ORLANDO, FL USA (UroToday.com) - During the “Advanced Prostate Cancer II” session, Dr. Neal Shore presented further data from the ALSYMPCA trial. ALSYMPCA is a Phase 3 trial of Ra-223 for the treatment of symptomatic metastatic castrate-resistant prostate cancer (mCRPC) in patients with no known visceral mets. Ra-223, an alpha-emitting pharmaceutical, has been shown to significantly prolong overall survival and time to first symptomatic skeletal event, compared to placebo. Of the 921 patients randomized, 57% and 43% had prior or no prior docetaxel (D+/D-), respectively, and safety data from the predefined ALSYMPCA D subgroups were presented.
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Regardless of D use, Ra-223 significantly prolonged overall survival (D+, HR = 0.70; D-, HR = 0.69). The risk of skeletal events was also reduced in the D+ and D- groups. D- patients did have lower rates of grade 3 or 4 anemia, neutropenia, and thrombocytopenia compared to the D+ group, but the overall frequency of grade 3 or 4 adverse events was low. A subgroup of 147 patients receiving chemotherapy after Ra-223 demonstrated comparable rates of grade 3 or 4 anemia and neutropenia between D+ and D- groups.
Dr. Shore concluded that Ra-223 significantly prolongs OS with a favorable safety profile in mCRPC patients with symptomatic bone metastases regardless of D use. Rates of grade 3 or 4 hematologic adverse events were slightly higher in D+ patients.
Click HERE to view the poster from this session
Presented by Neal D. Shore, MD, FACS at the American Urological Association (AUA) Annual Meeting - May 16 - 21, 2014 - Orlando, Florida USA
Myrtle Beach, SC USA
Written by Jeffrey J. Tomaszewski, MD, medical writer for UroToday.com