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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Nivolumab improved survival vs dacarbazine in patients with untreated advanced melanoma</title><author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name><affiliation><nlm:aff id="I1">Melanoma Institute Australia, University of Sydney, and Mater Hospital, Sydney, Australia</nlm:aff></affiliation></author><author><name sortKey="Atkinson, Victoria" sort="Atkinson, Victoria" uniqKey="Atkinson V" first="Victoria" last="Atkinson">Victoria Atkinson</name><affiliation><nlm:aff id="I2">Princess Alexandra Hospital, Wooloongabba & Gallipoli Medical Research Foundation, Greenslopes Private Hospital Queensland, Australia</nlm:aff></affiliation></author><author><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name><affiliation><nlm:aff id="I3">Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy</nlm:aff></affiliation></author><author><name sortKey="Brady, Benjamin" sort="Brady, Benjamin" uniqKey="Brady B" first="Benjamin" last="Brady">Benjamin Brady</name><affiliation><nlm:aff id="I4">Cabrini Health, Melbourne, Australia</nlm:aff></affiliation></author><author><name sortKey="Dutriaux, Caroline" sort="Dutriaux, Caroline" uniqKey="Dutriaux C" first="Caroline" last="Dutriaux">Caroline Dutriaux</name><affiliation><nlm:aff id="I5">Hôpital Saint André CHU, Bordeaux, France</nlm:aff></affiliation></author><author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name><affiliation><nlm:aff id="I6">University Hospital of Siena, Siena, Italy</nlm:aff></affiliation></author><author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name><affiliation><nlm:aff id="I7">Hôpital Claude Huriez, Lille, France</nlm:aff></affiliation></author><author><name sortKey="Hassel, Jessica C" sort="Hassel, Jessica C" uniqKey="Hassel J" first="Jessica C" last="Hassel">Jessica C Hassel</name><affiliation><nlm:aff id="I8">University Hospital Heidelberg & National Center for Tumor Diseases, Heidelberg, Germany</nlm:aff></affiliation></author><author><name sortKey="Rutkowski, Piotr" sort="Rutkowski, Piotr" uniqKey="Rutkowski P" first="Piotr" last="Rutkowski">Piotr Rutkowski</name><affiliation><nlm:aff id="I9">Maria Sklodowska-Curie Memorial Cancer Center & Institute of Oncology, Warsaw, Poland</nlm:aff></affiliation></author><author><name sortKey="Mcneil, Catriona" sort="Mcneil, Catriona" uniqKey="Mcneil C" first="Catriona" last="Mcneil">Catriona Mcneil</name><affiliation><nlm:aff id="I10">Chris O'Brien Lifehouse, The Melanoma Institute Australia & Royal Prince Alfred Hospital, Camperdown, Australia</nlm:aff></affiliation></author><author><name sortKey="Kalinka Warzocha, Ewa" sort="Kalinka Warzocha, Ewa" uniqKey="Kalinka Warzocha E" first="Ewa" last="Kalinka-Warzocha">Ewa Kalinka-Warzocha</name><affiliation><nlm:aff id="I11">Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lodz, Poland</nlm:aff></affiliation></author><author><name sortKey="Savage, Kerry J" sort="Savage, Kerry J" uniqKey="Savage K" first="Kerry J" last="Savage">Kerry J Savage</name><affiliation><nlm:aff id="I12">British Columbia Cancer Agency, Vancouver, Canada, Canada</nlm:aff></affiliation></author><author><name sortKey="Hernberg, Micaela" sort="Hernberg, Micaela" uniqKey="Hernberg M" first="Micaela" last="Hernberg">Micaela Hernberg</name><affiliation><nlm:aff id="I13">Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland</nlm:aff></affiliation></author><author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Celeste" last="Lebbé">Celeste Lebbé</name><affiliation><nlm:aff id="I14">APHP Dermatology and CIC Hôpital Saint Louis Paris 7 University, INSERM 976, Paris, France</nlm:aff></affiliation></author><author><name sortKey="Charles, Julie" sort="Charles, Julie" uniqKey="Charles J" first="Julie" last="Charles">Julie Charles</name><affiliation><nlm:aff id="I15">Grenoble University Hospital Grenoble France - INSERM U823, Joseph Fourier University, Grenoble, France</nlm:aff></affiliation></author><author><name sortKey="Mihalcioiu, Catalin" sort="Mihalcioiu, Catalin" uniqKey="Mihalcioiu C" first="Catalin" last="Mihalcioiu">Catalin Mihalcioiu</name><affiliation><nlm:aff id="I16">Royal Victoria Hospital, Alberta, Canada</nlm:aff></affiliation></author><author><name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name><affiliation><nlm:aff id="I17">Oncology Institute of Veneto IRCCS, Padua, Italy</nlm:aff></affiliation></author><author><name sortKey="Mauch, Cornelia" sort="Mauch, Cornelia" uniqKey="Mauch C" first="Cornelia" last="Mauch">Cornelia Mauch</name><affiliation><nlm:aff id="I18">Department of Dermatology, University Hospital Cologne and CIO Köln Bonn, Germany</nlm:aff></affiliation></author><author><name sortKey="Schmidt, Henrik" sort="Schmidt, Henrik" uniqKey="Schmidt H" first="Henrik" last="Schmidt">Henrik Schmidt</name><affiliation><nlm:aff id="I19">Department of Oncology, Aarhus University Hospital, Aarhus, Denmark</nlm:aff></affiliation></author><author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name><affiliation><nlm:aff id="I20">Department of Dermatology, University of Essen, Essen, Germany</nlm:aff></affiliation></author><author><name sortKey="Gogas, Helen" sort="Gogas, Helen" uniqKey="Gogas H" first="Helen" last="Gogas">Helen Gogas</name><affiliation><nlm:aff id="I21">University of Athens Medical School, Laiko General Hospital, Athens, Greece</nlm:aff></affiliation></author><author><name sortKey="Horak, Christine" sort="Horak, Christine" uniqKey="Horak C" first="Christine" last="Horak">Christine Horak</name><affiliation><nlm:aff id="I22">Bristol-Myers Squibb, Lawrenceville, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Sharkey, Brian" sort="Sharkey, Brian" uniqKey="Sharkey B" first="Brian" last="Sharkey">Brian Sharkey</name><affiliation><nlm:aff id="I23">Bristol-Myers Squibb, Wallingford, CT, USA</nlm:aff></affiliation></author><author><name sortKey="Waxman, Ian M" sort="Waxman, Ian M" uniqKey="Waxman I" first="Ian M" last="Waxman">Ian M Waxman</name><affiliation><nlm:aff id="I22">Bristol-Myers Squibb, Lawrenceville, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation><nlm:aff id="I24">Gustave, Roussy and INSERM U981, Villejuif-Paris-Sud, France</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmc">4315270</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4315270</idno><idno type="RBID">PMC:4315270</idno><idno type="doi">10.1186/1479-5876-13-S1-O6</idno><idno type="pmid">NONE</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">001163</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001163</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Nivolumab improved survival vs dacarbazine in patients with untreated advanced melanoma</title><author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name><affiliation><nlm:aff id="I1">Melanoma Institute Australia, University of Sydney, and Mater Hospital, Sydney, Australia</nlm:aff></affiliation></author><author><name sortKey="Atkinson, Victoria" sort="Atkinson, Victoria" uniqKey="Atkinson V" first="Victoria" last="Atkinson">Victoria Atkinson</name><affiliation><nlm:aff id="I2">Princess Alexandra Hospital, Wooloongabba & Gallipoli Medical Research Foundation, Greenslopes Private Hospital Queensland, Australia</nlm:aff></affiliation></author><author><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name><affiliation><nlm:aff id="I3">Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy</nlm:aff></affiliation></author><author><name sortKey="Brady, Benjamin" sort="Brady, Benjamin" uniqKey="Brady B" first="Benjamin" last="Brady">Benjamin Brady</name><affiliation><nlm:aff id="I4">Cabrini Health, Melbourne, Australia</nlm:aff></affiliation></author><author><name sortKey="Dutriaux, Caroline" sort="Dutriaux, Caroline" uniqKey="Dutriaux C" first="Caroline" last="Dutriaux">Caroline Dutriaux</name><affiliation><nlm:aff id="I5">Hôpital Saint André CHU, Bordeaux, France</nlm:aff></affiliation></author><author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name><affiliation><nlm:aff id="I6">University Hospital of Siena, Siena, Italy</nlm:aff></affiliation></author><author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name><affiliation><nlm:aff id="I7">Hôpital Claude Huriez, Lille, France</nlm:aff></affiliation></author><author><name sortKey="Hassel, Jessica C" sort="Hassel, Jessica C" uniqKey="Hassel J" first="Jessica C" last="Hassel">Jessica C Hassel</name><affiliation><nlm:aff id="I8">University Hospital Heidelberg & National Center for Tumor Diseases, Heidelberg, Germany</nlm:aff></affiliation></author><author><name sortKey="Rutkowski, Piotr" sort="Rutkowski, Piotr" uniqKey="Rutkowski P" first="Piotr" last="Rutkowski">Piotr Rutkowski</name><affiliation><nlm:aff id="I9">Maria Sklodowska-Curie Memorial Cancer Center & Institute of Oncology, Warsaw, Poland</nlm:aff></affiliation></author><author><name sortKey="Mcneil, Catriona" sort="Mcneil, Catriona" uniqKey="Mcneil C" first="Catriona" last="Mcneil">Catriona Mcneil</name><affiliation><nlm:aff id="I10">Chris O'Brien Lifehouse, The Melanoma Institute Australia & Royal Prince Alfred Hospital, Camperdown, Australia</nlm:aff></affiliation></author><author><name sortKey="Kalinka Warzocha, Ewa" sort="Kalinka Warzocha, Ewa" uniqKey="Kalinka Warzocha E" first="Ewa" last="Kalinka-Warzocha">Ewa Kalinka-Warzocha</name><affiliation><nlm:aff id="I11">Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lodz, Poland</nlm:aff></affiliation></author><author><name sortKey="Savage, Kerry J" sort="Savage, Kerry J" uniqKey="Savage K" first="Kerry J" last="Savage">Kerry J Savage</name><affiliation><nlm:aff id="I12">British Columbia Cancer Agency, Vancouver, Canada, Canada</nlm:aff></affiliation></author><author><name sortKey="Hernberg, Micaela" sort="Hernberg, Micaela" uniqKey="Hernberg M" first="Micaela" last="Hernberg">Micaela Hernberg</name><affiliation><nlm:aff id="I13">Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland</nlm:aff></affiliation></author><author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Celeste" last="Lebbé">Celeste Lebbé</name><affiliation><nlm:aff id="I14">APHP Dermatology and CIC Hôpital Saint Louis Paris 7 University, INSERM 976, Paris, France</nlm:aff></affiliation></author><author><name sortKey="Charles, Julie" sort="Charles, Julie" uniqKey="Charles J" first="Julie" last="Charles">Julie Charles</name><affiliation><nlm:aff id="I15">Grenoble University Hospital Grenoble France - INSERM U823, Joseph Fourier University, Grenoble, France</nlm:aff></affiliation></author><author><name sortKey="Mihalcioiu, Catalin" sort="Mihalcioiu, Catalin" uniqKey="Mihalcioiu C" first="Catalin" last="Mihalcioiu">Catalin Mihalcioiu</name><affiliation><nlm:aff id="I16">Royal Victoria Hospital, Alberta, Canada</nlm:aff></affiliation></author><author><name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name><affiliation><nlm:aff id="I17">Oncology Institute of Veneto IRCCS, Padua, Italy</nlm:aff></affiliation></author><author><name sortKey="Mauch, Cornelia" sort="Mauch, Cornelia" uniqKey="Mauch C" first="Cornelia" last="Mauch">Cornelia Mauch</name><affiliation><nlm:aff id="I18">Department of Dermatology, University Hospital Cologne and CIO Köln Bonn, Germany</nlm:aff></affiliation></author><author><name sortKey="Schmidt, Henrik" sort="Schmidt, Henrik" uniqKey="Schmidt H" first="Henrik" last="Schmidt">Henrik Schmidt</name><affiliation><nlm:aff id="I19">Department of Oncology, Aarhus University Hospital, Aarhus, Denmark</nlm:aff></affiliation></author><author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name><affiliation><nlm:aff id="I20">Department of Dermatology, University of Essen, Essen, Germany</nlm:aff></affiliation></author><author><name sortKey="Gogas, Helen" sort="Gogas, Helen" uniqKey="Gogas H" first="Helen" last="Gogas">Helen Gogas</name><affiliation><nlm:aff id="I21">University of Athens Medical School, Laiko General Hospital, Athens, Greece</nlm:aff></affiliation></author><author><name sortKey="Horak, Christine" sort="Horak, Christine" uniqKey="Horak C" first="Christine" last="Horak">Christine Horak</name><affiliation><nlm:aff id="I22">Bristol-Myers Squibb, Lawrenceville, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Sharkey, Brian" sort="Sharkey, Brian" uniqKey="Sharkey B" first="Brian" last="Sharkey">Brian Sharkey</name><affiliation><nlm:aff id="I23">Bristol-Myers Squibb, Wallingford, CT, USA</nlm:aff></affiliation></author><author><name sortKey="Waxman, Ian M" sort="Waxman, Ian M" uniqKey="Waxman I" first="Ian M" last="Waxman">Ian M Waxman</name><affiliation><nlm:aff id="I22">Bristol-Myers Squibb, Lawrenceville, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation><nlm:aff id="I24">Gustave, Roussy and INSERM U981, Villejuif-Paris-Sud, France</nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Translational Medicine</title><idno type="eISSN">1479-5876</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader></TEI><pmc article-type="abstract" xml:lang="en"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Transl Med</journal-id><journal-id journal-id-type="iso-abbrev">J Transl Med</journal-id><journal-title-group><journal-title>Journal of Translational Medicine</journal-title></journal-title-group><issn pub-type="epub">1479-5876</issn><publisher><publisher-name>BioMed Central</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmc">4315270</article-id><article-id pub-id-type="publisher-id">1479-5876-13-S1-O6</article-id><article-id pub-id-type="doi">10.1186/1479-5876-13-S1-O6</article-id><article-categories><subj-group subj-group-type="heading"><subject>Oral Presentation</subject></subj-group></article-categories><title-group><article-title>Nivolumab improved survival vs dacarbazine in patients with untreated advanced melanoma</article-title></title-group><contrib-group><contrib contrib-type="author" id="A1"><name><surname>Long</surname><given-names>Georgina V</given-names></name><xref ref-type="aff" rid="I1">1</xref></contrib><contrib contrib-type="author" id="A2"><name><surname>Atkinson</surname><given-names>Victoria</given-names></name><xref ref-type="aff" rid="I2">2</xref></contrib><contrib contrib-type="author" corresp="yes" id="A3"><name><surname>Ascierto</surname><given-names>Paolo A</given-names></name><xref ref-type="aff" rid="I3">3</xref></contrib><contrib contrib-type="author" id="A4"><name><surname>Brady</surname><given-names>Benjamin</given-names></name><xref ref-type="aff" rid="I4">4</xref></contrib><contrib contrib-type="author" id="A5"><name><surname>Dutriaux</surname><given-names>Caroline</given-names></name><xref ref-type="aff" rid="I5">5</xref></contrib><contrib contrib-type="author" id="A6"><name><surname>Maio</surname><given-names>Michele</given-names></name><xref ref-type="aff" rid="I6">6</xref></contrib><contrib contrib-type="author" id="A7"><name><surname>Mortier</surname><given-names>Laurent</given-names></name><xref ref-type="aff" rid="I7">7</xref></contrib><contrib contrib-type="author" id="A8"><name><surname>Hassel</surname><given-names>Jessica C </given-names></name><xref ref-type="aff" rid="I8">8</xref></contrib><contrib contrib-type="author" id="A9"><name><surname>Rutkowski</surname><given-names>Piotr</given-names></name><xref ref-type="aff" rid="I9">9</xref></contrib><contrib contrib-type="author" id="A10"><name><surname>McNeil</surname><given-names>Catriona</given-names></name><xref ref-type="aff" rid="I10">10</xref></contrib><contrib contrib-type="author" id="A11"><name><surname>Kalinka-Warzocha</surname><given-names>Ewa</given-names></name><xref ref-type="aff" rid="I11">11</xref></contrib><contrib contrib-type="author" id="A12"><name><surname>Savage</surname><given-names>Kerry J </given-names></name><xref ref-type="aff" rid="I12">12</xref></contrib><contrib contrib-type="author" id="A13"><name><surname>Hernberg</surname><given-names>Micaela</given-names></name><xref ref-type="aff" rid="I13">13</xref></contrib><contrib contrib-type="author" id="A14"><name><surname>Lebbé</surname><given-names>Celeste</given-names></name><xref ref-type="aff" rid="I14">14</xref></contrib><contrib contrib-type="author" id="A15"><name><surname>Charles</surname><given-names>Julie</given-names></name><xref ref-type="aff" rid="I15">15</xref></contrib><contrib contrib-type="author" id="A16"><name><surname>Mihalcioiu</surname><given-names>Catalin</given-names></name><xref ref-type="aff" rid="I16">16</xref></contrib><contrib contrib-type="author" id="A17"><name><surname>Chiarion-Sileni</surname><given-names>Vanna</given-names></name><xref ref-type="aff" rid="I17">17</xref></contrib><contrib contrib-type="author" id="A18"><name><surname>Mauch</surname><given-names>Cornelia</given-names></name><xref ref-type="aff" rid="I18">18</xref></contrib><contrib contrib-type="author" id="A19"><name><surname>Schmidt</surname><given-names>Henrik</given-names></name><xref ref-type="aff" rid="I19">19</xref></contrib><contrib contrib-type="author" id="A20"><name><surname>Schadendorf</surname><given-names>Dirk</given-names></name><xref ref-type="aff" rid="I20">20</xref></contrib><contrib contrib-type="author" id="A21"><name><surname>Gogas</surname><given-names>Helen</given-names></name><xref ref-type="aff" rid="I21">21</xref></contrib><contrib contrib-type="author" id="A22"><name><surname>Horak</surname><given-names>Christine</given-names></name><xref ref-type="aff" rid="I22">22</xref></contrib><contrib contrib-type="author" id="A23"><name><surname>Sharkey</surname><given-names>Brian</given-names></name><xref ref-type="aff" rid="I23">23</xref></contrib><contrib contrib-type="author" id="A24"><name><surname>Waxman</surname><given-names>Ian M </given-names></name><xref ref-type="aff" rid="I22">22</xref></contrib><contrib contrib-type="author" id="A25"><name><surname>Robert</surname><given-names>Caroline</given-names></name><xref ref-type="aff" rid="I24">24</xref></contrib></contrib-group><aff id="I1"><label>1</label>Melanoma Institute Australia, University of Sydney, and Mater Hospital, Sydney, Australia</aff><aff id="I2"><label>2</label>Princess Alexandra Hospital, Wooloongabba & Gallipoli Medical Research Foundation, Greenslopes Private Hospital Queensland, Australia</aff><aff id="I3"><label>3</label>Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy</aff><aff id="I4"><label>4</label>Cabrini Health, Melbourne, Australia</aff><aff id="I5"><label>5</label>Hôpital Saint André CHU, Bordeaux, France</aff><aff id="I6"><label>6</label>University Hospital of Siena, Siena, Italy</aff><aff id="I7"><label>7</label>Hôpital Claude Huriez, Lille, France</aff><aff id="I8"><label>8</label>University Hospital Heidelberg & National Center for Tumor Diseases, Heidelberg, Germany</aff><aff id="I9"><label>9</label>Maria Sklodowska-Curie Memorial Cancer Center & Institute of Oncology, Warsaw, Poland</aff><aff id="I10"><label>10</label>Chris O'Brien Lifehouse, The Melanoma Institute Australia & Royal Prince Alfred Hospital, Camperdown, Australia</aff><aff id="I11"><label>11</label>Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lodz, Poland</aff><aff id="I12"><label>12</label>British Columbia Cancer Agency, Vancouver, Canada, Canada</aff><aff id="I13"><label>13</label>Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland</aff><aff id="I14"><label>14</label>APHP Dermatology and CIC Hôpital Saint Louis Paris 7 University, INSERM 976, Paris, France</aff><aff id="I15"><label>15</label>Grenoble University Hospital Grenoble France - INSERM U823, Joseph Fourier University, Grenoble, France</aff><aff id="I16"><label>16</label>Royal Victoria Hospital, Alberta, Canada</aff><aff id="I17"><label>17</label>Oncology Institute of Veneto IRCCS, Padua, Italy</aff><aff id="I18"><label>18</label>Department of Dermatology, University Hospital Cologne and CIO Köln Bonn, Germany</aff><aff id="I19"><label>19</label>Department of Oncology, Aarhus University Hospital, Aarhus, Denmark</aff><aff id="I20"><label>20</label>Department of Dermatology, University of Essen, Essen, Germany</aff><aff id="I21"><label>21</label>University of Athens Medical School, Laiko General Hospital, Athens, Greece</aff><aff id="I22"><label>22</label>Bristol-Myers Squibb, Lawrenceville, NJ, USA</aff><aff id="I23"><label>23</label>Bristol-Myers Squibb, Wallingford, CT, USA</aff><aff id="I24"><label>24</label>Gustave, Roussy and INSERM U981, Villejuif-Paris-Sud, France</aff><pub-date pub-type="collection"><year>2015</year></pub-date><pub-date pub-type="epub"><day>15</day><month>1</month><year>2015</year></pub-date><volume>13</volume><issue>Suppl 1</issue><supplement><named-content content-type="supplement-title">Melanoma Bridge 2014: meeting abstracts</named-content><named-content content-type="supplement-editor">Paolo A Ascierto, Gennaro Ciliberto, John M Kirkwood, Francesco M Marincola, Giuseppe Masucci, Ignacio Melero, Nicola Mozzillo, Giuseppe Palmieri and Magdalena Thurin.</named-content><named-content content-type="supplement-sponsor">The publication charges for this supplement were funded by 3P solutions. Abstracts were evaluated by the Supplement Editors. Supplement Editor declarations: John Kirkwood reports grants from Prometheus and personal fees from BMS, Merck, GSK, Celgene, Vica and Ziopharm Oncology. Malero has received Consulting honoraria from Bristol Myers Squibb, Roche Genentech and Astra Zeneca. All other Supplement Editors declare that they have no competing interests.</named-content></supplement><fpage>O6</fpage><lpage>O6</lpage><permissions><copyright-statement>Copyright © 2015 Long et al; licensee BioMed Central Ltd.</copyright-statement><copyright-year>2015</copyright-year><copyright-holder>Long et al; licensee BioMed Central Ltd.</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/4.0"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0">http://creativecommons.org/licenses/by/4.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><self-uri xlink:href="http://www.translational-medicine.com/content/13/S1/O6"></self-uri><conference><conf-date>3-6 December 2014</conf-date><conf-name>Melanoma Bridge Meeting 2014</conf-name><conf-loc>Naples, Italy</conf-loc></conference></article-meta></front><body><sec><title>Background</title><p>The phase 1 study of nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor monoclonal antibody, showed promising antitumor activity in patients with advanced melanoma.</p></sec><sec sec-type="materials|methods"><title>Materials and methods</title><p>This phase 3 study compared nivolumab vs dacarbazine in treatment-naïve patients with BRAF wild-type metastatic melanoma. Patients were randomized 1:1 to receive nivolumab 3 mg/kg every 2 weeks (Q2W) + placebo Q3W (n = 210) or dacarbazine 1000 mg/m2 Q3W + placebo Q2W (n = 208) until disease progression or unacceptable toxicity. Randomization was stratified by M-stage and programmed death ligand-1 (PD-L1) status. The primary endpoint was overall survival (OS). Patients were followed for up to 16.7 months at the time of data cutoff, which occurred 5.2 months after the first visit of the last patient randomized.</p></sec><sec sec-type="results"><title>Results</title><p>The hazard ratio (HR) for death was 0.42 (99.79% CI 0.25–0.73; <italic>P</italic> < 0.0001) in favor of nivolumab, with 1-year OS rate 73% (95% CI, 66%–79%) for nivolumab vs 42% (95% CI, 33%–51%) for dacarbazine. Median OS was not reached for nivolumab and was 10.8 months for dacarbazine. Median progression-free survival (PFS) was 5.1 months for nivolumab and 2.2 months for dacarbazine (HR for death or progression 0.43, 95% CI 0.34–0.56; <italic>P</italic> < 0.0001). Objective response rate was 40% (84/210) vs 14% (29/208) for nivolumab and dacarbazine, respectively (<italic>P</italic> < 0.0001). Median duration of response was not reached for nivolumab and 6 months for dacarbazine. At the time of data cutoff, responses were ongoing in 86% (72/84) of nivolumab and 52% (15/29) of dacarbazine responders. PD-L1 positivity (using a 5% tumor cell surface staining cutoff) appeared to be associated with improved OS in the nivolumab arm (85% of PD-L1+ and 71% of PD-L1-/indeterminate patients alive at the time of last follow-up). Both PD-L1+ and PD-L1-/indeterminate patients receiving nivolumab had improved OS vs dacarbazine (un-stratified HR 0.30, 95% CI, 0.15–0.60 in PD-L1+ patients; 0.48, 95% CI, 0.32–0.71 in PD-L1-/indeterminate patient, both in favor of the nivolumab arm). The most common nivolumab-related adverse events (AEs) were fatigue, pruritus, and nausea. Drug-related grade 3–4 AEs were reported in 12% vs 18% of patients receiving nivolumab vs dacarbazine, respectively. AEs led to discontinuation in 7% and 12% of dacarbazine- vs nivolumab-treatment patients, respectively.</p></sec><sec sec-type="conclusions"><title>Conclusions</title><p>Compared to dacarbazine, nivolumab significantly improved OS and PFS in previously untreated patients with BRAF wild-type metastatic melanoma with an acceptable safety profile.</p></sec><sec><title>Clinical trial registration number</title><p>NCT01721772</p></sec></body></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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