Three-year safety results from the ALSYMPCA trial showed that treatment with radium-223 dichloride (Xofigo) for men with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastases was associated with minimal nonhematologic adverse events (AEs) and a low incidence of myelosuppression with long-term preservation of hematopoietic function.
ALSYMPCA is a phase III, double-blind, randomized, multinational trial designed to compare radium-223 with placebo and best standard care in patients with CRPC and at least 2 bone metastases. The study was the basis for 2013 FDA approval of radium-223 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.
In previously published results, radium-223 significantly improved overall survival (OS), with a median OS of 14.9 months compared with 11.3 months in the placebo arm (HR, 0.70; 95% CI, 0.58-0.83; P
<.001). Additionally, the time to the first skeletal-related event was a median of 15.6 months in the radium-223 arm versus 9.8 months in the placebo arm (HR, 0.66; 95% CI, 0.52-0.83; P
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