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
(2025) In European Urology Focus 11(6). p.926-936- Abstract
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... (More)
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.
(Less)
- author
- Rajwa, Pawel
; Borkowetz, Angelika
; Abbott, Thomas
; Alberti, Andrea
; Beyer, Katharina
; Bjartell, Anders
LU
; Brash, James T.
; Chilelli, Andrew
; Davies, Eleanor
; Meulder, Bertrand De
; Fazekas, Tamas
; Golozar, Asieh
; Hijazy, Ayman
; Josefsson, Andreas
; Kasivisvanathan, Veeru
; Kolde, Raivo
; Kotik, Daniel
; Leapman, Michael S.
; Miszczyk, Marcin
; Nicoletti, Rossella
; Prinsen, Peter
; Remmers, Sebastiaan
; Ribal, Maria J.
; Rivas, Juan Gómez
; Rodriguez-Sanchez, Lara
; Roobol, Monique J.
; Smith, Emma
; Snijder, Robert
; Steinbeisser, Carl
; Stroomberg, Hein V.
; Gandaglia, Giorgio
; Cornford, Philip
; Evans-Axelsson, Susan
LU
; N'Dow, James
and Willemse, Peter Paul M.
(Less) - author collaboration
- organization
- publishing date
- 2025
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Androgen receptor pathway inhibitor, Big data, Cardiovascular adverse events, Docetaxel, Hormone sensitive, Metastatic, PIONEER, Prostate cancer
- in
- European Urology Focus
- volume
- 11
- issue
- 6
- pages
- 926 - 936
- publisher
- Elsevier
- external identifiers
-
- pmid:41046191
- scopus:105017880501
- ISSN
- 2405-4569
- DOI
- 10.1016/j.euf.2025.08.005
- language
- English
- LU publication?
- yes
- id
- 62ec1033-6738-4f42-a2ca-702dee012ba1
- date added to LUP
- 2025-12-05 11:52:31
- date last changed
- 2025-12-19 16:17:10
@article{62ec1033-6738-4f42-a2ca-702dee012ba1,
abstract = {{<p>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.</p>}},
author = {{Rajwa, Pawel and Borkowetz, Angelika and Abbott, Thomas and Alberti, Andrea and Beyer, Katharina and Bjartell, Anders and Brash, James T. and Chilelli, Andrew and Davies, Eleanor and Meulder, Bertrand De and Fazekas, Tamas and Golozar, Asieh and Hijazy, Ayman and Josefsson, Andreas and Kasivisvanathan, Veeru and Kolde, Raivo and Kotik, Daniel and Leapman, Michael S. and Miszczyk, Marcin and Nicoletti, Rossella and Prinsen, Peter and Remmers, Sebastiaan and Ribal, Maria J. and Rivas, Juan Gómez and Rodriguez-Sanchez, Lara and Roobol, Monique J. and Smith, Emma and Snijder, Robert and Steinbeisser, Carl and Stroomberg, Hein V. and Gandaglia, Giorgio and Cornford, Philip and Evans-Axelsson, Susan and N'Dow, James and Willemse, Peter Paul M.}},
issn = {{2405-4569}},
keywords = {{Androgen receptor pathway inhibitor; Big data; Cardiovascular adverse events; Docetaxel; Hormone sensitive; Metastatic; PIONEER; Prostate cancer}},
language = {{eng}},
number = {{6}},
pages = {{926--936}},
publisher = {{Elsevier}},
series = {{European Urology Focus}},
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}},
url = {{http://dx.doi.org/10.1016/j.euf.2025.08.005}},
doi = {{10.1016/j.euf.2025.08.005}},
volume = {{11}},
year = {{2025}},
}