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En Bloc Versus Conventional Transurethral Resection of Bladder Tumors: A Systematic Review and Meta-analysis of Oncological, Histopathological, and Surgical Outcomes. 膀胱肿瘤整体切除术与传统经尿道切除术的比较:肿瘤学、组织病理学和手术结果的系统性回顾和 Meta 分析。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-19 DOI: 10.1016/j.euo.2024.10.004
Giuseppe Basile, Alessandro Uleri, Riccardo Leni, Donato Cannoletta, Luca Afferi, Michael Baboudjian, Pietro Diana, David D'Andrea, Jeremy Teoh, Benjamin Pradere, José D Subiela, Ekaterina Laukhtina, Thomas Seisen, Morgan Rouprêt, Alberto Briganti, Francesco Montorsi, Marco Moschini, Alberto Breda, Andrea Gallioli
{"title":"En Bloc Versus Conventional Transurethral Resection of Bladder Tumors: A Systematic Review and Meta-analysis of Oncological, Histopathological, and Surgical Outcomes.","authors":"Giuseppe Basile, Alessandro Uleri, Riccardo Leni, Donato Cannoletta, Luca Afferi, Michael Baboudjian, Pietro Diana, David D'Andrea, Jeremy Teoh, Benjamin Pradere, José D Subiela, Ekaterina Laukhtina, Thomas Seisen, Morgan Rouprêt, Alberto Briganti, Francesco Montorsi, Marco Moschini, Alberto Breda, Andrea Gallioli","doi":"10.1016/j.euo.2024.10.004","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.004","url":null,"abstract":"<p><strong>Background and objective: </strong>En bloc resection of bladder tumor (ERBT) has been introduced to enhance the quality of resection of bladder cancer. This review aims to compare the perioperative and oncological outcomes of ERBT and conventional transurethral resection of bladder tumor (cTURBT).</p><p><strong>Methods: </strong>A literature search was conducted using the PubMed/Medline, Embase, and Web of Science databases to identify randomized controlled trials published until May 2024. The primary outcomes were the risk of recurrence and progression. The secondary outcomes were detrusor muscle (DM) presence, muscularis mucosae (MM) detectability, bladder perforation and obturator nerve reflex rates, operative time, length of catheterization and hospitalization, and residual tumor at repeat transurethral resection of bladder tumor (reTURBT).</p><p><strong>Key findings and limitations: </strong>Seventeen studies met our inclusion criteria. No statistically significant difference was observed in 12-mo recurrence (risk ratio [RR] 0.81, 95% confidence interval [CI]: 0.65-1.02; p = 0.08), 24-mo recurrence (RR 1.02, 95% CI: 0.85-1.22; p = 0.8), and 12-mo progression (RR 0.68, 95% CI: 0.05-10.14; p = 0.8) rates. ERBT was significantly associated with a higher DM presence (RR 1.10, 95% CI: 1.01-1.20; p = 0.02), while no statistically significant difference emerged in the residual tumor at reTURBT and MM detectability (all p > 0.05). ERBT was significantly associated with a lower risk of bladder perforation (p = 0.002) and obturator nerve reflex (p < 0.001). Finally, ERBT was significantly associated with longer operative time, lower catheterization time, and lower length of hospital stay. The main limitation was heterogeneity among the included studies.</p><p><strong>Conclusions and clinical implications: </strong>ERBT is safer due to fewer intraoperative events, but there was no significant difference in oncological outcomes compared with cTURBT. Higher DM detection with ERBT enhances initial disease stratification, potentially improving clinical decision-making and care delivery.</p><p><strong>Patient summary: </strong>En bloc resection of bladder tumors is associated with lower intraoperative complications than and superior histopathological information to the conventional resection technique. However, the absence of a difference in oncological outcomes underscores the influence of factors such as tumor characteristics, surgeon expertise, and postoperative care on subsequent events.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461480","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}
引用次数: 0
Pairing the Right Individual with the Right Regimen: Patient Selection Criteria in the Treatment of Advanced Urothelial Carcinoma. 将合适的个体与合适的治疗方案配对:治疗晚期尿路上皮癌的患者选择标准。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-16 DOI: 10.1016/j.euo.2024.09.018
David J Benjamin, Arash Rezazadeh Kalebasty
{"title":"Pairing the Right Individual with the Right Regimen: Patient Selection Criteria in the Treatment of Advanced Urothelial Carcinoma.","authors":"David J Benjamin, Arash Rezazadeh Kalebasty","doi":"10.1016/j.euo.2024.09.018","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.018","url":null,"abstract":"<p><p>Enfortumab vedotin plus pembrolizumab is a very effective regimen in the treatment of advanced urothelial carcinoma but is difficult to tolerate. We discuss the rationale for establishing patient selection criteria for this combination, taking into consideration the potential for life-altering side effects, limited real-world experience with the regimen among oncologists, patient preferences in balancing treatment effectiveness against toxicity, and the precedent in establishing eligibility criteria for platinum-based chemotherapy.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461484","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}
引用次数: 0
Cost-effectiveness Analysis in the New Era of Treatment Strategies in Metastatic Urothelial Carcinoma Based on Checkmate-901 and EV302/Keynote-A39. 基于Checkmate-901和EV302/Keynote-A39的转移性尿路上皮癌治疗策略新时代的成本效益分析。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-15 DOI: 10.1016/j.euo.2024.10.003
Constantin Rieger, Jörg Schlüchtermann, Michaela Lehmann, Enno Storz, Richard Weiten, Christian Bach, David Pfister, Axel Heidenreich
{"title":"Cost-effectiveness Analysis in the New Era of Treatment Strategies in Metastatic Urothelial Carcinoma Based on Checkmate-901 and EV302/Keynote-A39.","authors":"Constantin Rieger, Jörg Schlüchtermann, Michaela Lehmann, Enno Storz, Richard Weiten, Christian Bach, David Pfister, Axel Heidenreich","doi":"10.1016/j.euo.2024.10.003","DOIUrl":"https://doi.org/10.1016/j.euo.2024.10.003","url":null,"abstract":"<p><strong>Background and objective: </strong>Metastatic urothelial carcinoma (mUCa) ranks as the costliest cancer to treat per patient due to frequent interventions and expensive follow-ups. Investigating first-line therapies, combinations such as enfortumab vedotin + pembrolizumab (EV + P) and gemcitabine/cisplatin + nivolumab exhibit significant overall survival benefits compared with the standard treatment (SoC; gemcitabine/cisplatin). Here, we conducted a cost-effectiveness analysis for mUCa.</p><p><strong>Methods: </strong>We developed a Markov model from a payer perspective, filtering clinical data from the phase 3 Checkmate-901 and EV302/Keynote-A39 trials. Monte Carlo simulation was used to identify the optimal treatment from a socioeconomic perspective in Germany and the USA. Finally, we compared the incremental cost-effectiveness ratio (ICER) of each modality at different willingness-to-pay (WTP) thresholds.</p><p><strong>Key findings and limitations: </strong>At a lifetime horizon, SoC, gemcitabine/cisplatin + nivolumab, and EV + P were associated with average costs of €163 424 (USA: $458 006), €206 853 (USA: $597 802), and €401 170 (USA: $1 228 455), and gained quality-adjusted life years (QALYs) of 1.21, 1.71, and 2.31, respectively. The ICERs of the newer strategies were €87 340 (USA: $281 142; gemcitabine/cisplatin + nivolumab) and €216 140 (USA: $700 448; EV + P). At a commonly used WTP threshold of €/$100 000, gemcitabine/cisplatin + nivolumab would be the optimal strategy in Germany, while EV + P would require a price reduction of 46% (USA: 82%) to be cost effective.</p><p><strong>Conclusions and clinical implications: </strong>QALYs nearly double with EV + P compared with the current SoC; yet, current costs may not be justified from a strict socioeconomic perspective. Despite its lower oncological benefit, gemcitabine/cisplatin + nivolumab should be considered for first-line therapy due to favorable cost effectiveness, especially in Europe. Establishing individual risk factors is essential for optimizing therapeutic response and treatment costs in the future.</p><p><strong>Patient summary: </strong>This report presents a cost-effectiveness analysis of emerging treatment options for metastatic urothelial carcinoma. The combination of enfortumab vedotin + pembrolizumab emerged as the most effective treatment; however, it also proved to be the costliest. From a purely socioeconomic standpoint, the combination of gemcitabine/cisplatin and nivolumab represents a cost-effective alternative at least in Germany.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461479","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}
引用次数: 0
Molecular Correlates of Prostate Cancer Visibility on Multiparametric Magnetic Resonance Imaging: A Systematic Review. 多参数磁共振成像中前列腺癌可见度的分子相关性:系统回顾
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-15 DOI: 10.1016/j.euo.2024.09.017
Tamás Fazekas, Maximilian Pallauf, Jakub Kufel, Marcin Miszczyk, Ichiro Tsuboi, Akihiro Matsukawa, Ekaterina Laukhtina, Mehdi Kardoust Parizi, Stefano Mancon, Anna Cadenar, Robert Schulz, Takafumi Yanagisawa, Michael Baboudjian, Tibor Szarvas, Giorgio Gandaglia, Derya Tilki, Péter Nyirády, Pawel Rajwa, Michael S Leapman, Shahrokh F Shariat
{"title":"Molecular Correlates of Prostate Cancer Visibility on Multiparametric Magnetic Resonance Imaging: A Systematic Review.","authors":"Tamás Fazekas, Maximilian Pallauf, Jakub Kufel, Marcin Miszczyk, Ichiro Tsuboi, Akihiro Matsukawa, Ekaterina Laukhtina, Mehdi Kardoust Parizi, Stefano Mancon, Anna Cadenar, Robert Schulz, Takafumi Yanagisawa, Michael Baboudjian, Tibor Szarvas, Giorgio Gandaglia, Derya Tilki, Péter Nyirády, Pawel Rajwa, Michael S Leapman, Shahrokh F Shariat","doi":"10.1016/j.euo.2024.09.017","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.017","url":null,"abstract":"<p><strong>Background and objective: </strong>Although prostate magnetic resonance imaging (MRI) is increasingly used to diagnose and stage prostate cancer (PCa), the biologic and clinical significance of MRI visibility of the disease is unclear. Our aim was to examine the existing knowledge regarding the molecular correlates of MRI visibility of PCa.</p><p><strong>Methods: </strong>The PubMed, Scopus, and Web of Science databases were queried through November 2023. We defined MRI-visible and MRI-invisible lesions based on the Prostate Imaging Reporting and Data System (PI-RADS) score, and compared these based on the genomic, transcriptomic, and proteomic characteristics.</p><p><strong>Key findings and limitations: </strong>From 2015 individual records, 25 were selected for qualitative data synthesis. Current evidence supports the polygenic nature of MRI visibility, primarily influenced by genes related to stroma, adhesion, and cellular organization. Several gene signatures related to MRI visibility were associated with oncologic outcomes, which support that tumors appearing as PI-RADS 4-5 lesions harbor lethal disease. Accordingly, MRI-invisible tumors detected by systematic biopsies were, generally, less aggressive and had a more favorable prognosis; however, some MRI-invisible tumors harbored molecular features of biologically aggressive PCa. Among the commercially available prognostic gene panels, only Decipher was strongly associated with MRI visibility.</p><p><strong>Conclusions and clinical implications: </strong>High PI-RADS score is associated with biologically and clinically aggressive PCa molecular phenotypes, and could potentially be used as a biomarker. However, MRI-invisible lesions can harbor adverse features, advocating the continued use of systemic biopsies. Further research to refine the integration of imaging data to prognostic assessment is warranted.</p><p><strong>Patient summary: </strong>Magnetic resonance imaging visibility of prostate cancer is a polygenic trait. Higher Prostate Imaging Reporting and Data System scores are associated with features of biologically and clinically aggressive cancer.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461483","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}
引用次数: 0
Prostate-specific Membrane Antigen Positron Emission Tomography Before Reaching the Phoenix Criteria for Biochemical Recurrence of Prostate Cancer After Radiotherapy: Earlier Detection of Recurrences. 前列腺特异性膜抗原正电子发射断层扫描在放疗后达到凤凰城前列腺癌生化复发标准前的应用:更早地发现复发。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-15 DOI: 10.1016/j.euo.2024.09.015
Evelien J E van Altena, Bernard H E Jansen, Marieke L Korbee, Remco J J Knol, Wietske I Luining, Jakko A Nieuwenhuijzen, Daniela E Oprea-Lager, Stéphanie L van der Pas, Jochem R N van der Voort van Zyp, Friso M van der Zant, Pim J van Leeuwen, Maurits Wondergem, André N Vis
{"title":"Prostate-specific Membrane Antigen Positron Emission Tomography Before Reaching the Phoenix Criteria for Biochemical Recurrence of Prostate Cancer After Radiotherapy: Earlier Detection of Recurrences.","authors":"Evelien J E van Altena, Bernard H E Jansen, Marieke L Korbee, Remco J J Knol, Wietske I Luining, Jakko A Nieuwenhuijzen, Daniela E Oprea-Lager, Stéphanie L van der Pas, Jochem R N van der Voort van Zyp, Friso M van der Zant, Pim J van Leeuwen, Maurits Wondergem, André N Vis","doi":"10.1016/j.euo.2024.09.015","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.015","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background and objective: &lt;/strong&gt;Biochemical recurrence (BCR) of prostate cancer (PCa) after curative radiotherapy (RT) is defined according to the Phoenix criteria, which is a prostate-specific antigen (PSA) rise of ≥2.0 ng/ml above the PSA nadir. Prostate-specific membrane antigen (PSMA)-based positron emission tomography/computed tomography (PET/CT) can identify PCa recurrences at very low PSA values. Our aim was to investigate the detection rate and extent of PCa recurrences using PSMA PET/CT after curative RT among patients with a PSA rise of ≥2.0 ng/ml above the nadir (Phoenix positive, Ph&lt;sup&gt;+&lt;/sup&gt;) and patients not reaching this threshold (Phoenix negative, Ph&lt;sup&gt;-&lt;/sup&gt;) and to compare therapeutic management and clinical outcomes in terms of time to androgen deprivation therapy (ADT) and castration-resistance PCa (CRPC), as well as overall survival.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a retrospective analysis of the Prostate Cancer Network Amsterdam (2015-2023) cohort of 568 patients who received curative-intent RT for PCa. Data on PSMA PET/CT outcomes, therapeutic management, and clinical follow-up were collected, including (re)initiation of ADT, progression to CRPC, and survival. Results were compared between groups using logistic regression and survival analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Key findings and limitations: &lt;/strong&gt;The study cohort comprised 222 patients (39.1%) classified as Ph&lt;sup&gt;-&lt;/sup&gt; and 346 (60.9%) classified as Ph&lt;sup&gt;+&lt;/sup&gt;. PSMA-avid lesions were detected in 170 Ph&lt;sup&gt;-&lt;/sup&gt; patients (76.6%) and 322 (93.1%) Ph&lt;sup&gt;+&lt;/sup&gt; patients. In these groups, 75.9% of Ph&lt;sup&gt;-&lt;/sup&gt; patients and 45.0% of Ph&lt;sup&gt;+&lt;/sup&gt; patients were eligible for local salvage therapy (odds ratio [OR 3.84]; p &lt; 0.001). Distant metastases were less frequent in the Ph&lt;sup&gt;-&lt;/sup&gt; group (n = 37, 21.8%) than in the Ph&lt;sup&gt;+&lt;/sup&gt; group (n = 157, 48.8%; OR 0.29; p &lt; 0.001). Survival analyses revealed longer times to ADT (re)initiation and progression to CRPC, as well as lower overall mortality, in the Ph&lt;sup&gt;-&lt;/sup&gt; group (log-rank p &lt; 0.001). The retrospective study design is the main limitation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and clinical implications: &lt;/strong&gt;For patients with PCa recurrence, PSMA PET/CT can detect this recurrence in the majority of cases not meeting the Phoenix criteria for BCR. Early imaging detects recurrences at a less advanced disease stage, allowing potential salvage treatments. In addition, early PSMA PET/CT is associated with longer times to ADT (re)initiation and progression to CRPC, as well as longer overall survival. These positive clinical implications warrant confirmation of our results in prospective studies to reduce potential leadtime bias.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Patient summary: &lt;/strong&gt;We investigated early use of a special type of scan called PSMA PET (prostate-specific membrane antigen positron emission tomography) in patients with suspicion of recurrence of their prostate cancer after radiotherapy. Ea","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461485","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}
引用次数: 0
Minimal Residual Disease Detection with Urine-derived DNA Is Prognostic for Recurrence-free Survival in Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Bladder Cancer Treated with Nadofaragene Firadenovec. 用尿源性DNA检测微小残留病灶可预示接受那多法拉金-菲拉多韦克治疗的对卡介苗-桂林杆菌无反应的非肌层浸润性膀胱癌的无复发生存率
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-14 DOI: 10.1016/j.euo.2024.09.016
Vikram M Narayan, Come Tholomier, Sharada Mokkapati, Alberto Martini, Vincent M Caruso, Mahdi Goudarzi, Brian C Mazzarella, Kevin G Phillips, Vincent T Bicocca, Trevor G Levin, Seppo Yla-Herttuala, David J McConkey, Colin P N Dinney
{"title":"Minimal Residual Disease Detection with Urine-derived DNA Is Prognostic for Recurrence-free Survival in Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Bladder Cancer Treated with Nadofaragene Firadenovec.","authors":"Vikram M Narayan, Come Tholomier, Sharada Mokkapati, Alberto Martini, Vincent M Caruso, Mahdi Goudarzi, Brian C Mazzarella, Kevin G Phillips, Vincent T Bicocca, Trevor G Levin, Seppo Yla-Herttuala, David J McConkey, Colin P N Dinney","doi":"10.1016/j.euo.2024.09.016","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.016","url":null,"abstract":"<p><strong>Background and objective: </strong>Urinary tumor DNA (utDNA) profiling identifies mutations associated with urothelial carcinoma and can be used to detect minimal residual disease (MRD). We evaluate the utility of utDNA profiling to predict treatment failure in bacillus Calmette-Guérin-unresponsive high-grade (HG) non-muscle-invasive bladder cancer (NMIBC) treated with nadofaragene firadenovec.</p><p><strong>Methods: </strong>Urine was collected from participants prior to induction (n = 32) and at their 3-mo evaluation (n = 18) in the parallel-arm, phase 2 study (NCT01687244) of nadofaragene firadenovec. The UroAmp MRD assay (Convergent Genomics, South San Francisco, CA, USA) was used to perform utDNA testing. Risk of HG NMIBC recurrence was determined using two algorithm versions, and recurrence-free survival (RFS) was assessed using a Kaplan-Meier analysis.</p><p><strong>Key findings and limitations: </strong>TP53, TERT, PIK3CA, ARID1A, PLEKHS1, ELF3, and ERBB2 were the most prevalently mutated genes. With pretreatment urine, the validated MRD algorithm resulted in 12-mo RFS of 56% for negative and 22% for positive patients (p = 0.097). The experimental, enhanced algorithm classified two additional patients as positive, giving RFS of 71% for negative and 20% for positive patients (p = 0.012). With 3-mo urine, both algorithms gave RFS of 100% for negative and 38% for positive patients (p = 0.038). Longitudinal utDNA testing classified patients as negative (7%), complete responders (13%), partial responders (27%), unresponsive (20%), and expanding (33%).</p><p><strong>Conclusions and clinical implications: </strong>Urinary MRD testing after nadofaragene firadenovec induction provided statistically significant prognostication of recurrence among phase 2 trial participants.</p><p><strong>Patient summary: </strong>By analyzing urine-borne tumor DNA, we can help determine which patients with high-grade non-muscle-invasive bladder cancer are at the greatest risk of recurrence when receiving second-line therapy.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461482","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}
引用次数: 0
Efficacy and Safety of Olaparib Plus Abiraterone Versus Placebo Plus Abiraterone in the First-line Treatment of Patients with Asymptomatic/Mildly Symptomatic and Symptomatic Metastatic Castration-resistant Prostate Cancer: Analyses from the Phase 3 PROpel Trial. 奥拉帕利加阿比特龙与安慰剂加阿比特龙一线治疗无症状/轻度症状和症状转移性钙化抵抗性前列腺癌患者的疗效和安全性:PROpel 3 期试验分析。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-08 DOI: 10.1016/j.euo.2024.09.013
Noel W Clarke, Andrew J Armstrong, Mototsugu Oya, Neal Shore, Giuseppe Procopio, João Daniel Guedes, Cagatay Arslan, Niven Mehra, Francis Parnis, Emma Brown, Friederike Schlürmann, Jae Young Joung, Mikio Sugimoto, Oliver Sartor, Christian Poehlein, David McGuinness, Arnold Degboe, Fred Saad
{"title":"Efficacy and Safety of Olaparib Plus Abiraterone Versus Placebo Plus Abiraterone in the First-line Treatment of Patients with Asymptomatic/Mildly Symptomatic and Symptomatic Metastatic Castration-resistant Prostate Cancer: Analyses from the Phase 3 PROpel Trial.","authors":"Noel W Clarke, Andrew J Armstrong, Mototsugu Oya, Neal Shore, Giuseppe Procopio, João Daniel Guedes, Cagatay Arslan, Niven Mehra, Francis Parnis, Emma Brown, Friederike Schlürmann, Jae Young Joung, Mikio Sugimoto, Oliver Sartor, Christian Poehlein, David McGuinness, Arnold Degboe, Fred Saad","doi":"10.1016/j.euo.2024.09.013","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.013","url":null,"abstract":"<p><strong>Background and objective: </strong>In PROpel (NCT03732820), olaparib + abiraterone resulted in a statistically significant radiographic progression-free survival (rPFS) benefit and numerically prolonged overall survival (OS) versus placebo + abiraterone in first-line (1L) metastatic castration-resistant prostate cancer (mCRPC) patients. Here, we report post hoc exploratory subgroup analyses in patients with asymptomatic/mildly symptomatic or symptomatic disease at baseline.</p><p><strong>Methods: </strong>Patients were randomised 1:1 to olaparib (300 mg b.i.d.) or placebo with abiraterone (1000 mg o.d.) + prednisone/prednisolone (5 mg b.i.d.). For this post hoc exploratory analysis, patients with a Brief Pain Inventory-Short Form (BPI-SF) item 3 score of <4 and no opiate use were classified as asymptomatic/mildly symptomatic; those with a BPI-SF item 3 score of ≥4 and/or opiate use were classified as symptomatic. Subgroup analyses included investigator-assessed rPFS, OS, objective response rate, time to second progression or death, health-related quality of life, and safety.</p><p><strong>Key findings and limitations: </strong>The median rPFS in asymptomatic/mildly symptomatic patients (n = 560) was 27.6 mo for olaparib + abiraterone versus 19.1 mo for placebo + abiraterone (hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.46-0.76). For symptomatic patients (n = 183), equivalent values were 14.1 versus 13.8 mo (HR, 0.78; 95% CI, 0.54-1.13). At the final planned OS analysis, the median OS in asymptomatic/mildly symptomatic patients was not reached for olaparib + abiraterone versus 39.5 mo for placebo + abiraterone (HR, 0.77; 95% CI, 0.59-1.00). For symptomatic patients, equivalent values were 22.9 versus 22.8 mo (HR, 0.82; 95% CI, 0.58-1.16). Other outcomes showed no meaningful differences between the subgroups.</p><p><strong>Conclusions and clinical implications: </strong>Olaparib + abiraterone provided efficacy benefits in 1L mCRPC patients with either asymptomatic/mildly symptomatic or symptomatic disease. A larger benefit occurred in asymptomatic/mildly symptomatic patients.</p><p><strong>Patient summary: </strong>PROpel, a phase 3 clinical trial, looked at whether combining olaparib with abiraterone delays the progression of patients' cancer compared with placebo plus abiraterone. Patients with or without pain symptoms associated with metastatic castration-resistant prostate cancer were eligible for enrolment into the trial. Results showed that olaparib plus abiraterone reduced the risk of disease progression and death, with a larger benefit observed in patients without or with mild pain symptoms than in those with pain symptoms.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142389152","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}
引用次数: 0
Immediate Versus Delayed Exercise on Health-related Quality of Life in Patients Initiating Androgen Deprivation Therapy: Results from a Year-long Randomised Trial. 立即运动与延迟运动对雄激素剥夺疗法患者健康相关生活质量的影响:为期一年的随机试验结果。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-05 DOI: 10.1016/j.euo.2024.09.012
Dennis R Taaffe, Robert U Newton, Suzanne K Chambers, Christian J Nelson, Nigel Spry, Hao Luo, Oliver Schumacher, David Joseph, Robert A Gardiner, Dickon Hayne, Daniel A Galvão
{"title":"Immediate Versus Delayed Exercise on Health-related Quality of Life in Patients Initiating Androgen Deprivation Therapy: Results from a Year-long Randomised Trial.","authors":"Dennis R Taaffe, Robert U Newton, Suzanne K Chambers, Christian J Nelson, Nigel Spry, Hao Luo, Oliver Schumacher, David Joseph, Robert A Gardiner, Dickon Hayne, Daniel A Galvão","doi":"10.1016/j.euo.2024.09.012","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.012","url":null,"abstract":"<p><strong>Background and objective: </strong>An array of treatment-related toxicities result from androgen deprivation therapy (ADT) in patients with prostate cancer (PCa), compromising function and health-related quality of life (HRQoL). Exercise has been demonstrated to counter a number of these adverse effects including decreased HRQoL; however, when exercise should be initiated is less clear. This study aims to examine whether commencing exercise when ADT is initiated rather than later during treatment is more effective in countering adverse effects on HRQoL.</p><p><strong>Methods: </strong>Men with PCa (48-84 yr) initiating ADT were randomised to immediate exercise (IMEX; n = 54) or delayed exercise (DEL; n = 48) for 12 mo. IMEX consisted of 6 mo of supervised resistance/aerobic/impact exercise commenced at the initiation of ADT with 6 mo of follow-up. DEL consisted of 6 mo of usual care followed by 6 mo of the same exercise programme. HRQoL was assessed using the Short Form-36 at baseline and 6 and 12 mo. Intention to treat was utilised for the analyses that included group × time repeated-measures analysis of variance using log transformed data.</p><p><strong>Key findings and limitations: </strong>There were a significant group × time interaction for the physical functioning domain (p = 0.045) and physical component summary score (p = 0.005), and a significant time effect for bodily pain (p < 0.001) and vitality domains (p < 0.001), with HRQoL maintained in IMEX and declining in DEL at 6 mo. Exercise in DEL reversed declines in vitality and in the physical component summary score, with no differences at 12 mo compared with baseline. Limitations include treatment alterations during the intervention.</p><p><strong>Conclusions and clinical implications: </strong>Concurrently initiating exercise and ADT in patients with PCa preserves HRQoL, whereas exercise initiated while on established ADT regimens reverses declines in some HRQoL domains.</p><p><strong>Patient summary: </strong>To avoid initial treatment-related adverse effects on health-related quality of life, exercise medicine should be initiated at the start of treatment.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380420","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}
引用次数: 0
Health-related Quality of Life Assessment in Renal Cell Cancer: A Scoping Review. 肾细胞癌中与健康相关的生活质量评估:范围综述。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-10-03 DOI: 10.1016/j.euo.2024.09.007
Franziska Gross, Ida Marie Lind Rasmussen, Elisabeth Grov Beisland, Gøril Tvedten Jorem, Christian Beisland, Helle Pappot, Juan Ignacio Arraras, Madeline Pe, Bernhard Holzner, Lisa M Wintner
{"title":"Health-related Quality of Life Assessment in Renal Cell Cancer: A Scoping Review.","authors":"Franziska Gross, Ida Marie Lind Rasmussen, Elisabeth Grov Beisland, Gøril Tvedten Jorem, Christian Beisland, Helle Pappot, Juan Ignacio Arraras, Madeline Pe, Bernhard Holzner, Lisa M Wintner","doi":"10.1016/j.euo.2024.09.007","DOIUrl":"10.1016/j.euo.2024.09.007","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background and objective: &lt;/strong&gt;In oncology, patient-reported outcome measures (PROMs) capturing health-related quality of life (HRQOL) play an increasing role in clinical trials, drug approval, and policy making. This scoping review aimed to identify and elaborate on HRQOL-focussed PROMs used in renal cell cancer (RCC) clinical trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;MEDLINE, Web of Science, PsychINFO, Academic Search Elite, CINAHL, Embase, and the Cochrane Library were searched systematically for original peer-reviewed articles on clinical trials including RCC patients and using PROMs, published between 1950 and 2023. Prespecified trial characteristics and information on the PROMs used were extracted. Frequencies and proportions of categorical data, and ranges and medians of continuous variables were calculated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Key findings and limitations: &lt;/strong&gt;Of the 48 unique studies included, the majority followed a randomised controlled design (34, 71%) and evaluated systemic treatments (38, 79%). The trials used 27 different PROMs (max = 6, median = 2), of which only 4 (15%) were developed specifically for kidney cancer patients. Of the trials, 46% did not use any RCC-specific PROM. European Quality of Life-5 Dimensions (EQ-5D), European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI) -15/19-item version, FKSI-Disease Related Symptoms, and Functional Assessment of Cancer Therapy-General (FACT-G) were the most frequently used questionnaires, with pain, ability to work, fatigue, worry, and sleep quality being the most commonly assessed issues.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and clinical implications: &lt;/strong&gt;A variety of PROMs are used in RCC patients, hindering interpretability across trials. The PROMs used differ in terms of both the domains assessed and how the issues are translated into questionnaire items. Though RCC-specific PROMs exist, these have flaws in terms of relevance to patients. To answer predefined relevant HRQOL research questions, revised RCC-specific PROMs and standardisation of their integration into clinical trials are warranted.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Patient summary: &lt;/strong&gt;Researchers are more and more interested in the health-related quality of life of kidney cancer patients and use questionnaires to measure it. This review shows that there are many different health-related quality of life questionnaires that are used in different combinations in clinical trials for kidney cancer patients. This makes it very difficult to compare these study results and draw reliable conclusions for the actual clinical treatment. It was even found that some of the questionnaires used do not capture things that patients actually consider important (eg, emotional issues such as dealing with thoughts about cancer and depression). Therefore, more work needs to be done to develop questionnaires that ask what is r","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375367","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}
引用次数: 0
Clinical Implementation of Urinary Biomarkers for Surveillance of Non-muscle-invasive Bladder Cancer (NMIBC): Considerations from the European Association of Urology NMIBC Guideline Panel. 用于监测非肌层浸润性膀胱癌(NMIBC)的尿液生物标记物的临床实施:欧洲泌尿学协会非肌浸润性膀胱癌指南小组的考虑因素。
IF 8.3 1区 医学
European urology oncology Pub Date : 2024-09-28 DOI: 10.1016/j.euo.2024.09.011
Fredrik Liedberg, Paramananthan Mariappan, Paolo Gontero
{"title":"Clinical Implementation of Urinary Biomarkers for Surveillance of Non-muscle-invasive Bladder Cancer (NMIBC): Considerations from the European Association of Urology NMIBC Guideline Panel.","authors":"Fredrik Liedberg, Paramananthan Mariappan, Paolo Gontero","doi":"10.1016/j.euo.2024.09.011","DOIUrl":"https://doi.org/10.1016/j.euo.2024.09.011","url":null,"abstract":"<p><p>Although high-level evidence is currently lacking, noninferiority randomised controlled trials in predefined risk groups in non-muscle-invasive bladder cancer are under way to scientifically prove the safety of urinary biomarker-guided follow-up. To facilitate recommendations for clinical use, it is essential to comply with the EU certification for in vitro diagnostics and to demonstrate cost effectiveness.</p>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":" ","pages":""},"PeriodicalIF":8.3,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344432","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}
引用次数: 0
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