Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial
In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benef...
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| creator | Parker, Christopher C. Coleman, Robert E. Sartor, Oliver Vogelzang, Nicholas J. Bottomley, David Heinrich, Daniel Helle, Svein I. O'Sullivan, Joe M. Fosså, Sophie D. Chodacki, Aleš Wiechno, Paweł Logue, John Seke, Mihalj Widmark, Anders Johannessen, Dag Clement Hoskin, Peter James, Nicholas D. Solberg, Arne Syndikus, Isabel Kliment, Jan Wedel, Steffen Boehmer, Sibylle Dall’Oglio, Marcos Franzén, Lars Bruland, Øyvind S. Petrenciuc, Oana Staudacher, Karin Li, Rui Nilsson, Sten |
| description | In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment.
To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection.
Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving ≥1 study-drug injection (600 radium-223 and 301 placebo). Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr.
All adverse events (AEs) were collected until 12 wk after the last injection; subsequently, only treatment-related AEs were collected. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Data analysis used descriptive statistics.
During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). Myelosuppression incidence was low. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Long-term follow-up showed no AML, MDS, or new primary bone cancer; secondary non–treatment-related malignancies occurred in four radium-223 and three placebo patients. One radium-223 patient had aplastic anemia 16 mo after the last injection. No other cases were observed. Limitations include short (3-yr) follow-up.
Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns.
Updated Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial findings show that radium-223 remained well tolerated during treatment and up to 3 yr after each patient's first injection.
Three-year safety follow-up of Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial patients with castration-resistant prostate cancer and symptomatic bone metastases revealed a co |
| doi_str_mv | 10.1016/j.eururo.2017.06.021 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_495448</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S030228381730516X</els_id><sourcerecordid>1920196760</sourcerecordid><originalsourceid>FETCH-LOGICAL-c484t-3afb9b0b1cf69d46b1bf51c228437c59535a7d398d751b6bbadb09b55048a6773</originalsourceid><addsrcrecordid>eNp9kk1v1DAQhiMEokvhHyDkI5csdmzn44K0bIEiFbGiC1fLHxPiJYm3tkO1_ML-LLzKUiEOPXk0fmbe0cybZS8JXhJMyje7JUx-8m5ZYFItcbnEBXmULUhd0bziJX6cLTDFRV7UtD7LnoWwwxhT3tCn2VlRV5hzhhfZ3bbzAPkBpEfXsoV4QK5FX6Wx05AXBUUXVne989YAsiPayGhhjAHd2tihtQzRp4wbcw_BhijHiDbepSBC-h01eCRHg64Pwz66IaEavXMjoM8QU60MEFDr3YA2XYoRTcKjcYP9DQat-n0nfRpkPAr_2-F_ha23sn-ePWllH-DF6T3Pvn14v11f5ldfPn5ar65yzWoWcypb1SisiG7LxrBSEdVyoouiZrTSvOGUy8rQpjYVJ6pUShqFG8U5ZrUsq4qeZ_ncN9zCflJi7-0g_UE4acUp9TNFIFjDGasf5C_s95Vw_oeYhkkQlrR54l_P_N67mwlCFIMNGvpejuCmIEiT7t2UVYkTymZUp4UED-19c4LF0SNiJ2aPiKNHBC5F8kgqe3VSmNQA5r7orykS8HYGIO3xlwUvgk5X12CsBx2FcfZhhT9LHdPx</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1920196760</pqid></control><display><type>article</type><title>Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial</title><source>Elsevier ScienceDirect Journals Complete</source><source>SWEPUB Freely available online</source><creator>Parker, Christopher C. ; Coleman, Robert E. ; Sartor, Oliver ; Vogelzang, Nicholas J. ; Bottomley, David ; Heinrich, Daniel ; Helle, Svein I. ; O'Sullivan, Joe M. ; Fosså, Sophie D. ; Chodacki, Aleš ; Wiechno, Paweł ; Logue, John ; Seke, Mihalj ; Widmark, Anders ; Johannessen, Dag Clement ; Hoskin, Peter ; James, Nicholas D. ; Solberg, Arne ; Syndikus, Isabel ; Kliment, Jan ; Wedel, Steffen ; Boehmer, Sibylle ; Dall’Oglio, Marcos ; Franzén, Lars ; Bruland, Øyvind S. ; Petrenciuc, Oana ; Staudacher, Karin ; Li, Rui ; Nilsson, Sten</creator><creatorcontrib>Parker, Christopher C. ; Coleman, Robert E. ; Sartor, Oliver ; Vogelzang, Nicholas J. ; Bottomley, David ; Heinrich, Daniel ; Helle, Svein I. ; O'Sullivan, Joe M. ; Fosså, Sophie D. ; Chodacki, Aleš ; Wiechno, Paweł ; Logue, John ; Seke, Mihalj ; Widmark, Anders ; Johannessen, Dag Clement ; Hoskin, Peter ; James, Nicholas D. ; Solberg, Arne ; Syndikus, Isabel ; Kliment, Jan ; Wedel, Steffen ; Boehmer, Sibylle ; Dall’Oglio, Marcos ; Franzén, Lars ; Bruland, Øyvind S. ; Petrenciuc, Oana ; Staudacher, Karin ; Li, Rui ; Nilsson, Sten</creatorcontrib><description>In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment.
To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection.
Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving ≥1 study-drug injection (600 radium-223 and 301 placebo). Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr.
All adverse events (AEs) were collected until 12 wk after the last injection; subsequently, only treatment-related AEs were collected. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Data analysis used descriptive statistics.
During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). Myelosuppression incidence was low. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Long-term follow-up showed no AML, MDS, or new primary bone cancer; secondary non–treatment-related malignancies occurred in four radium-223 and three placebo patients. One radium-223 patient had aplastic anemia 16 mo after the last injection. No other cases were observed. Limitations include short (3-yr) follow-up.
Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns.
Updated Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial findings show that radium-223 remained well tolerated during treatment and up to 3 yr after each patient's first injection.
Three-year safety follow-up of Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial patients with castration-resistant prostate cancer and symptomatic bone metastases revealed a continued low incidence of myelosuppression, minimal nonhematologic adverse events, and secondary malignancies (none related to treatment) in four radium-223 patients and three placebo patients.</description><identifier>ISSN: 0302-2838</identifier><identifier>ISSN: 1873-7560</identifier><identifier>EISSN: 1873-7560</identifier><identifier>DOI: 10.1016/j.eururo.2017.06.021</identifier><identifier>PMID: 28705540</identifier><language>eng</language><publisher>Switzerland: Elsevier B.V</publisher><subject>ALSYMPCA ; Bone metastases ; Castration-resistant ; Castration-resistant prostate cancer ; Follow-up ; Long-term safety ; prostate cancer ; Radium-223</subject><ispartof>European urology, 2018-03, Vol.73 (3), p.427-435</ispartof><rights>2017 European Association of Urology</rights><rights>Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c484t-3afb9b0b1cf69d46b1bf51c228437c59535a7d398d751b6bbadb09b55048a6773</citedby><cites>FETCH-LOGICAL-c484t-3afb9b0b1cf69d46b1bf51c228437c59535a7d398d751b6bbadb09b55048a6773</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S030228381730516X$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28705540$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-145355$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:137648313$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Parker, Christopher C.</creatorcontrib><creatorcontrib>Coleman, Robert E.</creatorcontrib><creatorcontrib>Sartor, Oliver</creatorcontrib><creatorcontrib>Vogelzang, Nicholas J.</creatorcontrib><creatorcontrib>Bottomley, David</creatorcontrib><creatorcontrib>Heinrich, Daniel</creatorcontrib><creatorcontrib>Helle, Svein I.</creatorcontrib><creatorcontrib>O'Sullivan, Joe M.</creatorcontrib><creatorcontrib>Fosså, Sophie D.</creatorcontrib><creatorcontrib>Chodacki, Aleš</creatorcontrib><creatorcontrib>Wiechno, Paweł</creatorcontrib><creatorcontrib>Logue, John</creatorcontrib><creatorcontrib>Seke, Mihalj</creatorcontrib><creatorcontrib>Widmark, Anders</creatorcontrib><creatorcontrib>Johannessen, Dag Clement</creatorcontrib><creatorcontrib>Hoskin, Peter</creatorcontrib><creatorcontrib>James, Nicholas D.</creatorcontrib><creatorcontrib>Solberg, Arne</creatorcontrib><creatorcontrib>Syndikus, Isabel</creatorcontrib><creatorcontrib>Kliment, Jan</creatorcontrib><creatorcontrib>Wedel, Steffen</creatorcontrib><creatorcontrib>Boehmer, Sibylle</creatorcontrib><creatorcontrib>Dall’Oglio, Marcos</creatorcontrib><creatorcontrib>Franzén, Lars</creatorcontrib><creatorcontrib>Bruland, Øyvind S.</creatorcontrib><creatorcontrib>Petrenciuc, Oana</creatorcontrib><creatorcontrib>Staudacher, Karin</creatorcontrib><creatorcontrib>Li, Rui</creatorcontrib><creatorcontrib>Nilsson, Sten</creatorcontrib><title>Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial</title><title>European urology</title><addtitle>Eur Urol</addtitle><description>In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment.
To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection.
Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving ≥1 study-drug injection (600 radium-223 and 301 placebo). Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr.
All adverse events (AEs) were collected until 12 wk after the last injection; subsequently, only treatment-related AEs were collected. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Data analysis used descriptive statistics.
During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). Myelosuppression incidence was low. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Long-term follow-up showed no AML, MDS, or new primary bone cancer; secondary non–treatment-related malignancies occurred in four radium-223 and three placebo patients. One radium-223 patient had aplastic anemia 16 mo after the last injection. No other cases were observed. Limitations include short (3-yr) follow-up.
Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns.
Updated Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial findings show that radium-223 remained well tolerated during treatment and up to 3 yr after each patient's first injection.
Three-year safety follow-up of Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial patients with castration-resistant prostate cancer and symptomatic bone metastases revealed a continued low incidence of myelosuppression, minimal nonhematologic adverse events, and secondary malignancies (none related to treatment) in four radium-223 patients and three placebo patients.</description><subject>ALSYMPCA</subject><subject>Bone metastases</subject><subject>Castration-resistant</subject><subject>Castration-resistant prostate cancer</subject><subject>Follow-up</subject><subject>Long-term safety</subject><subject>prostate cancer</subject><subject>Radium-223</subject><issn>0302-2838</issn><issn>1873-7560</issn><issn>1873-7560</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>D8T</sourceid><recordid>eNp9kk1v1DAQhiMEokvhHyDkI5csdmzn44K0bIEiFbGiC1fLHxPiJYm3tkO1_ML-LLzKUiEOPXk0fmbe0cybZS8JXhJMyje7JUx-8m5ZYFItcbnEBXmULUhd0bziJX6cLTDFRV7UtD7LnoWwwxhT3tCn2VlRV5hzhhfZ3bbzAPkBpEfXsoV4QK5FX6Wx05AXBUUXVne989YAsiPayGhhjAHd2tihtQzRp4wbcw_BhijHiDbepSBC-h01eCRHg64Pwz66IaEavXMjoM8QU60MEFDr3YA2XYoRTcKjcYP9DQat-n0nfRpkPAr_2-F_ha23sn-ePWllH-DF6T3Pvn14v11f5ldfPn5ar65yzWoWcypb1SisiG7LxrBSEdVyoouiZrTSvOGUy8rQpjYVJ6pUShqFG8U5ZrUsq4qeZ_ncN9zCflJi7-0g_UE4acUp9TNFIFjDGasf5C_s95Vw_oeYhkkQlrR54l_P_N67mwlCFIMNGvpejuCmIEiT7t2UVYkTymZUp4UED-19c4LF0SNiJ2aPiKNHBC5F8kgqe3VSmNQA5r7orykS8HYGIO3xlwUvgk5X12CsBx2FcfZhhT9LHdPx</recordid><startdate>20180301</startdate><enddate>20180301</enddate><creator>Parker, Christopher C.</creator><creator>Coleman, Robert E.</creator><creator>Sartor, Oliver</creator><creator>Vogelzang, Nicholas J.</creator><creator>Bottomley, David</creator><creator>Heinrich, Daniel</creator><creator>Helle, Svein I.</creator><creator>O'Sullivan, Joe M.</creator><creator>Fosså, Sophie D.</creator><creator>Chodacki, Aleš</creator><creator>Wiechno, Paweł</creator><creator>Logue, John</creator><creator>Seke, Mihalj</creator><creator>Widmark, Anders</creator><creator>Johannessen, Dag Clement</creator><creator>Hoskin, Peter</creator><creator>James, Nicholas D.</creator><creator>Solberg, Arne</creator><creator>Syndikus, Isabel</creator><creator>Kliment, Jan</creator><creator>Wedel, Steffen</creator><creator>Boehmer, Sibylle</creator><creator>Dall’Oglio, Marcos</creator><creator>Franzén, Lars</creator><creator>Bruland, Øyvind S.</creator><creator>Petrenciuc, Oana</creator><creator>Staudacher, Karin</creator><creator>Li, Rui</creator><creator>Nilsson, Sten</creator><general>Elsevier B.V</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>ADHXS</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>D93</scope><scope>ZZAVC</scope></search><sort><creationdate>20180301</creationdate><title>Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial</title><author>Parker, Christopher C. ; Coleman, Robert E. ; Sartor, Oliver ; Vogelzang, Nicholas J. ; Bottomley, David ; Heinrich, Daniel ; Helle, Svein I. ; O'Sullivan, Joe M. ; Fosså, Sophie D. ; Chodacki, Aleš ; Wiechno, Paweł ; Logue, John ; Seke, Mihalj ; Widmark, Anders ; Johannessen, Dag Clement ; Hoskin, Peter ; James, Nicholas D. ; Solberg, Arne ; Syndikus, Isabel ; Kliment, Jan ; Wedel, Steffen ; Boehmer, Sibylle ; Dall’Oglio, Marcos ; Franzén, Lars ; Bruland, Øyvind S. ; Petrenciuc, Oana ; Staudacher, Karin ; Li, Rui ; Nilsson, Sten</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c484t-3afb9b0b1cf69d46b1bf51c228437c59535a7d398d751b6bbadb09b55048a6773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>ALSYMPCA</topic><topic>Bone metastases</topic><topic>Castration-resistant</topic><topic>Castration-resistant prostate cancer</topic><topic>Follow-up</topic><topic>Long-term safety</topic><topic>prostate cancer</topic><topic>Radium-223</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Parker, Christopher C.</creatorcontrib><creatorcontrib>Coleman, Robert E.</creatorcontrib><creatorcontrib>Sartor, Oliver</creatorcontrib><creatorcontrib>Vogelzang, Nicholas J.</creatorcontrib><creatorcontrib>Bottomley, David</creatorcontrib><creatorcontrib>Heinrich, Daniel</creatorcontrib><creatorcontrib>Helle, Svein I.</creatorcontrib><creatorcontrib>O'Sullivan, Joe M.</creatorcontrib><creatorcontrib>Fosså, Sophie D.</creatorcontrib><creatorcontrib>Chodacki, Aleš</creatorcontrib><creatorcontrib>Wiechno, Paweł</creatorcontrib><creatorcontrib>Logue, John</creatorcontrib><creatorcontrib>Seke, Mihalj</creatorcontrib><creatorcontrib>Widmark, Anders</creatorcontrib><creatorcontrib>Johannessen, Dag Clement</creatorcontrib><creatorcontrib>Hoskin, Peter</creatorcontrib><creatorcontrib>James, Nicholas D.</creatorcontrib><creatorcontrib>Solberg, Arne</creatorcontrib><creatorcontrib>Syndikus, Isabel</creatorcontrib><creatorcontrib>Kliment, Jan</creatorcontrib><creatorcontrib>Wedel, Steffen</creatorcontrib><creatorcontrib>Boehmer, Sibylle</creatorcontrib><creatorcontrib>Dall’Oglio, Marcos</creatorcontrib><creatorcontrib>Franzén, Lars</creatorcontrib><creatorcontrib>Bruland, Øyvind S.</creatorcontrib><creatorcontrib>Petrenciuc, Oana</creatorcontrib><creatorcontrib>Staudacher, Karin</creatorcontrib><creatorcontrib>Li, Rui</creatorcontrib><creatorcontrib>Nilsson, Sten</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>SWEPUB Umeå universitet full text</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SWEPUB Umeå universitet</collection><collection>SwePub Articles full text</collection><jtitle>European urology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Parker, Christopher C.</au><au>Coleman, Robert E.</au><au>Sartor, Oliver</au><au>Vogelzang, Nicholas J.</au><au>Bottomley, David</au><au>Heinrich, Daniel</au><au>Helle, Svein I.</au><au>O'Sullivan, Joe M.</au><au>Fosså, Sophie D.</au><au>Chodacki, Aleš</au><au>Wiechno, Paweł</au><au>Logue, John</au><au>Seke, Mihalj</au><au>Widmark, Anders</au><au>Johannessen, Dag Clement</au><au>Hoskin, Peter</au><au>James, Nicholas D.</au><au>Solberg, Arne</au><au>Syndikus, Isabel</au><au>Kliment, Jan</au><au>Wedel, Steffen</au><au>Boehmer, Sibylle</au><au>Dall’Oglio, Marcos</au><au>Franzén, Lars</au><au>Bruland, Øyvind S.</au><au>Petrenciuc, Oana</au><au>Staudacher, Karin</au><au>Li, Rui</au><au>Nilsson, Sten</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial</atitle><jtitle>European urology</jtitle><addtitle>Eur Urol</addtitle><date>2018-03-01</date><risdate>2018</risdate><volume>73</volume><issue>3</issue><spage>427</spage><epage>435</epage><pages>427-435</pages><issn>0302-2838</issn><issn>1873-7560</issn><eissn>1873-7560</eissn><abstract>In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment.
To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection.
Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving ≥1 study-drug injection (600 radium-223 and 301 placebo). Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr.
All adverse events (AEs) were collected until 12 wk after the last injection; subsequently, only treatment-related AEs were collected. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Data analysis used descriptive statistics.
During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). Myelosuppression incidence was low. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Long-term follow-up showed no AML, MDS, or new primary bone cancer; secondary non–treatment-related malignancies occurred in four radium-223 and three placebo patients. One radium-223 patient had aplastic anemia 16 mo after the last injection. No other cases were observed. Limitations include short (3-yr) follow-up.
Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns.
Updated Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial findings show that radium-223 remained well tolerated during treatment and up to 3 yr after each patient's first injection.
Three-year safety follow-up of Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial patients with castration-resistant prostate cancer and symptomatic bone metastases revealed a continued low incidence of myelosuppression, minimal nonhematologic adverse events, and secondary malignancies (none related to treatment) in four radium-223 patients and three placebo patients.</abstract><cop>Switzerland</cop><pub>Elsevier B.V</pub><pmid>28705540</pmid><doi>10.1016/j.eururo.2017.06.021</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_495448 |
| source | Elsevier ScienceDirect Journals Complete; SWEPUB Freely available online |
| subjects | ALSYMPCA Bone metastases Castration-resistant Castration-resistant prostate cancer Follow-up Long-term safety prostate cancer Radium-223 |
| title | Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-21T20%3A05%3A02IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Three-year%20Safety%20of%20Radium-223%20Dichloride%20in%20Patients%20with%20Castration-resistant%20Prostate%20Cancer%20and%20Symptomatic%20Bone%20Metastases%20from%20Phase%203%20Randomized%20Alpharadin%20in%20Symptomatic%20Prostate%20Cancer%20Trial&rft.jtitle=European%20urology&rft.au=Parker,%20Christopher%20C.&rft.date=2018-03-01&rft.volume=73&rft.issue=3&rft.spage=427&rft.epage=435&rft.pages=427-435&rft.issn=0302-2838&rft.eissn=1873-7560&rft_id=info:doi/10.1016/j.eururo.2017.06.021&rft_dat=%3Cproquest_swepu%3E1920196760%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1920196760&rft_id=info:pmid/28705540&rft_els_id=S030228381730516X&rfr_iscdi=true |