SUMMARY: Abiraterone acetate (ZYTIGA®) is a novel, targeted, oral androgen biosynthesis inhibitor that decreases androgen production in the adrenal glands, testes and prostate cancer cells by inhibiting a steroidal enzyme CYP17. This agent was approved by the FDA in April, 2011 for use in combination with prednisone for the treatment of patients with metastatic CRPC (Castrate Resistant Prostate Cancer), who have received prior chemotherapy containing docetaxel (TAXOTERE®). This approval was based on a randomized, placebo controlled phase III trial which included 1195 patients with metastatic CRPC, previously treated with one or two chemotherapy regimens, at least one of which contained TAXOTERE®. Patients were randomly assigned (2:1) to receive either ZYTIGA® plus low-dose prednisone (N=797) or placebo plus low dose prednisone (N=398). Treatment was continued until disease progression. The primary endpoint was overall survival. Results from a pre-specified interim analysis demonstrated that patients treated with ZYTIGA® plus low-dose prednisone showed a statistically significant improvement in overall survival as well secondary endpoints such as, time to PSA progression and radiographic progression-free survival. Treatment with ZYTIGA® resulted in a 35 percent reduction in the risk of death and a 36 percent increase in median survival compared with placebo. The most common adverse events were edema, hypertension, joint discomfort, diarrhea, hypokalemia, and hypophosphatemia. This novel therapeutic agent is a major and important medical advance in the management of patients with metastatic CRPC. With the availability of several new agents for the treatment of CRPC, it may be important to properly sequence these available drugs to get the best of each treatment intervention and thus improve overall survival. Annals of Oncology 21 (Supplement 8): viii1-viii12. 2010. Ref Type: Abstract
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