![]() ![]() ![]() In a randomized phase III study in patients with CRPC and symptomatic bone metastases (ALSYMPCA), Ra-223 significantly prolonged OS compared with placebo (median: 14.9 versus 11.3 months hazard ratio: 0.70, p < 0.001). ![]() Radium-223 (Ra-223) is the first targeted alpha therapy that prolongs overall survival (OS) in patients with bone mCRPC. Therefore, it is essential to manage bone metastasis effectively as part of metastatic castration-resistant prostate cancer (mCRPC) treatment. Bone metastasis is associated with reduced quality of life (QoL), and with increased disability, risk of death, and treatment costs. Radium-223 safety and effectiveness in patients without concomitant ARATs were favorable.Īs prostate cancer (PC) advances, bone metastasis is common, ultimately occurring in 80–90% of patients. In a real-life setting, radium-223 was well tolerated irrespective of prior chemotherapy, but relatively higher incidences of TEAEs and hematotoxicities were suggested in patients with two lines of prior chemotherapy, possibly reflecting more advanced disease. Safety and effectiveness in patients without concomitant ARATs ( n = 201) were similar to those in the overall population. Multivariate analysis showed that two lines of prior chemotherapy, and hemoglobin, platelet, and lactate dehydrogenase values were baseline factors significantly related to ≥ grade 2 platelet count decreased. Incidences of TEAEs (61%), drug-related TEAEs (36%), and ≥ grade 3 drug-related hematological events (12%) were numerically higher in 33 patients who had received two lines of prior chemotherapy. 7% in the no prior-chemo and prior-chemo groups, respectively. Incidences of treatment-emergent adverse events (TEAEs), drug-related TEAEs, and ≥ grade 3 drug-related hematological TEAEs were 47% vs. In the overall population ( n = 296), the prior-chemo group ( n = 126) tended to have more bone metastases, more analgesic use, and higher prostate-specific antigen values than the no prior-chemo group ( n = 170). Six-month safety and effectiveness were evaluated in subgroups who had/had not received prior chemotherapy (prior-chemo/no prior-chemo groups), and a subgroup who had not received concomitant androgen-receptor axis-targeted agents (ARATs). This non-interventional, prospective study enrolled mCRPC patients selected for radium-223 treatment in clinical practice. Based on results from Japanese post-marketing surveillance, exploratory analyses were performed to investigate real-world outcomes of radium-223 for metastatic CRPC (mCRPC) according to patient characteristics. ![]()
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