Radium‐223 in Asian patients with castration‐resistant prostate cancer with symptomatic bone metastases: A single‐arm phase 3 study
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‐resis...
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| Veröffentlicht in: | Asia-Pacific journal of clinical oncology 2021-12, Vol.17 (6), p.462-470 |
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| creator | Zhou, Tie Zhou, Fangjian Guo, Jianming Shi, Hongcheng Yao, Xudong Guo, Hongqian Yuan, Jian Tian, Ye Zhang, Xiaodong Wang, Shuxia Jiang, Yongguang Zou, Qing Zhou, Daqing Li, Hanzhong Li, Fang Lee, Jae Lyun Chen, Chung‐Hsin Park, Se Hoon Ng, Quan Sing Ma, Jianhui Zheng, Rong Ding, Qiang Liu, Xingdang Li, Rui Krissel, Heiko Wagner, Volker J. Sun, Yinghao |
| description | 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.
This article reports the outcomes of a single‐arm, multicenter, phase 3 study, which investigated the efficacy and safety of radium‐223 in Asian patients with castrate‐resistant prostate cancer (CRPC) and symptomatic bone metastases. Radium‐223 is effective and safe in Asian patients, and results in a trend towards improved quality of life. |
| doi_str_mv | 10.1111/ajco.13479 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_webof</sourceid><recordid>TN_cdi_webofscience_primary_000585392600001CitationCount</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2626287900</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4259-821f1a449b4edda7de69ff25e302765e0e6fdd929ec90b559f22fdda6b5375873</originalsourceid><addsrcrecordid>eNqNUU2LFDEQDaK46-jFXxDwpsyaj053x4MwNH6ysCB6Dunu6p0M00mbpHeZm1dv_kZ_ibXbw4AXMTmkqHrvpaoeIc85u-B4XttdFy64LCr9gJzzqpDrSpXy4SlW6ow8SWnHmNRC88fkTEqmuK7FOfn5xfZuHn__-CWEpM7TTXLW08lmBz4neuvylnY25YiZ4BEXIbmUrc90igGDDFj3HcQFmw7jlMOI6I62wQMdISPdJkhv6IYm56_3gDI2jnTaYppKmvLcH56SR4PdJ3h2fFfk2_t3X5uP68urD5-azeW6K4TS61rwgdui0G0BfW-rHko9DEKBZKIqFTAoh77HOaHTrFVKD0JgwpatkpWqK7kibxfdaW5H6DscM9q9maIbbTyYYJ35u-Ld1lyHG4Oaoqw5Crw4CsTwfYaUzS7M0WPPRpR460rjplfk5YLqcEspwnD6gTNzZ5u5s83c24bgegHfQhuG1OHuOzgRGGOqVuhdiRHjjcv3XjRh9hmpr_6fimh-RLs9HP7Rktl8bq6W5v4AT-q_5Q</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2626287900</pqid></control><display><type>article</type><title>Radium‐223 in Asian patients with castration‐resistant prostate cancer with symptomatic bone metastases: A single‐arm phase 3 study</title><source>Access via Wiley Online Library</source><source>Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></source><creator>Zhou, Tie ; Zhou, Fangjian ; Guo, Jianming ; Shi, Hongcheng ; Yao, Xudong ; Guo, Hongqian ; Yuan, Jian ; Tian, Ye ; Zhang, Xiaodong ; Wang, Shuxia ; Jiang, Yongguang ; Zou, Qing ; Zhou, Daqing ; Li, Hanzhong ; Li, Fang ; Lee, Jae Lyun ; Chen, Chung‐Hsin ; Park, Se Hoon ; Ng, Quan Sing ; Ma, Jianhui ; Zheng, Rong ; Ding, Qiang ; Liu, Xingdang ; Li, Rui ; Krissel, Heiko ; Wagner, Volker J. ; Sun, Yinghao</creator><creatorcontrib>Zhou, Tie ; Zhou, Fangjian ; Guo, Jianming ; Shi, Hongcheng ; Yao, Xudong ; Guo, Hongqian ; Yuan, Jian ; Tian, Ye ; Zhang, Xiaodong ; Wang, Shuxia ; Jiang, Yongguang ; Zou, Qing ; Zhou, Daqing ; Li, Hanzhong ; Li, Fang ; Lee, Jae Lyun ; Chen, Chung‐Hsin ; Park, Se Hoon ; Ng, Quan Sing ; Ma, Jianhui ; Zheng, Rong ; Ding, Qiang ; Liu, Xingdang ; Li, Rui ; Krissel, Heiko ; Wagner, Volker J. ; Sun, Yinghao</creatorcontrib><description>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.
This article reports the outcomes of a single‐arm, multicenter, phase 3 study, which investigated the efficacy and safety of radium‐223 in Asian patients with castrate‐resistant prostate cancer (CRPC) and symptomatic bone metastases. Radium‐223 is effective and safe in Asian patients, and results in a trend towards improved quality of life.</description><identifier>ISSN: 1743-7555</identifier><identifier>EISSN: 1743-7563</identifier><identifier>DOI: 10.1111/ajco.13479</identifier><identifier>PMID: 33051982</identifier><language>eng</language><publisher>HOBOKEN: Wiley</publisher><subject>Adverse events ; Alkaline phosphatase ; Asian patients ; Bone cancer ; Bone diseases ; bone metastases ; castrate‐resistant prostate cancer ; Castration ; Life Sciences & Biomedicine ; Metastases ; Metastasis ; Oncology ; Original ; Patients ; Prostate cancer ; Radium ; radium‐223 ; Safety ; Science & Technology ; Survival ; targeted alpha therapy</subject><ispartof>Asia-Pacific journal of clinical oncology, 2021-12, Vol.17 (6), p.462-470</ispartof><rights>2020 The Authors. published by John Wiley & Sons Australia, Ltd</rights><rights>2020. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>7</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000585392600001</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c4259-821f1a449b4edda7de69ff25e302765e0e6fdd929ec90b559f22fdda6b5375873</citedby><cites>FETCH-LOGICAL-c4259-821f1a449b4edda7de69ff25e302765e0e6fdd929ec90b559f22fdda6b5375873</cites><orcidid>0000-0002-9420-7162 ; 0000-0003-1810-6121</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fajco.13479$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fajco.13479$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,315,781,785,886,1418,27928,27929,39262,45578,45579</link.rule.ids></links><search><creatorcontrib>Zhou, Tie</creatorcontrib><creatorcontrib>Zhou, Fangjian</creatorcontrib><creatorcontrib>Guo, Jianming</creatorcontrib><creatorcontrib>Shi, Hongcheng</creatorcontrib><creatorcontrib>Yao, Xudong</creatorcontrib><creatorcontrib>Guo, Hongqian</creatorcontrib><creatorcontrib>Yuan, Jian</creatorcontrib><creatorcontrib>Tian, Ye</creatorcontrib><creatorcontrib>Zhang, Xiaodong</creatorcontrib><creatorcontrib>Wang, Shuxia</creatorcontrib><creatorcontrib>Jiang, Yongguang</creatorcontrib><creatorcontrib>Zou, Qing</creatorcontrib><creatorcontrib>Zhou, Daqing</creatorcontrib><creatorcontrib>Li, Hanzhong</creatorcontrib><creatorcontrib>Li, Fang</creatorcontrib><creatorcontrib>Lee, Jae Lyun</creatorcontrib><creatorcontrib>Chen, Chung‐Hsin</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Ng, Quan Sing</creatorcontrib><creatorcontrib>Ma, Jianhui</creatorcontrib><creatorcontrib>Zheng, Rong</creatorcontrib><creatorcontrib>Ding, Qiang</creatorcontrib><creatorcontrib>Liu, Xingdang</creatorcontrib><creatorcontrib>Li, Rui</creatorcontrib><creatorcontrib>Krissel, Heiko</creatorcontrib><creatorcontrib>Wagner, Volker J.</creatorcontrib><creatorcontrib>Sun, Yinghao</creatorcontrib><title>Radium‐223 in Asian patients with castration‐resistant prostate cancer with symptomatic bone metastases: A single‐arm phase 3 study</title><title>Asia-Pacific journal of clinical oncology</title><addtitle>ASIA-PAC J CLIN ONCO</addtitle><description>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.
This article reports the outcomes of a single‐arm, multicenter, phase 3 study, which investigated the efficacy and safety of radium‐223 in Asian patients with castrate‐resistant prostate cancer (CRPC) and symptomatic bone metastases. Radium‐223 is effective and safe in Asian patients, and results in a trend towards improved quality of life.</description><subject>Adverse events</subject><subject>Alkaline phosphatase</subject><subject>Asian patients</subject><subject>Bone cancer</subject><subject>Bone diseases</subject><subject>bone metastases</subject><subject>castrate‐resistant prostate cancer</subject><subject>Castration</subject><subject>Life Sciences & Biomedicine</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Oncology</subject><subject>Original</subject><subject>Patients</subject><subject>Prostate cancer</subject><subject>Radium</subject><subject>radium‐223</subject><subject>Safety</subject><subject>Science & Technology</subject><subject>Survival</subject><subject>targeted alpha therapy</subject><issn>1743-7555</issn><issn>1743-7563</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>HGBXW</sourceid><recordid>eNqNUU2LFDEQDaK46-jFXxDwpsyaj053x4MwNH6ysCB6Dunu6p0M00mbpHeZm1dv_kZ_ibXbw4AXMTmkqHrvpaoeIc85u-B4XttdFy64LCr9gJzzqpDrSpXy4SlW6ow8SWnHmNRC88fkTEqmuK7FOfn5xfZuHn__-CWEpM7TTXLW08lmBz4neuvylnY25YiZ4BEXIbmUrc90igGDDFj3HcQFmw7jlMOI6I62wQMdISPdJkhv6IYm56_3gDI2jnTaYppKmvLcH56SR4PdJ3h2fFfk2_t3X5uP68urD5-azeW6K4TS61rwgdui0G0BfW-rHko9DEKBZKIqFTAoh77HOaHTrFVKD0JgwpatkpWqK7kibxfdaW5H6DscM9q9maIbbTyYYJ35u-Ld1lyHG4Oaoqw5Crw4CsTwfYaUzS7M0WPPRpR460rjplfk5YLqcEspwnD6gTNzZ5u5s83c24bgegHfQhuG1OHuOzgRGGOqVuhdiRHjjcv3XjRh9hmpr_6fimh-RLs9HP7Rktl8bq6W5v4AT-q_5Q</recordid><startdate>202112</startdate><enddate>202112</enddate><creator>Zhou, Tie</creator><creator>Zhou, Fangjian</creator><creator>Guo, Jianming</creator><creator>Shi, Hongcheng</creator><creator>Yao, Xudong</creator><creator>Guo, Hongqian</creator><creator>Yuan, Jian</creator><creator>Tian, Ye</creator><creator>Zhang, Xiaodong</creator><creator>Wang, Shuxia</creator><creator>Jiang, Yongguang</creator><creator>Zou, Qing</creator><creator>Zhou, Daqing</creator><creator>Li, Hanzhong</creator><creator>Li, Fang</creator><creator>Lee, Jae Lyun</creator><creator>Chen, Chung‐Hsin</creator><creator>Park, Se Hoon</creator><creator>Ng, Quan Sing</creator><creator>Ma, Jianhui</creator><creator>Zheng, Rong</creator><creator>Ding, Qiang</creator><creator>Liu, Xingdang</creator><creator>Li, Rui</creator><creator>Krissel, Heiko</creator><creator>Wagner, Volker J.</creator><creator>Sun, Yinghao</creator><general>Wiley</general><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>H94</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9420-7162</orcidid><orcidid>https://orcid.org/0000-0003-1810-6121</orcidid></search><sort><creationdate>202112</creationdate><title>Radium‐223 in Asian patients with castration‐resistant prostate cancer with symptomatic bone metastases: A single‐arm phase 3 study</title><author>Zhou, Tie ; Zhou, Fangjian ; Guo, Jianming ; Shi, Hongcheng ; Yao, Xudong ; Guo, Hongqian ; Yuan, Jian ; Tian, Ye ; Zhang, Xiaodong ; Wang, Shuxia ; Jiang, Yongguang ; Zou, Qing ; Zhou, Daqing ; Li, Hanzhong ; Li, Fang ; Lee, Jae Lyun ; Chen, Chung‐Hsin ; Park, Se Hoon ; Ng, Quan Sing ; Ma, Jianhui ; Zheng, Rong ; Ding, Qiang ; Liu, Xingdang ; Li, Rui ; Krissel, Heiko ; Wagner, Volker J. ; Sun, Yinghao</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4259-821f1a449b4edda7de69ff25e302765e0e6fdd929ec90b559f22fdda6b5375873</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adverse events</topic><topic>Alkaline phosphatase</topic><topic>Asian patients</topic><topic>Bone cancer</topic><topic>Bone diseases</topic><topic>bone metastases</topic><topic>castrate‐resistant prostate cancer</topic><topic>Castration</topic><topic>Life Sciences & Biomedicine</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Oncology</topic><topic>Original</topic><topic>Patients</topic><topic>Prostate cancer</topic><topic>Radium</topic><topic>radium‐223</topic><topic>Safety</topic><topic>Science & Technology</topic><topic>Survival</topic><topic>targeted alpha therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhou, Tie</creatorcontrib><creatorcontrib>Zhou, Fangjian</creatorcontrib><creatorcontrib>Guo, Jianming</creatorcontrib><creatorcontrib>Shi, Hongcheng</creatorcontrib><creatorcontrib>Yao, Xudong</creatorcontrib><creatorcontrib>Guo, Hongqian</creatorcontrib><creatorcontrib>Yuan, Jian</creatorcontrib><creatorcontrib>Tian, Ye</creatorcontrib><creatorcontrib>Zhang, Xiaodong</creatorcontrib><creatorcontrib>Wang, Shuxia</creatorcontrib><creatorcontrib>Jiang, Yongguang</creatorcontrib><creatorcontrib>Zou, Qing</creatorcontrib><creatorcontrib>Zhou, Daqing</creatorcontrib><creatorcontrib>Li, Hanzhong</creatorcontrib><creatorcontrib>Li, Fang</creatorcontrib><creatorcontrib>Lee, Jae Lyun</creatorcontrib><creatorcontrib>Chen, Chung‐Hsin</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Ng, Quan Sing</creatorcontrib><creatorcontrib>Ma, Jianhui</creatorcontrib><creatorcontrib>Zheng, Rong</creatorcontrib><creatorcontrib>Ding, Qiang</creatorcontrib><creatorcontrib>Liu, Xingdang</creatorcontrib><creatorcontrib>Li, Rui</creatorcontrib><creatorcontrib>Krissel, Heiko</creatorcontrib><creatorcontrib>Wagner, Volker J.</creatorcontrib><creatorcontrib>Sun, Yinghao</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Asia-Pacific journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhou, Tie</au><au>Zhou, Fangjian</au><au>Guo, Jianming</au><au>Shi, Hongcheng</au><au>Yao, Xudong</au><au>Guo, Hongqian</au><au>Yuan, Jian</au><au>Tian, Ye</au><au>Zhang, Xiaodong</au><au>Wang, Shuxia</au><au>Jiang, Yongguang</au><au>Zou, Qing</au><au>Zhou, Daqing</au><au>Li, Hanzhong</au><au>Li, Fang</au><au>Lee, Jae Lyun</au><au>Chen, Chung‐Hsin</au><au>Park, Se Hoon</au><au>Ng, Quan Sing</au><au>Ma, Jianhui</au><au>Zheng, Rong</au><au>Ding, Qiang</au><au>Liu, Xingdang</au><au>Li, Rui</au><au>Krissel, Heiko</au><au>Wagner, Volker J.</au><au>Sun, Yinghao</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Radium‐223 in Asian patients with castration‐resistant prostate cancer with symptomatic bone metastases: A single‐arm phase 3 study</atitle><jtitle>Asia-Pacific journal of clinical oncology</jtitle><stitle>ASIA-PAC J CLIN ONCO</stitle><date>2021-12</date><risdate>2021</risdate><volume>17</volume><issue>6</issue><spage>462</spage><epage>470</epage><pages>462-470</pages><issn>1743-7555</issn><eissn>1743-7563</eissn><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.
This article reports the outcomes of a single‐arm, multicenter, phase 3 study, which investigated the efficacy and safety of radium‐223 in Asian patients with castrate‐resistant prostate cancer (CRPC) and symptomatic bone metastases. Radium‐223 is effective and safe in Asian patients, and results in a trend towards improved quality of life.</abstract><cop>HOBOKEN</cop><pub>Wiley</pub><pmid>33051982</pmid><doi>10.1111/ajco.13479</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-9420-7162</orcidid><orcidid>https://orcid.org/0000-0003-1810-6121</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adverse events Alkaline phosphatase Asian patients Bone cancer Bone diseases bone metastases castrate‐resistant prostate cancer Castration Life Sciences & Biomedicine Metastases Metastasis Oncology Original Patients Prostate cancer Radium radium‐223 Safety Science & Technology Survival targeted alpha therapy |
| title | Radium‐223 in Asian patients with castration‐resistant prostate cancer with symptomatic bone metastases: A single‐arm phase 3 study |
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