medwireNews: Among men initiating abiraterone acetate for advanced prostate cancer, the mortality risk may be higher for those with versus without pre-existing cardiovascular disease (CVD), suggests a real-world study presented at the AACR Annual Meeting 2019 in Atlanta, Georgia, USA.
“There is risk associated with abiraterone acetate and the survival benefit observed in clinical trials might not hold true to patients who do not meet the trial eligibility criteria,” said Grace Lu-Yao (Sidney Kimmel Cancer Center – Jefferson Health, Philadelphia, Pennsylvania, USA) in a press conference.
She explained that clinically significant heart disease is often an exclusion criterion for clinical trials, whereas real-world data suggest that two in three men with advanced prostate cancer have a history of major CVD, such as acute myocardial infarction, congestive heart failure, or stroke.
The team therefore drew on the linked Surveillance, Epidemiology and End Results–Medicare databases to evaluate real-world outcomes, identifying 2845 men diagnosed between 1991 and 2013 who received abiraterone during 2011–2014; just over two-thirds (67.6%) had at least one pre-existing CVD.
Overall survival with abiraterone was significantly poorer for men with one or two, or three or more CV conditions than for those with no CVD.
And the all-cause mortality rate at 6 months ranged from 21.4% for the group with ischemic heart disease to 25.6% for the acute myocardial infarction group, while the rate was 15.9% for the group without pre-existing CVD.
Interestingly, the rate of hospitalization in the 6 months after initiating abiraterone was increased not only for men with CVD, but also for those without. Specifically, the incidence rate ratios (IRRs) for hospitalization in the CVD group ranged from 1.34 for atrial fibrillation to 1.55 for acute myocardial infarction, and for the no CVD group the IRR was 1.53.
“The increased post-treatment hospitalization rate shows that there is risk associated with abiraterone acetate for all patients,” Lu-Yao told the press.
She added: “As we move abiraterone acetate treatment to patients with earlier stages of the disease and longer life expectancy, it is important to evaluate whether the benefits outweigh the risks based on the health status of the patients and to ensure that patients are carefully monitored for potential side effects.”
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AACR Annual Meeting 2019; Atlanta, Georgia, USA: 29 March–3 April
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