European urology oncology最新文献_第2页

Assessment of Pathologic Response in Kidney Cancer: Back to the Microscope for Now 肾癌病理反应的评估：暂时回到显微镜下。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.11.013

Axel Bex , Grant D. Stewart

引用次数: 0

Patient-reported Quality of Life in PROFIT, a Phase 3 Randomized Clinical Trial Evaluating Moderately Hypofractionated Radiotherapy for Intermediate-risk Prostate Cancer PROFIT中患者报告的生活质量，一项评估中度低分割放疗治疗中危前列腺癌的3期随机临床试验。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.03.017

Noelia Sanmamed , Ian Dayes , Charles Catton , Amy Liu , Stephane Supiot , Himu Lukka , Glenn Bauman , Zijin Liu , Jean-Paul Bahary , Shahida Ahmed , Patrick Cheung , Matthew Parliament , Michael Sia , Theodorus Tsakiridis , Shankar Siva , Tom Corbett , Colin Tang , Tim Craig , Jarad Martin , Peter Chung

Background and objective

The PROFIT trial was designed to compare moderately hypofractionated (HF) radiotherapy versus conventional fractionation (CF) for patients with intermediate-risk prostate cancer (IR-PC). Similar efficacy and toxicity outcomes were previously reported. The aim of the current analysis was to evaluate differences in long-term patient-reported outcomes (PROs) between the HF and CF arms in PROFIT.

Methods

For the PROFIT phase 3 randomized clinical trial, patients with IR-PC (n = 1206) were enrolled from 14 sites in Canada, 12 in Australia, and one in France and randomized to receive 78 Gy in 39 fractions over 8 wk (CF) or 60 Gy in 20 fractions over 4 wk (HF). PROs were evaluated at baseline and 24 and 48 mo using the Expanded Prostate Cancer Index Composite, American Urological Association Symptom Score (AUASS), and the 12-item Short Form Health Survey (SF-12) comprising a physical component summary (PCS) and a mental component summary (MCS). A minimally important difference (MID) was defined as a deterioration in domain- or subdomain-specific health-related quality of life (HRQoL) score by ≥0.5 times the standard deviation at each time point in comparison to baseline. Statistical significance was set at p < 0.01.

Key findings and limitations

AUASS results were similar and stable over time in both arms (median 5 points, interquartile range 2–9; p > 0.2). There were no significant differences in scores for urinary, bowel, sexual, and hormonal domains or subdomains between the arms at any time point (p > 0.02). The greatest decline over time occurred in sexual domain, with a decrease of ≥10 points from baseline to 24 mo in both arms. SF-12 mean scores for both PSC and MSC were similar in the two arms and remained stable at all time points. The only significant differences in the proportion of patients reporting MIDs were for the bowel subdomains at 48 mo, with significant MID reductions favoring HF for both the bowel summary score (53% vs 44%; p = 0.01) and bowel function score (51% vs 39%; p = 0.001). Overall treatment satisfaction was high in both arms: ≥88% of patients were either satisfied or extremely satisfied with their treatment.

Conclusions and clinical implications

PRO results from the PROFIT trial suggest no significant differences in urinary, bowel, sexual, hormonal, and general HRQoL between CF and HF radiotherapy schedules. This study provides level 1 evidence supporting the use of moderate HF radiotherapy as standard treatment in patients with IR-PC.

This trial is registered on ClinicalTrials.gov as NCT00304759.

背景和目的：PROFIT试验旨在比较中度低分割放疗（HF）与常规分割放疗（CF）对中危前列腺癌（IR-PC）患者的治疗效果。以前报道过类似的疗效和毒性结果。当前分析的目的是评估PROFIT中HF组和CF组长期患者报告结局（PROs）的差异。方法：PROFIT 3期随机临床试验，从加拿大的14个地点、澳大利亚的12个地点和法国的1个地点招募了IR-PC患者（n = 1206），随机分为39组接受78 Gy的8周治疗（CF）或20组接受60 Gy的4周治疗（HF）。使用扩展前列腺癌指数综合、美国泌尿科协会症状评分（AUASS）和包含身体成分摘要（PCS）和精神成分摘要（MCS）的12项简短健康调查（SF-12）在基线和24和48个月时评估PROs。最小重要差异（MID）定义为在每个时间点与基线相比，特定领域或子领域的健康相关生活质量（HRQoL）评分恶化≥0.5倍。主要发现和局限性：随时间推移，两组的AUASS结果相似且稳定(中位数5点，四分位数范围2-9；p > 0.2)。两组在任何时间点的尿、肠、性、激素域或子域评分均无显著差异（p < 0.05）。随着时间的推移，最大的下降发生在性领域，从基线到24个月，双臂下降≥10点。两组PSC和MSC的SF-12平均评分相似，在所有时间点保持稳定。报告MIDs的患者比例的唯一显著差异是在48个月时肠亚域，在肠总评分中，MIDs显著减少有利于HF (53% vs 44%；P = 0.01)和肠功能评分(51% vs 39%；p = 0.001)。两组患者的总体治疗满意度都很高：≥88%的患者对治疗满意或非常满意。结论和临床意义：PROFIT试验的PRO结果显示，CF和HF放疗方案在尿、肠、性、激素和一般HRQoL方面没有显著差异。这项研究提供了一级证据，支持中度HF放疗作为IR-PC患者的标准治疗。该试验在ClinicalTrials.gov上注册为NCT00304759。

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引用次数: 0

Preventative Function-sparing Radical Prostatectomy: Experience in a Tertiary Referral Centre 保留功能的预防性根治性前列腺切除术：三级转诊中心的经验。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.02.005

Alexander Haese , Markus Graefen , Aliaksandra Pott , Felix Preisser

Background and objective

The oncological and functional outcomes after preventative radical prostatectomy (pRP) are unknown. Our aim was to assess functional and oncological outcomes and the patient perspective, motivation, and postprocedural experiences of a highly selected pRP cohort.

Methods

We identified patients who underwent pRP between 2012 and 2021 in a single high-volume centre without a prostate cancer (PCa) diagnosis before surgery. Functional and oncological outcomes were assessed via validated questionnaires. In-depth semistructured interviews were conducted with the patients about their pRP experience.

Key findings and limitations

Seven patients who ranged in age from 37 to 57 yr underwent pRP. Final pathology revealed PCa in 71% of cases, which was International Society of Urological Pathology grade group 1 in two patients, and grade group 2 in three. The mean distress score was 7.7 points before pRP versus 1.3 points after surgery. At ≥12 mo after pRP, all the patients had erections firm enough for intercourse and were fully continent. A significant improvement in quality of life was reported because of mental relief and maintenance of physical functioning. The interviewees emphasised the importance of patient-centred medicine. Limitations include the small sample size, lack of a control cohort, and the single-centre setting.

Conclusions and clinical implications

No patient regretted his decision after pRP and all patients were free of recurrence. For men with a serious fear of PCa that causes them distress and affects their quality of life, pRP could be a good option outside of guideline recommendations if performed by experts for well-informed patients. Improvements in the legal foundation for this approach are needed.

背景与目的：预防性根治性前列腺切除术（pRP）后的肿瘤和功能预后尚不清楚。我们的目的是评估一个精心挑选的pRP队列的功能和肿瘤结果以及患者的观点、动机和术后经验。方法：我们确定了2012年至2021年间在单个大容量中心接受pRP的患者，术前没有前列腺癌（PCa）诊断。功能和肿瘤结果通过有效的问卷进行评估。对患者的pRP经历进行了深入的半结构化访谈。主要发现和局限性：7例年龄在37至57岁之间的患者接受了pRP。最终病理显示71%的病例为PCa，其中2例为国际泌尿外科病理学会1级组，3例为2级组。pRP前的平均窘迫评分为7.7分，手术后为1.3分。在pRP后≥12个月，所有患者的勃起都足够坚固，可以进行性交，并且完全勃起。据报道，由于精神上的缓解和身体功能的维持，生活质量有了显著改善。受访者强调了以病人为中心的医学的重要性。局限性包括样本量小、缺乏对照队列和单中心设置。结论及临床意义：无患者在pRP术后后悔，所有患者均无复发。对于那些对前列腺癌有严重恐惧的男性来说，如果专家对消息灵通的患者进行pRP治疗，pRP可能是指南建议之外的一个很好的选择。需要改进这种做法的法律基础。

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引用次数: 0

Prediction of Prostate Cancer Biochemical Recurrence After Radical Prostatectomy by Collagen Models Using Multiomic Profiles 应用多组谱胶原模型预测根治性前列腺切除术后前列腺癌生化复发。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.03.016

Maria Frantzi , Piotr Tymoszuk , Stefan Salcher , Enrique Gomez-Gomez , Ana C. Morillo , Felix Melchior , Ana Blanca , Harald Mischak , Antonia Vlahou , Andreas Pircher , Isabel Heidegger

Background and objective

The interplay between prostate cancer and the tumor microenvironment is well documented and of primary importance in disease evolution. Herein, we investigated the prognostic value of tissue and urinary collagen-related molecular signatures in predicting biochemical recurrence (BCR) after radical prostatectomy (RP).

Methods

A comprehensive analysis of 55 collagen-related features was conducted using transcriptomic datasets (n = 1393), with further validation at the proteomic level (n = 69). Additionally, a distinct cohort (n = 73) underwent a urine-based peptidomic analysis, culminating in the validation of a urine-derived prognostic model. Independent prognostic significance was assessed using Cox proportional hazards modeling, while the model’s predictive performance was benchmarked against established clinical metrics.

Key findings and limitations

An expression analysis of 55 collagen-related transcripts identified 11 transcripts significantly associated with BCR (C-index: 0.55–0.72, p < 0.002). Multivariable models incorporating these transcripts enhanced prognostic accuracy, surpassing clinical variables (C-index: 0.66–0.89, p < 0.002). Proteomic validation confirmed five key collagen proteins, while a urine-based collagen model (C-index: 0.73, 95% confidence interval: 0.62–0.85) demonstrated a strong prognostic potential, although limited by small patient numbers. Additionally, tissue collagen-based models predicted overall survival with a significant prognostic value (C-index: 0.59–0.70, p < 0.01).

Conclusions and clinical implications

Collagen-based molecular signatures in both tissue and urine emerge as robust prognostic biomarkers for predicting BCR following RP.

背景与目的：前列腺癌与肿瘤微环境之间的相互作用已被充分记录，并且在疾病演变中具有重要意义。在此，我们研究了组织和尿胶原相关分子特征在预测根治性前列腺切除术（RP）后生化复发（BCR）中的预后价值。方法：利用转录组学数据集（n = 1393）对55个胶原相关特征进行综合分析，并在蛋白质组学水平（n = 69）进一步验证。此外，一个独特的队列（n = 73）进行了基于尿液的肽组学分析，最终验证了尿液衍生的预后模型。使用Cox比例风险模型评估独立预后意义，而模型的预测性能以既定的临床指标为基准。主要发现和局限性：对55个胶原相关转录本的表达分析发现了11个与BCR显著相关的转录本（c指数：0.55-0.72,p）。结论和临床意义：组织和尿液中基于胶原的分子特征是预测RP后BCR的强有力的预后生物标志物。

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引用次数: 0

Pathologic Response to Immunotherapy Is Associated with Survival in Patients Undergoing Delayed Nephrectomy for Metastatic Renal Cell Carcinoma 转移性肾癌延迟肾切除术患者对免疫治疗的病理反应与生存相关。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.11.003

Yash S. Khandwala , Stephen W. Reese , Burcin A. Ucpinar , Andrea Knezevic , Lennert Eismann , Chih-Ying Wu , Rohan Mittal , Sahil Doshi , Daniel Barbakoff , Andrea Lopez Sanmiguel , Jonathan Coleman , Mark Dawidek , Robert J. Motzer , Paul Russo , Oguz Akin , Ritesh R. Kotecha , Ying-Bei Chen , Martin H. Voss , A. Ari Hakimi

Background and objective

The role of consolidative nephrectomy (CN) in metastatic renal cell carcinoma (mRCC) patients treated with immune checkpoint inhibitors remains unknown. As patients derive variable benefit from immunotherapy (IO), an understanding of how treatment response is associated with long-term outcomes could inform patient surgical selection. We thus conducted a retrospective study to evaluate whether radiographic and pathologic tumor responses after IO are associated with survival in patients undergoing CN at a high-volume academic center.

Methods

We identified mRCC patients treated with at least one IO-containing regimen followed by CN between 2015 and 2024. A radiographic response was assessed using the Response Evaluation Criteria in Solid Tumors. A pathologic response was measured using the percentage of residual viable tumor (RVT), with a major pathologic response (MPR) defined as RVT <10%. Outcomes included progression-free (PFS) and overall (OS) survival, analyzed using Cox proportional hazards models.

Key findings and limitations

Sixty patients underwent CN after IO. The median time to nephrectomy was 9 mo (interquartile range: 7, 14), and the 2-yr OS rate was 75% (95% confidence interval [CI]: 60–85%). Fifteen patients (26%) had an MPR and 21 patients (35%) had a radiographic response of the primary tumor. The radiographic response was protective but not significantly associated with PFS or OS. The MPR was significantly associated with PFS (hazard ratio [HR]: 0.05, 95% CI: 0.01–0.41; p = 0.005) and OS (HR: 0.07, 95% CI: 0.01–0.88; p = 0.039).

Conclusions and clinical implications

Patients with an MPR at nephrectomy had longer PFS and OS. A pathologic response helps guide postnephrectomy treatment timing and sequencing, although future efforts should further validate the utility of post-IO pathologic endpoints.

背景与目的：巩固性肾切除术（CN）在接受免疫检查点抑制剂治疗的转移性肾细胞癌（mRCC）患者中的作用尚不清楚。由于患者从免疫治疗（IO）中获得不同的益处，了解治疗反应与长期预后的关系可以为患者的手术选择提供信息。因此，我们在一个大容量学术中心进行了一项回顾性研究，以评估IO后放射学和病理肿瘤反应是否与CN患者的生存相关。方法：我们确定了2015年至2024年间接受至少一种含io方案治疗的mRCC患者，随后接受CN治疗。使用实体瘤反应评价标准评估放射学反应。病理反应用残余活肿瘤（RVT）的百分比来衡量，主要病理反应（MPR）定义为RVT。肾切除术的中位时间为9个月（四分位数范围：7,14），2年OS率为75%（95%可信区间[CI]: 60-85%）。15名患者（26%）有MPR， 21名患者（35%）有原发肿瘤的放射学反应。放射学反应具有保护作用，但与PFS或OS无显著相关性。MPR与PFS（风险比[HR]: 0.05, 95% CI: 0.01 ~ 0.41; p = 0.005）和OS（风险比[HR]: 0.07, 95% CI: 0.01 ~ 0.88; p = 0.039）显著相关。结论和临床意义：MPR肾切除术患者有较长的PFS和OS。病理反应有助于指导肾切除术后的治疗时机和排序，尽管未来的努力应进一步验证io后病理终点的效用。

{"title":"Pathologic Response to Immunotherapy Is Associated with Survival in Patients Undergoing Delayed Nephrectomy for Metastatic Renal Cell Carcinoma","authors":"Yash S. Khandwala , Stephen W. Reese , Burcin A. Ucpinar , Andrea Knezevic , Lennert Eismann , Chih-Ying Wu , Rohan Mittal , Sahil Doshi , Daniel Barbakoff , Andrea Lopez Sanmiguel , Jonathan Coleman , Mark Dawidek , Robert J. Motzer , Paul Russo , Oguz Akin , Ritesh R. Kotecha , Ying-Bei Chen , Martin H. Voss , A. Ari Hakimi","doi":"10.1016/j.euo.2025.11.003","DOIUrl":"10.1016/j.euo.2025.11.003","url":null,"abstract":"<div><h3>Background and objective</h3><div>The role of consolidative nephrectomy (CN) in metastatic renal cell carcinoma (mRCC) patients treated with immune checkpoint inhibitors remains unknown. As patients derive variable benefit from immunotherapy (IO), an understanding of how treatment response is associated with long-term outcomes could inform patient surgical selection. We thus conducted a retrospective study to evaluate whether radiographic and pathologic tumor responses after IO are associated with survival in patients undergoing CN at a high-volume academic center.</div></div><div><h3>Methods</h3><div>We identified mRCC patients treated with at least one IO-containing regimen followed by CN between 2015 and 2024. A radiographic response was assessed using the Response Evaluation Criteria in Solid Tumors. A pathologic response was measured using the percentage of residual viable tumor (RVT), with a major pathologic response (MPR) defined as RVT <10%. Outcomes included progression-free (PFS) and overall (OS) survival, analyzed using Cox proportional hazards models.</div></div><div><h3>Key findings and limitations</h3><div>Sixty patients underwent CN after IO. The median time to nephrectomy was 9 mo (interquartile range: 7, 14), and the 2-yr OS rate was 75% (95% confidence interval [CI]: 60–85%). Fifteen patients (26%) had an MPR and 21 patients (35%) had a radiographic response of the primary tumor. The radiographic response was protective but not significantly associated with PFS or OS. The MPR was significantly associated with PFS (hazard ratio [HR]: 0.05, 95% CI: 0.01–0.41; <em>p</em> = 0.005) and OS (HR: 0.07, 95% CI: 0.01–0.88; <em>p</em> = 0.039).</div></div><div><h3>Conclusions and clinical implications</h3><div>Patients with an MPR at nephrectomy had longer PFS and OS. A pathologic response helps guide postnephrectomy treatment timing and sequencing, although future efforts should further validate the utility of post-IO pathologic endpoints.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"9 1","pages":"Pages 101-110"},"PeriodicalIF":9.3,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145631489","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

A Novel Transurethral Robotic Platform for Performing En Bloc Resection of Bladder Tumour: Results from the First Phase of the VIABLE Trial 一种用于膀胱肿瘤整体切除的新型经尿道机器人平台：可行性试验第一阶段的结果。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.11.005

Jeremy Yuen-Chun Teoh, Francesco Maria Bracco, Julius Ho-Fai Wong, Alex Qinyang Liu, Violet Wai-Fan Yuen, Franco Pui-Tak Lai

The Virtuoso Endoscopy System (VES) is a novel robotic surgical system designed for transurethral excision of bladder lesions. In this first-in-human study, we evaluated the feasibility of using the VES to perform safe and effective excision in six patients with 12 bladder lesions. VES excision of bladder lesions was successful in all six patients, and all 12 bladder lesions (100%) were excised via an en bloc or modified en bloc technique. The mean procedural time was 52 ± 20 min. None of the patients required conversion to standard equipment for bladder lesion resection. Accurate staging, defined as the presence of detrusor muscle in the specimen, was achieved for all bladder lesions (100%). Evaluable margins were present in 91% of the bladder lesion specimens. None of the patients developed any intraoperative adverse events or complications. Two patients had postoperative adverse events (33%). One case of postoperative urinary retention (grade 1) resolved after conservative management. One case of chest infection was later found to be secondary to a newly diagnosed oesophageal tumour with tracheal invasion. There were no bladder perforations, any 30-d reoperations, or 30-d mortality events.

The trial is registered on ClinicalTrials.gov as NCT06940648.

Virtuoso内窥镜系统（VES）是一种新型机器人手术系统，专为经尿道膀胱病变切除而设计。在这项首次人体研究中，我们评估了使用VES对6例患有12个膀胱病变的患者进行安全有效切除的可行性。所有6例患者均成功切除膀胱病变，所有12例膀胱病变（100%）均通过整体或改良整体技术切除。平均手术时间52±20 min。没有患者需要转换到标准设备进行膀胱病变切除术。所有膀胱病变（100%）的准确分期，定义为标本中存在逼尿肌。91%的膀胱病变标本存在可评估的边缘。所有患者均未发生任何术中不良事件或并发症。2例患者发生术后不良事件（33%）。1例术后尿潴留（1级）经保守治疗后消失。一例胸部感染后来被发现是继发于新诊断的食管肿瘤并气管侵犯。无膀胱穿孔，无30 d再手术，无30 d死亡事件。该试验在ClinicalTrials.gov上注册为NCT06940648。

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引用次数: 0

Results from a Phase 2 Study of Induction Docetaxel and Carboplatin Followed by Maintenance Rucaparib in the Treatment of Patients with Metastatic Castration-resistant Prostate Cancer with DNA Homologous Recombination Repair Deficiency 一项诱导多西紫杉醇和卡铂联合维持性鲁卡帕尼治疗DNA同源重组修复缺陷转移性阉割抵抗性前列腺癌患者的2期研究结果

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.04.026

Ruben Raychaudhuri , Heather H. Cheng , Roman Gulati , Michael T. Schweizer , Aaron Lin , Todd Yezefski , Hiba M. Khan , Evan Y. Yu , Jessica E. Hawley , Peter S. Nelson , Colin C. Pritchard , Bruce Montgomery

Background and objective

Our aim was to determine whether induction chemotherapy followed by PARP inhibitor (PARPi) maintenance improves outcomes for patients with metastatic castration-resistant prostate cancer (mCRPC) harboring alterations in homologous recombination repair (HRR) genes in comparison to a historical control cohort treated with PARPi monotherapy.

Methods

This single-arm, open-label, investigator-initiated phase 2 trial (NCT02985021) enrolled 18 patients with mCRPC with pathogenic alterations in HRR genes between 2018 and 2021 at a single center. Patients received four cycles of induction chemotherapy with docetaxel (60 mg/m²) and carboplatin (area under the curve 5) every 21 d, followed by maintenance rucaparib (600 mg twice daily) until progression or unacceptable toxicity. The primary outcome was radiographic progression-free survival (rPFS). Subsequent to study inception, multiple other studies reported alterations in genes of the BRCA complex (BRCA-C: BRCA1, BRCA2, PALB2) as most predictive of PARPi response; therefore, a post hoc analysis comparing patients with alterations in BRCA-C genes to a historical control cohort was performed.

Key findings and limitations

After median follow-up of 40.3 mo (interquartile range 38.5–not reached [NR]), the median rPFS for all patients was 8.1 mo (95% confidence interval [CI] 6.5–31.2), similar to a historical control cohort treated with PARPi monotherapy. Among the 12 patients with BRCA-C alterations, median rPFS was 17.7 mo (95% CI 7.5–NR; p = 0.05). A key limitation is the single-arm design.

Conclusions and clinical implications

Induction platinum-based chemotherapy followed by maintenance PARPi therapy did not improve outcomes for patients with mCRPC broadly selected for HRR deficiency. However, results were promising in the more stringently selected group with BRCA-C gene alterations. Further studies comparing this approach to PARPi monotherapy are warranted.

背景和目的：我们的目的是确定诱导化疗后维持PARP抑制剂（PARPi）是否能改善转移性去势抵抗性前列腺癌（mCRPC）患者的预后，这些患者携带同源重组修复（HRR）基因改变，与历史对照队列相比，PARPi单药治疗可改善预后。方法：这项单臂、开放标签、研究者启动的2期试验（NCT02985021）在单中心招募了18例2018年至2021年间HRR基因致病性改变的mCRPC患者。患者接受4个周期的诱导化疗，每21 d使用多西紫杉醇（60mg /m2）和卡铂（曲线下面积5），随后使用维持性鲁卡帕尼（600mg，每日两次），直到进展或不可接受的毒性。主要终点是放射学无进展生存期（rPFS）。在研究开始之后，其他多项研究报道了BRCA复合物（BRCA- c: BRCA1, BRCA2, PALB2）基因的改变是最能预测PARPi反应的；因此，将BRCA-C基因改变的患者与历史对照队列进行了事后分析。主要发现和局限性：中位随访40.3个月（四分位数间距38.5-未达到[NR]）后，所有患者的中位rPFS为8.1个月（95%置信区间[CI] 6.5-31.2），与PARPi单药治疗的历史对照队列相似。在12例BRCA-C改变的患者中，中位rPFS为17.7个月(95% CI 7.5-NR；p = 0.05)。一个关键的限制是单臂设计。结论和临床意义：诱导铂类化疗后的维持性PARPi治疗并不能改善因HRR缺乏而广泛选择的mCRPC患者的预后。然而，在BRCA-C基因改变的严格选择组中，结果是有希望的。将这种方法与PARPi单药治疗进行比较的进一步研究是有必要的。

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引用次数: 0

Stereotactic Body Radiation Therapy for Primary Renal Cancer and Genetic Markers of Response: A Phase 2 Trial 原发性肾癌的立体定向放射治疗和反应的遗传标记：2期试验。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.06.001

Cheryn Song , Chang Ohk Sung , Dongsu Kim , Yunlim Kim , Hanjong Ahn , Mi-hyun Kim , Jeong Kon Kim , Yong Mee Cho , Yeon Joo Kim , Young Seok Kim

Controlled outcome assessment of radiotherapy for primary renal cell carcinoma (RCC) remains limited, particularly regarding its impact on ipsilateral renal function and predictors of response. We evaluated oncological and renal function outcomes of stereotactic body radiation therapy (SBRT) for RCC and identified genomic predictors of response. Our study cohort comprised 83 surgically unfit patients with cT1a RCC who were prospectively enrolled to receive SBRT of 42 Gy in three fractions between 2016 and 2022. The median tumor size was 2.3 cm and local control was achieved in 78 patients, including eight with a complete response. The 3-yr survival rates were 96% (95% confidence interval [CI] 89.8–99.9) for progression-free survival and 96% (95% CI 89.4–99.9%) for cancer-specific survival. The glomerular filtration rate of the treated kidney decreased up to 12–18 mo (−9.8 ml/min/1.73 m²) but stabilized thereafter. Transcriptome sequencing conducted on biopsy specimens from five responders and eight nonresponders showed enrichment of apical surface/junction pathways among responders, and enrichment of cell cycle, DNA repair, oxidative phosphorylation, and hypoxia pathways among nonresponders. A machine learning model based on gene expression demonstrated good predictive performance, with a cross-validated area under the receiver operating characteristic curve of 0.9. SBRT for T1a RCC was acceptable in terms of intermediate-term cancer control and preservation of renal function. Distinctive genomic profiles may aid in identifying optimal candidates pending external validation.

原发性肾细胞癌（RCC）放疗的对照结果评估仍然有限，特别是关于其对同侧肾功能的影响和反应的预测因素。我们评估了立体定向全身放射治疗（SBRT）对RCC的肿瘤和肾功能结果，并确定了反应的基因组预测因子。我们的研究队列包括83例不适合手术的cT1a RCC患者，他们在2016年至2022年期间分三个部分接受42 Gy的SBRT。78例患者肿瘤中位大小为2.3 cm，局部得到控制，其中8例完全缓解。无进展生存率为96%(95%可信区间[CI] 89.8-99.9)，癌症特异性生存率为96% （95% CI 89.4-99.9%）。治疗后肾脏的肾小球滤过率下降至12-18个月（-9.8 ml/min/1.73 m2），但此后稳定。对5名应答者和8名无应答者的活检标本进行的转录组测序显示，应答者的根尖表面/连接通路富集，无应答者的细胞周期、DNA修复、氧化磷酸化和缺氧通路富集。基于基因表达的机器学习模型具有良好的预测性能，其在接收者工作特征曲线下的交叉验证面积为0.9。就中期癌症控制和肾功能保存而言，SBRT治疗T1a型RCC是可以接受的。独特的基因组档案可能有助于确定最佳候选者等待外部验证。

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引用次数: 0

Patient-reported Outcomes for Men with Metastatic Castration-resistant Prostate Cancer Who Received Olaparib plus Abiraterone Versus Placebo plus Abiraterone in the Phase 3 PROpel Study 在3期PROpel研究中，接受奥拉帕尼加阿比特龙与安慰剂加阿比特龙治疗的转移性去势抵抗性前列腺癌男性患者报告的结果

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.09.010

Andrew J. Armstrong , Fred Saad , Mototsugu Oya , Karina Vianna , Mustafa Özgüroğlu , Craig Gedye , Gary L. Buchschacher Jr. , Ji Youl Lee , Urban Emmenegger , Jiří Navrátil , Juan Antonio Virizuela , Anibal Salazar , Denis Maillet , Hiroji Uemura , Christian Hosius , David McGuinness , Arnold Degboe , Noel Clarke

Background and objective

The phase 3 PROpel study showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) with olaparib + abiraterone versus placebo + abiraterone in the first-line setting for patients with metastatic castration-resistant prostate cancer (mCRPC) unselected by mutation status for homologous recombination repair genes. Here we report patient-reported outcomes and results for other symptom-related endpoints.

Methods

Patients were randomized 1:1 to either olaparib (300 mg twice daily) or placebo, both given with abiraterone acetate (1000 mg once daily) plus prednisone or prednisolone. The primary endpoint was rPFS (at planned primary analysis; data cutoff July 30, 2021). Prespecified secondary endpoints included patient-reported outcomes evaluating health-related quality of life (HRQoL; Functional Assessment of Cancer Therapy-Prostate [FACT-P]) and pain (Brief Pain Inventory-Short Form [BPI-SF]) (prespecified final analysis of overall survival; data cutoff October 12, 2022).

Key findings and limitations

Between October 31, 2018 and March 11, 2020, 1103 patients were screened, of whom 399 were randomized to olaparib + abiraterone and 397 to placebo + abiraterone. There were no overall differences between the treatment arms in the least-squares mean change from baseline in FACT-P total score or subscales, or in BPI-SF scores for worst pain, pain severity, and pain interference.

Conclusions and clinical implications

In PROpel, there were no differences in HRQoL or pain scores reported by patients with mCRPC receiving olaparib + abiraterone versus placebo + abiraterone, suggesting that patients can derive a clinical benefit from olaparib + abiraterone while maintaining similar HRQoL in comparison with current standard-of-care treatment.

The PROpel trial is registered on ClinicalTrials.gov as NCT03732820.

背景和目的：3期PROpel研究显示，在未选择同源重组修复基因突变状态的转移性阉化抵抗性前列腺癌（mCRPC）患者的一线环境中，奥拉帕尼+阿比特龙与安慰剂+阿比特龙相比，放射学无进展生存期（rPFS）有统计学意义和临床意义的改善。在这里，我们报告了患者报告的结果和其他症状相关终点的结果。方法：患者按1:1随机分为奥拉帕尼组（300 mg每日2次）或安慰剂组，两组均给予醋酸阿比特龙（1000 mg每日1次）加强的松或泼尼松。主要终点为rPFS（计划的初步分析，数据截止日期为2021年7月30日）。预先指定的次要终点包括患者报告的评估健康相关生活质量的结果（HRQoL；癌症治疗功能评估-前列腺[FACT-P]）和疼痛（简短疼痛量表-简短表格[BPI-SF]）（预先指定的总生存期最终分析，数据截止日期为2022年10月12日）。2018年10月31日至2020年3月11日期间，筛选了1103例患者，其中399例随机分为奥拉帕尼+阿比特龙组，397例随机分为安慰剂+阿比特龙组。在FACT-P总分或亚量表，以及最严重疼痛、疼痛严重程度和疼痛干扰的BPI-SF评分中，治疗组与基线的最小二乘平均变化没有总体差异。结论和临床意义：在PROpel研究中，接受奥拉帕尼+阿比特龙与安慰剂+阿比特龙治疗的mCRPC患者的HRQoL或疼痛评分没有差异，这表明患者可以从奥拉帕尼+阿比特龙中获得临床获益，同时与目前的标准治疗相比保持相似的HRQoL。PROpel试验已在ClinicalTrials.gov注册为NCT03732820。

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引用次数: 0

Bladder EpiCheck triggered Photodynamic Diagnosis biopsies Detect High-grade Bladder Cancer Recurrences Missed by White Light Cystoscopy 膀胱上皮检查触发光动力诊断活检发现白光膀胱镜检查未发现的高级别膀胱癌复发。

IF 9.3 1区医学 Q1 ONCOLOGY

European urology oncology

Pub Date : 2026-02-01 DOI: 10.1016/j.euo.2025.11.007

Paramananthan Mariappan , Jasmin Hart-Brooke , Rebecca Sparks , Tanya Lord-McKenzie

Background and objective

White light cystoscopy (WLC) misses ∼70% of carcinoma in situ bladder recurrences that could be identified via photodynamic diagnosis (PDD). The Bladder EpiCheck (BE) test has high sensitivity and specificity, with a recognised anticipatory positive signal. Our aim was to determine the diagnostic accuracy of BE and WLC against PDD-guided biopsy as the diagnostic benchmark during surveillance for high-grade (HG) non–muscle-invasive bladder cancer (NMIBC).

Methods

As part of a National Health Service (NHS) quality improvement project, all consecutive patients with HG-NMIBC who were fit for general anaesthesia and on surveillance in a tertiary centre underwent both WLC and BE from July 2023 to August 2024. Data were prospectively collected. Voided urine was collected before WLC for BE testing. Positive WLC and/or BE results triggered PDD-guided biopsy/resection under general anaesthesia. Performance metrics for WLC and BE were calculated on the basis of biopsies performed within 6 mo of a surveillance visit.

Key findings and limitations

Valid BE results were available for 315 HG-NMIBC surveillance visits. Of the 37 pathologically confirmed recurrences, 23 (62%, 95% confidence interval [CI] 46–76%) were detected by WLC and 34 (92%, 95% CI 79–97%) by BE (p = 0.0074). Of the 30 HG recurrences, 19 (63%, 95% CI 46–78%) were detected by WLC and 27 (90%, 95% CI 74–97%) by BE (p = 0.0386). Most of the HG cancers missed by WLC and detected by BE (73%) were Tis. Performing PDD-guided biopsies for patients with negative WLC and positive BE results increased the BE specificity from 87% (95% CI 82–90%) to 93% (95% CI 89-96%), and the positive predictive value from 35% (95% CI 24–48%) to 57% (95% CI 44–68%) at 6 mo, and to 70% (95% CI 58–80%) at longer-term follow-up. The main limitations are the nonrandomised setting and the lack of a control group.

Conclusions and clinical implications

BE addition to WLC, with PDD-guided biopsy performed for BE-positive cases, reveals the true performance of BE and WLC and significantly improves the detection of HG disease, allowing earlier intervention with potentially bladder-sparing options.

背景和目的：白光膀胱镜检查（WLC）漏诊了70%的可通过光动力学诊断（PDD）识别的膀胱原位癌复发。膀胱上皮检查（BE）具有高灵敏度和特异性，具有公认的预期阳性信号。我们的目的是确定BE和WLC对pdd引导活检的诊断准确性，作为监测高级别（HG）非肌肉浸润性膀胱癌（NMIBC）的诊断基准。方法：作为国家卫生服务（NHS）质量改进项目的一部分，从2023年7月至2024年8月，所有适合全身麻醉并在三级中心接受监测的连续HG-NMIBC患者均接受了WLC和BE。前瞻性地收集数据。在WLC前收集空尿进行BE检测。全身麻醉下WLC和/或BE阳性触发pdd引导活检/切除。WLC和BE的绩效指标是根据监测访问后6个月内进行的活检计算的。主要发现和局限性：315次HG-NMIBC监测访问可获得有效的BE结果。在病理证实的37例复发中，WLC检测到23例（62%，95%可信区间[CI] 46 ~ 76%）， BE检测到34例（92%,95% CI 79 ~ 97%）（p = 0.0074）。在30例HG复发中，WLC检测到19例（63%,95% CI 46-78%）， BE检测到27例（90%,95% CI 74-97%）（p = 0.0386）。WLC漏诊和BE检出的HG癌（73%）多为Tis。对WLC阴性和BE阳性的患者进行pdd引导活检，BE特异性从87% （95% CI 82-90%）增加到93% (95% CI 89-96%)， 6个月时阳性预测值从35% （95% CI 24-48%）增加到57% (95% CI 44-68%)，长期随访时阳性预测值从70% （95% CI 58-80%）。主要的限制是非随机设置和缺乏对照组。结论和临床意义：BE + WLC，在pdd引导下对BE阳性病例进行活检，揭示了BE和WLC的真实表现，并显着提高了HG疾病的检测，允许早期干预，可能的膀胱保留选择。

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引用次数: 0