Major Adverse Cardiovascular Events in Men with High-risk Localized or Metastatic Prostate Cancer Starting Long-term Hormone Therapy in the STAMPEDE Trial
Abstract
BACKGROUND: Major adverse cardiovascular events (MACE) are a leading cause of noncancer death in men with prostate cancer (PCa). Androgen receptor pathway inhibitors (ARPIs) improve oncologic outcomes but may exacerbate cardiovascular risk. The Systematic Coronary Risk Evaluation 2(SCORE2) estimates 10-yr cardiovascular risk, yet its validity in men receiving treatment for PCa is untested.
OBJECTIVE: To evaluate the cardiovascular safety of ARPIs and other treatment intensification strategies within the STAMPEDE trial and assess SCORE2 performance.
DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis included patients allocated to the abiraterone acetate plus prednisolone (AAP), AAP plus enzalutamide (ENZ), docetaxel (DOC), zoledronic acid (ZA), and radiotherapy (RT) comparisons in STAMPEDE with linked health care records in England.
INTERVENTION: Treatment intensification with AAP, AAP plus ENZ, DOC, ZA, or prostate RT in addition to standard-of-care androgen deprivation therapy (ADT).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: MACE were identified using prespecified International Classification of Diseases, 10th Revision, and Office of Population Censuses and Surveys Classification of Interventions and Procedures codes. Flexible parametric competing-risk models estimated cumulative incidence and subdistribution hazard ratios (SDHRs). SCORE2 discrimination and calibration were evaluated.
RESULTS AND LIMITATIONS: A total of 6292 men were included. The 5-yr…
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