Due to its chemical similarity to calcium, radium-223 is absorbed into the bone, primarily in the areas with high metabolic activity. Radium-223 dichloride (radium-223) is a first-in-class targeted alpha therapy that has been developed for the treatment of skeletal metastases. However, none of these treatments have provided significant improvements in OS.
Bisphosphonates (e.g., zoledronic acid) and denosumab have been shown to decrease the risk of SREs and strontium-89 has been shown to alleviate pain in patients with mCRPC and bone metastases. In patients with metastatic castration-resistant prostate cancer (mCRPC), bone metastases are associated with skeletal-related events (SREs), including fractures, that reduce quality of life and shorten overall survival (OS). Taken together with median OS, which was comparable to that in the pivotal phase III ALSYMPCA study, these results support continued benefit from radium-223 in Japanese patients with mCRPC.īone is one of the most common metastatic sites among patients with prostate cancer. In Japanese patients with symptomatic mCRPC and bone metastases, radium-223 had a favorable long-term safety profile with no second primary malignancies reported. No serious post-treatment drug-related AEs were reported. Eight patients (16.3%) experienced post-treatment drug-related AEs, which were all hematological (anemia and decreased lymphocyte, platelet, and white blood cell counts). Throughout the entire study, there were no reports of second primary malignancy or other pre-specified conditions. Of the 49 patients enrolled in the study, 44 (89.8%) entered the survival follow-up period and 33 (67.3%) died. Pre-specified conditions, such as acute myelogenous leukemia, myelodysplastic syndrome, aplastic anemia, primary bone cancer, or other primary malignancies, were reported regardless of causality. Adverse events (AEs) considered to be related to radium-223 were reported until 3 years after the first injection. Patients with symptomatic mCRPC, ≥ 2 bone metastases and no known visceral metastases received up to 6 injections of radium-223 (55 kBq/kg), one every 4 weeks. The aim of the present analysis was to assess the long-term safety with radium-223 in Japanese patients with mCRPC. Radium-223 is a first-in-class targeted alpha therapy to prolong overall survival (OS) in castration-resistant prostate cancer with bone metastases (mCRPC).
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