|Title:||Radium-223 in Asian patients with castration-resistant prostate cancer with symptomatic bone metastases: A single-arm phase 3 study||Authors:||Zhou T.
|Keywords:||Asian patients; bone metastases; castrate-resistant prostate cancer; radium-223; targeted alpha therapy||Issue Date:||2020||Publisher:||Blackwell Publishing Ltd||Source:||Asia-Pacific Journal of Clinical Oncology||Abstract:||
Aim: Radium-223, a targeted alpha therapy, is approved widely for the treatment of patients with metastatic castrate-resistant prostate cancer, based on a pivotal phase 3 study in predominantly white patients. We investigated the efficacy and safety of radium-223 in Asian patients with castrate-resistant prostate cancer and metastatic bone disease. Methods: This multicenter, prospective, single-arm, open-label phase 3 trial evaluated the efficacy and safety of the standard radium-223 regimen (55 kBq/kg every 4 weeks for six cycles) in patients from Asian countries. The primary endpoints were the safety and overall survival. Results: A total of 226 patients were enrolled and received at least one dose of radium-223. Median overall survival was 14.0 months (95% confidence interval [CI], 11.2–17.4). Median time to total alkaline phosphatase and prostate-specific antigen progression were 7.5 (95% CI, 6.8–7.7) and 3.6 (95% CI, 3.1–3.7) months, respectively. Median skeletal-related event-free survival was 26.0 months (95% CI, 12.6–not reached). Grade ?3 treatment-emergent adverse events were reported in 103 (46%) of 226 patients, with anemia being the most common event (34 [15%] patients). Grade ?3 drug-related treatment-emergent adverse events occurred in 39 (17%) of 226 patients. Serious treatment-emergent adverse events were reported in 65 (29%) of 226 patients. Seven (3%) patients had an adverse event leading to death; none were considered to be related to radium-223. Conclusion: The results of this study support the use of the standard radium-223 regimen for the treatment of Asian patients with castrate-resistant prostate cancer and symptomatic bone metastases. ? 2020 The Authors. Asia-Pacific Journal of Clinical Oncology published by John Wiley & Sons Australia, Ltd
|ISSN:||1743-7555||DOI:||10.1111/ajco.13479||metadata.dc.subject.other:||radioisotope; radium; Radium-223; bone tumor; castration resistant prostate cancer; clinical trial; human; male; multicenter study; phase 3 clinical trial; prospective study; Bone Neoplasms; Humans; Male; Prospective Studies; Prostatic Neoplasms, Castration-Resistant; Radioisotopes; Radium
|Appears in Collections:||醫學系|
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.