926P - Safety of abiraterone acetate (AA) in patients with castration resistant prostate cancer (CRPC) and concomitant cardiac risk

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
Presenter Giuseppe Procopio
Authors G. Procopio1, E. Verzoni2, I. Testa2, S. Stagni3, S. Villa4, R. Valdagni4, F.G.M. De Braud2
  • 1Oncologia Medica, ISTITUTO NAZIONALE DEI TUMORI DI MILANO, 20133 - MILAN/IT
  • 2Medical Oncology, ISTITUTO NAZIONALE DEI TUMORI DI MILANO, 20133 - MILAN/IT
  • 3Urology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 4Radiotherapy, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT

Abstract

Introduction

Abiraterone acetate (AA) is an inhibitor of extragonadal androgen biosynthesis that prolongs overall survival in CRPC patients who have received a chemotherapy including docetaxel. The most common adverse events related to AA therapy were fluid retention, hypertension, hypokaliemia and cardiac disorders. No safety data are available in patients with concomitant cardiac disease.

Methods

Metastatic CRPC patients were enrolled in this prospective study if they were also suffering from a concomitant controlled cardiovascular disease. AA 1000 mg per day and prednisone 5 mg bid were administered orally until grade 3-4 adverse events (AE) or disease progression. The primary endpoint was the safety profile while the secondary endpoints were progression-free survival and PSA response.

Results

From April to September 2011, 46 CRPC patients with concomitant cardiovascular disorders have been treated with AA. Main patients characteristics were: median age 71 years (range 57-81); baseline mean PSA value 40 ng/ml (6.32-995); the most common sites of disease were bone (33 pts, 81 %), lung (13 pts, 33%) and liver (6 pts, 15 %). All patients were previously challenged with at least 2 lines of hormone therapy and 1 chemotherapy regimen including docetaxel. The most common pre-existing cardiac disorders were hypertension 24 (66%), arrhythmias 4 (12 %), cardiac ischemia 4 (9 %) and conduction irregularity 2 (4 %). Additionally 10 patients (27 %) had metabolic disorders including dyslipidemia and hyperglycemia. AA was feasible without inducing grade 3-4 AE nor treatment modification. The most common grade 1-2 AE were asthenia (27%), hypertension (18%) and fluid retention (28%). After a median time of treatment of 10 months (range 4-12 months) no dose modifications due to toxicity were required. No efficacy data are still available.

Conclusions

Treatment with AA was feasible and well tolerated also in patients suffering from cardiac comorbidities and risk factors for cardiovascular disease.

Disclosure

All authors have declared no conflicts of interest.