The aim of a study was to evaluate the safety profile of Abiraterone acetate ( Zytiga ) in metastatic castration-resistant prostate cancer ( mCRPC ) men with cardiovascular comorbidity, as little conclusive safety data are available in this patient subset.
A retrospective analysis of mCRPC patients with controlled cardiovascular comorbidities, receiving Abiraterone 1000 mg administered orally once daily and Prednisone 5 mg twice daily, between April 2011 and July 2012, was performed.
A total of 51 mCRPC patients were evaluated.
Metastatic sites included the bone ( 74% ), lungs, and liver ( 26% ).
All patients were previously treated with at least 2 lines of hormone and 1 Docetaxel-based chemotherapy.
Preexisting cardiac risk factors included hypertension ( 41% ), cardiac ischemia ( 12% ), arrhythmias ( 6% ), dislipidemia ( 18% ), and hyperglycemia ( 30% ).
No grade 3-4 adverse events were observed. Grade 1-2 adverse events included fluid retention ( 18% ), asthenia ( 15% ), and hypertension ( 16% ).
Median progression-free survival was 5.1 months ( 95% confidence interval, 0.5-12 ).
Prostate specific antigen ( PSA ) assessment revealed a good overall disease control rate ( 64% ).
In conclusion, Abiraterone acetate appears to be safe and well tolerated even in patients with cardiovascular comorbidities or with increased risk factors for cardiovascular diseases. ( Xagena )
Procopio G et al, Am J Clin Oncol 2015;38:479-482