Pawel Rajwa, Angelika Borkowetz, Thomas Abbott, Andrea Alberti, Katharina Beyer, Anders Bjartell, James T Brash, Andrew Chilelli, Eleanor Davies, Bertrand De Meulder, Tamas Fazekas, Asieh Golozar, Ayman Hijazy, Andreas Josefsson, Veeru Kasivisvanathan, Raivo Kolde, Daniel Kotik, Michael S Leapman, Marcin Miszczyk, Rossella Nicoletti, Peter Prinsen, Sebastiaan Remmers, Maria J Ribal, Juan Gómez Rivas, Lara Rodriguez-Sanchez, Monique J Roobol, Emma Smith, Robert Snijder, Carl Steinbeisser, Hein V Stroomberg, Giorgio Gandaglia, Philip Cornford, Susan Evans-Axelsson, James N'Dow, Peter-Paul M Willemse
{"title":"转移性激素敏感前列腺癌患者全身治疗后心血管不良事件的观察性健康数据分析：使用PIONEER平台的大数据分析","authors":"Pawel Rajwa, Angelika Borkowetz, Thomas Abbott, Andrea Alberti, Katharina Beyer, Anders Bjartell, James T Brash, Andrew Chilelli, Eleanor Davies, Bertrand De Meulder, Tamas Fazekas, Asieh Golozar, Ayman Hijazy, Andreas Josefsson, Veeru Kasivisvanathan, Raivo Kolde, Daniel Kotik, Michael S Leapman, Marcin Miszczyk, Rossella Nicoletti, Peter Prinsen, Sebastiaan Remmers, Maria J Ribal, Juan Gómez Rivas, Lara Rodriguez-Sanchez, Monique J Roobol, Emma Smith, Robert Snijder, Carl Steinbeisser, Hein V Stroomberg, Giorgio Gandaglia, Philip Cornford, Susan Evans-Axelsson, James N'Dow, Peter-Paul M Willemse","doi":"10.1016/j.euf.2025.08.005","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>Although cardiovascular toxicity from modern systemic treatments in metastatic hormone-sensitive prostate cancer (mHSPC) remains a concern, real-world data are limited. We aimed to characterise patients treated for mHSPC across multiple large cohorts and estimate cardiovascular adverse event (AE) risks.</p><p><strong>Methods: </strong>Leveraging PIONEER's Big Data platform, with databases standardised using the Observational Medical Outcomes Partnership model, we defined cohorts and calculated the incidence rates of AEs per 1000 person-years. The time to first event was assessed via a Kaplan-Meier analysis, and the mean cumulative function (MCF) was estimated for recurrent events. Analyses were stratified by therapy and database.</p><p><strong>Key findings and limitations: </strong>We included 90 087 mHSPC patients from five databases, treated with androgen deprivation therapy (ADT) + androgen receptor pathway inhibitor (ARPI) + docetaxel (DOC) (n = 3743), ADT + ARPI (n = 13 588), ADT + DOC (n = 16 287), or ADT alone (n = 56 469). The distribution of age (63.5-73.7 yr) and comorbidities varied between databases (eg, for hypertension 22-79%). Diabetes was reported in up to 33%, heart failure in 17%, obesity in 25%, and kidney impairment in 26% of men. The highest incidence rates of AEs were as follows: 115 cases (ADT) for acute cardiac events, 403 (ADT + ARPI) for cerebral events, 214 (ADT + ARPI) for thromboembolism, 34 (ADT) for chronic heart failure, and 143 (ADT + ARPI + DOC) for hypertension. The 3-yr acute cardiac event-free survival rate ranged from 79% to 97%, and the 3-yr MCF for acute cardiac events was up to 0.33. Limitations include the retrospective nature and a lack of AE grading.</p><p><strong>Conclusions and clinical implications: </strong>Our study highlights important heterogeneity in real-world, observational mHSPC data. The included patients demonstrated a substantial comorbidity burden, often exceeding that reported in clinical trials, alongside a high rate of cardiovascular AEs.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":5.6000,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Observational Health Data Analysis of the Cardiovascular Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform.\",\"authors\":\"Pawel Rajwa, Angelika Borkowetz, Thomas Abbott, Andrea Alberti, Katharina Beyer, Anders Bjartell, James T Brash, Andrew Chilelli, Eleanor Davies, Bertrand De Meulder, Tamas Fazekas, Asieh Golozar, Ayman Hijazy, Andreas Josefsson, Veeru Kasivisvanathan, Raivo Kolde, Daniel Kotik, Michael S Leapman, Marcin Miszczyk, Rossella Nicoletti, Peter Prinsen, Sebastiaan Remmers, Maria J Ribal, Juan Gómez Rivas, Lara Rodriguez-Sanchez, Monique J Roobol, Emma Smith, Robert Snijder, Carl Steinbeisser, Hein V Stroomberg, Giorgio Gandaglia, Philip Cornford, Susan Evans-Axelsson, James N'Dow, Peter-Paul M Willemse\",\"doi\":\"10.1016/j.euf.2025.08.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>Although cardiovascular toxicity from modern systemic treatments in metastatic hormone-sensitive prostate cancer (mHSPC) remains a concern, real-world data are limited. We aimed to characterise patients treated for mHSPC across multiple large cohorts and estimate cardiovascular adverse event (AE) risks.</p><p><strong>Methods: </strong>Leveraging PIONEER's Big Data platform, with databases standardised using the Observational Medical Outcomes Partnership model, we defined cohorts and calculated the incidence rates of AEs per 1000 person-years. The time to first event was assessed via a Kaplan-Meier analysis, and the mean cumulative function (MCF) was estimated for recurrent events. Analyses were stratified by therapy and database.</p><p><strong>Key findings and limitations: </strong>We included 90 087 mHSPC patients from five databases, treated with androgen deprivation therapy (ADT) + androgen receptor pathway inhibitor (ARPI) + docetaxel (DOC) (n = 3743), ADT + ARPI (n = 13 588), ADT + DOC (n = 16 287), or ADT alone (n = 56 469). The distribution of age (63.5-73.7 yr) and comorbidities varied between databases (eg, for hypertension 22-79%). Diabetes was reported in up to 33%, heart failure in 17%, obesity in 25%, and kidney impairment in 26% of men. The highest incidence rates of AEs were as follows: 115 cases (ADT) for acute cardiac events, 403 (ADT + ARPI) for cerebral events, 214 (ADT + ARPI) for thromboembolism, 34 (ADT) for chronic heart failure, and 143 (ADT + ARPI + DOC) for hypertension. The 3-yr acute cardiac event-free survival rate ranged from 79% to 97%, and the 3-yr MCF for acute cardiac events was up to 0.33. Limitations include the retrospective nature and a lack of AE grading.</p><p><strong>Conclusions and clinical implications: </strong>Our study highlights important heterogeneity in real-world, observational mHSPC data. 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Observational Health Data Analysis of the Cardiovascular Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform.
Background and objective: Although cardiovascular toxicity from modern systemic treatments in metastatic hormone-sensitive prostate cancer (mHSPC) remains a concern, real-world data are limited. We aimed to characterise patients treated for mHSPC across multiple large cohorts and estimate cardiovascular adverse event (AE) risks.
Methods: Leveraging PIONEER's Big Data platform, with databases standardised using the Observational Medical Outcomes Partnership model, we defined cohorts and calculated the incidence rates of AEs per 1000 person-years. The time to first event was assessed via a Kaplan-Meier analysis, and the mean cumulative function (MCF) was estimated for recurrent events. Analyses were stratified by therapy and database.
Key findings and limitations: We included 90 087 mHSPC patients from five databases, treated with androgen deprivation therapy (ADT) + androgen receptor pathway inhibitor (ARPI) + docetaxel (DOC) (n = 3743), ADT + ARPI (n = 13 588), ADT + DOC (n = 16 287), or ADT alone (n = 56 469). The distribution of age (63.5-73.7 yr) and comorbidities varied between databases (eg, for hypertension 22-79%). Diabetes was reported in up to 33%, heart failure in 17%, obesity in 25%, and kidney impairment in 26% of men. The highest incidence rates of AEs were as follows: 115 cases (ADT) for acute cardiac events, 403 (ADT + ARPI) for cerebral events, 214 (ADT + ARPI) for thromboembolism, 34 (ADT) for chronic heart failure, and 143 (ADT + ARPI + DOC) for hypertension. The 3-yr acute cardiac event-free survival rate ranged from 79% to 97%, and the 3-yr MCF for acute cardiac events was up to 0.33. Limitations include the retrospective nature and a lack of AE grading.
Conclusions and clinical implications: Our study highlights important heterogeneity in real-world, observational mHSPC data. The included patients demonstrated a substantial comorbidity burden, often exceeding that reported in clinical trials, alongside a high rate of cardiovascular AEs.
期刊介绍：
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.
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