SAN FRANCISCO, CA USA (UroToday.com) - The results of a randomized, controlled trial of novel agent 223Ra in patients with CRPC bone metastasis were presented by Sten Nilsson, MD, PhD.
The oncologic outcomes have been previously presented and showed an overall survival benefit. However, theoretical toxicity with use of 223Ra in patients is secondary hematologic malignancies or abnormalities because it is bone-targeted.
Nine-hundred twenty-one patients were randomized 2:1 to receive the study drug or placebo and the results presented by Dr. Nilsson showed that there were no identified patients with acute myelogenous leukemia, myelodysplastic syndrome, or other bone malignancies. There were secondary malignancies diagnosed in both the placebo and 223Ra arms but the rates were not statistically different. One patient did develop aplastic anemia in the 223Ra arm but that patient also had cytotoxic chemotherapy. Due to the high rate of death in this study, few patients who were treated with the drug will be available to analyze at longer follow-up points. This should be kept in mind if the drug is moved to use in earlier stages of disease -- as has been the paradigm in systemic therapies which target the androgen axis -- as patients might live longer after treatment with 223Ra and be at risk of developing such secondary hematologic disorders.
Highlights of a presentation by Sten Nilsson, MD, PhD at the 2014 Genitourinary Cancers Symposium - January 30 - February 1, 2014 - San Francisco Marriott Marquis - San Francisco, California USA
Karolinska University Hospital, Stockholm, Sweden
Click HERE to listen to an exclusive interview with one of the authors of this study
Click HERE to view the poster from this session
Written by Phillip Abbosh, MD, PhD, medical writer for UroToday.com