European urologyPub Date : 2024-09-23DOI: 10.1016/j.eururo.2024.09.003
Dana E Rathkopf, Guilhem Roubaud, Kim N Chi, Eleni Efstathiou, Gerhardt Attard, David Olmos, Eric J Small, Marniza Saad, Elena Castro, Won Kim, Daphne Wu, Kristi Bertzos, Shiva Dibaj, Jenny Zhang, Peter Francis, Matthew R Smith
{"title":"Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial.","authors":"Dana E Rathkopf, Guilhem Roubaud, Kim N Chi, Eleni Efstathiou, Gerhardt Attard, David Olmos, Eric J Small, Marniza Saad, Elena Castro, Won Kim, Daphne Wu, Kristi Bertzos, Shiva Dibaj, Jenny Zhang, Peter Francis, Matthew R Smith","doi":"10.1016/j.eururo.2024.09.003","DOIUrl":"https://doi.org/10.1016/j.eururo.2024.09.003","url":null,"abstract":"<p><strong>Background and objective: </strong>The phase 3 MAGNITUDE trial assessed the efficacy and safety of niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) and alterations in homologous recombination repair (HRR) genes. Here we report final analysis results for patient-reported outcomes (PROs) in the HRR<sup>+</sup> cohort with a focus on BRCA1/2 alterations (BRCA<sup>+</sup>).</p><p><strong>Methods: </strong>Protocol-specified endpoints evaluated patient-reported symptoms, health-related quality of life (HRQoL), and tolerability (side-effect bother) using the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EQ-5D-5L questionnaires. Evaluations were completed on day 1 of designated treatment cycles and during follow-up.</p><p><strong>Key findings and limitations: </strong>All patients with BRCA<sup>+</sup> mCRPC (n = 225) were included in the PRO analyses with average on-treatment PRO compliance >80% when completed on-site. Time to deterioration in pain according to BPI-SF and FACT-P scores did not significantly differ between niraparib + AAP and placebo + AAP. During treatment, EQ-5D-5L revealed no clinically meaningful differences in overall HRQoL between treatment arms in the BRCA+ subgroup. Finally, tolerability was similar between arms; side effect bother rated as \"not at all\" or \"a little bit\" ranged from 79.8% to 95.9% during treatment. Limitations include a sample size that may not have been powered to detect a difference in PROs.</p><p><strong>Conclusions and clinical implications: </strong>Treatment with niraparib + AAP maintained HRQoL with minimal side-effect bother reported by most patients with BRCA<sup>+</sup> mCRPC. Differences between treatment groups in time to pain deterioration did not meet conventional levels of statistical significance. The MAGNITUDE trial is registered on ClinicalTrials.gov as NCT03748641.</p>","PeriodicalId":94000,"journal":{"name":"European urology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142335132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
European urologyPub Date : 2024-09-03DOI: 10.1016/j.eururo.2024.07.013
Sujit S Nair, Hassan Muhammad, Parag Jain, Chensu Xie, Ina Pavlova, Rachel Brody, Wei Huang, Maria Nakadar, Xiangfu Zhang, Hirak Basu, George Wilding, Rajat Roy, Dimple Chakravarty, Ashutosh K Tewari
{"title":"A Novel Artificial Intelligence-powered Tool for Precise Risk Stratification of Prostate Cancer Progression in Patients with Clinical Intermediate Risk.","authors":"Sujit S Nair, Hassan Muhammad, Parag Jain, Chensu Xie, Ina Pavlova, Rachel Brody, Wei Huang, Maria Nakadar, Xiangfu Zhang, Hirak Basu, George Wilding, Rajat Roy, Dimple Chakravarty, Ashutosh K Tewari","doi":"10.1016/j.eururo.2024.07.013","DOIUrl":"https://doi.org/10.1016/j.eururo.2024.07.013","url":null,"abstract":"","PeriodicalId":94000,"journal":{"name":"European urology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142134863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
European urologyPub Date : 2024-08-21DOI: 10.1016/j.eururo.2024.07.015
Ronald de Wit, David J Vaughn, Yves Fradet, Lawrence Fong, Miguel A Climent, Andrea Necchi, Daniel P Petrylak, Winald R Gerritsen, Howard Gurney, David I Quinn, Stéphane Culine, Cora N Sternberg, Dean F Bajorin, Toni K Choueiri, Jin Xu, Kentaro Imai, Blanca Homet Moreno, Joaquim Bellmunt, Jae-Lyun Lee
{"title":"Impact of Prior Chemotherapy on Response to Second-line Pembrolizumab in Urothelial Cancer: Exploratory Analysis of the Phase 3 KEYNOTE-045 Trial.","authors":"Ronald de Wit, David J Vaughn, Yves Fradet, Lawrence Fong, Miguel A Climent, Andrea Necchi, Daniel P Petrylak, Winald R Gerritsen, Howard Gurney, David I Quinn, Stéphane Culine, Cora N Sternberg, Dean F Bajorin, Toni K Choueiri, Jin Xu, Kentaro Imai, Blanca Homet Moreno, Joaquim Bellmunt, Jae-Lyun Lee","doi":"10.1016/j.eururo.2024.07.015","DOIUrl":"https://doi.org/10.1016/j.eururo.2024.07.015","url":null,"abstract":"<p><strong>Background and objective: </strong>Until recently, the standard first-line treatment for advanced urothelial carcinoma (UC) was platinum-based combination chemotherapy followed by avelumab maintenance therapy for patients without progressive disease (PD). For patients with advanced UC who experience PD or recurrence, standard-of-care treatment is pembrolizumab monotherapy based on the phase 3 KEYNOTE-045 study. This post hoc analysis of the KEYNOTE-045 study evaluated the efficacy of pembrolizumab compared with chemotherapy by the best response to prior platinum-based chemotherapy.</p><p><strong>Methods: </strong>Patients with advanced UC that progressed or recurred after first-line platinum-based chemotherapy were randomly assigned 1:1 to receive either pembrolizumab 200 mg every 3 wk (Q3W) for ≤2 yr or investigator's choice of chemotherapy (paclitaxel [175 mg/m<sup>2</sup>], docetaxel [75 mg/m<sup>2</sup>], or vinflunine [320 mg/m<sup>2</sup>], each Q3W). Endpoints included overall survival (OS) from the initiation of the last treatment prior to death, objective response rate (ORR), and duration of response (DOR) as per Response Evaluation Criteria in Solid Tumors version 1.1 from the date of the first response.</p><p><strong>Key findings and limitations: </strong>An objective response to pembrolizumab was observed in all groups in terms of a prior response to first-line platinum-based chemotherapy. Median OS, ORR, and median DOR were numerically greater with pembrolizumab than with chemotherapy across subgroups. Patients with PD as the best response to prior platinum-based chemotherapy had the poorest OS outcomes. Limitations include a lack of formal hypothesis testing.</p><p><strong>Conclusions and clinical implications: </strong>When compared with chemotherapy, prolonged OS and durable responses to second-line pembrolizumab were observed independently of the response to or type of prior platinum-based chemotherapy. These findings further support pembrolizumab as second-line treatment for advanced UC.</p>","PeriodicalId":94000,"journal":{"name":"European urology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142038019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
European urologyPub Date : 2024-08-01Epub Date: 2024-05-16DOI: 10.1016/j.eururo.2024.05.002
Christian D Fankhauser, Marian S Wettstein, Christoph Würnschimmel, Maarten van Smeden, Noel W Clarke
{"title":"Re: External Validation of the Rotterdam Prostate Cancer Risk Calculator and Comparison with Stockholm3 for Prostate Cancer Diagnosis in a Swedish Population-based Screening Cohort.","authors":"Christian D Fankhauser, Marian S Wettstein, Christoph Würnschimmel, Maarten van Smeden, Noel W Clarke","doi":"10.1016/j.eururo.2024.05.002","DOIUrl":"10.1016/j.eururo.2024.05.002","url":null,"abstract":"","PeriodicalId":94000,"journal":{"name":"European urology","volume":" ","pages":"187-188"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140961322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
European urologyPub Date : 2024-05-29DOI: 10.1016/j.eururo.2024.05.018
Fabian P Stangl, Isabel Heidegger, Pia Kraft, Rianne J M Lammers, Mark Horvath, Muslim Dogan Deger, Elvira Polo-Alonso, Mike Wenzel, Andreas Affentranger, Katrine Schou-Jensen, Lobna Ali, Robert A Keenan, Laura Gallardo-Zamora, Josias Franco Alva, Domenico Trerè, Georgios Tsampoukas, Peter Hoyerup, Clara Cerrato, Nicolas Raison, Sabine Brookman-May, Juan Luis Vásquez
{"title":"Challenging the Urologist of the Future: Time for a Change?","authors":"Fabian P Stangl, Isabel Heidegger, Pia Kraft, Rianne J M Lammers, Mark Horvath, Muslim Dogan Deger, Elvira Polo-Alonso, Mike Wenzel, Andreas Affentranger, Katrine Schou-Jensen, Lobna Ali, Robert A Keenan, Laura Gallardo-Zamora, Josias Franco Alva, Domenico Trerè, Georgios Tsampoukas, Peter Hoyerup, Clara Cerrato, Nicolas Raison, Sabine Brookman-May, Juan Luis Vásquez","doi":"10.1016/j.eururo.2024.05.018","DOIUrl":"https://doi.org/10.1016/j.eururo.2024.05.018","url":null,"abstract":"<p><p>Physicians need both medical expertise and diverse skills for effective patient care. Adaptability is also key in embracing advances in technology and new techniques. We outline six thought-provoking points to guide the new generation of urologists.</p>","PeriodicalId":94000,"journal":{"name":"European urology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141177017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
European urologyPub Date : 2024-05-01DOI: 10.1016/j.eururo.2024.04.035
A.R. Padhani, Frédéric Lecouvet, G. Petralia, Dow-Mu Koh
{"title":"Re: Alonso Garcia-Ruiz, Carlos Macarro, Francesca Zacchi, et al. Whole-body Magnetic Resonance Imaging as a Treatment Response Biomarker in Castration-resistant Prostate Cancer with Bone Metastases: The iPROMET Clinical Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2024.02.016.","authors":"A.R. Padhani, Frédéric Lecouvet, G. Petralia, Dow-Mu Koh","doi":"10.1016/j.eururo.2024.04.035","DOIUrl":"https://doi.org/10.1016/j.eururo.2024.04.035","url":null,"abstract":"","PeriodicalId":94000,"journal":{"name":"European urology","volume":"51 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141058405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}