KLI

Radium-223 in Asian patients with castration-resistant prostate cancer with symptomatic bone metastases: A single-arm phase 3 study

Metadata Downloads
Abstract
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.

Keywords: Asian patients; bone metastases; castrate-resistant prostate cancer; radium-223; targeted alpha therapy.
Author(s)
이재련Chung-Hsin ChenDaqing ZhouFangjian ZhouHanzhong LiHeiko KrisselHongcheng ShiHongqian GuoJian YuanJianhui MaJianming GuoQiang DingQing ZouQuan Sing NgRong ZhengRui LiSe Hoon ParkShuxia WangTie ZhouVolker J WagnerXiaodong ZhangXingdang LiuXudong YaoYe TianYinghao SunYong
Issued Date
2021
Type
Article
Keyword
Asian patientsbone metastasescastrate-resistant prostate cancerradium-223targeted alpha therapy.
DOI
10.1111/ajco.13479
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8462
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_gale_infotracacademiconefile_A683788148&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Radium-223%20in%20Asian%20patients%20with%20castration-resistant%20prostate%20cancer%20with%20symptomatic%20bone%20metastases:%20A%20single-arm%20phase%203%20study&offset=0&pcAvailability=true
Publisher
Asia-Pacific Journal of Clinical Oncology
Location
미국
Language
영어
ISSN
1743-7555
Citation Volume
17
Citation Number
6
Citation Start Page
462
Citation End Page
470
Appears in Collections:
Medicine > Medicine
Authorize & License
  • Authorize공개
Files in This Item:
  • There are no files associated with this item.

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.