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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors</title><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:aff id="aff1">Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX;</nlm:aff></affiliation></author><author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name><affiliation><nlm:aff id="aff1">Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX;</nlm:aff></affiliation></author><author><name sortKey="Kim, Dong Wook" sort="Kim, Dong Wook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name><affiliation><nlm:aff id="aff2">Department of Hematology, Seoul St. Mary’s Hospital, Seoul, South Korea;</nlm:aff></affiliation></author><author><name sortKey="Khoury, H Jean" sort="Khoury, H Jean" uniqKey="Khoury H" first="H. Jean" last="Khoury">H. Jean Khoury</name><affiliation><nlm:aff id="aff3">Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA;</nlm:aff></affiliation></author><author><name sortKey="Brummendorf, Tim H" sort="Brummendorf, Tim H" uniqKey="Brummendorf T" first="Tim H." last="Brümmendorf">Tim H. Brümmendorf</name><affiliation><nlm:aff id="aff4">Hematology, Oncology, and Stem Cell Transplantation, Universitätsklinikum Aachen, Rheinisch-Westfaelische Technische Hochschule Aachen, Aachen, Germany;</nlm:aff></affiliation><affiliation><nlm:aff id="aff5">Hematology, Oncology, and Stem Cell Transplantation, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany;</nlm:aff></affiliation></author><author><name sortKey="Porkka, Kimmo" sort="Porkka, Kimmo" uniqKey="Porkka K" first="Kimmo" last="Porkka">Kimmo Porkka</name><affiliation><nlm:aff id="aff6">Division of Hematology, Helsinki University Central Hospital, Helsinki, Finland;</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="aff7">Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy;</nlm:aff></affiliation></author><author><name sortKey="Durrant, Simon" sort="Durrant, Simon" uniqKey="Durrant S" first="Simon" last="Durrant">Simon Durrant</name><affiliation><nlm:aff id="aff8">Bone Marrow Transplant Unit, Royal Brisbane Hospital, Herston, Australia;</nlm:aff></affiliation></author><author><name sortKey="Leip, Eric" sort="Leip, Eric" uniqKey="Leip E" first="Eric" last="Leip">Eric Leip</name><affiliation><nlm:aff id="aff9">Oncology Clinical Statistics,</nlm:aff></affiliation></author><author><name sortKey="Kelly, Virginia" sort="Kelly, Virginia" uniqKey="Kelly V" first="Virginia" last="Kelly">Virginia Kelly</name><affiliation><nlm:aff wicri:cut=", and" id="aff10">Oncology Clinical Research</nlm:aff></affiliation></author><author><name sortKey="Turnbull, Kathleen" sort="Turnbull, Kathleen" uniqKey="Turnbull K" first="Kathleen" last="Turnbull">Kathleen Turnbull</name><affiliation><nlm:aff id="aff11">Oncology Clinical Development, Pfizer Inc., Cambridge, MA;</nlm:aff></affiliation></author><author><name sortKey="Besson, Nadine" sort="Besson, Nadine" uniqKey="Besson N" first="Nadine" last="Besson">Nadine Besson</name><affiliation><nlm:aff wicri:cut="; and" id="aff12">Pfizer Global Research and Development, Paris, France</nlm:aff></affiliation></author><author><name sortKey="Gambacorti Passerini, Carlo" sort="Gambacorti Passerini, Carlo" uniqKey="Gambacorti Passerini C" first="Carlo" last="Gambacorti-Passerini">Carlo Gambacorti-Passerini</name><affiliation><nlm:aff id="aff13">Clinical Research Unit, University of Milano-Bicocca, Monza, Italy</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24345751</idno><idno type="pmc">4467890</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467890</idno><idno type="RBID">PMC:4467890</idno><idno type="doi">10.1182/blood-2013-07-513937</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000173</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000173</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors</title><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:aff id="aff1">Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX;</nlm:aff></affiliation></author><author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name><affiliation><nlm:aff id="aff1">Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX;</nlm:aff></affiliation></author><author><name sortKey="Kim, Dong Wook" sort="Kim, Dong Wook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name><affiliation><nlm:aff id="aff2">Department of Hematology, Seoul St. Mary’s Hospital, Seoul, South Korea;</nlm:aff></affiliation></author><author><name sortKey="Khoury, H Jean" sort="Khoury, H Jean" uniqKey="Khoury H" first="H. Jean" last="Khoury">H. Jean Khoury</name><affiliation><nlm:aff id="aff3">Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA;</nlm:aff></affiliation></author><author><name sortKey="Brummendorf, Tim H" sort="Brummendorf, Tim H" uniqKey="Brummendorf T" first="Tim H." last="Brümmendorf">Tim H. Brümmendorf</name><affiliation><nlm:aff id="aff4">Hematology, Oncology, and Stem Cell Transplantation, Universitätsklinikum Aachen, Rheinisch-Westfaelische Technische Hochschule Aachen, Aachen, Germany;</nlm:aff></affiliation><affiliation><nlm:aff id="aff5">Hematology, Oncology, and Stem Cell Transplantation, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany;</nlm:aff></affiliation></author><author><name sortKey="Porkka, Kimmo" sort="Porkka, Kimmo" uniqKey="Porkka K" first="Kimmo" last="Porkka">Kimmo Porkka</name><affiliation><nlm:aff id="aff6">Division of Hematology, Helsinki University Central Hospital, Helsinki, Finland;</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="aff7">Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy;</nlm:aff></affiliation></author><author><name sortKey="Durrant, Simon" sort="Durrant, Simon" uniqKey="Durrant S" first="Simon" last="Durrant">Simon Durrant</name><affiliation><nlm:aff id="aff8">Bone Marrow Transplant Unit, Royal Brisbane Hospital, Herston, Australia;</nlm:aff></affiliation></author><author><name sortKey="Leip, Eric" sort="Leip, Eric" uniqKey="Leip E" first="Eric" last="Leip">Eric Leip</name><affiliation><nlm:aff id="aff9">Oncology Clinical Statistics,</nlm:aff></affiliation></author><author><name sortKey="Kelly, Virginia" sort="Kelly, Virginia" uniqKey="Kelly V" first="Virginia" last="Kelly">Virginia Kelly</name><affiliation><nlm:aff wicri:cut=", and" id="aff10">Oncology Clinical Research</nlm:aff></affiliation></author><author><name sortKey="Turnbull, Kathleen" sort="Turnbull, Kathleen" uniqKey="Turnbull K" first="Kathleen" last="Turnbull">Kathleen Turnbull</name><affiliation><nlm:aff id="aff11">Oncology Clinical Development, Pfizer Inc., Cambridge, MA;</nlm:aff></affiliation></author><author><name sortKey="Besson, Nadine" sort="Besson, Nadine" uniqKey="Besson N" first="Nadine" last="Besson">Nadine Besson</name><affiliation><nlm:aff wicri:cut="; and" id="aff12">Pfizer Global Research and Development, Paris, France</nlm:aff></affiliation></author><author><name sortKey="Gambacorti Passerini, Carlo" sort="Gambacorti Passerini, Carlo" uniqKey="Gambacorti Passerini C" first="Carlo" last="Gambacorti-Passerini">Carlo Gambacorti-Passerini</name><affiliation><nlm:aff id="aff13">Clinical Research Unit, University of Milano-Bicocca, Monza, Italy</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="2014">2014</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>Bosutinib had manageable toxicity and acceptable tolerability, with adverse events distinct from that of other tyrosine kinase inhibitors.</p></list-item><list-item><p>Adverse events were primarily characterized by early-onset gastrointestinal events that were low grade, transient, and manageable.</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">24345751</article-id><article-id pub-id-type="pmc">4467890</article-id><article-id pub-id-type="publisher-id">2013/513937</article-id><article-id pub-id-type="doi">10.1182/blood-2013-07-513937</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>29</subject><subject>8</subject><subject>39</subject><subject>33</subject></subj-group><subj-group subj-group-type="heading"><subject>Clinical Trials and Observations</subject></subj-group></article-categories><title-group><article-title>Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Kantarjian</surname><given-names>Hagop M.</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Cortes</surname><given-names>Jorge E.</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Kim</surname><given-names>Dong-Wook</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Khoury</surname><given-names>H. Jean</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Brümmendorf</surname><given-names>Tim H.</given-names></name><xref ref-type="aff" rid="aff4">4</xref><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Porkka</surname><given-names>Kimmo</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Martinelli</surname><given-names>Giovanni</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Durrant</surname><given-names>Simon</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Leip</surname><given-names>Eric</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Kelly</surname><given-names>Virginia</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Turnbull</surname><given-names>Kathleen</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Besson</surname><given-names>Nadine</given-names></name><xref ref-type="aff" rid="aff12">12</xref></contrib><contrib contrib-type="author"><name><surname>Gambacorti-Passerini</surname><given-names>Carlo</given-names></name><xref ref-type="aff" rid="aff13">13</xref></contrib><aff id="aff1"><label>1</label>Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX;</aff><aff id="aff2"><label>2</label>Department of Hematology, Seoul St. Mary’s Hospital, Seoul, South Korea;</aff><aff id="aff3"><label>3</label>Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA;</aff><aff id="aff4"><label>4</label>Hematology, Oncology, and Stem Cell Transplantation, Universitätsklinikum Aachen, Rheinisch-Westfaelische Technische Hochschule Aachen, Aachen, Germany;</aff><aff id="aff5"><label>5</label>Hematology, Oncology, and Stem Cell Transplantation, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany;</aff><aff id="aff6"><label>6</label>Division of Hematology, Helsinki University Central Hospital, Helsinki, Finland;</aff><aff id="aff7"><label>7</label>Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy;</aff><aff id="aff8"><label>8</label>Bone Marrow Transplant Unit, Royal Brisbane Hospital, Herston, Australia;</aff><aff id="aff9"><label>9</label>Oncology Clinical Statistics,</aff><aff id="aff10"><label>10</label>Oncology Clinical Research, and</aff><aff id="aff11"><label>11</label>Oncology Clinical Development, Pfizer Inc., Cambridge, MA;</aff><aff id="aff12"><label>12</label>Pfizer Global Research and Development, Paris, France; and</aff><aff id="aff13"><label>13</label>Clinical Research Unit, University of Milano-Bicocca, Monza, Italy</aff></contrib-group><pub-date pub-type="ppub"><day>27</day><month>2</month><year>2014</year></pub-date><pub-date pub-type="epreprint"><day>17</day><month>12</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>27</day><month>2</month><year>2014</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>123</volume><issue>9</issue><fpage>1309</fpage><lpage>1318</lpage><history><date date-type="received"><day>09</day><month>7</month><year>2013</year></date><date date-type="accepted"><day>04</day><month>12</month><year>2013</year></date></history><permissions><copyright-statement>© 2014 by The American Society of Hematology</copyright-statement><copyright-year>2014</copyright-year></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="1309.pdf"></self-uri><related-article related-article-type="article-reference" id="d35e249" vol="123" page="1284" xlink:href="24578491" ext-link-type="pubmed"></related-article><abstract abstract-type="executive-summary"><title>Key Points</title><p><list list-type="bullet"><list-item><p>Bosutinib had manageable toxicity and acceptable tolerability, with adverse events distinct from that of other tyrosine kinase inhibitors.</p></list-item><list-item><p>Adverse events were primarily characterized by early-onset gastrointestinal events that were low grade, transient, and manageable.</p></list-item></list></p></abstract><abstract><p>Bosutinib is an oral, dual SRC/ABL tyrosine kinase inhibitor (TKI) with clinical activity in Philadelphia chromosome–positive (Ph<sup>+</sup>) leukemia. We assessed the safety and tolerability of bosutinib 500 mg per day in a phase 1/2 study in chronic-phase (CP) chronic myeloid leukemia (CML) or advanced Ph<sup>+</sup> leukemia following resistance/intolerance to imatinib and possibly other TKIs. Patient cohorts included second-line CP CML (n = 286), third-/fourth-line CP CML (n = 118), and advanced leukemia (n = 166). Median bosutinib duration was 11.1 (range, 0.03-83.4) months. Treatment-emergent adverse events (TEAEs) in each cohort were primarily gastrointestinal (diarrhea [86%/83%/74%], nausea [46%/48%/48%], and vomiting [37%/38%/43%]). Diarrhea presented early, with few (8%) patients experiencing grade 3/4 events; dose reduction due to diarrhea occurred in 6% of affected patients. Grade 3/4 myelosuppression TEAEs were reported in 41% of patients; among affected patients, 46% were managed with bosutinib interruption and 32% with dose reduction. Alanine aminotransferase elevation TEAEs occurred in 17% of patients (grade 3/4, 7%); among patients managed with dose interruption, bosutinib rechallenge was successful in 74%. Bosutinib demonstrated acceptable safety with manageable toxicities in Ph<sup>+</sup> leukemia. This trial (NCT00261846) was registered at <ext-link ext-link-type="uri" xlink:href="http://www.ClinicalTrials.gov">www.ClinicalTrials.gov</ext-link> (this manuscript is based on a different data snapshot from that in <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link>).</p></abstract><counts><page-count count="10"></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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