Dr. Shore on a Long-Term Safety Analysis of the COU-AA-302 Study

Neal D. Shore, MD, FACS, medical director, Carolina Urologic Research Center, Myrtle Beach, discusses a long-term safety analysis of the COU-AA-302 study, which he presented at the 2014 AUA Annual Meeting.

This trial led to the FDA approval of abiraterone acetate in December 2012 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) prior to chemotherapy. The rationale for this analysis was to compare long term safety data to the COU-AA-301 trial.

In the analysis Shore presented, researchers looked at risks for all adverse events and divided them into subsets, including hypertension, hyperglycemia, infection, and cardiovascular events. It was found that there was no difference in the safety data seen in the COU-AA-301 trial.

The bottom line, Shore says, is that abiraterone acetate is a well tolerate, oral therapy that can prolong life and delay progression-free survival.

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