Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer: comparison of skeletal-related events and symptomatic skeletal events.
Identifieur interne : 003028 ( PubMed/Corpus ); précédent : 003027; suivant : 003029Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer: comparison of skeletal-related events and symptomatic skeletal events.
Auteurs : M R Smith ; R E Coleman ; L. Klotz ; K. Pittman ; P. Milecki ; S. Ng ; K N Chi ; A. Balakumaran ; R. Wei ; H. Wang ; A. Braun ; K. FizaziSource :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2015.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Bone Density Conservation Agents, Denosumab.
- complications : Bone Neoplasms.
- pathology : Prostatic Neoplasms, Castration-Resistant.
- secondary : Bone Neoplasms.
- Aged, Double-Blind Method, Humans, Male, Middle Aged.
Abstract
In a phase III trial in patients with castration-resistant prostate cancer (CRPC) and bone metastases, denosumab was superior to zoledronic acid in reducing skeletal-related events (SREs; radiation to bone, pathologic fracture, surgery to bone, or spinal cord compression). This study reassessed the efficacy of denosumab using symptomatic skeletal events (SSEs) as a prespecified exploratory end point.
DOI: 10.1093/annonc/mdu519
PubMed: 25425475
Links to Exploration step
pubmed:25425475Le document en format XML
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Klotz</name><affiliation><nlm:affiliation>Division of Urology, Sunnybrook and Women's College Health Sciences Centre, Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Pittman, K" sort="Pittman, K" uniqKey="Pittman K" first="K" last="Pittman">K. Pittman</name><affiliation><nlm:affiliation>Department of Medical Oncology, The Queen Elizabeth Hospital, Woodville, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Milecki, P" sort="Milecki, P" uniqKey="Milecki P" first="P" last="Milecki">P. Milecki</name><affiliation><nlm:affiliation>Department of Electroradiology, Poznan University of Medical Sciences, Poznan Department of Radiotherapy, Wielkopolskie Centrum Onkologii, Poznan, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Ng, S" sort="Ng, S" uniqKey="Ng S" first="S" last="Ng">S. Ng</name><affiliation><nlm:affiliation>St John of God Hospital, Subiaco, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Chi, K N" sort="Chi, K N" uniqKey="Chi K" first="K N" last="Chi">K N Chi</name><affiliation><nlm:affiliation>Department of Medical Oncology, BC Cancer Agency, Vancouver, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Balakumaran, A" sort="Balakumaran, A" uniqKey="Balakumaran A" first="A" last="Balakumaran">A. Balakumaran</name><affiliation><nlm:affiliation>Department of Hematology/Oncology.</nlm:affiliation></affiliation></author><author><name sortKey="Wei, R" sort="Wei, R" uniqKey="Wei R" first="R" last="Wei">R. Wei</name><affiliation><nlm:affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, H" sort="Wang, H" uniqKey="Wang H" first="H" last="Wang">H. Wang</name><affiliation><nlm:affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Braun, A" sort="Braun, A" uniqKey="Braun A" first="A" last="Braun">A. Braun</name><affiliation><nlm:affiliation>Department of Hematology/Oncology.</nlm:affiliation></affiliation></author><author><name sortKey="Fizazi, K" sort="Fizazi, K" uniqKey="Fizazi K" first="K" last="Fizazi">K. Fizazi</name><affiliation><nlm:affiliation>Department of Medical Oncology, Institut Gustave Roussy, University of Paris Sud, Paris, France.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25425475</idno><idno type="pmid">25425475</idno><idno type="doi">10.1093/annonc/mdu519</idno><idno type="wicri:Area/PubMed/Corpus">003028</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003028</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer: comparison of skeletal-related events and symptomatic skeletal events.</title><author><name sortKey="Smith, M R" sort="Smith, M R" uniqKey="Smith M" first="M R" last="Smith">M R Smith</name><affiliation><nlm:affiliation>Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Boston, USA smith.matthew@mgh.harvard.edu.</nlm:affiliation></affiliation></author><author><name sortKey="Coleman, R E" sort="Coleman, R E" uniqKey="Coleman R" first="R E" last="Coleman">R E Coleman</name><affiliation><nlm:affiliation>Academic Unit of Clinical Oncology, Sheffield Cancer Research Centre, Sheffield, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Klotz, L" sort="Klotz, L" uniqKey="Klotz L" first="L" last="Klotz">L. Klotz</name><affiliation><nlm:affiliation>Division of Urology, Sunnybrook and Women's College Health Sciences Centre, Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Pittman, K" sort="Pittman, K" uniqKey="Pittman K" first="K" last="Pittman">K. Pittman</name><affiliation><nlm:affiliation>Department of Medical Oncology, The Queen Elizabeth Hospital, Woodville, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Milecki, P" sort="Milecki, P" uniqKey="Milecki P" first="P" last="Milecki">P. Milecki</name><affiliation><nlm:affiliation>Department of Electroradiology, Poznan University of Medical Sciences, Poznan Department of Radiotherapy, Wielkopolskie Centrum Onkologii, Poznan, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Ng, S" sort="Ng, S" uniqKey="Ng S" first="S" last="Ng">S. Ng</name><affiliation><nlm:affiliation>St John of God Hospital, Subiaco, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Chi, K N" sort="Chi, K N" uniqKey="Chi K" first="K N" last="Chi">K N Chi</name><affiliation><nlm:affiliation>Department of Medical Oncology, BC Cancer Agency, Vancouver, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Balakumaran, A" sort="Balakumaran, A" uniqKey="Balakumaran A" first="A" last="Balakumaran">A. Balakumaran</name><affiliation><nlm:affiliation>Department of Hematology/Oncology.</nlm:affiliation></affiliation></author><author><name sortKey="Wei, R" sort="Wei, R" uniqKey="Wei R" first="R" last="Wei">R. Wei</name><affiliation><nlm:affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Wang, H" sort="Wang, H" uniqKey="Wang H" first="H" last="Wang">H. Wang</name><affiliation><nlm:affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Braun, A" sort="Braun, A" uniqKey="Braun A" first="A" last="Braun">A. Braun</name><affiliation><nlm:affiliation>Department of Hematology/Oncology.</nlm:affiliation></affiliation></author><author><name sortKey="Fizazi, K" sort="Fizazi, K" uniqKey="Fizazi K" first="K" last="Fizazi">K. Fizazi</name><affiliation><nlm:affiliation>Department of Medical Oncology, Institut Gustave Roussy, University of Paris Sud, Paris, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title><idno type="eISSN">1569-8041</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Bone Density Conservation Agents (therapeutic use)</term><term>Bone Neoplasms (complications)</term><term>Bone Neoplasms (secondary)</term><term>Denosumab (therapeutic use)</term><term>Double-Blind Method</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Prostatic Neoplasms, Castration-Resistant (pathology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Bone Density Conservation Agents</term><term>Denosumab</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Bone Neoplasms</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Bone Neoplasms</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Double-Blind Method</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In a phase III trial in patients with castration-resistant prostate cancer (CRPC) and bone metastases, denosumab was superior to zoledronic acid in reducing skeletal-related events (SREs; radiation to bone, pathologic fracture, surgery to bone, or spinal cord compression). This study reassessed the efficacy of denosumab using symptomatic skeletal events (SSEs) as a prespecified exploratory end point.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25425475</PMID><DateCreated><Year>2015</Year><Month>01</Month><Day>24</Day></DateCreated><DateCompleted><Year>2016</Year><Month>02</Month><Day>24</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1569-8041</ISSN><JournalIssue CitedMedium="Internet"><Volume>26</Volume><Issue>2</Issue><PubDate><Year>2015</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title><ISOAbbreviation>Ann. Oncol.</ISOAbbreviation></Journal><ArticleTitle>Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer: comparison of skeletal-related events and symptomatic skeletal events.</ArticleTitle><Pagination><MedlinePgn>368-74</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdu519</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In a phase III trial in patients with castration-resistant prostate cancer (CRPC) and bone metastases, denosumab was superior to zoledronic acid in reducing skeletal-related events (SREs; radiation to bone, pathologic fracture, surgery to bone, or spinal cord compression). This study reassessed the efficacy of denosumab using symptomatic skeletal events (SSEs) as a prespecified exploratory end point.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Patients with CRPC, no previous bisphosphonate exposure, and radiographic evidence of bone metastasis were randomized to subcutaneous denosumab 120 mg plus i.v. placebo every 4 weeks (Q4W), or i.v. zoledronic acid 4 mg plus subcutaneous placebo Q4W during the blinded treatment phase. SSEs were defined as radiation to bone, symptomatic pathologic fracture, surgery to bone, or symptomatic spinal cord compression. The relationship between SSE or SRE and time to moderate/severe pain was assessed using the Brief Pain Inventory Short Form.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Treatment with denosumab significantly reduced the risk of developing first SSE [HR, 0.78; 95% confidence interval (CI) 0.66-0.93; P = 0.005] and first and subsequent SSEs (rate ratio, 0.78; 95% CI 0.65-0.92; P = 0.004) compared with zoledronic acid. The treatment differences in the number of patients with SSEs or SREs were similar (n = 48 and n = 45, respectively). Among patients with no/mild pain at baseline, both SSEs and SREs were associated with moderate/severe pain development (P < 0.0001). Fewer patients had skeletal complications, particularly fractures, when defined as SSE versus SRE.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">In patients with CRPC and bone metastases, denosumab reduced the risk of skeletal complications versus zoledronic acid regardless of whether the end point was defined as SSE or SRE.</AbstractText><CopyrightInformation>© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>M R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Boston, USA smith.matthew@mgh.harvard.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coleman</LastName><ForeName>R E</ForeName><Initials>RE</Initials><AffiliationInfo><Affiliation>Academic Unit of Clinical Oncology, Sheffield Cancer Research Centre, Sheffield, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Klotz</LastName><ForeName>L</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Division of Urology, Sunnybrook and Women's College Health Sciences Centre, Toronto, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pittman</LastName><ForeName>K</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, The Queen Elizabeth Hospital, Woodville, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Milecki</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Electroradiology, Poznan University of Medical Sciences, Poznan Department of Radiotherapy, Wielkopolskie Centrum Onkologii, Poznan, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ng</LastName><ForeName>S</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>St John of God Hospital, Subiaco, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chi</LastName><ForeName>K N</ForeName><Initials>KN</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, BC Cancer Agency, Vancouver, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Balakumaran</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Hematology/Oncology.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wei</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wang</LastName><ForeName>H</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Braun</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Hematology/Oncology.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fizazi</LastName><ForeName>K</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Institut Gustave Roussy, University of Paris Sud, Paris, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>K24 CA121990</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>11</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Ann Oncol</MedlineTA><NlmUniqueID>9007735</NlmUniqueID><ISSNLinking>0923-7534</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D050071">Bone Density Conservation Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>4EQZ6YO2HI</RegistryNumber><NameOfSubstance UI="D000069448">Denosumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2013 Jul 18;369(3):213-23</RefSource><PMID Version="1">23863050</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s</RefSource><PMID Version="1">17062708</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Hum Pathol. 2000 May;31(5):578-83</RefSource><PMID Version="1">10836297</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Natl Cancer Inst. 2002 Oct 2;94(19):1458-68</RefSource><PMID Version="1">12359855</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2011 Mar 5;377(9768):813-22</RefSource><PMID 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