>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 >3 yr.</p><p><strong>Patient summary: </strong>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
{"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":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To report the results from AVENANCE, a real-world study of avelumab first-line maintenance treatment.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Intervention: </strong>Previous, ongoing, or planned avelumab first-line maintenance treatment.</p><p><strong>Outcome measurements and statistical analysis: </strong>Overall survival (OS) from avelumab initiation (primary endpoint) and safety were evaluated.</p><p><strong>Results and limitations: </strong>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.</p><p><strong>Conclusions: </strong>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 >3 yr.</p><p><strong>Patient summary: </strong>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":null,"pages":null},"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}
Pub Date : 2024-10-23DOI: 10.1016/j.euo.2024.10.001
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
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.
{"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":null,"pages":null},"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}
Pub Date : 2024-10-22DOI: 10.1016/j.euo.2024.10.005
Enrico Checcucci, Christoph Oing, Daniele Amparore, Francesco Porpiglia, Pasquale Rescigno
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.
{"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":null,"pages":null},"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}
Pub Date : 2024-10-22DOI: 10.1016/j.euo.2024.10.002
Jan Chandra Engel, Martin Eklund, Fredrik Jäderling, Thorgerdur Palsdottir, Ugo Falagario, Andrea Discacciati, Tobias Nordström
Background and objective: The optimal biopsy strategy in prostate cancer screening is unknown. This study aims to assess the diagnostic effects of omitting systematic biopsies in a screening cohort.
Methods: We used data from the STHLM3-MRI trial. A total of 7609 men aged 50-74 yr were randomised to undergo magnetic resonance imaging (MRI) if having an elevated risk of prostate cancer (prostate-specific antigen [PSA] ≥3 ng/ml or Stockholm3 ≥11%). Participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3 underwent targeted and systematic biopsies. Cancer detection rates from combined and targeted-only biopsies were presented as a risk ratio (RR). Subgroup analyses were stratified by age, PSA density (PSAd), and PI-RADS. Differences in reclassification rates at radical prostatectomy were calculated.
Key findings and limitations: The median age of the participants was 66 yr (interquartile range: 61-71) and PSA 3.8 ng/ml (2.9-5.8). Out of 395 men undergoing combined biopsies, 52 (13.2%) had International Society of Urological Pathology (ISUP) grade group (GG) 1 and 230 (58%) had ISUP GG ≥2 prostate cancer. Omission of systematic biopsies reduced cancer detection rates (RR of ISUP GG 1: 0.83 [95% confidence interval 0.64-1.07]; ISUP GG ≥2: 0.85 [0.81-0.90]; and ISUP GG ≥3: 0.86 [0.79-0.95]). Each case of averted ISUP GG 1 cancer was associated with 3.8 cases of missed ISUP GG ≥2 and 1.1 case of ISUP GG ≥3 cancer. Detection of fewer ISUP GG ≥2 cases than the number of avoided ISUP 1 cancer cases was observed in all subgroups when systematic biopsies were omitted. Using PSAd ≥0.05 ng/ml2 as a cut-off for a biopsy resulted in the same numbers of ISUP GG 1 tumours saved, with higher detection rates of ISUP GG ≥2 tumours. In 146 men undergoing radical prostatectomy, 46 (31.5%) versus 28 (19.2%) were upgraded following targeted biopsies versus a combined biopsy strategy (p < 0.05).
Conclusions and clinical implications: Complete omission of systematic biopsies in prostate cancer screening is associated with decreased detection of significant cancer, while reducing overdetection of insignificant cancer to a smaller extent. This strategy also increased the risk of histopathological misclassification.
Patient summary: In a prostate cancer screening setting, we examined the diagnostic effects of systematic biopsies in addition to targeted biopsies in men with suspicious magnetic resonance imaging lesions. We found that exclusion of systematic biopsies led to reduced detection of clinically significant prostate cancer. Our findings emphasise the importance of incorporating systematic biopsies alongside targeted biopsies for improved diagnostic outcomes.
{"title":"Diagnostic Effects of Omitting Systematic Biopsies in Prostate Cancer Screening.","authors":"Jan Chandra Engel, Martin Eklund, Fredrik Jäderling, Thorgerdur Palsdottir, Ugo Falagario, Andrea Discacciati, Tobias Nordström","doi":"10.1016/j.euo.2024.10.002","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.002","url":null,"abstract":"<p><strong>Background and objective: </strong>The optimal biopsy strategy in prostate cancer screening is unknown. This study aims to assess the diagnostic effects of omitting systematic biopsies in a screening cohort.</p><p><strong>Methods: </strong>We used data from the STHLM3-MRI trial. A total of 7609 men aged 50-74 yr were randomised to undergo magnetic resonance imaging (MRI) if having an elevated risk of prostate cancer (prostate-specific antigen [PSA] ≥3 ng/ml or Stockholm3 ≥11%). Participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3 underwent targeted and systematic biopsies. Cancer detection rates from combined and targeted-only biopsies were presented as a risk ratio (RR). Subgroup analyses were stratified by age, PSA density (PSAd), and PI-RADS. Differences in reclassification rates at radical prostatectomy were calculated.</p><p><strong>Key findings and limitations: </strong>The median age of the participants was 66 yr (interquartile range: 61-71) and PSA 3.8 ng/ml (2.9-5.8). Out of 395 men undergoing combined biopsies, 52 (13.2%) had International Society of Urological Pathology (ISUP) grade group (GG) 1 and 230 (58%) had ISUP GG ≥2 prostate cancer. Omission of systematic biopsies reduced cancer detection rates (RR of ISUP GG 1: 0.83 [95% confidence interval 0.64-1.07]; ISUP GG ≥2: 0.85 [0.81-0.90]; and ISUP GG ≥3: 0.86 [0.79-0.95]). Each case of averted ISUP GG 1 cancer was associated with 3.8 cases of missed ISUP GG ≥2 and 1.1 case of ISUP GG ≥3 cancer. Detection of fewer ISUP GG ≥2 cases than the number of avoided ISUP 1 cancer cases was observed in all subgroups when systematic biopsies were omitted. Using PSAd ≥0.05 ng/ml<sup>2</sup> as a cut-off for a biopsy resulted in the same numbers of ISUP GG 1 tumours saved, with higher detection rates of ISUP GG ≥2 tumours. In 146 men undergoing radical prostatectomy, 46 (31.5%) versus 28 (19.2%) were upgraded following targeted biopsies versus a combined biopsy strategy (p < 0.05).</p><p><strong>Conclusions and clinical implications: </strong>Complete omission of systematic biopsies in prostate cancer screening is associated with decreased detection of significant cancer, while reducing overdetection of insignificant cancer to a smaller extent. This strategy also increased the risk of histopathological misclassification.</p><p><strong>Patient summary: </strong>In a prostate cancer screening setting, we examined the diagnostic effects of systematic biopsies in addition to targeted biopsies in men with suspicious magnetic resonance imaging lesions. We found that exclusion of systematic biopsies led to reduced detection of clinically significant prostate cancer. Our findings emphasise the importance of incorporating systematic biopsies alongside targeted biopsies for improved diagnostic outcomes.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":null,"pages":null},"PeriodicalIF":8.3,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497768","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}