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Safety of Abiraterone Acetate in Castration-resistant Prostate Cancer Patients With Concomitant Cardiovascular Risk Factors

Procopio, Giuseppe, MD*; Grassi, Paolo, MD*; Testa, Isabella, MD*; Verzoni, Elena, MD*; Torri, Valter, MD; Salvioni, Roberto, MD; Valdagni, Riccardo, MD§; de Braud, Filippo, MD*

American Journal of Clinical Oncology: October 2015 - Volume 38 - Issue 5 - p 479–482
doi: 10.1097/COC.0b013e3182a790ce
Original Articles: Genitourinary

Objectives: The aim of this study was to evaluate the safety profile of abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) men with cardiovascular comorbidity, as little conclusive safety data are available in this patient subset.

Patients and Methods: A retrospective analysis of mCRPC patients with controlled cardiovascular comorbidities, receiving AA 1000 mg administered orally once daily and prednisone 5 mg twice daily, between April 2011 and July 2012, was performed. All clinical and instrumental variables and toxicity data were analyzed by descriptive statistics: mean, standard deviation, minimum and maximum values for continuous variables, and absolute and relative frequencies for categorical variables.

Results: 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 assessment revealed a good overall disease control rate (64%).

Conclusions: AA appears to be safe and well tolerated even in patients with cardiovascular comorbidities or with increased risk factors for cardiovascular diseases.

Departments of *Medical Oncology


§Prostate Programme, Fondazione IRCCS Istituto Nazionale dei Tumori

Mario Negri Institute for Pharmacological Research, Milan, Italy

G.P. is a consultant to Jannsen, Sanofi, and Astellas and is currently a Board Member for Astellas. The remaining authors declare no conflicts of interest.

Reprints: Giuseppe Procopio, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Via G. Venezian 1, Milan 20133, Italy. E-mail:

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