TY - JOUR
T1 - Observational Health Data Analysis of the Cardiovascular Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer
T2 - Big Data Analytics Using the PIONEER Platform
AU - Rajwa, Pawel
AU - Borkowetz, Angelika
AU - Abbott, Thomas
AU - Alberti, Andrea
AU - Beyer, Katharina
AU - Bjartell, Anders
AU - Brash, James T
AU - Chilelli, Andrew
AU - Davies, Eleanor
AU - Meulder, Bertrand De
AU - Fazekas, Tamas
AU - Golozar, Asieh
AU - Hijazy, Ayman
AU - Josefsson, Andreas
AU - Kasivisvanathan, Veeru
AU - Kolde, Raivo
AU - Kotik, Daniel
AU - Leapman, Michael S
AU - Miszczyk, Marcin
AU - Nicoletti, Rossella
AU - Prinsen, Peter
AU - Remmers, Sebastiaan
AU - Ribal, Maria J
AU - Rivas, Juan Gómez
AU - Rodriguez-Sanchez, Lara
AU - Roobol, Monique J
AU - Smith, Emma
AU - Snijder, Robert
AU - Steinbeisser, Carl
AU - Stroomberg, Hein V
AU - Gandaglia, Giorgio
AU - Cornford, Philip
AU - Evans-Axelsson, Susan
AU - N'Dow, James
AU - Willemse, Peter-Paul M
N1 - Publisher Copyright:
© 2025
PY - 2025/11
Y1 - 2025/11
N2 - 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.
AB - 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.
KW - Androgen receptor pathway inhibitor
KW - Big data
KW - Cardiovascular adverse events
KW - Docetaxel
KW - Hormone sensitive
KW - Metastatic
KW - PIONEER
KW - Prostate cancer
UR - https://www.scopus.com/pages/publications/105017880501
U2 - 10.1016/j.euf.2025.08.005
DO - 10.1016/j.euf.2025.08.005
M3 - Article
C2 - 41046191
SN - 2405-4569
VL - 11
SP - 926
EP - 936
JO - European Urology Focus
JF - European Urology Focus
IS - 6
ER -