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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts</title><author><name sortKey="Dombret, Herve" sort="Dombret, Herve" uniqKey="Dombret H" first="Hervé" last="Dombret">Hervé Dombret</name><affiliation><nlm:aff id="aff1">Hôpital Saint Louis, Institut Universitaire d’Hématologie, University Paris Diderot, Paris, France;</nlm:aff></affiliation></author><author><name sortKey="Seymour, John F" sort="Seymour, John F" uniqKey="Seymour J" first="John F." last="Seymour">John F. Seymour</name><affiliation><nlm:aff id="aff2">Peter MacCallum Cancer Centre, East Melbourne, Australia, and University of Melbourne, Parkville, Australia;</nlm:aff></affiliation></author><author><name sortKey="Butrym, Aleksandra" sort="Butrym, Aleksandra" uniqKey="Butrym A" first="Aleksandra" last="Butrym">Aleksandra Butrym</name><affiliation><nlm:aff id="aff3">Wroclaw Medical University, Wroclaw, Poland;</nlm:aff></affiliation></author><author><name sortKey="Wierzbowska, Agnieszka" sort="Wierzbowska, Agnieszka" uniqKey="Wierzbowska A" first="Agnieszka" last="Wierzbowska">Agnieszka Wierzbowska</name><affiliation><nlm:aff id="aff4">Medical University of Lodz, Lodz, Poland;</nlm:aff></affiliation></author><author><name sortKey="Selleslag, Dominik" sort="Selleslag, Dominik" uniqKey="Selleslag D" first="Dominik" last="Selleslag">Dominik Selleslag</name><affiliation><nlm:aff id="aff5">Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium;</nlm:aff></affiliation></author><author><name sortKey="Jang, Jun Ho" sort="Jang, Jun Ho" uniqKey="Jang J" first="Jun Ho" last="Jang">Jun Ho Jang</name><affiliation><nlm:aff id="aff6">Samsung Medical Center, Seoul, Republic of Korea;</nlm:aff></affiliation></author><author><name sortKey="Kumar, Rajat" sort="Kumar, Rajat" uniqKey="Kumar R" first="Rajat" last="Kumar">Rajat Kumar</name><affiliation><nlm:aff id="aff7">Cancer Care Manitoba, Winnipeg, Canada;</nlm:aff></affiliation></author><author><name sortKey="Cavenagh, James" sort="Cavenagh, James" uniqKey="Cavenagh J" first="James" last="Cavenagh">James Cavenagh</name><affiliation><nlm:aff id="aff8">Barts Health National Health Service Trust, London, United Kingdom;</nlm:aff></affiliation></author><author><name sortKey="Schuh, Andre C" sort="Schuh, Andre C" uniqKey="Schuh A" first="Andre C." last="Schuh">Andre C. Schuh</name><affiliation><nlm:aff id="aff9">Princess Margaret Cancer Centre, Toronto, Canada;</nlm:aff></affiliation></author><author><name sortKey="Candoni, Anna" sort="Candoni, Anna" uniqKey="Candoni A" first="Anna" last="Candoni">Anna Candoni</name><affiliation><nlm:aff id="aff10">Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, Italy;</nlm:aff></affiliation></author><author><name sortKey="Recher, Christian" sort="Recher, Christian" uniqKey="Recher C" first="Christian" last="Récher">Christian Récher</name><affiliation><nlm:aff id="aff11">Centre Hospitalier Universitaire de Toulouse, Toulouse, France;</nlm:aff></affiliation></author><author><name sortKey="Sandhu, Irwindeep" sort="Sandhu, Irwindeep" uniqKey="Sandhu I" first="Irwindeep" last="Sandhu">Irwindeep Sandhu</name><affiliation><nlm:aff id="aff12">University of Alberta Hospital, Edmonton, Canada;</nlm:aff></affiliation></author><author><name sortKey="Bernal Del Castillo, Teresa" sort="Bernal Del Castillo, Teresa" uniqKey="Bernal Del Castillo T" first="Teresa" last="Bernal Del Castillo">Teresa Bernal Del Castillo</name><affiliation><nlm:aff id="aff13">Hospital Central de Asturias, Oviedo, Spain;</nlm:aff></affiliation></author><author><name sortKey="Al Ali, Haifa Kathrin" sort="Al Ali, Haifa Kathrin" uniqKey="Al Ali H" first="Haifa Kathrin" last="Al-Ali">Haifa Kathrin Al-Ali</name><affiliation><nlm:aff id="aff14">Universitätsklinikum Leipzig, Leipzig, Germany;</nlm:aff></affiliation></author><author><name sortKey="Martinelli, Giovanni" sort="Martinelli, Giovanni" uniqKey="Martinelli G" first="Giovanni" last="Martinelli">Giovanni Martinelli</name><affiliation><nlm:aff id="aff15">Institute of Hematology and Medical Oncology “L. e A. Seràgnoli,” Bologna, Italy;</nlm:aff></affiliation></author><author><name sortKey="Falantes, Jose" sort="Falantes, Jose" uniqKey="Falantes J" first="Jose" last="Falantes">Jose Falantes</name><affiliation><nlm:aff id="aff16">Hospital Universitario Virgen del Rocio/Instituto de BioMedicinia de Sevilla, Sevilla, Spain;</nlm:aff></affiliation></author><author><name sortKey="Noppeney, Richard" sort="Noppeney, Richard" uniqKey="Noppeney R" first="Richard" last="Noppeney">Richard Noppeney</name><affiliation><nlm:aff id="aff17">Universitätsklinikum Essen Klinik für Hämatologie, Essen, Germany;</nlm:aff></affiliation></author><author><name sortKey="Stone, Richard M" sort="Stone, Richard M" uniqKey="Stone R" first="Richard M." last="Stone">Richard M. Stone</name><affiliation><nlm:aff id="aff18">Dana-Farber Cancer Institute, Boston, MA;</nlm:aff></affiliation></author><author><name sortKey="Minden, Mark D" sort="Minden, Mark D" uniqKey="Minden M" first="Mark D." last="Minden">Mark D. Minden</name><affiliation><nlm:aff id="aff9">Princess Margaret Cancer Centre, Toronto, Canada;</nlm:aff></affiliation></author><author><name sortKey="Mcintyre, Heidi" sort="Mcintyre, Heidi" uniqKey="Mcintyre H" first="Heidi" last="Mcintyre">Heidi Mcintyre</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Songer, Steve" sort="Songer, Steve" uniqKey="Songer S" first="Steve" last="Songer">Steve Songer</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Lucy, Lela M" sort="Lucy, Lela M" uniqKey="Lucy L" first="Lela M." last="Lucy">Lela M. Lucy</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Beach, C L" sort="Beach, C L" uniqKey="Beach C" first="C. L." last="Beach">C. L. Beach</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Dohner, Hartmut" sort="Dohner, Hartmut" uniqKey="Dohner H" first="Hartmut" last="Döhner">Hartmut Döhner</name><affiliation><nlm:aff id="aff20">Universitätsklinikum Ulm, Ulm, Germany</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25987659</idno><idno type="pmc">4504945</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504945</idno><idno type="RBID">PMC:4504945</idno><idno type="doi">10.1182/blood-2015-01-621664</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000174</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000174</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts</title><author><name sortKey="Dombret, Herve" sort="Dombret, Herve" uniqKey="Dombret H" first="Hervé" last="Dombret">Hervé Dombret</name><affiliation><nlm:aff id="aff1">Hôpital Saint Louis, Institut Universitaire d’Hématologie, University Paris Diderot, Paris, France;</nlm:aff></affiliation></author><author><name sortKey="Seymour, John F" sort="Seymour, John F" uniqKey="Seymour J" first="John F." last="Seymour">John F. Seymour</name><affiliation><nlm:aff id="aff2">Peter MacCallum Cancer Centre, East Melbourne, Australia, and University of Melbourne, Parkville, Australia;</nlm:aff></affiliation></author><author><name sortKey="Butrym, Aleksandra" sort="Butrym, Aleksandra" uniqKey="Butrym A" first="Aleksandra" last="Butrym">Aleksandra Butrym</name><affiliation><nlm:aff id="aff3">Wroclaw Medical University, Wroclaw, Poland;</nlm:aff></affiliation></author><author><name sortKey="Wierzbowska, Agnieszka" sort="Wierzbowska, Agnieszka" uniqKey="Wierzbowska A" first="Agnieszka" last="Wierzbowska">Agnieszka Wierzbowska</name><affiliation><nlm:aff id="aff4">Medical University of Lodz, Lodz, Poland;</nlm:aff></affiliation></author><author><name sortKey="Selleslag, Dominik" sort="Selleslag, Dominik" uniqKey="Selleslag D" first="Dominik" last="Selleslag">Dominik Selleslag</name><affiliation><nlm:aff id="aff5">Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium;</nlm:aff></affiliation></author><author><name sortKey="Jang, Jun Ho" sort="Jang, Jun Ho" uniqKey="Jang J" first="Jun Ho" last="Jang">Jun Ho Jang</name><affiliation><nlm:aff id="aff6">Samsung Medical Center, Seoul, Republic of Korea;</nlm:aff></affiliation></author><author><name sortKey="Kumar, Rajat" sort="Kumar, Rajat" uniqKey="Kumar R" first="Rajat" last="Kumar">Rajat Kumar</name><affiliation><nlm:aff id="aff7">Cancer Care Manitoba, Winnipeg, Canada;</nlm:aff></affiliation></author><author><name sortKey="Cavenagh, James" sort="Cavenagh, James" uniqKey="Cavenagh J" first="James" last="Cavenagh">James Cavenagh</name><affiliation><nlm:aff id="aff8">Barts Health National Health Service Trust, London, United Kingdom;</nlm:aff></affiliation></author><author><name sortKey="Schuh, Andre C" sort="Schuh, Andre C" uniqKey="Schuh A" first="Andre C." last="Schuh">Andre C. Schuh</name><affiliation><nlm:aff id="aff9">Princess Margaret Cancer Centre, Toronto, Canada;</nlm:aff></affiliation></author><author><name sortKey="Candoni, Anna" sort="Candoni, Anna" uniqKey="Candoni A" first="Anna" last="Candoni">Anna Candoni</name><affiliation><nlm:aff id="aff10">Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, Italy;</nlm:aff></affiliation></author><author><name sortKey="Recher, Christian" sort="Recher, Christian" uniqKey="Recher C" first="Christian" last="Récher">Christian Récher</name><affiliation><nlm:aff id="aff11">Centre Hospitalier Universitaire de Toulouse, Toulouse, France;</nlm:aff></affiliation></author><author><name sortKey="Sandhu, Irwindeep" sort="Sandhu, Irwindeep" uniqKey="Sandhu I" first="Irwindeep" last="Sandhu">Irwindeep Sandhu</name><affiliation><nlm:aff id="aff12">University of Alberta Hospital, Edmonton, Canada;</nlm:aff></affiliation></author><author><name sortKey="Bernal Del Castillo, Teresa" sort="Bernal Del Castillo, Teresa" uniqKey="Bernal Del Castillo T" first="Teresa" last="Bernal Del Castillo">Teresa Bernal Del Castillo</name><affiliation><nlm:aff id="aff13">Hospital Central de Asturias, Oviedo, Spain;</nlm:aff></affiliation></author><author><name sortKey="Al Ali, Haifa Kathrin" sort="Al Ali, Haifa Kathrin" uniqKey="Al Ali H" first="Haifa Kathrin" last="Al-Ali">Haifa Kathrin Al-Ali</name><affiliation><nlm:aff id="aff14">Universitätsklinikum Leipzig, Leipzig, Germany;</nlm:aff></affiliation></author><author><name sortKey="Martinelli, Giovanni" sort="Martinelli, Giovanni" uniqKey="Martinelli G" first="Giovanni" last="Martinelli">Giovanni Martinelli</name><affiliation><nlm:aff id="aff15">Institute of Hematology and Medical Oncology “L. e A. Seràgnoli,” Bologna, Italy;</nlm:aff></affiliation></author><author><name sortKey="Falantes, Jose" sort="Falantes, Jose" uniqKey="Falantes J" first="Jose" last="Falantes">Jose Falantes</name><affiliation><nlm:aff id="aff16">Hospital Universitario Virgen del Rocio/Instituto de BioMedicinia de Sevilla, Sevilla, Spain;</nlm:aff></affiliation></author><author><name sortKey="Noppeney, Richard" sort="Noppeney, Richard" uniqKey="Noppeney R" first="Richard" last="Noppeney">Richard Noppeney</name><affiliation><nlm:aff id="aff17">Universitätsklinikum Essen Klinik für Hämatologie, Essen, Germany;</nlm:aff></affiliation></author><author><name sortKey="Stone, Richard M" sort="Stone, Richard M" uniqKey="Stone R" first="Richard M." last="Stone">Richard M. Stone</name><affiliation><nlm:aff id="aff18">Dana-Farber Cancer Institute, Boston, MA;</nlm:aff></affiliation></author><author><name sortKey="Minden, Mark D" sort="Minden, Mark D" uniqKey="Minden M" first="Mark D." last="Minden">Mark D. Minden</name><affiliation><nlm:aff id="aff9">Princess Margaret Cancer Centre, Toronto, Canada;</nlm:aff></affiliation></author><author><name sortKey="Mcintyre, Heidi" sort="Mcintyre, Heidi" uniqKey="Mcintyre H" first="Heidi" last="Mcintyre">Heidi Mcintyre</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Songer, Steve" sort="Songer, Steve" uniqKey="Songer S" first="Steve" last="Songer">Steve Songer</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Lucy, Lela M" sort="Lucy, Lela M" uniqKey="Lucy L" first="Lela M." last="Lucy">Lela M. Lucy</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Beach, C L" sort="Beach, C L" uniqKey="Beach C" first="C. L." last="Beach">C. L. Beach</name><affiliation><nlm:aff wicri:cut="; and" id="aff19">Celgene Corporation, Summit, NJ</nlm:aff></affiliation></author><author><name sortKey="Dohner, Hartmut" sort="Dohner, Hartmut" uniqKey="Dohner H" first="Hartmut" last="Döhner">Hartmut Döhner</name><affiliation><nlm:aff id="aff20">Universitätsklinikum Ulm, Ulm, Germany</nlm:aff></affiliation></author></analytic><series><title level="j">Blood</title><idno type="ISSN">0006-4971</idno><idno type="eISSN">1528-0020</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Key Points</title><p><list list-type="bullet"><list-item><p>Azacitidine increased median overall survival by 3.8 months vs current commonly used AML treatments (10.4 vs 6.5 months; <italic>P</italic> = .1009).</p></list-item><list-item><p>Azacitidine safety in patients age ≥65 years with AML (>30% blasts) was consistent with its known safety profile in other trials.</p></list-item></list></p></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Blood</journal-id><journal-id journal-id-type="iso-abbrev">Blood</journal-id><journal-id journal-id-type="hwp">bloodjournal</journal-id><journal-id journal-id-type="pmc">blood</journal-id><journal-id journal-id-type="publisher-id">Blood</journal-id><journal-title-group><journal-title>Blood</journal-title></journal-title-group><issn pub-type="ppub">0006-4971</issn><issn pub-type="epub">1528-0020</issn><publisher><publisher-name>American Society of Hematology</publisher-name><publisher-loc>Washington, DC</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25987659</article-id><article-id pub-id-type="pmc">4504945</article-id><article-id pub-id-type="publisher-id">2015/621664</article-id><article-id pub-id-type="doi">10.1182/blood-2015-01-621664</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>2</subject><subject>29</subject><subject>8</subject><subject>33</subject></subj-group><subj-group subj-group-type="heading"><subject>Plenary Paper</subject></subj-group><series-title>Clinical Trials and Observations</series-title></article-categories><title-group><article-title>International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Dombret</surname><given-names>Hervé</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Seymour</surname><given-names>John F.</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Butrym</surname><given-names>Aleksandra</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Wierzbowska</surname><given-names>Agnieszka</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Selleslag</surname><given-names>Dominik</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Jang</surname><given-names>Jun Ho</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Kumar</surname><given-names>Rajat</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Cavenagh</surname><given-names>James</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Schuh</surname><given-names>Andre C.</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Candoni</surname><given-names>Anna</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Récher</surname><given-names>Christian</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Sandhu</surname><given-names>Irwindeep</given-names></name><xref ref-type="aff" rid="aff12">12</xref></contrib><contrib contrib-type="author"><name><surname>Bernal del Castillo</surname><given-names>Teresa</given-names></name><xref ref-type="aff" rid="aff13">13</xref></contrib><contrib contrib-type="author"><name><surname>Al-Ali</surname><given-names>Haifa Kathrin</given-names></name><xref ref-type="aff" rid="aff14">14</xref></contrib><contrib contrib-type="author"><name><surname>Martinelli</surname><given-names>Giovanni</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name><surname>Falantes</surname><given-names>Jose</given-names></name><xref ref-type="aff" rid="aff16">16</xref></contrib><contrib contrib-type="author"><name><surname>Noppeney</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="aff17">17</xref></contrib><contrib contrib-type="author"><name><surname>Stone</surname><given-names>Richard M.</given-names></name><xref ref-type="aff" rid="aff18">18</xref></contrib><contrib contrib-type="author"><name><surname>Minden</surname><given-names>Mark D.</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>McIntyre</surname><given-names>Heidi</given-names></name><xref ref-type="aff" rid="aff19">19</xref></contrib><contrib contrib-type="author"><name><surname>Songer</surname><given-names>Steve</given-names></name><xref ref-type="aff" rid="aff19">19</xref></contrib><contrib contrib-type="author"><name><surname>Lucy</surname><given-names>Lela M.</given-names></name><xref ref-type="aff" rid="aff19">19</xref></contrib><contrib contrib-type="author"><name><surname>Beach</surname><given-names>C. L.</given-names></name><xref ref-type="aff" rid="aff19">19</xref></contrib><contrib contrib-type="author"><name><surname>Döhner</surname><given-names>Hartmut</given-names></name><xref ref-type="aff" rid="aff20">20</xref></contrib><aff id="aff1"><label>1</label>Hôpital Saint Louis, Institut Universitaire d’Hématologie, University Paris Diderot, Paris, France;</aff><aff id="aff2"><label>2</label>Peter MacCallum Cancer Centre, East Melbourne, Australia, and University of Melbourne, Parkville, Australia;</aff><aff id="aff3"><label>3</label>Wroclaw Medical University, Wroclaw, Poland;</aff><aff id="aff4"><label>4</label>Medical University of Lodz, Lodz, Poland;</aff><aff id="aff5"><label>5</label>Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium;</aff><aff id="aff6"><label>6</label>Samsung Medical Center, Seoul, Republic of Korea;</aff><aff id="aff7"><label>7</label>Cancer Care Manitoba, Winnipeg, Canada;</aff><aff id="aff8"><label>8</label>Barts Health National Health Service Trust, London, United Kingdom;</aff><aff id="aff9"><label>9</label>Princess Margaret Cancer Centre, Toronto, Canada;</aff><aff id="aff10"><label>10</label>Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, Italy;</aff><aff id="aff11"><label>11</label>Centre Hospitalier Universitaire de Toulouse, Toulouse, France;</aff><aff id="aff12"><label>12</label>University of Alberta Hospital, Edmonton, Canada;</aff><aff id="aff13"><label>13</label>Hospital Central de Asturias, Oviedo, Spain;</aff><aff id="aff14"><label>14</label>Universitätsklinikum Leipzig, Leipzig, Germany;</aff><aff id="aff15"><label>15</label>Institute of Hematology and Medical Oncology “L. e A. Seràgnoli,” Bologna, Italy;</aff><aff id="aff16"><label>16</label>Hospital Universitario Virgen del Rocio/Instituto de BioMedicinia de Sevilla, Sevilla, Spain;</aff><aff id="aff17"><label>17</label>Universitätsklinikum Essen Klinik für Hämatologie, Essen, Germany;</aff><aff id="aff18"><label>18</label>Dana-Farber Cancer Institute, Boston, MA;</aff><aff id="aff19"><label>19</label>Celgene Corporation, Summit, NJ; and</aff><aff id="aff20"><label>20</label>Universitätsklinikum Ulm, Ulm, Germany</aff></contrib-group><pub-date pub-type="ppub"><day>16</day><month>7</month><year>2015</year></pub-date><pub-date pub-type="epreprint"><day>18</day><month>5</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>16</day><month>7</month><year>2015</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>126</volume><issue>3</issue><fpage>291</fpage><lpage>299</lpage><history><date date-type="received"><day>13</day><month>1</month><year>2015</year></date><date date-type="accepted"><day>07</day><month>5</month><year>2015</year></date></history><permissions><copyright-statement>© 2015 by The American Society of Hematology</copyright-statement><copyright-year>2015</copyright-year></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="291.pdf"></self-uri><related-article id="d35e366" related-article-type="article-reference" ext-link-type="doi" xlink:href="10.1182/blood-2015-06-648071">Huls</related-article><abstract abstract-type="executive-summary"><title>Key Points</title><p><list list-type="bullet"><list-item><p>Azacitidine increased median overall survival by 3.8 months vs current commonly used AML treatments (10.4 vs 6.5 months; <italic>P</italic> = .1009).</p></list-item><list-item><p>Azacitidine safety in patients age ≥65 years with AML (>30% blasts) was consistent with its known safety profile in other trials.</p></list-item></list></p></abstract><abstract><p>This multicenter, randomized, open-label, phase 3 trial evaluated azacitidine efficacy and safety vs conventional care regimens (CCRs) in 488 patients age ≥65 years with newly diagnosed acute myeloid leukemia (AML) with >30% bone marrow blasts. Before randomization, a CCR (standard induction chemotherapy, low-dose ara-c, or supportive care only) was preselected for each patient. Patients then were assigned 1:1 to azacitidine (n = 241) or CCR (n = 247). Patients assigned to CCR received their preselected treatment. Median overall survival (OS) was increased with azacitidine vs CCR: 10.4 months (95% confidence interval [CI], 8.0-12.7 months) vs 6.5 months (95% CI, 5.0-8.6 months), respectively (hazard ratio [HR] was 0.85; 95% CI, 0.69-1.03; stratified log-rank <italic>P</italic> = .1009). One-year survival rates with azacitidine and CCR were 46.5% and 34.2%, respectively (difference, 12.3%; 95% CI, 3.5%-21.0%). A prespecified analysis censoring patients who received AML treatment after discontinuing study drug showed median OS with azacitidine vs CCR was 12.1 months (95% CI, 9.2-14.2 months) vs 6.9 months (95% CI, 5.1-9.6 months; HR, 0.76; 95% CI, 0.60-0.96; stratified log-rank <italic>P</italic> = .0190). Univariate analysis showed favorable trends for azacitidine compared with CCR across all subgroups defined by baseline demographic and disease features. Adverse events were consistent with the well-established safety profile of azacitidine. Azacitidine may be an important treatment option for this difficult-to-treat AML population. This trial was registered at <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link> as #NCT01074047.</p></abstract><counts><page-count count="9"></page-count></counts><custom-meta-group><custom-meta><meta-name>access</meta-name><meta-value>free</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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