Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial
Identifieur interne : 000701 ( Pmc/Curation ); précédent : 000700; suivant : 000702Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial
Auteurs : N. Raje ; S. Vadhan-Raj [États-Unis] ; W. Willenbacher [Autriche] ; E. Terpos [Grèce] ; V. Hungria [Brésil] ; A. Spencer [Australie] ; Y. Alexeeva [Russie] ; T. Facon [France] ; A K Stewart [États-Unis] ; A. Feng [États-Unis] ; A. Braun [États-Unis] ; A. Balakumaran [États-Unis] ; G D Roodman [États-Unis]Source :
- Blood Cancer Journal [ 2044-5385 ] ; 2016.
Abstract
In a phase 3 trial of denosumab vs zoledronic acid in patients (
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DOI: 10.1038/bcj.2015.96
PubMed: 26745852
PubMed Central: 4742634
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N. Raje<affiliation><nlm:aff id="aff1"><institution>Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center</institution>,<country>Boston</country>, MA,<country>USA</country></nlm:aff><wicri:noCountry code="nlm country">Boston</wicri:noCountry></affiliation>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial</title><author><name sortKey="Raje, N" sort="Raje, N" uniqKey="Raje N" first="N" last="Raje">N. Raje</name><affiliation><nlm:aff id="aff1"><institution>Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center</institution>,<country>Boston</country>, MA,<country>USA</country></nlm:aff><wicri:noCountry code="nlm country">Boston</wicri:noCountry></affiliation></author><author><name sortKey="Vadhan Raj, S" sort="Vadhan Raj, S" uniqKey="Vadhan Raj S" first="S" last="Vadhan-Raj">S. Vadhan-Raj</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>University of Texas, MD Anderson Cancer Center</institution>, Houston, TX,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Willenbacher, W" sort="Willenbacher, W" uniqKey="Willenbacher W" first="W" last="Willenbacher">W. Willenbacher</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Internal Medicine V, Haematology and Oncology, Medical University of Innsbruck</institution>, Innsbruck,<country>Austria</country></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Terpos, E" sort="Terpos, E" uniqKey="Terpos E" first="E" last="Terpos">E. Terpos</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine</institution>, Athens,<country>Greece</country></nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hungria, V" sort="Hungria, V" uniqKey="Hungria V" first="V" last="Hungria">V. Hungria</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Irmandade da Santa Casa de Misericordia de Sao Paulo</institution>, São Paulo,<country>Brazil</country></nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Spencer, A" sort="Spencer, A" uniqKey="Spencer A" first="A" last="Spencer">A. Spencer</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>The Alfred Hospital</institution>, Melbourne, Victoria,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Alexeeva, Y" sort="Alexeeva, Y" uniqKey="Alexeeva Y" first="Y" last="Alexeeva">Y. Alexeeva</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>City Hospital No. 31</institution>, Saint Petersburg,<country>Russia</country></nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Facon, T" sort="Facon, T" uniqKey="Facon T" first="T" last="Facon">T. Facon</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Hôpital Claude Huriez</institution>, Lille,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Stewart, A K" sort="Stewart, A K" uniqKey="Stewart A" first="A K" last="Stewart">A K Stewart</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Mayo Clinic</institution>, Scottsdale, AZ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Feng, A" sort="Feng, A" uniqKey="Feng A" first="A" last="Feng">A. Feng</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Amgen Inc.</institution>, Thousand Oaks, CA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Braun, A" sort="Braun, A" uniqKey="Braun A" first="A" last="Braun">A. Braun</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Amgen Inc.</institution>, Thousand Oaks, CA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Balakumaran, A" sort="Balakumaran, A" uniqKey="Balakumaran A" first="A" last="Balakumaran">A. Balakumaran</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Amgen Inc.</institution>, Thousand Oaks, CA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Roodman, G D" sort="Roodman, G D" uniqKey="Roodman G" first="G D" last="Roodman">G D Roodman</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Indiana University School of Medicine</institution>, Indianapolis, IN,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26745852</idno><idno type="pmc">4742634</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4742634</idno><idno type="RBID">PMC:4742634</idno><idno type="doi">10.1038/bcj.2015.96</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000702</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000702</idno><idno type="wicri:Area/Pmc/Curation">000701</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000701</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial</title><author><name sortKey="Raje, N" sort="Raje, N" uniqKey="Raje N" first="N" last="Raje">N. Raje</name><affiliation><nlm:aff id="aff1"><institution>Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center</institution>,<country>Boston</country>, MA,<country>USA</country></nlm:aff><wicri:noCountry code="nlm country">Boston</wicri:noCountry></affiliation></author><author><name sortKey="Vadhan Raj, S" sort="Vadhan Raj, S" uniqKey="Vadhan Raj S" first="S" last="Vadhan-Raj">S. Vadhan-Raj</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>University of Texas, MD Anderson Cancer Center</institution>, Houston, TX,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Willenbacher, W" sort="Willenbacher, W" uniqKey="Willenbacher W" first="W" last="Willenbacher">W. Willenbacher</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Internal Medicine V, Haematology and Oncology, Medical University of Innsbruck</institution>, Innsbruck,<country>Austria</country></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Terpos, E" sort="Terpos, E" uniqKey="Terpos E" first="E" last="Terpos">E. Terpos</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine</institution>, Athens,<country>Greece</country></nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hungria, V" sort="Hungria, V" uniqKey="Hungria V" first="V" last="Hungria">V. Hungria</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Irmandade da Santa Casa de Misericordia de Sao Paulo</institution>, São Paulo,<country>Brazil</country></nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Spencer, A" sort="Spencer, A" uniqKey="Spencer A" first="A" last="Spencer">A. Spencer</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>The Alfred Hospital</institution>, Melbourne, Victoria,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Alexeeva, Y" sort="Alexeeva, Y" uniqKey="Alexeeva Y" first="Y" last="Alexeeva">Y. Alexeeva</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>City Hospital No. 31</institution>, Saint Petersburg,<country>Russia</country></nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Facon, T" sort="Facon, T" uniqKey="Facon T" first="T" last="Facon">T. Facon</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Hôpital Claude Huriez</institution>, Lille,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Stewart, A K" sort="Stewart, A K" uniqKey="Stewart A" first="A K" last="Stewart">A K Stewart</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Mayo Clinic</institution>, Scottsdale, AZ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Feng, A" sort="Feng, A" uniqKey="Feng A" first="A" last="Feng">A. Feng</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Amgen Inc.</institution>, Thousand Oaks, CA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Braun, A" sort="Braun, A" uniqKey="Braun A" first="A" last="Braun">A. Braun</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Amgen Inc.</institution>, Thousand Oaks, CA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Balakumaran, A" sort="Balakumaran, A" uniqKey="Balakumaran A" first="A" last="Balakumaran">A. Balakumaran</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Amgen Inc.</institution>, Thousand Oaks, CA,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Roodman, G D" sort="Roodman, G D" uniqKey="Roodman G" first="G D" last="Roodman">G D Roodman</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Indiana University School of Medicine</institution>, Indianapolis, IN,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Blood Cancer Journal</title><idno type="eISSN">2044-5385</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>In a phase 3 trial of denosumab vs zoledronic acid in patients (<italic>n</italic>=1776) with bone metastases and solid tumors or multiple myeloma, denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events. There was no difference in overall survival between the two groups; however, an <italic>ad hoc</italic> overall survival analysis in the multiple myeloma subset of patients (<italic>n</italic>=180) favored zoledronic acid (hazard ratio (HR) 2.26; 95% confidence interval (CI) 1.13–4.50; <italic>P</italic>=0.014). In the present analysis, we found imbalances between the groups with respect to baseline risk characteristics. HRs with two-sided 95% CIs were estimated using the Cox model. After adjustment in a covariate analysis, the CI crossed unity (HR 1.86; 95% CI 0.90–3.84; <italic>P</italic>=0.0954). Furthermore, we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group; after accounting for these, the HR was 1.31 (95% CI 0.80–2.15; <italic>P</italic>=0.278). In conclusion, the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Blood Cancer J</journal-id><journal-id journal-id-type="iso-abbrev">Blood Cancer J</journal-id><journal-title-group><journal-title>Blood Cancer Journal</journal-title></journal-title-group><issn pub-type="epub">2044-5385</issn><publisher><publisher-name>Nature Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26745852</article-id><article-id pub-id-type="pmc">4742634</article-id><article-id pub-id-type="pii">bcj201596</article-id><article-id pub-id-type="doi">10.1038/bcj.2015.96</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial</article-title><alt-title alt-title-type="running">Denosumab vs zoledronic acid in multiple myeloma</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Raje</surname><given-names>N</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="corresp" rid="caf1">*</xref></contrib><contrib contrib-type="author"><name><surname>Vadhan-Raj</surname><given-names>S</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Willenbacher</surname><given-names>W</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Terpos</surname><given-names>E</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Hungria</surname><given-names>V</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Spencer</surname><given-names>A</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Alexeeva</surname><given-names>Y</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Facon</surname><given-names>T</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Stewart</surname><given-names>A K</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Feng</surname><given-names>A</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Braun</surname><given-names>A</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Balakumaran</surname><given-names>A</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Roodman</surname><given-names>G D</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><aff id="aff1"><label>1</label><institution>Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center</institution>,<country>Boston</country>, MA,<country>USA</country></aff><aff id="aff2"><label>2</label><institution>University of Texas, MD Anderson Cancer Center</institution>, Houston, TX,<country>USA</country></aff><aff id="aff3"><label>3</label><institution>Internal Medicine V, Haematology and Oncology, Medical University of Innsbruck</institution>, Innsbruck,<country>Austria</country></aff><aff id="aff4"><label>4</label><institution>Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine</institution>, Athens,<country>Greece</country></aff><aff id="aff5"><label>5</label><institution>Irmandade da Santa Casa de Misericordia de Sao Paulo</institution>, São Paulo,<country>Brazil</country></aff><aff id="aff6"><label>6</label><institution>The Alfred Hospital</institution>, Melbourne, Victoria,<country>Australia</country></aff><aff id="aff7"><label>7</label><institution>City Hospital No. 31</institution>, Saint Petersburg,<country>Russia</country></aff><aff id="aff8"><label>8</label><institution>Hôpital Claude Huriez</institution>, Lille,<country>France</country></aff><aff id="aff9"><label>9</label><institution>Mayo Clinic</institution>, Scottsdale, AZ,<country>USA</country></aff><aff id="aff10"><label>10</label><institution>Amgen Inc.</institution>, Thousand Oaks, CA,<country>USA</country></aff><aff id="aff11"><label>11</label><institution>Indiana University School of Medicine</institution>, Indianapolis, IN,<country>USA</country></aff></contrib-group><author-notes><corresp id="caf1"><label>*</label><institution>Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center</institution>, Boston, MA 02114, <country>USA</country>. E-mail: <email>nraje@partners.org</email></corresp></author-notes><pub-date pub-type="ppub"><month>01</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>08</day><month>01</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>1</month><year>2016</year></pub-date><volume>6</volume><issue>1</issue><fpage>e378</fpage><lpage></lpage><history><date date-type="received"><day>14</day><month>04</month><year>2015</year></date><date date-type="rev-recd"><day>18</day><month>08</month><year>2015</year></date><date date-type="accepted"><day>02</day><month>09</month><year>2015</year></date></history><permissions><copyright-statement>Copyright © 2016 Macmillan Publishers Limited</copyright-statement><copyright-year>2016</copyright-year><copyright-holder>Macmillan Publishers Limited</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/"><pmc-comment>author-paid</pmc-comment>
<license-p>This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/">http://creativecommons.org/licenses/by-nc-nd/4.0/</ext-link></license-p></license></permissions><abstract><p>In a phase 3 trial of denosumab vs zoledronic acid in patients (<italic>n</italic>=1776) with bone metastases and solid tumors or multiple myeloma, denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events. There was no difference in overall survival between the two groups; however, an <italic>ad hoc</italic> overall survival analysis in the multiple myeloma subset of patients (<italic>n</italic>=180) favored zoledronic acid (hazard ratio (HR) 2.26; 95% confidence interval (CI) 1.13–4.50; <italic>P</italic>=0.014). In the present analysis, we found imbalances between the groups with respect to baseline risk characteristics. HRs with two-sided 95% CIs were estimated using the Cox model. After adjustment in a covariate analysis, the CI crossed unity (HR 1.86; 95% CI 0.90–3.84; <italic>P</italic>=0.0954). Furthermore, we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group; after accounting for these, the HR was 1.31 (95% CI 0.80–2.15; <italic>P</italic>=0.278). In conclusion, the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial.</p></abstract></article-meta></front><floats-group><fig id="fig1"><label>Figure 1</label><caption><p>(<bold>a</bold>) Overall survival analysis, multiple myeloma subset. (<bold>b</bold>) Time to death, consent withdrawn or lost to follow-up. Q4W, every 4 weeks.</p></caption><graphic xlink:href="bcj201596f1"></graphic></fig><fig id="fig2"><label>Figure 2</label><caption><p>Overall survival rate: Myeloma IX study vs study 244 multiple myeloma subgroup.</p></caption><graphic xlink:href="bcj201596f2"></graphic></fig><table-wrap id="tbl1"><label>Table 1</label><caption><title>Baseline/on-study characteristics in the multiple myeloma subset of the phase 3 study</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="char" char="("></col><col align="char" char="("></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><italic>Characteristic,</italic> n <italic>(%)</italic></th><th align="center" valign="top" char="(" charoff="50"><italic>Zoledronic acid (</italic>n=<italic>93)</italic></th><th align="center" valign="top" char="(" charoff="50"><italic>Denosumab (</italic>n=<italic>87)</italic></th></tr></thead><tbody valign="top"><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Sex</italic></td></tr><tr><td align="left" valign="top" charoff="50"> Male</td><td align="char" valign="top" char="(" charoff="50">54 (58%)</td><td align="char" valign="top" char="(" charoff="50">57 (66%)</td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Age, years</italic></td></tr><tr><td align="left" valign="top" charoff="50"> Mean (s.d.)</td><td align="char" valign="top" char="(" charoff="50">63 (11)</td><td align="char" valign="top" char="(" charoff="50">62 (10)</td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>ECOG performance status at study entry</italic></td></tr><tr><td align="left" valign="top" charoff="50"> 0</td><td align="char" valign="top" char="(" charoff="50">30 (32%)</td><td align="char" valign="top" char="(" charoff="50">21 (24%)</td></tr><tr><td align="left" valign="top" charoff="50"> 1</td><td align="char" valign="top" char="(" charoff="50">44 (47%)</td><td align="char" valign="top" char="(" charoff="50">50 (58%)</td></tr><tr><td align="left" valign="top" charoff="50"> 2</td><td align="char" valign="top" char="(" charoff="50">18 (19%)</td><td align="char" valign="top" char="(" charoff="50">15 (17%)</td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Creatinine clearance at baseline</italic></td></tr><tr><td align="left" valign="top" charoff="50"> ⩾30 ml/min to <40 ml/min</td><td align="char" valign="top" char="(" charoff="50">2 (2%)</td><td align="char" valign="top" char="(" charoff="50">9 (10%)</td></tr><tr><td align="left" valign="top" charoff="50"> ⩾40 ml/min to ⩽60 ml/min</td><td align="char" valign="top" char="(" charoff="50">23 (25%)</td><td align="char" valign="top" char="(" charoff="50">2 (2%)</td></tr><tr><td align="left" valign="top" charoff="50"> >60 ml/min</td><td align="char" valign="top" char="(" charoff="50">64 (69%)</td><td align="char" valign="top" char="(" charoff="50">76 (87%)</td></tr><tr><td align="left" valign="top" charoff="50"> Missing</td><td align="char" valign="top" char="(" charoff="50">4 (4%)</td><td align="char" valign="top" char="(" charoff="50">0 (0%)</td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Primary ISS stage at diagnosis–multiple myeloma</italic></td></tr><tr><td align="left" valign="top" charoff="50"> I</td><td align="char" valign="top" char="(" charoff="50">13 (14%)</td><td align="char" valign="top" char="(" charoff="50">9 (10%)</td></tr><tr><td align="left" valign="top" charoff="50"> II</td><td align="char" valign="top" char="(" charoff="50">23 (25%)</td><td align="char" valign="top" char="(" charoff="50">28 (32%)</td></tr><tr><td align="left" valign="top" charoff="50"> III</td><td align="char" valign="top" char="(" charoff="50">56 (60%)</td><td align="char" valign="top" char="(" charoff="50">49 (56%)</td></tr><tr><td align="left" valign="top" charoff="50">Autologous stem cell transplant (before or on study), <italic>n</italic></td><td align="center" valign="top" char="(" charoff="50">93
23 (25%)</td><td align="center" valign="top" char="(" charoff="50">86
15 (17%)</td></tr><tr><td align="left" valign="top" charoff="50"><italic>Anti-myeloma treatments on study,</italic><xref ref-type="fn" rid="t1-fn2">a</xref> n</td><td align="center" valign="top" char="(" charoff="50">92</td><td align="center" valign="top" char="(" charoff="50">86</td></tr><tr><td align="left" valign="top" charoff="50"> Melphalan</td><td align="char" valign="top" char="(" charoff="50">48 (52%)</td><td align="char" valign="top" char="(" charoff="50">34 (40%)</td></tr><tr><td align="left" valign="top" charoff="50"> Thalidomide</td><td align="char" valign="top" char="(" charoff="50">44 (48%)</td><td align="char" valign="top" char="(" charoff="50">32 (37%)</td></tr><tr><td align="left" valign="top" charoff="50"> Bortezomib</td><td align="char" valign="top" char="(" charoff="50">25 (27%)</td><td align="char" valign="top" char="(" charoff="50">28 (33%)</td></tr><tr><td align="left" valign="top" charoff="50"> Cyclophosphamide</td><td align="char" valign="top" char="(" charoff="50">19 (21%)</td><td align="char" valign="top" char="(" charoff="50">25 (29%)</td></tr><tr><td align="left" valign="top" charoff="50"> Lenalidomide</td><td align="char" valign="top" char="(" charoff="50">19 (21%)</td><td align="char" valign="top" char="(" charoff="50">16 (19%)</td></tr></tbody></table><table-wrap-foot><fn id="t1-fn1"><p>Abbreviations: ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System.</p></fn><fn id="t1-fn2"><label>a</label><p>Further details on combination regimens were not collected.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl2"><label>Table 2</label><caption><title>Patient disposition</title></caption><table frame="hsides" rules="groups" border="1"><colgroup><col align="left"></col><col align="char" char="("></col><col align="char" char="("></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><italic>Characteristic,</italic> n <italic>(%)</italic></th><th align="center" valign="top" char="(" charoff="50"><italic>Zoledronic acid (</italic>n=<italic>93)</italic></th><th align="center" valign="top" char="(" charoff="50"><italic>Denosumab (</italic>n=<italic>87)</italic></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50"><italic>Withdrew before primary data cutoff</italic></td><td align="char" valign="top" char="(" charoff="50">45 (48%)</td><td align="char" valign="top" char="(" charoff="50">48 (55%)</td></tr><tr><td align="left" valign="top" charoff="50"> Death</td><td align="char" valign="top" char="(" charoff="50">8 (9%)</td><td align="char" valign="top" char="(" charoff="50">19 (22%)</td></tr><tr><td align="left" valign="top" charoff="50"> Consent withdrawn</td><td align="char" valign="top" char="(" charoff="50">16 (17%)</td><td align="char" valign="top" char="(" charoff="50">11 (13%)</td></tr><tr><td align="left" valign="top" charoff="50"> Other</td><td align="char" valign="top" char="(" charoff="50">3 (3%)</td><td align="char" valign="top" char="(" charoff="50">6 (7%)</td></tr><tr><td align="left" valign="top" charoff="50"> Disease progression</td><td align="char" valign="top" char="(" charoff="50">1 (1%)</td><td align="char" valign="top" char="(" charoff="50">6 (7%)</td></tr><tr><td align="left" valign="top" charoff="50"> Subject request</td><td align="char" valign="top" char="(" charoff="50">6 (7%)</td><td align="char" valign="top" char="(" charoff="50">3 (3%)</td></tr><tr><td align="left" valign="top" charoff="50"> Adverse event</td><td align="char" valign="top" char="(" charoff="50">7 (8%)</td><td align="char" valign="top" char="(" charoff="50">2 (3%)</td></tr><tr><td align="left" valign="top" charoff="50"> Protocol deviation</td><td align="char" valign="top" char="(" charoff="50">0 (0%)</td><td align="char" valign="top" char="(" charoff="50">1 (1%)</td></tr><tr><td align="left" valign="top" charoff="50"> Noncompliance</td><td align="char" valign="top" char="(" charoff="50">2 (2%)</td><td align="char" valign="top" char="(" charoff="50">0 (0%)</td></tr><tr><td align="left" valign="top" charoff="50"> Ineligibility determined</td><td align="char" valign="top" char="(" charoff="50">1 (1%)</td><td align="char" valign="top" char="(" charoff="50">0 (0%)</td></tr><tr><td align="left" valign="top" charoff="50"> Lost to follow-up</td><td align="char" valign="top" char="(" charoff="50">1 (1%)</td><td align="char" valign="top" char="(" charoff="50">0 (0%)</td></tr></tbody></table></table-wrap></floats-group></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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