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Published on: March 6, 2018
Risk for stroke and myocardial infarction with abiraterone versus enzalutamide in metastatic prostate cancer patients
A A Kulkarni1, N Rubin2, A Tholkes3
1Division of Hematology, Oncology, and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, USA.
Insights
Abiraterone and enzalutamide are novel anti-androgen agents used for prostate cancer (PC). Real-world data shows abiraterone use is associated with a higher risk of myocardial infarction (MI) or stroke compared to enzalutamide in metastatic PC patients.
Area of Science:
- Cardiology
- Oncology
- Pharmacology
Background:
- Abiraterone and enzalutamide are novel anti-androgen agents used in treating metastatic prostate cancer (PC).
- Clinical trials suggest a link between these drugs and cardiovascular (CV) morbidity.
- The real-world clinical relevance of this CV risk in PC patients remains unclear.
Purpose of the Study:
- To assess the real-world association between abiraterone and enzalutamide use and cardiovascular (CV) events in metastatic prostate cancer (PC) patients.
- To compare the risks of acute myocardial infarction (MI) or stroke between abiraterone and enzalutamide treatments.
- To provide evidence for guiding treatment decisions in PC patients with high CV risk.
Main Methods:
- Retrospective review of the MarketScan claims database (2013-2018) for metastatic PC patients treated with androgen deprivation therapy (ADT) and novel anti-androgens.
- Primary outcome: composite of acute MI or stroke. Secondary outcomes: individual risks of MI and stroke.
- Cox regression analysis was used to determine the independent association of abiraterone versus enzalutamide with CV risk, adjusting for covariates.
Main Results:
- A total of 6294 patients were analyzed; 4017 (63.8%) received abiraterone and 2217 (32.2%) received enzalutamide.
- The primary composite endpoint of MI or stroke occurred in 6.3% of patients (4.3 per 100 patient-years).
- Abiraterone use was associated with a 31% increased risk of MI or stroke compared to enzalutamide (HR 1.31; P=0.01).
Conclusions:
- This is the first real-world study evaluating MI and stroke risk in metastatic PC patients on novel anti-androgens.
- Findings indicate a higher risk of MI and stroke with abiraterone compared to enzalutamide.
- Enzalutamide may be a preferable treatment option for prostate cancer patients with elevated cardiovascular risk.
Background:
Abiraterone and enzalutamide use is associated with significant cardiovascular (CV) morbidity in clinical trials, but the magnitude and clinical relevance of this association in real-world prostate cancer (PC) population remain unknown.
Materials And Methods:
We retrospectively reviewed the MarketScan claims databases (1 January 2013 to 30 September 2018) to identify adults with diagnosis of metastatic PC who received treatment with androgen deprivation therapy (ADT) and novel antiandrogen agents (abiraterone or enzalutamide). The primary CV outcome measure was composite outcome of acute myocardial infarction (MI) or stroke. Secondary outcomes were individual risks of MI or stroke. We used an intention-to-treat approach to analyze the CV outcomes associated with drug exposure among patients with metastatic PC. Cox regression model was used to estimate the independent association of two drugs with CV risk after adjustment for age, baseline atrial fibrillation, and Charlson Comorbidity Index.
Results:
A total of 6294 patients with metastatic PC who were treated with ADT and either abiraterone or enzalutamide were included in the final analysis. Of these, 4017 (63.8%) patients used abiraterone and 2217 (32.2%) patients used enzalutamide. During the study period, 255 (6.3%) primary endpoint events occurred, resulting in an incidence rate of 4.3 per 100 patient-years. In multivariable analysis, abiraterone use was associated with a 31% increased risk of MI or stroke compared to enzalutamide (hazard ratio 1.31; 95% confidence interval 1.05-1.63; P = 0.01). The incidence rate was similar in patients who switched initial therapy from abiraterone to enzalutamide or vice versa (5.0 versus 5.6 per 100 patient-years, respectively).
Conclusions:
To our knowledge, this is the first real-world assessment of MI and stroke among metastatic PC patients receiving novel anti-androgens. Our findings of increased MI and stroke risk with abiraterone compared with enzalutamide are consistent with data from clinical trials and suggest that enzalutamide may be preferable for prostate cancer patients at high CV risk.
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