Rajwa, P; Borkowetz, A; Abbott, T; Alberti, A; Beyer, K; Bjartell, A; Brash, JT; ... Willemse, PPM; + view all Rajwa, P; Borkowetz, A; Abbott, T; Alberti, A; Beyer, K; Bjartell, A; Brash, JT; Chilelli, A; Davies, E; Meulder, BD; Fazekas, T; Golozar, A; Hijazy, A; Josefsson, A; Kasivisvanathan, V; Kolde, R; Kotik, D; Leapman, MS; Miszczyk, M; Nicoletti, R; Prinsen, P; Remmers, S; Ribal, MJ; Rivas, JG; Rodriguez-Sanchez, L; Roobol, MJ; Smith, E; Snijder, R; Steinbeisser, C; Stroomberg, HV; Gandaglia, G; Cornford, P; Evans-Axelsson, S; N'Dow, J; Willemse, PPM; - view fewer (2025) 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. European Urology Focus 10.1016/j.euf.2025.08.005. (In press).

Text Kasivisvanathan_Observational Health Data Analysis of the Cardiovascular Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer_AAM.pdf Access restricted to UCL open access staff until 4 October 2026. Download (299kB)

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 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.

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