Elderly patients who have prostate cancer (PCa) and pre-existing cardiovascular diseases (CVDs) have a higher death risk shortly after taking abiraterone or enzalutamide than similar patients free of CVDs, according to new study findings.

Androgen signaling inhibitors are frequently used in older men in real-world practice. However, pivotal trials concerning their use excluded men with clinically significant CVDs or uncontrolled hypertension. Grace Lu-Yao, PhD, MPH, of Jefferson College of Population Health in Philadelphia, and colleagues studied 2845 patients aged 65 years and older treated with abiraterone and 1031 treated with enzalutamide from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Two-thirds of all patients (67%) had at least 1 CVD, including acute myocardial infarction, atrial fibrillation, congestive heart failure, stroke, or ischemic heart disease, before starting the androgen signaling inhibitor.

Compared with the absence of CVD, the presence of 1 or 2 pre-existing CVDs was significantly associated with a 16% higher risk of dying from any cause within 6 months, the investigators reported in European Urology. The presence of 3 or more CVDs was significantly associated with a 56% increase in death risk.

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In addition, 3 or more CVDs was significantly associated with 56% and 43% increased risk of 6-month mortality among no-chemotherapy and post-chemotherapy patients, respectively.

Abiraterone also was associated with a significant increase in hospitalization within 6 months of treatment among men with several CVDs, according to the investigators. In addition, preexisting hypertension related with posttreatment hospitalization.

“Our findings raise important questions regarding the potential toxicity of AA or ENZ [abiraterone or enzalutamide] in ‘real-world’ patients, and should spur clinicians to integrate this knowledge into their clinical decision-making for patients with PCa and CVD,” Dr Lu-Yao’s team wrote. “These findings also suggest that more careful patient selection and monitoring of outcomes following the administration of AA or ENZ are essential for achieving optimal outcomes.”

In an accompanying editorial, Derek J. Rosario, MBChB, MD, and Liam Bourke, PhD, of Sheffield Hallam University in Sheffield, United Kingdom, wrote: “The authors suggest that oncology multidisciplinary teams should include input from cardiologists to inform decisions. In the real-world scenario, this is just not feasible in any health care system. Medical and surgical oncologists with an interest in prostate cancer should take a more active role in the identification and stratification of CVD risk. Such assessments are relatively simple and do not require specific cardiological expertise. Identification and optimisation of CVD risk can no longer be ignored in the uro-oncological arena.”

 Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Lu-Yao G, Nikita N, Keith SW, et al. Mortality and Hospitalization Risk Following Oral Androgen Signaling Inhibitors Among Men with Advanced Prostate Cancer by Pre-existing Cardiovascular Comorbidities. Eur Urol. doi: 10.1016/j.eururo.2019.07.031

Rosario DJ and Bourke L. Cardiovascular Disease and the Androgen Receptor: Here We Go Again? Eur Urol. doi: 10.1016/j.eururo.2019.07.031