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Improved quality of care for testicular germ cell cancer patients by the implementation of an interdisciplinary testis cancer clinic 通过实施跨学科睾丸癌诊所,提高了睾丸生殖细胞癌患者的护理质量。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-31 DOI: 10.1016/j.urolonc.2025.10.007
Nico C. Grossmann M.D. , Luca Funk M.Med. (UZH) , Christian D. Fankhauser M.D., M.P.H. , Jörg Beyer M.D. , Anja Lorch M.D. , Thomas Hermanns M.D.

Introduction

Adherence to clinical guidelines in the management of testicular germ-cell cancer ensures optimal oncological outcomes, minimizes the risk of overtreatment and undertreatment, and reduces unnecessary investigations including radiographic imaging. An interdisciplinary testis cancer clinic (ITCC) in the Department of urology of the University Hospital Zürich was therefore established in 2016 led by a urologist and medical oncologist, who had both specialized in germ-cell cancer. Aside from treatment decision visits, structured follow-up schedules were integrated to guarantee guideline-conformant therapy and follow-up. We aimed to evaluate the impact of the ITCC on guideline adherence and follow-up.

Materials and Methods

A retrospective analysis was conducted on all testicular germ-cell cancer patients treated from 2012 to 2020 in our hospital. Patients were categorized into 2 groups: those followed prior to the establishment of the ITCC and those thereafter. We compared patient characteristics, follow-up protocols, and the compliance with guideline-recommended follow-up schedules.

Results

We included 143 patients, with 77 in the pre-ITCC group and 66 in the ITCC group. Adherence to clinical follow-up guidelines over a 5-year period was significantly higher in the ITCC group, with 89% completeness of the recommended consultations and diagnostics compared to only 21% in the pre-ITCC group. Additionally, the median number of computed tomography scans was significantly lower in the ITCC group during each of the 5 years of follow-up. The time between orchiectomy and start of further therapies was significantly shorter in the ITCC group (median 24 days versus 32 days, P < 0.01) and significantly less patients were lost to follow-up (11% versus 36%, P < 0.001).

Conclusions

A well-structured ITCC can improve the quality of care of testis cancer patients by optimizing adherence to follow-up schedules and therefore expediting further therapies, reducing unnecessary diagnostics and minimizing loss to follow-up.
导言:在睾丸生殖细胞癌的治疗中,遵守临床指南可确保最佳的肿瘤结果,最大限度地降低过度治疗和治疗不足的风险,并减少不必要的检查,包括放射成像。因此,2016年在浙江大学附属 rich医院泌尿科成立了一个跨学科睾丸癌诊所(ITCC),由专门研究生殖细胞癌的泌尿科医生和医学肿瘤学家领导。除了治疗决策访问外,还整合了结构化的随访时间表,以保证符合指南的治疗和随访。我们的目的是评估ITCC对指南依从性和随访的影响。材料与方法:回顾性分析我院2012 - 2020年收治的所有睾丸生殖细胞癌患者。患者分为两组:在ITCC成立之前随访的患者和在ITCC成立之后随访的患者。我们比较了患者特征、随访方案和指南推荐的随访计划的依从性。结果:我们纳入143例患者,其中77例为ITCC前期组,66例为ITCC组。ITCC组在5年期间对临床随访指南的依从性明显更高,推荐的咨询和诊断的完整性为89%,而ITCC前组仅为21%。此外,在5年的随访中,ITCC组的计算机断层扫描中位数明显较低。ITCC组从睾丸切除术到开始进一步治疗的时间显著缩短(中位24天对32天,P < 0.01),失访患者显著减少(11%对36%,P < 0.001)。结论:结构良好的ITCC可以通过优化对随访计划的依从性来提高睾丸癌患者的护理质量,从而加快进一步治疗,减少不必要的诊断并最大限度地减少随访损失。
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引用次数: 0
Evaluation of event-free survival as a surrogate for overall survival in genitourinary rhabdomyosarcoma 泌尿生殖系统横纹肌肉瘤无事件生存期替代总生存期的评估
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-30 DOI: 10.1016/j.urolonc.2025.08.023
Zijing Cheng Ph.D. , Timothy Campbell M.D. , Trevor C. Hunt M.D. , Ashley Li M.D. , Carl Ceraolo M.D. , Karen Doersch M.D., Ph.D. , Jathin Bandari M.D.

Purpose

Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in pediatric patients. Due to rarity, treatment advancements are infrequent and randomized controlled trials (RCTs) are challenging to conduct and interpret. Surrogate endpoints are particularly useful in RCTs for rare diseases; however, they are not always accurate or effective. Event-free survival (EFS) is a common surrogate endpoint for overall survival (OS), but has never been validated in genitourinary (GU) RMS.

Methods

Data from three clinical trials were pooled, including 111 subjects with GU primary sites across low-, intermediate-, and high-risk RMS. These trials employed various chemotherapy regimens ± radiation, based on risk-group. The definitive endpoint was OS and the surrogate endpoint was EFS. A 2-stage meta-analytic copula modeling approach was selected to assess surrogacy. The Plackett model was chosen to estimate treatment effects. Sensitivity analyses included convergence testing, goodness-of-fit, and leave-one-out cross-validation.

Results

Of 111 subjects, 56 (50.5%) were randomized into control and 55 (49.5%) into treatment arms. Surrogacy analysis revealed a moderate to strong association between EFS and OS, with trial-level associations (Rtrial2 of 1.0) showing a stronger correlation than individual-level associations (Kendall’s τ of 0.67). The surrogate threshold effect was 0.44. Robustness was limited by sample size due to disease and trial rarity.

Conclusions

In GU RMS, EFS is a moderate to strong surrogate endpoint for OS. These findings support its use as a surrogate endpoint, and the strength of this surrogacy may enable future clinical trial design to utilize EFS with greater emphasis than in prior studies.
目的:habdomyosarcoma (RMS)是儿童最常见的软组织肉瘤。由于罕见,治疗进展很少,随机对照试验(rct)的进行和解释具有挑战性。替代终点在罕见病的随机对照试验中特别有用;然而,它们并不总是准确或有效的。无事件生存期(EFS)是总生存期(OS)的常用替代终点,但从未在泌尿生殖系统(GU) RMS中得到验证。方法汇总三项临床试验的数据,包括111例低、中、高风险RMS的GU原发部位患者。这些试验采用各种化疗方案±放疗,基于风险组。最终终点为OS,替代终点为EFS。采用两阶段荟萃分析copula建模方法评估代孕。我们选择Plackett模型来评估治疗效果。敏感性分析包括收敛检验、拟合优度和留一交叉验证。结果111例受试者中,56例(50.5%)被随机分为对照组,55例(49.5%)被随机分为治疗组。代孕分析显示,EFS和OS之间存在中等至强烈的相关性,试验水平的相关性(Rtrial2为1.0)比个体水平的相关性更强(Kendall 's τ为0.67)。替代阈值效应为0.44。由于疾病和试验稀有性,稳健性受到样本量的限制。结论在GU RMS中,EFS是OS的中强替代终点。这些研究结果支持将其作为替代终点,并且这种替代的强度可能使未来的临床试验设计比以前的研究更强调使用EFS。
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引用次数: 0
Evaluation of PI-RADS version 2.1 vs. 2.0 for detecting clinically significant prostate cancer in biopsy-naïve men PI-RADS 2.1与2.0版本在biopsy-naïve男性中检测具有临床意义的前列腺癌的评价
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-30 DOI: 10.1016/j.urolonc.2025.10.004
Kathryn E. Fink , Mitchell M. Huang M.D. , Eric V. Li M.D. , Mohammad R. Siddiqui M.D. , Nicole Handa M.D. , Austin Drysch , Ridwan Alam M.D., M.P.H. , Anugayathri Jawahar M.D. , Edward M. Schaeffer M.D., Ph.D. , Ashley E. Ross M.D., Ph.D. , Hiten D. Patel M.D., M.P.H.

Introduction

To evaluate the diagnostic performance of version 2.1 of the prostate imaging reporting and data system (PI-RADS v2.1) compared to version 2.0 (PI-RADS v2.0) for detecting clinically significant prostate cancer (csPCa), we analyzed a cohort using multiparametric MRI (mpMRI). PI-RADS was developed to standardize mpMRI acquisition and interpretation, with version 2.1 introducing revisions to the assessment of transition zone (TZ) lesions aimed at improving detection of prostate cancer (PCa).

Methods

We conducted a retrospective study of biopsy-naive men who underwent mpMRI between 2018 and 2022. Patients were grouped by interpretation under PI-RADS v2.0 or v2.1. The primary outcome was detection of csPCa, defined as Grade Group ≥2 on subsequent biopsy. Analyses were performed for the cohort and stratified by the region of the index lesion.

Results

Of 1,427 patients, 1,144 (80.2%) underwent mpMRI evaluated under v2.1 and 283 (19.8%) under v2.0. Compared to v2.0, the v2.1 group had more PI-RADS 5 lesions (21% vs. 16%) and fewer PI-RADS 1 to 2 lesions (8% vs. 14%) (P = 0.004). csPCa detection per patient was higher in the v2.1 group (50% vs. 43%, P = 0.04), driven by improved detection in the TZ (55.1% vs. 39.3%, P = 0.04). No significant difference was seen in the peripheral zone (PZ). Multivariable analysis showed higher csPCa detection for TZ lesions with v2.1 (OR: 1.34, 95% CI: 1.02–1.76, P = 0.03).

Conclusions

PI-RADS v2.1 was associated with csPCa detection in TZ lesions compared to v2.0.
简介:为了评估前列腺成像报告和数据系统(PI-RADS v2.1)与2.0版本(PI-RADS v2.0)在检测临床意义的前列腺癌(csPCa)方面的诊断性能,我们使用多参数MRI (mpMRI)分析了一个队列。PI-RADS是为了标准化mpMRI采集和解释而开发的,其2.1版本引入了对过渡区(TZ)病变评估的修订,旨在提高前列腺癌(PCa)的检测。方法:我们对2018年至2022年期间接受mpMRI检查的未接受活检的男性进行了回顾性研究。在PI-RADS v2.0或v2.1下进行解释分组。主要终点是csPCa的检测,在随后的活检中定义为≥2级组。对队列进行分析,并按主要病变区域分层。结果:1427例患者中,1144例(80.2%)接受了v2.1下的mpMRI评估,283例(19.8%)接受了v2.0下的mpMRI评估。与v2.0相比,v2.1组PI-RADS 5级病变较多(21%比16%),PI-RADS 1 ~ 2级病变较少(8%比14%)(P = 0.004)。v2.1组患者csPCa检出率较高(50%比43%,P = 0.04),这是由于TZ检出率提高(55.1%比39.3%,P = 0.04)。外周区(PZ)无明显差异。多变量分析显示,v2.1的TZ病变csPCa检出率较高(OR: 1.34, 95% CI: 1.02-1.76, P = 0.03)。结论:PI-RADS v2.1版本与v2.0版本相比,与TZ病变csPCa检测相关。
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引用次数: 0
Comparison of 4 local anesthetic techniques for open radical cystectomy: A prospective, randomized controlled trial 开放性根治性膀胱切除术4种局部麻醉技术的比较:一项前瞻性、随机对照试验。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-30 DOI: 10.1016/j.urolonc.2025.09.019
Jiping Zeng MD , Isamu Tachibana MD , Josh Sadowski , Yar Yeap MD , Amy McCutchan MD , Elisa Sarmiento MPH , Pengyue Zhang PhD , Adam Lemmon MD , Brendon Burke MD , Clint Cary MD, MPH, MBA , Hristos Z. Kaimakliotis MD , Timothy A. Masterson MD

Background and Objective

Open radical cystectomy with urinary diversion is associated with high morbidity, partly due to perioperative opioid use and delayed return of bowel function. We designed a prospective, randomized controlled trial to compare 4 common perioperative analgesic techniques.

Methods

A total of 160 patients between 2019 and 2021 were prospectively enrolled and randomized into 4 groups – thoracic epidural anesthesia (TEA), rectus sheath block (RSB), surgeon infiltration (SI) with either liposomal bupivacaine (LB) or standard bupivacaine (SB). The primary outcome was Visual Analog Scale (VAS) scores at different time points. Secondary outcomes including opioid use, incidence of treatment related side effects, and length of stay (LOS) were measured.

Results

There was no statistical difference regarding VAS scores among 4 groups at 24-, 48, or 96-hour marks. At 72-hour, both TEA and SI with SB had lower VAS scores compared to SI with LB at rest. Compared to SI with SB, TEA had lower cumulative opioid use in first 72 hours postoperatively. The opioid use at individual timepoint, treated related side effects and LOS were similar across groups. TEA was not associated with increased incidence of hypotension, AKI, or delayed ambulation. The ileus rates were higher in SI groups than in TEA and RSB groups (not statistically significant). Limitations include variability in analgesic techniques and timing to transition to PO opioids.

Conclusions

Four analgesic methods perform similarly regarding pain control, opioid use, treatment related side effects and LOS in radical cystectomy.
背景和目的:开放性根治性膀胱切除术合并尿路转移具有高发病率,部分原因是围手术期阿片类药物的使用和肠道功能的延迟恢复。我们设计了一项前瞻性、随机对照试验来比较4种常见的围手术期镇痛技术。方法:在2019年至2021年期间,共160例患者被前瞻性纳入,随机分为4组:胸椎硬膜外麻醉(TEA)、直肌鞘阻滞(RSB)、布比卡因脂质体(LB)或标准布比卡因(SB)手术浸润(SI)。主要观察指标为视觉模拟评分(VAS)在不同时间点的评分。次要结局包括阿片类药物的使用、治疗相关副作用的发生率和住院时间(LOS)。结果:4组患者在24、48、96小时VAS评分比较,差异均无统计学意义。在72小时时,TEA和SI合并SB的VAS评分均低于SI合并LB的VAS评分。与SI和SB相比,TEA在术后72小时内的阿片类药物累积使用较低。各时间点阿片类药物使用、治疗相关副作用和LOS在各组间相似。TEA与低血压、AKI或行动迟缓的发生率增加无关。SI组的肠梗阻率高于TEA和RSB组(无统计学意义)。局限性包括止痛技术的可变性和向PO阿片类药物过渡的时间。结论:在根治性膀胱切除术中,四种镇痛方法在疼痛控制、阿片类药物使用、治疗相关副作用和LOS方面表现相似。
{"title":"Comparison of 4 local anesthetic techniques for open radical cystectomy: A prospective, randomized controlled trial","authors":"Jiping Zeng MD ,&nbsp;Isamu Tachibana MD ,&nbsp;Josh Sadowski ,&nbsp;Yar Yeap MD ,&nbsp;Amy McCutchan MD ,&nbsp;Elisa Sarmiento MPH ,&nbsp;Pengyue Zhang PhD ,&nbsp;Adam Lemmon MD ,&nbsp;Brendon Burke MD ,&nbsp;Clint Cary MD, MPH, MBA ,&nbsp;Hristos Z. Kaimakliotis MD ,&nbsp;Timothy A. Masterson MD","doi":"10.1016/j.urolonc.2025.09.019","DOIUrl":"10.1016/j.urolonc.2025.09.019","url":null,"abstract":"<div><h3>Background and Objective</h3><div>Open radical cystectomy with urinary diversion is associated with high morbidity, partly due to perioperative opioid use and delayed return of bowel function. We designed a prospective, randomized controlled trial to compare 4 common perioperative analgesic techniques.</div></div><div><h3>Methods</h3><div>A total of 160 patients between 2019 and 2021 were prospectively enrolled and randomized into 4 groups – thoracic epidural anesthesia (TEA), rectus sheath block (RSB), surgeon infiltration (SI) with either liposomal bupivacaine (LB) or standard bupivacaine (SB). The primary outcome was Visual Analog Scale (VAS) scores at different time points. Secondary outcomes including opioid use, incidence of treatment related side effects, and length of stay (LOS) were measured.</div></div><div><h3>Results</h3><div>There was no statistical difference regarding VAS scores among 4 groups at 24-, 48, or 96-hour marks. At 72-hour, both TEA and SI with SB had lower VAS scores compared to SI with LB at rest. Compared to SI with SB, TEA had lower cumulative opioid use in first 72 hours postoperatively. The opioid use at individual timepoint, treated related side effects and LOS were similar across groups. TEA was not associated with increased incidence of hypotension, AKI, or delayed ambulation. The ileus rates were higher in SI groups than in TEA and RSB groups (not statistically significant). Limitations include variability in analgesic techniques and timing to transition to PO opioids.</div></div><div><h3>Conclusions</h3><div>Four analgesic methods perform similarly regarding pain control, opioid use, treatment related side effects and LOS in radical cystectomy.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 64.e7-64.e14"},"PeriodicalIF":2.3,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145422002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Letter to the editor regarding the article “Enhanced diagnostic accuracy of micro-ultrasound in prostate cancer detection: An updated series from a single-center prospective study” 致编辑关于文章“提高微超声在前列腺癌检测中的诊断准确性:来自单中心前瞻性研究的更新系列”的信
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-30 DOI: 10.1016/j.urolonc.2025.08.019
Huseyin Besiroglu, Mustafa Kadihasanoglu
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引用次数: 0
A systematic review and meta-analysis evaluating the incidence, microbiological profile and risk factors associated with urinary tract infection after radical cystectomy 一项评估根治性膀胱切除术后尿路感染发生率、微生物特征和相关危险因素的系统综述和荟萃分析。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-29 DOI: 10.1016/j.urolonc.2025.09.027
Alberto Artiles Medina , César Mínguez Ojeda , José Daniel Subiela , David López Curtis , Ana Domínguez Gutiérrez , Sandra Chamorro Tojeiro , Irene De La Parra Sánchez , Miguel Ángel Jiménez Cidre , Victoria Gómez Dos Santos , Francisco Javier Burgos Revilla
We aimed to evaluate the incidence, microbiological patterns and risk factors of UTIs following radical cystectomy (RC). The study was registered with PROSPERO (CRD42024586612). We searched the PubMed/MEDLINE and Embase databases for articles published until December 2024. The selected records consisted of observational studies with at least two of the following main outcomes: UTI incidence, urosepsis rate, positive urine culture rate, isolated pathogens in urine culture and UTI-associated factors in the 90-day period after RC. Risk of bias was assessed for single-arm and nonrandomised comparative studies. We identified 1845 records and included 17 studies, comprising 18,976 patients who underwent RC. Overall, the pooled 90-day UTI incidence after RC was 21% (95% CI, 17%–25%). Among patients who develop UTI, pooled incidence of urosepsis was 25% (95% CI, 19%–32%). Pooled urine culture positivity reached 79% (95% CI, 74%–84%), with a 25% (95% CI, 17%–34%) and 11% (95% CI, 6%–18%) rate of polymicrobial and fungal infections, respectively.
Pooled prevalence of common bacterial isolates obtained from urine cultures was 26% (95% CI, 18%–35%) for Escherichia coli, 26% (95% CI, 17%–35%) for Enterococcus spp. and 12% (95% CI, 8%–16%) for Klebsiella pneumoniae. Risk factors for 90-day UTI after RC included estimated glomerular filtration rate <60 ml/min/1.73 m2 (RR 1.75, 95% CI, 1.44–2.12), orthotopic neobladder (RR 2.02, 95% CI, 1.17–3.48), postoperative hydronephrosis (RR 1.73, 95% CI, 1.28–2.34) and ureterointestinal stricture (RR 1.98, 95% CI, 1.65–2.38). UTIs are common after RC and clinically present as urosepsis in nearly 25% of cases. A high rate of mixed infections is observed, and the rate of fungal infection can reach 10%. These findings are important for patient counselling and may be utilised to guide empirical antibiotic treatment in everyday clinical practice.
我们旨在评估根治性膀胱切除术(RC)后尿路感染的发生率、微生物学模式和危险因素。该研究已在PROSPERO注册(CRD42024586612)。我们在PubMed/MEDLINE和Embase数据库中检索了2024年12月之前发表的文章。所选记录包括观察性研究,至少有以下两个主要结果:尿路感染发生率、尿脓毒症率、尿培养阳性率、尿培养中分离的病原体和尿路感染相关因素在RC后90天内。对单臂和非随机对照研究进行偏倚风险评估。我们确定了1845份记录,纳入了17项研究,包括18976名接受RC的患者。总体而言,RC术后90天尿路感染发生率为21% (95% CI, 17%-25%)。在发生尿路感染的患者中,尿脓毒症的总发生率为25% (95% CI, 19%-32%)。合并尿培养阳性达到79% (95% CI, 74%-84%),多微生物和真菌感染率分别为25% (95% CI, 17%-34%)和11% (95% CI, 6%-18%)。从尿液培养中获得的常见细菌分离株的总流行率为大肠杆菌26% (95% CI, 18%-35%),肠球菌26% (95% CI, 17%-35%),肺炎克雷伯菌12% (95% CI, 8%-16%)。RC术后90天UTI的危险因素包括肾小球滤过率2 (RR 1.75, 95% CI, 1.44-2.12)、原位新膀胱(RR 2.02, 95% CI, 1.17-3.48)、术后肾积水(RR 1.73, 95% CI, 1.28-2.34)和输尿管肠狭窄(RR 1.98, 95% CI, 1.65-2.38)。尿路感染在RC后很常见,临床上表现为尿脓毒症的病例约占25%。混合感染发生率高,真菌感染发生率可达10%。这些发现对患者咨询很重要,并可用于指导日常临床实践中的经验性抗生素治疗。
{"title":"A systematic review and meta-analysis evaluating the incidence, microbiological profile and risk factors associated with urinary tract infection after radical cystectomy","authors":"Alberto Artiles Medina ,&nbsp;César Mínguez Ojeda ,&nbsp;José Daniel Subiela ,&nbsp;David López Curtis ,&nbsp;Ana Domínguez Gutiérrez ,&nbsp;Sandra Chamorro Tojeiro ,&nbsp;Irene De La Parra Sánchez ,&nbsp;Miguel Ángel Jiménez Cidre ,&nbsp;Victoria Gómez Dos Santos ,&nbsp;Francisco Javier Burgos Revilla","doi":"10.1016/j.urolonc.2025.09.027","DOIUrl":"10.1016/j.urolonc.2025.09.027","url":null,"abstract":"<div><div>We aimed to evaluate the incidence, microbiological patterns and risk factors of UTIs following radical cystectomy (RC). The study was registered with PROSPERO (CRD42024586612). We searched the PubMed/MEDLINE and Embase databases for articles published until December 2024. The selected records consisted of observational studies with at least two of the following main outcomes: UTI incidence, urosepsis rate, positive urine culture rate, isolated pathogens in urine culture and UTI-associated factors in the 90-day period after RC. Risk of bias was assessed for single-arm and nonrandomised comparative studies. We identified 1845 records and included 17 studies, comprising 18,976 patients who underwent RC. Overall, the pooled 90-day UTI incidence after RC was 21% (95% CI, 17%–25%). Among patients who develop UTI, pooled incidence of urosepsis was 25% (95% CI, 19%–32%). Pooled urine culture positivity reached 79% (95% CI, 74%–84%), with a 25% (95% CI, 17%–34%) and 11% (95% CI, 6%–18%) rate of polymicrobial and fungal infections, respectively.</div><div>Pooled prevalence of common bacterial isolates obtained from urine cultures was 26% (95% CI, 18%–35%) for <em>Escherichia coli</em>, 26% (95% CI, 17%–35%) for <em>Enterococcus</em> spp. and 12% (95% CI, 8%–16%) for <em>Klebsiella pneumoniae</em>. Risk factors for 90-day UTI after RC included estimated glomerular filtration rate &lt;60 ml/min/1.73 m<sup>2</sup> (RR 1.75, 95% CI, 1.44–2.12), orthotopic neobladder (RR 2.02, 95% CI, 1.17–3.48), postoperative hydronephrosis (RR 1.73, 95% CI, 1.28–2.34) and ureterointestinal stricture (RR 1.98, 95% CI, 1.65–2.38). UTIs are common after RC and clinically present as urosepsis in nearly 25% of cases. A high rate of mixed infections is observed, and the rate of fungal infection can reach 10%. These findings are important for patient counselling and may be utilised to guide empirical antibiotic treatment in everyday clinical practice.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 12-26"},"PeriodicalIF":2.3,"publicationDate":"2025-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145402105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Molecular subtyping of advanced bladder cancer patients and patient-derived organoids based on a 3-marker immunohistochemistry approach to evaluate chemotherapy sensitivity 基于3标记免疫组织化学方法评估化疗敏感性的晚期膀胱癌患者和患者源性类器官的分子分型
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-27 DOI: 10.1016/j.urolonc.2025.09.023
Bastiaan J. Viergever M.Sc. , Alba C. Zuidema Ph.D. , Trudy Jonges M.D. , Susanne J. Van Schelven B.Sc. , Denise Westland B.Sc. , Eric Kalkhoven Ph.D. , Onno Kranenburg Ph.D. , Richard P. Meijer M.D., Ph.D.

Background

Bladder cancer is among the top ten most common cancers globally and one of the most expensive to treat, primarily due to high recurrence rates stemming from significant heterogeneity and mutational rates. The standard treatment, cisplatin-based combination chemotherapy, yields only 40–56% clinical responses, highlighting the need for improved patient stratification to enable precision treatments. Currently, in general practice patient stratification is based on physical fitness and immunohistopathological characterization. While molecular subtyping has traditionally relied on RNA-sequencing, this method is clinically impractical due to cost and often lacking direct sensitivity correlation. Therefore, we aim to develop an immunohistochemistry-based classification system for the major bladder cancer subtypes.

Methods and Patient Summary

We used the log10 IHC ratios of 3 markers to classify major bladder cancer subtypes.
We applied this subtyping in 3 patient cohorts. First on a tissue microarray cohort (n = 53) from cystectomy treated MIBC patients. Furthermore, a cisplatin-based neoadjuvant chemotherapy cohort with pre- and post-treatment tissues (n = 18). Finally, patient derived bladder cancer organoid cohort (n = 8) for direct subtype specific drug sensitivity testing.

Key Findings and Limitations

Our findings reveal that the classification system offers a valuable approach for subtyping patients individually, in cohorts and in patient-derived organoids (n = 8 distinct organoid lines). Second, this classification system allows detection of subtype changing in patients undergoing neoadjuvant chemotherapy. Furthermore, the classification system effectively distinguishes between significantly (P = 4.07e−10) cisplatin-sensitive (basal-like) and cisplatin-resistant (luminal-like) subtypes in bladder cancer organoids and is hypothesis generating.

Conclusions and Clinical Implications

Our findings suggest that our 3-marker classification system could be valuable as method in future BC patient subtyping for clinical stratification of patients undergoing cisplatin-based treatment.
背景:膀胱癌是全球十大最常见的癌症之一,也是最昂贵的治疗之一,主要是由于显著的异质性和突变率导致的高复发率。标准治疗,以顺铂为基础的联合化疗,仅产生40-56%的临床反应,这突出了改进患者分层以实现精确治疗的必要性。目前,在一般实践中,患者分层是基于身体健康和免疫组织病理学特征。虽然分子分型传统上依赖于rna测序,但由于成本和往往缺乏直接的灵敏度相关性,这种方法在临床上是不切实际的。因此,我们的目标是建立一个基于免疫组织化学的膀胱癌主要亚型的分类系统。方法及患者总结:采用3种标志物的log10 IHC比值对膀胱癌主要亚型进行分类。我们在3个患者队列中应用了这种亚型。首先是一个组织微阵列队列(n = 53),来自膀胱切除术治疗的MIBC患者。此外,一项以顺铂为基础的新辅助化疗治疗前后组织队列研究(n = 18)。最后,对患者衍生的膀胱癌类器官队列(n = 8)进行直接亚型特异性药敏试验。主要发现和局限性:我们的研究结果表明,该分类系统为个体、队列和患者来源的类器官(n = 8个不同的类器官系)提供了一种有价值的方法。其次,该分类系统可以检测出新辅助化疗患者的亚型变化。此外,该分类系统有效区分了膀胱癌类器官中顺铂敏感(基底样)和顺铂耐药(发光样)亚型(P = 4.07e-10),并产生了假设。结论和临床意义:我们的研究结果表明,我们的3标记物分类系统可以作为未来接受顺铂治疗的BC患者临床分层的有价值的方法。
{"title":"Molecular subtyping of advanced bladder cancer patients and patient-derived organoids based on a 3-marker immunohistochemistry approach to evaluate chemotherapy sensitivity","authors":"Bastiaan J. Viergever M.Sc. ,&nbsp;Alba C. Zuidema Ph.D. ,&nbsp;Trudy Jonges M.D. ,&nbsp;Susanne J. Van Schelven B.Sc. ,&nbsp;Denise Westland B.Sc. ,&nbsp;Eric Kalkhoven Ph.D. ,&nbsp;Onno Kranenburg Ph.D. ,&nbsp;Richard P. Meijer M.D., Ph.D.","doi":"10.1016/j.urolonc.2025.09.023","DOIUrl":"10.1016/j.urolonc.2025.09.023","url":null,"abstract":"<div><h3>Background</h3><div>Bladder cancer is among the top ten most common cancers globally and one of the most expensive to treat, primarily due to high recurrence rates stemming from significant heterogeneity and mutational rates. The standard treatment, cisplatin-based combination chemotherapy, yields only 40–56% clinical responses, highlighting the need for improved patient stratification to enable precision treatments. Currently, in general practice patient stratification is based on physical fitness and immunohistopathological characterization. While molecular subtyping has traditionally relied on RNA-sequencing, this method is clinically impractical due to cost and often lacking direct sensitivity correlation. Therefore, we aim to develop an immunohistochemistry-based classification system for the major bladder cancer subtypes.</div></div><div><h3>Methods and Patient Summary</h3><div>We used the log10 IHC ratios of 3 markers to classify major bladder cancer subtypes.</div><div>We applied this subtyping in 3 patient cohorts. First on a tissue microarray cohort (<em>n</em> = 53) from cystectomy treated MIBC patients. Furthermore, a cisplatin-based neoadjuvant chemotherapy cohort with pre- and post-treatment tissues (<em>n</em> = 18). Finally, patient derived bladder cancer organoid cohort (<em>n</em> = 8) for direct subtype specific drug sensitivity testing.</div></div><div><h3>Key Findings and Limitations</h3><div>Our findings reveal that the classification system offers a valuable approach for subtyping patients individually, in cohorts and in patient-derived organoids (<em>n</em> = 8 distinct organoid lines). Second, this classification system allows detection of subtype changing in patients undergoing neoadjuvant chemotherapy. Furthermore, the classification system effectively distinguishes between significantly (<em>P</em> = 4.07e−10) cisplatin-sensitive (basal-like) and cisplatin-resistant (luminal-like) subtypes in bladder cancer organoids and is hypothesis generating.</div></div><div><h3>Conclusions and Clinical Implications</h3><div>Our findings suggest that our 3-marker classification system could be valuable as method in future BC patient subtyping for clinical stratification of patients undergoing cisplatin-based treatment.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 64.e15-64.e25"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of sacituzumab govitecan after enfortumab vedotin in advanced urothelial carcinoma: Analysis of the UNITE study 在晚期尿路上皮癌治疗中,沙西妥珠单抗govitecan的疗效与维多酮联合用药研究的分析。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-27 DOI: 10.1016/j.urolonc.2025.09.025
Tanya Jindal B.S., B.A. , Cindy Y. Jiang M.D. , Omar Alhalabi M.D. , Matthew Davidsohn B.S. , Dory Freeman B.S., B.S.N. , Ilana Y. Epstein B.S. , Dimitra Rafailia Bakaloudi M.D. , Rafee Talukder M.D. , Amanda Nizam M.D. , Charles B. Nguyen M.D. , Eugene Oh B.A. , Irene Tsung M.D. , Michael J. Glover M.D. , Ali Raza Khaki M.D. , Amy K. Taylor M.D. , Salvador Jaime-Casas M.D. , Albert Jang M.D. , Emily Lemke D.N.P. , Cameron Pywell M.D. , Sean T. Evans M.D. , Vadim S. Koshkin M.D.

Background

Sacituzumab govitecan (SG) is an antibody-drug conjugate used for advanced urothelial carcinoma (aUC) refractory to platinum-based chemotherapy and immune checkpoint inhibitors (ICI). Real-world data are needed to better define SG outcomes, particularly following treatment with enfortumab vedotin (EV). In this analysis, we aim to evaluate efficacy of SG after EV and assess putative biomarkers associated with outcomes.

Methods

In the UNITE retrospective study, we identified patients who received ≥1 SG cycle after therapy with EV. Observed response rate (ORR) was assessed in evaluable patients and correlated with baseline clinical characteristics and biomarkers. ORRs were compared using logistic regression, while progression free survival (PFS) and overall survival (OS) from SG start were estimated via Kaplan-Meier and Cox proportional hazard (PH) model. Biomarkers of response were evaluated in multivariate Cox PH models after accounting for relevant clinical variables.

Results

Among 107 patients treated with SG after EV, 97 (91%) had NGS data. Median age was 69 years, 73% were male, 33% had ≥4 prior lines of therapy, and 42% received G-CSF. ORR was 18% (95% CI: 10%–26%), median PFS 3.2 months, and median OS 6.0 months. In patients with disease control on EV, ORR was 22% compared to 8% in primary progressors on EV. No significant associations were found between molecular biomarkers and SG outcomes in the multivariate analysis.

Conclusion

SG showed modest activity after EV in heavily pretreated patients with aUC. ORR with SG after EV was lower than reported in phase 2 and phase 3 clinical trials for SG in the postplatinum/ICI setting.
背景:Sacituzumab govitecan (SG)是一种抗体-药物偶联物,用于对铂基化疗和免疫检查点抑制剂(ICI)难治的晚期尿路上皮癌(aUC)。需要真实世界的数据来更好地定义SG的结果,特别是在使用强制维多汀(EV)治疗后。在本分析中,我们旨在评估EV后SG的疗效,并评估与结果相关的推定生物标志物。方法:在UNITE回顾性研究中,我们确定了在EV治疗后接受≥1个SG周期的患者。观察到的缓解率(ORR)在可评估的患者中进行评估,并与基线临床特征和生物标志物相关。orr使用逻辑回归进行比较,而无进展生存期(PFS)和SG开始的总生存期(OS)通过Kaplan-Meier和Cox比例风险(PH)模型进行估计。在考虑相关临床变量后,在多变量Cox PH模型中评估反应的生物标志物。结果:在107例EV后SG治疗的患者中,97例(91%)有NGS数据。中位年龄为69岁,73%为男性,33%既往治疗≥4次,42%接受过G-CSF。ORR为18% (95% CI: 10%-26%),中位PFS为3.2个月,中位OS为6.0个月。在疾病控制的EV患者中,ORR为22%,而初始EV进展者为8%。在多变量分析中,未发现分子生物标志物与SG结果之间存在显著关联。结论:重度预处理的aUC患者在EV后SG表现出适度的活性。EV后SG的ORR低于铂/ICI后SG的2期和3期临床试验中报道的ORR。
{"title":"Efficacy of sacituzumab govitecan after enfortumab vedotin in advanced urothelial carcinoma: Analysis of the UNITE study","authors":"Tanya Jindal B.S., B.A. ,&nbsp;Cindy Y. Jiang M.D. ,&nbsp;Omar Alhalabi M.D. ,&nbsp;Matthew Davidsohn B.S. ,&nbsp;Dory Freeman B.S., B.S.N. ,&nbsp;Ilana Y. Epstein B.S. ,&nbsp;Dimitra Rafailia Bakaloudi M.D. ,&nbsp;Rafee Talukder M.D. ,&nbsp;Amanda Nizam M.D. ,&nbsp;Charles B. Nguyen M.D. ,&nbsp;Eugene Oh B.A. ,&nbsp;Irene Tsung M.D. ,&nbsp;Michael J. Glover M.D. ,&nbsp;Ali Raza Khaki M.D. ,&nbsp;Amy K. Taylor M.D. ,&nbsp;Salvador Jaime-Casas M.D. ,&nbsp;Albert Jang M.D. ,&nbsp;Emily Lemke D.N.P. ,&nbsp;Cameron Pywell M.D. ,&nbsp;Sean T. Evans M.D. ,&nbsp;Vadim S. Koshkin M.D.","doi":"10.1016/j.urolonc.2025.09.025","DOIUrl":"10.1016/j.urolonc.2025.09.025","url":null,"abstract":"<div><h3>Background</h3><div>Sacituzumab govitecan (SG) is an antibody-drug conjugate used for advanced urothelial carcinoma (aUC) refractory to platinum-based chemotherapy and immune checkpoint inhibitors (ICI). Real-world data are needed to better define SG outcomes, particularly following treatment with enfortumab vedotin (EV). In this analysis, we aim to evaluate efficacy of SG after EV and assess putative biomarkers associated with outcomes.</div></div><div><h3>Methods</h3><div>In the UNITE retrospective study, we identified patients who received ≥1 SG cycle after therapy with EV. Observed response rate (ORR) was assessed in evaluable patients and correlated with baseline clinical characteristics and biomarkers. ORRs were compared using logistic regression, while progression free survival (PFS) and overall survival (OS) from SG start were estimated via Kaplan-Meier and Cox proportional hazard (PH) model. Biomarkers of response were evaluated in multivariate Cox PH models after accounting for relevant clinical variables.</div></div><div><h3>Results</h3><div>Among 107 patients treated with SG after EV, 97 (91%) had NGS data. Median age was 69 years, 73% were male, 33% had ≥4 prior lines of therapy, and 42% received G-CSF. ORR was 18% (95% CI: 10%–26%), median PFS 3.2 months, and median OS 6.0 months. In patients with disease control on EV, ORR was 22% compared to 8% in primary progressors on EV. No significant associations were found between molecular biomarkers and SG outcomes in the multivariate analysis.</div></div><div><h3>Conclusion</h3><div>SG showed modest activity after EV in heavily pretreated patients with aUC. ORR with SG after EV was lower than reported in phase 2 and phase 3 clinical trials for SG in the postplatinum/ICI setting.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 65.e1-65.e11"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Time-dependent changes in pathological risk factors of recurrence after renal cell carcinoma surgery 肾细胞癌术后复发病理危险因素的时间依赖性变化。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-27 DOI: 10.1016/j.urolonc.2025.10.003
Hiroyuki Shikuma MD , Yuki Kohada MD , Keisuke Goto MD, PhD , Masanobu Shigeta MD, PhD , Mitsuru Kajiwara MD, PhD , Akira Yano MD, PhD , Yuichi Kadonishi MD , Shuntaro Koda MD, PhD , Kohei Kobatake MD, PhD , Yohei Sekino MD, PhD , Hiroyuki Kitano MD, PhD , Akihiro Goriki MD, PhD , Keisuke Hieda MD, PhD , Nobuyuki Hinata MD, PhD

Objectives

To evaluate time-dependent changes in pathological risk factors for recurrence in patients with renal cell carcinoma (RCC) after surgery, we assessed the impact of prolonged recurrence-free survival (RFS) on subsequent recurrence rates and pathological risk factors using conditional survival (CS) analysis.

Patients and Methods

This retrospective multicenter study included 994 patients who underwent radical or partial nephrectomy for localized RCC between 2010 and 2019. Conditional RFS (C-RFS) and conditional cumulative incidence of cancer-specific mortality (CCSM) were calculated to assess the time-dependent recurrence risk. The impact of pathological factors on recurrence was evaluated using multivariable Cox regression and hazard function analyses.

Results

The 5-year C-RFS and CCSM remained stable over time, with no significant improvement even as the postoperative duration increased. Although pathological tumor stage and World Health Organization/International Society of Urological Pathology grade were significant predictors of recurrence at baseline, their prognostic values declined over time. In contrast, lymphovascular invasion (LVI) consistently remained a significant risk factor for recurrence throughout the follow-up period, as demonstrated by the CS analysis (baseline: LVI-positive, 64.3%; LVI-negative, 92.5%; 5-year LVI-positive, 74.1%; LVI-negative, 92.3%), multivariate Cox regression analyses (baseline hazard ratio [HR], 3.03; 3-year HR, 4.33), and hazard curves.

Conclusion

Even with longer event-free time after surgery, improvements in subsequent C-RFS and CCSM were limited. Although the influence of most pathological risk factors diminished over time, LVI remained a consistent predictor of recurrence. These findings underscore the importance of postoperative strategies that account for the dynamic changes in pathological risk factors in RCC.
目的:为了评估肾细胞癌(RCC)患者术后复发病理危险因素的时间依赖性变化,我们使用条件生存(CS)分析评估了延长无复发生存(RFS)对随后复发率和病理危险因素的影响。患者和方法:这项回顾性多中心研究包括2010年至2019年期间接受局部肾细胞癌根治性或部分性肾切除术的994例患者。计算条件RFS (C-RFS)和条件累积癌症特异性死亡率(CCSM)以评估随时间变化的复发风险。采用多变量Cox回归和危害函数分析评估病理因素对复发的影响。结果:随着时间的推移,5年C-RFS和CCSM保持稳定,即使术后时间延长,也没有明显改善。尽管病理肿瘤分期和世界卫生组织/国际泌尿病理学会分级是基线时复发的重要预测因素,但它们的预后价值随着时间的推移而下降。相比之下,CS分析(基线:LVI阳性,64.3%;LVI阴性,92.5%;5年LVI阳性,74.1%;LVI阴性,92.3%)、多变量Cox回归分析(基线风险比[HR], 3.03; 3年风险比,4.33)和危险曲线均表明,淋巴血管侵犯(LVI)在整个随访期间始终是复发的重要危险因素。结论:即使术后无事件时间较长,后续C-RFS和CCSM的改善也是有限的。尽管大多数病理性危险因素的影响随着时间的推移而减弱,LVI仍然是复发的一致预测因子。这些发现强调了RCC病理危险因素动态变化的术后策略的重要性。
{"title":"Time-dependent changes in pathological risk factors of recurrence after renal cell carcinoma surgery","authors":"Hiroyuki Shikuma MD ,&nbsp;Yuki Kohada MD ,&nbsp;Keisuke Goto MD, PhD ,&nbsp;Masanobu Shigeta MD, PhD ,&nbsp;Mitsuru Kajiwara MD, PhD ,&nbsp;Akira Yano MD, PhD ,&nbsp;Yuichi Kadonishi MD ,&nbsp;Shuntaro Koda MD, PhD ,&nbsp;Kohei Kobatake MD, PhD ,&nbsp;Yohei Sekino MD, PhD ,&nbsp;Hiroyuki Kitano MD, PhD ,&nbsp;Akihiro Goriki MD, PhD ,&nbsp;Keisuke Hieda MD, PhD ,&nbsp;Nobuyuki Hinata MD, PhD","doi":"10.1016/j.urolonc.2025.10.003","DOIUrl":"10.1016/j.urolonc.2025.10.003","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate time-dependent changes in pathological risk factors for recurrence in patients with renal cell carcinoma (RCC) after surgery, we assessed the impact of prolonged recurrence-free survival (RFS) on subsequent recurrence rates and pathological risk factors using conditional survival (CS) analysis.</div></div><div><h3>Patients and Methods</h3><div>This retrospective multicenter study included 994 patients who underwent radical or partial nephrectomy for localized RCC between 2010 and 2019. Conditional RFS (C-RFS) and conditional cumulative incidence of cancer-specific mortality (C<img>CSM) were calculated to assess the time-dependent recurrence risk. The impact of pathological factors on recurrence was evaluated using multivariable Cox regression and hazard function analyses.</div></div><div><h3>Results</h3><div>The 5-year C-RFS and C<img>CSM remained stable over time, with no significant improvement even as the postoperative duration increased. Although pathological tumor stage and World Health Organization/International Society of Urological Pathology grade were significant predictors of recurrence at baseline, their prognostic values declined over time. In contrast, lymphovascular invasion (LVI) consistently remained a significant risk factor for recurrence throughout the follow-up period, as demonstrated by the CS analysis (baseline: LVI-positive, 64.3%; LVI-negative, 92.5%; 5-year LVI-positive, 74.1%; LVI-negative, 92.3%), multivariate Cox regression analyses (baseline hazard ratio [HR], 3.03; 3-year HR, 4.33), and hazard curves.</div></div><div><h3>Conclusion</h3><div>Even with longer event-free time after surgery, improvements in subsequent C-RFS and C<img>CSM were limited. Although the influence of most pathological risk factors diminished over time, LVI remained a consistent predictor of recurrence. These findings underscore the importance of postoperative strategies that account for the dynamic changes in pathological risk factors in RCC.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 69.e1-69.e9"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Measuring what matters to patients: Systematic literature review of patient-reported outcomes assessment and reporting in locally advanced or metastatic urothelial cancer real-world and clinical studies 衡量对患者重要的:对局部晚期或转移性尿路上皮癌患者报告的结果评估和报告的系统文献综述,现实世界和临床研究。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-10-27 DOI: 10.1016/j.urolonc.2025.09.016
Mairead Kearney MB, BCh, MPH, MBA, MSc , Thomas Macmillan MSc , Julia Poritz PhD , Sherrie Schreiber-Gosche MSc , Mihaela Georgiana Musat PhD

Introduction

A systematic literature review (SLR) was conducted to evaluate patient-reported outcome (PRO) instruments used in clinical trials and real-world evidence (RWE) studies of locally advanced/metastatic urothelial cancer (la/mUC) therapies.

Methods

Five databases were used to identify publications up to May 29, 2024 and recent conference abstracts of phase 2/3 clinical trials and RWE studies. We reviewed reported adverse events and qualitative research to evaluate PRO instrument reporting quality using the CONSORT-PRO and ESMO-MCBS checklists.

Results

The SLR identified 37 trials and 12 RWE studies. High heterogeneity in PRO instrument choice was observed (11/18 different instruments were used in 1 study each). The most common instrument was the EORTC QLQ-C30 (36 studies). Minimal clinically important difference thresholds were not consistently used (9/36 studies reporting EORTC QLQ-C30 used a 10-point threshold). Based on qualitative research findings, assessed PRO instruments did not comprehensively capture patient concerns, with symptom coverage ranging from 27% to 82%. Unexpectedly, baseline EORTC QLQ-C30 and Short Form-36 scores indicated that patients with la/mUC have a similar quality of life to the general population. In 18/37 clinical trials, PRO timepoints preceded the median clinical follow-up, with differences ranging from 0.96 to 59.4 months.

Conclusions

PROs can assist in the tailoring of treatment strategies to improve outcomes and can aid in enhancing communication between patients and healthcare professionals about treatment choice. Our evaluation of PRO reporting quality identified room for improvement in most studies, indicating a need for robust, consistent reporting of PRO data to adequately capture the experiences of patients with la/mUC.
本研究对局部晚期/转移性尿路上皮癌(la/mUC)治疗的临床试验和真实世界证据(RWE)研究中使用的患者报告结果(PRO)仪器进行了系统的文献综述(SLR)。方法:使用5个数据库来识别截至2024年5月29日的出版物和最近的2/3期临床试验和RWE研究的会议摘要。我们回顾了报告的不良事件和定性研究,使用conber -PRO和ESMO-MCBS核对表评估PRO仪器报告的质量。结果:SLR纳入了37项试验和12项RWE研究。观察到PRO仪器选择的高度异质性(每项研究使用11/18种不同的仪器)。最常见的仪器是EORTC QLQ-C30(36项研究)。最小临床重要差异阈值并未一致使用(9/36报告EORTC QLQ-C30的研究使用10分阈值)。根据定性研究结果,评估的PRO仪器没有全面捕获患者的担忧,症状覆盖率从27%到82%不等。出乎意料的是,基线EORTC QLQ-C30和Short - form36评分表明la/mUC患者的生活质量与一般人群相似。在18/37的临床试验中,PRO时间点先于中位临床随访,差异范围为0.96 ~ 59.4个月。结论:pro可以帮助制定治疗策略以改善结果,并有助于加强患者与医疗保健专业人员之间关于治疗选择的沟通。我们对PRO报告质量的评估确定了大多数研究的改进空间,表明需要健全、一致的PRO数据报告,以充分捕捉la/mUC患者的经历。
{"title":"Measuring what matters to patients: Systematic literature review of patient-reported outcomes assessment and reporting in locally advanced or metastatic urothelial cancer real-world and clinical studies","authors":"Mairead Kearney MB, BCh, MPH, MBA, MSc ,&nbsp;Thomas Macmillan MSc ,&nbsp;Julia Poritz PhD ,&nbsp;Sherrie Schreiber-Gosche MSc ,&nbsp;Mihaela Georgiana Musat PhD","doi":"10.1016/j.urolonc.2025.09.016","DOIUrl":"10.1016/j.urolonc.2025.09.016","url":null,"abstract":"<div><h3>Introduction</h3><div>A systematic literature review (SLR) was conducted to evaluate patient-reported outcome (PRO) instruments used in clinical trials and real-world evidence (RWE) studies of locally advanced/metastatic urothelial cancer (la/mUC) therapies.</div></div><div><h3>Methods</h3><div>Five databases were used to identify publications up to May 29, 2024 and recent conference abstracts of phase 2/3 clinical trials and RWE studies. We reviewed reported adverse events and qualitative research to evaluate PRO instrument reporting quality using the CONSORT-PRO and ESMO-MCBS checklists.</div></div><div><h3>Results</h3><div>The SLR identified 37 trials and 12 RWE studies. High heterogeneity in PRO instrument choice was observed (11/18 different instruments were used in 1 study each). The most common instrument was the EORTC QLQ-C30 (36 studies). Minimal clinically important difference thresholds were not consistently used (9/36 studies reporting EORTC QLQ-C30 used a 10-point threshold). Based on qualitative research findings, assessed PRO instruments did not comprehensively capture patient concerns, with symptom coverage ranging from 27% to 82%. Unexpectedly, baseline EORTC QLQ-C30 and Short Form-36 scores indicated that patients with la/mUC have a similar quality of life to the general population. In 18/37 clinical trials, PRO timepoints preceded the median clinical follow-up, with differences ranging from 0.96 to 59.4 months.</div></div><div><h3>Conclusions</h3><div>PROs can assist in the tailoring of treatment strategies to improve outcomes and can aid in enhancing communication between patients and healthcare professionals about treatment choice. Our evaluation of PRO reporting quality identified room for improvement in most studies, indicating a need for robust, consistent reporting of PRO data to adequately capture the experiences of patients with la/mUC.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"44 1","pages":"Pages 63.e21-63.e33"},"PeriodicalIF":2.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145393281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Urologic Oncology-seminars and Original Investigations
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