Pub Date : 2025-02-01DOI: 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 , EORTC Quality of Life Group
<div><h3>Background and objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Key findings and limitations</h3><div>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.</div></div><div><h3>Conclusions and clinical implications</h3><div>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.</div></div><div><h3>Patient summary</h3><div>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 t
{"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 , EORTC Quality of Life Group","doi":"10.1016/j.euo.2024.09.007","DOIUrl":"10.1016/j.euo.2024.09.007","url":null,"abstract":"<div><h3>Background and objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Key findings and limitations</h3><div>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.</div></div><div><h3>Conclusions and clinical implications</h3><div>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.</div></div><div><h3>Patient summary</h3><div>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 t","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 201-212"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The relevance of next-generation hormone therapies and circulating tumor cells (CTCs) are not elucidated in biochemical recurrence after prostatectomy.
Objective
To evaluate the combination of abiraterone acetate plus prednisone (AAP), prostate bed radiotherapy (PBRT), and goserelin in biochemically relapsing men after prostatectomy, and to investigate the utility of CTCs.
Design, setting, and participants
In this single-arm multicenter phase 2 trial, 46 biochemically relapsing men were enrolled between December 2012 and January 2019. The median follow-up was 47 mo.
Intervention
All patients received AAP 1000 mg daily (but 750 mg during PBRT), salvage PBRT, and goserelin.
Outcome measurements and statistical analysis
The primary outcome was 3-yr biochemical recurrence-free survival (bRFS) when prostate-specific antigen (PSA) levels were ≥0.2 ng/ml. The secondary outcomes included alternative bRFS (alt-bRFS) when PSA levels were ≥0.5 ng/ml and safety assessment. CTC count was assessed.
Results and limitations
The 3-yr bRFS and alt-bRFS were 81.5% (95% confidence interval or CI [66.4–90.3%]) and 95.6% (95% CI [83.5-98.9%]), respectively. The most common acute radiotherapy-related adverse effect (AE; all grades was pollakiuria (41.3%). The most common late AE (all grades) was urinary incontinence (15.2%). Grade 3-4 acute or late radiotherapy-related AEs were scarce. Most frequent AEs nonrelated to radiotherapy were hot flashes (76%), hypertension (63%), and hepatic cytolysis (50%, of which 20% were of grades 3-4). Of the patients, 11% had a CTC count of ≥5, which was correlated with poorer bRFS (p = 0.042) and alt-bRFS (p = 0.008). The association between CTC count and higher rates of relapse was independent of the baseline PSA level and PSA doubling time (p = 0.42 and p = 0.09, respectively). This study was nonrandomized with a limited number of patients, and few clinical events were reported.
Conclusions
Adding AAP to salvage radiation therapy and goserelin resulted in high bRFS and alt-bRFS. AEs remained manageable, although a close liver surveillance is advised. CTC count appears as a promising biomarker for prognosis and predicting response to treatment.
Patient summary
Our study was a phase 2 clinical trial that exhibited the efficacy and tolerance of a novel androgen-receptor targeting agent (abiraterone acetate plus prednisone) in patients with prostate cancer who experienced rising prostate-specific antigen after radical prostatectomy, in combination with prostate bed radiotherapy. The results also indicated the feasibility and potential value of circulating tumor cell detection, which constitutes a possible advance in managing prostate cancers.
{"title":"Combination of Abiraterone Acetate, Prostate Bed Radiotherapy, and Luteinizing Hormone-releasing Hormone Agonists in Biochemically Relapsing Patients After Prostatectomy (CARLHA): A Phase 2 Clinical Trial","authors":"Loic Ah-Thiane , Loic Campion , Nedjla Allouache , Emmanuel Meyer , Pascal Pommier , Nathalie Mesgouez-Nebout , Anne-Agathe Serre , Gilles Créhange , Valentine Guimas , Emmanuel Rio , Paul Sargos , Sylvain Ladoire , Céline Mahier Ait Oukhatar , Stéphane Supiot","doi":"10.1016/j.euo.2024.04.014","DOIUrl":"10.1016/j.euo.2024.04.014","url":null,"abstract":"<div><h3>Background</h3><div>The relevance of next-generation hormone therapies and circulating tumor cells (CTCs) are not elucidated in biochemical recurrence after prostatectomy.</div></div><div><h3>Objective</h3><div>To evaluate the combination of abiraterone acetate plus prednisone (AAP), prostate bed radiotherapy (PBRT), and goserelin in biochemically relapsing men after prostatectomy, and to investigate the utility of CTCs.</div></div><div><h3>Design, setting, and participants</h3><div>In this single-arm multicenter phase 2 trial, 46 biochemically relapsing men were enrolled between December 2012 and January 2019. The median follow-up was 47 mo.</div></div><div><h3>Intervention</h3><div>All patients received AAP 1000 mg daily (but 750 mg during PBRT), salvage PBRT, and goserelin.</div></div><div><h3>Outcome measurements and statistical analysis</h3><div>The primary outcome was 3-yr biochemical recurrence-free survival (bRFS) when prostate-specific antigen (PSA) levels were ≥0.2 ng/ml. The secondary outcomes included alternative bRFS (alt-bRFS) when PSA levels were ≥0.5 ng/ml and safety assessment. CTC count was assessed.</div></div><div><h3>Results and limitations</h3><div>The 3-yr bRFS and alt-bRFS were 81.5% (95% confidence interval or CI [66.4–90.3%]) and 95.6% (95% CI [83.5-98.9%]), respectively. The most common acute radiotherapy-related adverse effect (AE; all grades was pollakiuria (41.3%). The most common late AE (all grades) was urinary incontinence (15.2%). Grade 3-4 acute or late radiotherapy-related AEs were scarce. Most frequent AEs nonrelated to radiotherapy were hot flashes (76%), hypertension (63%), and hepatic cytolysis (50%, of which 20% were of grades 3-4). Of the patients, 11% had a CTC count of ≥5, which was correlated with poorer bRFS (<em>p</em> = 0.042) and alt-bRFS (<em>p</em> = 0.008). The association between CTC count and higher rates of relapse was independent of the baseline PSA level and PSA doubling time (<em>p</em> = 0.42 and <em>p</em> = 0.09, respectively). This study was nonrandomized with a limited number of patients, and few clinical events were reported.</div></div><div><h3>Conclusions</h3><div>Adding AAP to salvage radiation therapy and goserelin resulted in high bRFS and alt-bRFS. AEs remained manageable, although a close liver surveillance is advised. CTC count appears as a promising biomarker for prognosis and predicting response to treatment.</div></div><div><h3>Patient summary</h3><div>Our study was a phase 2 clinical trial that exhibited the efficacy and tolerance of a novel androgen-receptor targeting agent (abiraterone acetate plus prednisone) in patients with prostate cancer who experienced rising prostate-specific antigen after radical prostatectomy, in combination with prostate bed radiotherapy. The results also indicated the feasibility and potential value of circulating tumor cell detection, which constitutes a possible advance in managing prostate cancers.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 38-46"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140907917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.05.004
Xiaoyang Du , Shuang Hao , Henrik Olsson , Kimmo Kartasalo , Nita Mulliqi , Balram Rai , Dominik Menges , Emelie Heintz , Lars Egevad , Martin Eklund , Mark Clements
Background and objective
Image-based artificial intelligence (AI) methods have shown high accuracy in prostate cancer (PCa) detection. Their impact on patient outcomes and cost effectiveness in comparison to human pathologists remains unknown. Our aim was to evaluate the effectiveness and cost-effectiveness of AI-assisted pathology for PCa diagnosis in Sweden.
Methods
We modeled quadrennial prostate-specific antigen (PSA) screening for men between the ages of 50 and 74 yr over a lifetime horizon using a health care perspective. Men with PSA ≥3 ng/ml were referred for standard biopsy (SBx), for which cores were either examined via AI followed by a pathologist for AI-labeled positive cores, or a pathologist alone. The AI performance characteristics were estimated using an internal STHLM3 validation data set. Outcome measures included the number of tests, PCa incidence and mortality, overdiagnosis, quality-adjusted life years (QALYs), and the potential reduction in pathologist-evaluated biopsy cores if AI were used. Cost-effectiveness was assessed using the incremental cost-effectiveness ratio.
Key findings and limitations
In comparison to a pathologist alone, the AI-assisted workflow increased the number of PSA tests, SBx procedures, and PCa deaths by ≤0.03%, and slightly reduced PCa incidence and overdiagnosis. AI would reduce the proportion of biopsy cores evaluated by a pathologist by 80%. At a cost of €10 per case, the AI-assisted workflow would cost less and result in <0.001% lower QALYs in comparison to a pathologist alone. The results were sensitive to the AI cost.
Conclusions and clinical implications
According to our model, AI-assisted pathology would significantly decrease the workload of pathologists, would not affect patient quality of life, and would yield cost savings in Sweden when compared to a human pathologist alone.
Patient summary
We compared outcomes for prostate cancer patients and relevant costs for two methods of assessing prostate biopsies in Sweden: (1) artificial intelligence (AI) technology and review of positive biopsies by a human pathologist; and (2) a human pathologist alone for all biopsies. We found that addition of AI would reduce the pathology workload and save money, and would not affect patient outcomes when compared to a human pathologist alone. The results suggest that adding AI to prostate pathology in Sweden would save costs.
{"title":"Effectiveness and Cost-effectiveness of Artificial Intelligence–assisted Pathology for Prostate Cancer Diagnosis in Sweden: A Microsimulation Study","authors":"Xiaoyang Du , Shuang Hao , Henrik Olsson , Kimmo Kartasalo , Nita Mulliqi , Balram Rai , Dominik Menges , Emelie Heintz , Lars Egevad , Martin Eklund , Mark Clements","doi":"10.1016/j.euo.2024.05.004","DOIUrl":"10.1016/j.euo.2024.05.004","url":null,"abstract":"<div><h3>Background and objective</h3><div>Image-based artificial intelligence (AI) methods have shown high accuracy in prostate cancer (PCa) detection. Their impact on patient outcomes and cost effectiveness in comparison to human pathologists remains unknown. Our aim was to evaluate the effectiveness and cost-effectiveness of AI-assisted pathology for PCa diagnosis in Sweden.</div></div><div><h3>Methods</h3><div>We modeled quadrennial prostate-specific antigen (PSA) screening for men between the ages of 50 and 74 yr over a lifetime horizon using a health care perspective. Men with PSA ≥3 ng/ml were referred for standard biopsy (SBx), for which cores were either examined via AI followed by a pathologist for AI-labeled positive cores, or a pathologist alone. The AI performance characteristics were estimated using an internal STHLM3 validation data set. Outcome measures included the number of tests, PCa incidence and mortality, overdiagnosis, quality-adjusted life years (QALYs), and the potential reduction in pathologist-evaluated biopsy cores if AI were used. Cost-effectiveness was assessed using the incremental cost-effectiveness ratio.</div></div><div><h3>Key findings and limitations</h3><div>In comparison to a pathologist alone, the AI-assisted workflow increased the number of PSA tests, SBx procedures, and PCa deaths by ≤0.03%, and slightly reduced PCa incidence and overdiagnosis. AI would reduce the proportion of biopsy cores evaluated by a pathologist by 80%. At a cost of €10 per case, the AI-assisted workflow would cost less and result in <0.001% lower QALYs in comparison to a pathologist alone. The results were sensitive to the AI cost.</div></div><div><h3>Conclusions and clinical implications</h3><div>According to our model, AI-assisted pathology would significantly decrease the workload of pathologists, would not affect patient quality of life, and would yield cost savings in Sweden when compared to a human pathologist alone.</div></div><div><h3>Patient summary</h3><div>We compared outcomes for prostate cancer patients and relevant costs for two methods of assessing prostate biopsies in Sweden: (1) artificial intelligence (AI) technology and review of positive biopsies by a human pathologist; and (2) a human pathologist alone for all biopsies. We found that addition of AI would reduce the pathology workload and save money, and would not affect patient outcomes when compared to a human pathologist alone. The results suggest that adding AI to prostate pathology in Sweden would save costs.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 80-86"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141093309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.08.009
Julien Anract , Clément Klein , Ugo Pinar , Morgan Rouprêt , Nicolas Barry Delongchamps , Grégoire Robert
Background and objective
Histopathological examination of surgical specimens for benign prostatic hyperplasia (BPH) can detect incidental prostate cancer (iPCa). The aim of our study was to develop a predictive model for iPCa diagnosis for patients for whom BPH surgery is being considered.
Methods
We conducted a retrospective analysis of medical files for patients who underwent BPH surgery in three academic centers between 2012 and 2022. Patients diagnosed with PCa before surgery were excluded. We calculated the global iPCa rate, and the clinically significant iPCa rate (grade group ≥2). Univariate and multivariable regression models were used to assess factors predictive of iPCa. The area under the receiver operating characteristic curve (AUC) was compared for each risk factor and for the global model. We used χ2 automated interaction detection (CHAID) for decision tree analysis.
Key findings and limitations
We included 2452 patients in the analysis, of whom 247 (10.0%) had iPCa, which was clinically significant in 49/247 cases (20.2%). Multivariable analysis revealed that age and prostate-specific antigen density (PSAD) were independent predictive factors for iPCa diagnosis. The AUC for a model including age and PSAD was 0.65. CHAID analysis revealed that patients with PSAD >0.1 ng/ml/cm3 had an iPCa risk of 23.4% (χ2 = 52.6; p < 0.001). For those patients, age >72 yr increased the iPCa risk to 35.4% (χ2 = 11.1, p = 0.008). Our study is mainly limited by its retrospective design.
Conclusions and clinical implications
Age and PSAD were independent risk factors for iPCa diagnosis. The combination of age >72 yr and PSAD >0.1 ng/ml/cm3 was associated with an iPCa rate of 35.4%.
Patient summary
We performed a study to find predictors of prostate cancer for patients undergoing surgery for benign enlargement of the prostate. Our model can identify patients at risk, and diagnose their cancer before surgery. This could avoid unnecessary or harmful procedures.
{"title":"Incidental Prostate Cancer in Patients Undergoing Surgery for Benign Prostatic Hyperplasia: A Predictive Model","authors":"Julien Anract , Clément Klein , Ugo Pinar , Morgan Rouprêt , Nicolas Barry Delongchamps , Grégoire Robert","doi":"10.1016/j.euo.2024.08.009","DOIUrl":"10.1016/j.euo.2024.08.009","url":null,"abstract":"<div><h3>Background and objective</h3><div>Histopathological examination of surgical specimens for benign prostatic hyperplasia (BPH) can detect incidental prostate cancer (iPCa). The aim of our study was to develop a predictive model for iPCa diagnosis for patients for whom BPH surgery is being considered.</div></div><div><h3>Methods</h3><div>We conducted a retrospective analysis of medical files for patients who underwent BPH surgery in three academic centers between 2012 and 2022. Patients diagnosed with PCa before surgery were excluded. We calculated the global iPCa rate, and the clinically significant iPCa rate (grade group ≥2). Univariate and multivariable regression models were used to assess factors predictive of iPCa. The area under the receiver operating characteristic curve (AUC) was compared for each risk factor and for the global model. We used χ<sup>2</sup> automated interaction detection (CHAID) for decision tree analysis.</div></div><div><h3>Key findings and limitations</h3><div>We included 2452 patients in the analysis, of whom 247 (10.0%) had iPCa, which was clinically significant in 49/247 cases (20.2%). Multivariable analysis revealed that age and prostate-specific antigen density (PSAD) were independent predictive factors for iPCa diagnosis. The AUC for a model including age and PSAD was 0.65. CHAID analysis revealed that patients with PSAD >0.1 ng/ml/cm<sup>3</sup> had an iPCa risk of 23.4% (χ<sup>2</sup> = 52.6; <em>p</em> < 0.001). For those patients, age >72 yr increased the iPCa risk to 35.4% (χ<sup>2</sup> = 11.1, <em>p</em> = 0.008). Our study is mainly limited by its retrospective design.</div></div><div><h3>Conclusions and clinical implications</h3><div>Age and PSAD were independent risk factors for iPCa diagnosis. The combination of age >72 yr and PSAD >0.1 ng/ml/cm<sup>3</sup> was associated with an iPCa rate of 35.4%.</div></div><div><h3>Patient summary</h3><div>We performed a study to find predictors of prostate cancer for patients undergoing surgery for benign enlargement of the prostate. Our model can identify patients at risk, and diagnose their cancer before surgery. This could avoid unnecessary or harmful procedures.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 145-151"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.12.004
Olivier Cussenot , Morgan Rouprêt , Shahrokh F. Shariat
{"title":"Time to Refine Prostate Cancer Epidemiology: Defining New Endpoints for Effective Screening and Causal Epidemiological Studies","authors":"Olivier Cussenot , Morgan Rouprêt , Shahrokh F. Shariat","doi":"10.1016/j.euo.2024.12.004","DOIUrl":"10.1016/j.euo.2024.12.004","url":null,"abstract":"","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 7-8"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.12.011
Mehul Gupta , Connor Wells , Meredith M. Regan , Wanling Xie , Vishal Navani , Renee Maria Saliby , Naveen S. Basappa , Frede Donskov , Takeshi Yuasa , Kosuke Takemura , Christian K. Kollmannsberger , Megan Crumbaker , Aly-Khan A. Lalani , Thomas Powles , Hedyeh Ebrahimi , Rana R. McKay , Jae-Lyun Lee , Ravindran Kanesvaran , Toni K. Choueiri , Daniel Y.C. Heng
Background and objective
Patients receiving immune checkpoint blockade (ICB) therapy may experience periods of prolonged disease control without a need for systemic therapy. Treatment-free survival (TFS) is an important measure for this period, but no data are available for patients with metastatic renal cell carcinoma (mRCC) starting first-line agents. Our aim was to analyze TFS outcomes for patients with mRCC starting first-line therapy.
Methods
We analyzed data for patients with mRCC starting first-line systemic therapy with VEGFR-targeted monotherapy, an ICB + VEGFR combination, or an ICB doublet from February 1, 2014 to February 1, 2023 from the multicenter International Metastatic RCC Database Consortium (IMDC) database. We estimated 36-mo TFS as the difference in restricted mean survival time between (1) the time to first-line therapy discontinuation and (2) the time to subsequent systemic therapy initiation.
Key findings and limitations
The study population included 3758 patients receiving either first-line VEGFR monotherapy (n = 2635), an ICB + VEGFR combination (n = 354), or doublet ICB (n = 769) were included. For the IMDC favorable-risk cohort, the 36-mo TFS estimate was 3.1 mo (95% confidence interval [CI] 1.5–4.6) for the VEGFR monotherapy group and 3.7 mo (95% CI 0.2–7.2) for the ICB + VEGFR group. For the IMDC intermediate-/poor-risk cohort, TFS was 2.1 mo (95% CI 1.4–2.8) for the VEGFR monotherapy group, 3.7 mo (95% CI 1.0–6.4) for the ICB + VEGFR group, and 5.3 mo (95% CI 3.8–6.8) for ICB doublet group. Limitations include the retrospective design and an inability to quantify time spent with adverse events.
Conclusions and clinical implications
Our study demonstrates that patients with IMDC intermediate or poor risk treated with ICB doublet therapy experienced longer TFS than those treated with VEGFR monotherapy in the first-line setting. These results emphasize the utility of TFS as an informative endpoint and provide survival estimates to inform decision-making in mRCC.
Patient summary
For patients with metastatic kidney cancer, we compared the survival time free from a second treatment line for different first-line treatment options. The results show that the time free from second-line treatment was longer when first-line treatment was with a combination of two immunotherapy drugs (ipilimumab and nivolumab) in comparison to other treatment options.
背景和目的：接受免疫检查点阻断（ICB）治疗的患者可能会经历一段较长时间的疾病控制，而不需要全身治疗。无治疗生存期（TFS）是这一时期的重要指标，但没有关于转移性肾细胞癌（mRCC）患者起始一线药物的数据。我们的目的是分析mRCC患者开始一线治疗的TFS结果。方法：我们分析了2014年2月1日至2023年2月1日来自多中心国际转移性RCC数据库联盟（IMDC）数据库的mRCC患者的数据，这些患者开始接受一线全身治疗，包括VEGFR靶向单药治疗、ICB + VEGFR联合治疗或ICB双药治疗。我们估计36个月的TFS是(1)到一线治疗停止的时间和(2)到随后的全身治疗开始的时间之间的限制平均生存时间的差异。主要发现和局限性：研究人群包括3758名接受一线VEGFR单药治疗（n = 2635）、ICB + VEGFR联合治疗（n = 354）或ICB双药治疗（n = 769）的患者。对于IMDC有利风险队列，VEGFR单药组的36个月TFS估计为3.1个月（95%置信区间[CI] 1.5-4.6）， ICB + VEGFR组的36个月TFS估计为3.7个月（95%置信区间[CI] 0.2-7.2）。对于IMDC中/低风险队列，VEGFR单药组的TFS为2.1个月（95% CI 1.4-2.8）， ICB + VEGFR组的TFS为3.7个月（95% CI 1.0-6.4）， ICB双药组的TFS为5.3个月（95% CI 3.8-6.8）。局限性包括回顾性设计和无法量化不良事件所花费的时间。结论和临床意义：我们的研究表明，在一线环境中，接受ICB双药治疗的中度或低风险IMDC患者的TFS比接受VEGFR单药治疗的患者更长。这些结果强调了TFS作为信息终点的效用，并为mRCC的决策提供了生存估计。患者总结：对于转移性肾癌患者，我们比较了不同一线治疗方案的第二治疗线的生存时间。结果显示，与其他治疗方案相比，一线治疗联合使用两种免疫治疗药物（ipilimumab和nivolumab）时，脱离二线治疗的时间更长。
{"title":"Treatment-free Survival After First-line Therapies for Metastatic Renal Cell Carcinoma: An International Metastatic Renal Cell Carcinoma Database Consortium Analysis","authors":"Mehul Gupta , Connor Wells , Meredith M. Regan , Wanling Xie , Vishal Navani , Renee Maria Saliby , Naveen S. Basappa , Frede Donskov , Takeshi Yuasa , Kosuke Takemura , Christian K. Kollmannsberger , Megan Crumbaker , Aly-Khan A. Lalani , Thomas Powles , Hedyeh Ebrahimi , Rana R. McKay , Jae-Lyun Lee , Ravindran Kanesvaran , Toni K. Choueiri , Daniel Y.C. Heng","doi":"10.1016/j.euo.2024.12.011","DOIUrl":"10.1016/j.euo.2024.12.011","url":null,"abstract":"<div><h3>Background and objective</h3><div>Patients receiving immune checkpoint blockade (ICB) therapy may experience periods of prolonged disease control without a need for systemic therapy. Treatment-free survival (TFS) is an important measure for this period, but no data are available for patients with metastatic renal cell carcinoma (mRCC) starting first-line agents. Our aim was to analyze TFS outcomes for patients with mRCC starting first-line therapy.</div></div><div><h3>Methods</h3><div>We analyzed data for patients with mRCC starting first-line systemic therapy with VEGFR-targeted monotherapy, an ICB + VEGFR combination, or an ICB doublet from February 1, 2014 to February 1, 2023 from the multicenter International Metastatic RCC Database Consortium (IMDC) database. We estimated 36-mo TFS as the difference in restricted mean survival time between (1) the time to first-line therapy discontinuation and (2) the time to subsequent systemic therapy initiation.</div></div><div><h3>Key findings and limitations</h3><div>The study population included 3758 patients receiving either first-line VEGFR monotherapy (<em>n</em> = 2635), an ICB + VEGFR combination (<em>n</em> = 354), or doublet ICB (<em>n</em> = 769) were included. For the IMDC favorable-risk cohort, the 36-mo TFS estimate was 3.1 mo (95% confidence interval [CI] 1.5–4.6) for the VEGFR monotherapy group and 3.7 mo (95% CI 0.2–7.2) for the ICB + VEGFR group. For the IMDC intermediate-/poor-risk cohort, TFS was 2.1 mo (95% CI 1.4–2.8) for the VEGFR monotherapy group, 3.7 mo (95% CI 1.0–6.4) for the ICB + VEGFR group, and 5.3 mo (95% CI 3.8–6.8) for ICB doublet group. Limitations include the retrospective design and an inability to quantify time spent with adverse events.</div></div><div><h3>Conclusions and clinical implications</h3><div>Our study demonstrates that patients with IMDC intermediate or poor risk treated with ICB doublet therapy experienced longer TFS than those treated with VEGFR monotherapy in the first-line setting. These results emphasize the utility of TFS as an informative endpoint and provide survival estimates to inform decision-making in mRCC.</div></div><div><h3>Patient summary</h3><div>For patients with metastatic kidney cancer, we compared the survival time free from a second treatment line for different first-line treatment options. The results show that the time free from second-line treatment was longer when first-line treatment was with a combination of two immunotherapy drugs (ipilimumab and nivolumab) in comparison to other treatment options.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 171-178"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.05.005
Wei Shen Tan , Amar Ahmad , Yin Zhou , Arjun Nathan , Ayodeji Ogunbo , Olayinka Gbolahan , Neha Kallam , Rebecca Smith , Maen Khalifeh , Wei Phin Tan , Daniel Cohen , Dimitrios Volanis , Fiona M. Walter , Peter Sasieni , Ashish M. Kamat , John D. Kelly
Background
Hematuria is a cardinal symptom of urinary tract cancer and would require further investigations.
Objective
To determine the ability of renal bladder ultrasound (RBUS) with the Hematuria Cancer Risk Score (HCRS) to inform cystoscopy use in patients with hematuria.
Design, setting, and participants
The development cohort comprised 1984 patients with hematuria from 40 UK hospitals (DETECT 1; ClinicalTrials.gov: NCT02676180) who received RBUS. An independent validation cohort comprised 500 consecutive patients referred to secondary care for a suspicion of bladder cancer.
Outcome measurements and statistical analysis
Sensitivity and true negative of the HCRS and RBUS were assessed.
Results and limitations
A total of 134 (7%) and 36 (8%) patients in the development and validation cohorts, respectively, had a diagnosis of urinary tract cancer. Validation of the HCRS achieves good discrimination with an area under the receiver operating characteristic curve of 0.727 (95% confidence interval 0.648–0.800) in the validation cohort with sensitivity of 95% for the identification of cancer. Utilizing the cutoff of 4.500 derived from the HCRS in combination with RBUS in the development cohort, 680 (34%) patients would have been spared cystoscopy at the cost of missing a G1 Ta bladder cancer and a urinary tract cancer patient, while 117 (25%) patients would have avoided cystoscopy at the cost of missing a single patient of G1 Ta bladder cancer with sensitivity for the identification of cancer of 97% in the validation cohort.
Conclusions
The HCRS with RBUS offers good discriminatory ability in identifying patients who would benefit from cystoscopy, sparing selected patient cohorts from an invasive procedure.
Patient summary
The hematuria cancer risk score with renal bladder ultrasound allows for the triage of patients with hematuria who would benefit from visual examination of the bladder (cystoscopy). This resulted in 25% of patients safely omitting cystoscopy, which is an invasive procedure, and would lead to health care cost savings.
{"title":"Hematuria Cancer Risk Score with Ultrasound Informs Cystoscopy Use in Patients with Hematuria","authors":"Wei Shen Tan , Amar Ahmad , Yin Zhou , Arjun Nathan , Ayodeji Ogunbo , Olayinka Gbolahan , Neha Kallam , Rebecca Smith , Maen Khalifeh , Wei Phin Tan , Daniel Cohen , Dimitrios Volanis , Fiona M. Walter , Peter Sasieni , Ashish M. Kamat , John D. Kelly","doi":"10.1016/j.euo.2024.05.005","DOIUrl":"10.1016/j.euo.2024.05.005","url":null,"abstract":"<div><h3>Background</h3><div>Hematuria is a cardinal symptom of urinary tract cancer and would require further investigations.</div></div><div><h3>Objective</h3><div>To determine the ability of renal bladder ultrasound (RBUS) with the Hematuria Cancer Risk Score (HCRS) to inform cystoscopy use in patients with hematuria.</div></div><div><h3>Design, setting, and participants</h3><div>The development cohort comprised 1984 patients with hematuria from 40 UK hospitals (DETECT 1; ClinicalTrials.gov: NCT02676180) who received RBUS. An independent validation cohort comprised 500 consecutive patients referred to secondary care for a suspicion of bladder cancer.</div></div><div><h3>Outcome measurements and statistical analysis</h3><div>Sensitivity and true negative of the HCRS and RBUS were assessed.</div></div><div><h3>Results and limitations</h3><div>A total of 134 (7%) and 36 (8%) patients in the development and validation cohorts, respectively, had a diagnosis of urinary tract cancer. Validation of the HCRS achieves good discrimination with an area under the receiver operating characteristic curve of 0.727 (95% confidence interval 0.648–0.800) in the validation cohort with sensitivity of 95% for the identification of cancer. Utilizing the cutoff of 4.500 derived from the HCRS in combination with RBUS in the development cohort, 680 (34%) patients would have been spared cystoscopy at the cost of missing a G1 Ta bladder cancer and a urinary tract cancer patient, while 117 (25%) patients would have avoided cystoscopy at the cost of missing a single patient of G1 Ta bladder cancer with sensitivity for the identification of cancer of 97% in the validation cohort.</div></div><div><h3>Conclusions</h3><div>The HCRS with RBUS offers good discriminatory ability in identifying patients who would benefit from cystoscopy, sparing selected patient cohorts from an invasive procedure.</div></div><div><h3>Patient summary</h3><div>The hematuria cancer risk score with renal bladder ultrasound allows for the triage of patients with hematuria who would benefit from visual examination of the bladder (cystoscopy). This resulted in 25% of patients safely omitting cystoscopy, which is an invasive procedure, and would lead to health care cost savings.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 87-93"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141175240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.euo.2024.05.010
Laura S. Mertens , Harman Maxim Bruins , Roberto Contieri , Marek Babjuk , Bhavan P. Rai , Albert Carrión Puig , Jose Luis Dominguez Escrig , Paolo Gontero , Antoine G. van der Heijden , Fredrik Liedberg , Alberto Martini , Alexandra Masson-Lecomte , Richard P. Meijer , Hugh Mostafid , Yann Neuzillet , Benjamin Pradere , John Redlef , Bas W.G. van Rhijn , Matthieu Rouanne , Morgan Rouprêt , J. Alfred Witjes
Background and objective
There is no standardized regimen for follow-up after radical cystectomy (RC) for bladder cancer (BC). To address this gap, we conducted a multicenter study involving urologist members from the European Association of Urology (EAU) bladder cancer guideline panels. Our objective was to identify consistent post-RC follow-up strategies and develop a practice-based framework based on expert opinion.
Methods
We surveyed 27 urologist members of the EAU guideline panels for non–muscle-invasive bladder cancer and muscle-invasive and metastatic bladder cancer using a pre-tested questionnaire with dichotomous responses. The survey inquired about follow-up strategies after RC and the use of risk-adapted strategies. Consistency was defined as >75% affirmative responses for follow-up practices commencing 3 mo after RC. Descriptive statistics were used for analysis.
Key findings and limitations
We received responses from 96% of the panel members, who provided data from 21 European hospitals. Risk-adapted follow-up is used in 53% of hospitals, with uniform criteria for high-risk (at least ≥pT3 or pN+) and low-risk ([y]pT0/a/1N0) cases. In the absence of agreement for risk-based follow up, a non-risk-adapted framework for follow-up was developed. Higher conformity was observed within the initial 3 yr, followed by a decline in subsequent follow-up. Follow-up was most frequent during the first year, including patient assessments, physical examinations, and laboratory tests. Computed tomography of the chest and abdomen/pelvis was the most common imaging modality, initially at least biannually, and then annually from years 2 to 5. There was a lack of consistency for continuing follow-up beyond 10 yr after RC.
Conclusions and clinical implications
This practice-based post-RC follow-up framework developed by EAU bladder cancer experts may serve as a valuable guide for urologists in the absence of prospective randomized studies.
Patient summary
We asked urologists from the EAU bladder cancer guideline panels about their patient follow-up after surgical removal of the bladder for bladder cancer. We found that although urologists have varying approaches, there are also common follow-up practices across the panel. We created a practical follow-up framework that could be useful for urologists in their day-to-day practice.
{"title":"Consistencies in Follow-up After Radical Cystectomy for Bladder Cancer: A Framework Based on Expert Practices Collaboratively Developed by the European Association of Urology Bladder Cancer Guideline Panels","authors":"Laura S. Mertens , Harman Maxim Bruins , Roberto Contieri , Marek Babjuk , Bhavan P. Rai , Albert Carrión Puig , Jose Luis Dominguez Escrig , Paolo Gontero , Antoine G. van der Heijden , Fredrik Liedberg , Alberto Martini , Alexandra Masson-Lecomte , Richard P. Meijer , Hugh Mostafid , Yann Neuzillet , Benjamin Pradere , John Redlef , Bas W.G. van Rhijn , Matthieu Rouanne , Morgan Rouprêt , J. Alfred Witjes","doi":"10.1016/j.euo.2024.05.010","DOIUrl":"10.1016/j.euo.2024.05.010","url":null,"abstract":"<div><h3>Background and objective</h3><div>There is no standardized regimen for follow-up after radical cystectomy (RC) for bladder cancer (BC). To address this gap, we conducted a multicenter study involving urologist members from the European Association of Urology (EAU) bladder cancer guideline panels. Our objective was to identify consistent post-RC follow-up strategies and develop a practice-based framework based on expert opinion.</div></div><div><h3>Methods</h3><div>We surveyed 27 urologist members of the EAU guideline panels for non–muscle-invasive bladder cancer and muscle-invasive and metastatic bladder cancer using a pre-tested questionnaire with dichotomous responses. The survey inquired about follow-up strategies after RC and the use of risk-adapted strategies. Consistency was defined as >75% affirmative responses for follow-up practices commencing 3 mo after RC. Descriptive statistics were used for analysis.</div></div><div><h3>Key findings and limitations</h3><div>We received responses from 96% of the panel members, who provided data from 21 European hospitals. Risk-adapted follow-up is used in 53% of hospitals, with uniform criteria for high-risk (at least ≥pT3 or pN+) and low-risk ([y]pT0/a/1N0) cases. In the absence of agreement for risk-based follow up, a non-risk-adapted framework for follow-up was developed. Higher conformity was observed within the initial 3 yr, followed by a decline in subsequent follow-up. Follow-up was most frequent during the first year, including patient assessments, physical examinations, and laboratory tests. Computed tomography of the chest and abdomen/pelvis was the most common imaging modality, initially at least biannually, and then annually from years 2 to 5. There was a lack of consistency for continuing follow-up beyond 10 yr after RC.</div></div><div><h3>Conclusions and clinical implications</h3><div>This practice-based post-RC follow-up framework developed by EAU bladder cancer experts may serve as a valuable guide for urologists in the absence of prospective randomized studies.</div></div><div><h3>Patient summary</h3><div>We asked urologists from the EAU bladder cancer guideline panels about their patient follow-up after surgical removal of the bladder for bladder cancer. We found that although urologists have varying approaches, there are also common follow-up practices across the panel. We created a practical follow-up framework that could be useful for urologists in their day-to-day practice.</div></div>","PeriodicalId":12256,"journal":{"name":"European urology oncology","volume":"8 1","pages":"Pages 105-110"},"PeriodicalIF":8.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141436796","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}
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