PURPOSE: Published efficacy and safety data from clinical trials of three recently approved agents for the management of metastatic castration-resistant prostate cancer (CRPC) are reviewed.
SUMMARY: Sipuleucel-T is approved by the Food and Drug Administration (FDA) for the treatment of asymptomatic or minimally symptomatic patients with CRPC. In a placebo-controlled Phase III clinical trial, the use of sipuleucel-T was associated with an average improvement in median overall survival of 4.1 months. Abiraterone acetate and cabazitaxel are approved by FDA as second-line treatments for patients with CRPC who experience disease progression during first-line docetaxel therapy. In Phase III trials, abiraterone acetate was associated with improved overall survival relative to placebo use (14.8 months versus 10.9 months), and cabazitaxel was found to confer an overall survival advantage over mitoxantrone therapy (median survival, 15.1 months versus 12.7 months), corresponding to a 30% reduction in the relative risk of death (hazard ratio, 0.7; 95% confidence interval, 0.59-0.83; p < 0.0001). The three agents range in cost from $40,000 to $93,000 for a full course of therapy. Sipuleucel therapy entails leukapheresis procedures for the collection of autologous cells used in dose preparation, requiring careful planning and coordination of care.
CONCLUSION: Sipuleucel-T, abiraterone acetate, and cabazitaxel offer new options for the treatment of patients with CRPC, including those with disease resistant to standard first-line therapies. The agents' varying administration requirements, as well as patient-specific factors and cost issues, are key considerations in the drug selection process.
Simondsen K, Kolesar J. Are you the author?
Pharmacy Department, University of Wisconsin (UW) Hospital and Clinics, Madison; UW Carbone Comprehensive Cancer Center, Madison.
Reference: Am J Health Syst Pharm. 2013 May 15;70(10):856-65.