https://scholars.lib.ntu.edu.tw/handle/123456789/542062
標題: | Radium-223 in Asian patients with castration-resistant prostate cancer with symptomatic bone metastases: A single-arm phase 3 study | 作者: | Zhou T. Zhou F. Guo J. Shi H. Yao X. Guo H. Yuan J. Tian Y. Zhang X. Wang S. Jiang Y. Zou Q. Zhou D. Li H. Li F. Lee J.L. CHUNG-HSIN CHEN Park S.H. Ng Q.S. Ma J. Zheng R. Ding Q. Liu X. Li R. Krissel H. Wagner V.J. Sun Y. |
關鍵字: | Asian patients; bone metastases; castrate-resistant prostate cancer; radium-223; targeted alpha therapy | 公開日期: | 2020 | 出版社: | Blackwell Publishing Ltd | 來源出版物: | Asia-Pacific Journal of Clinical Oncology | 摘要: | 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 |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85092455674&doi=10.1111%2fajco.13479&partnerID=40&md5=73ed9b6f5b90b6dff331a797c7278764 https://scholars.lib.ntu.edu.tw/handle/123456789/542062 |
ISSN: | 1743-7555 | DOI: | 10.1111/ajco.13479 | SDG/關鍵字: | 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 |
顯示於: | 醫學系 |
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