Overall survival with ponatinib versus allogeneic stem cell transplantation in Philadelphia chromosome‐positive leukemias with the T315I mutation
Identifieur interne : 002214 ( Pmc/Curation ); précédent : 002213; suivant : 002215Overall survival with ponatinib versus allogeneic stem cell transplantation in Philadelphia chromosome‐positive leukemias with the T315I mutation
Auteurs : Franck E. Nicolini ; Grzegorz W. Basak ; Dong-Wook Kim ; Eduardo Olavarria ; Javier Pinilla-Ibarz ; Jane F. Apperley ; Timothy Hughes ; Dietger Niederwieser ; Michael J. Mauro ; Charles Chuah ; Andreas Hochhaus ; Giovanni Martinelli ; Maral Dersarkissian ; Mei Sheng Duh ; Lisa J. Mcgarry ; Hagop M. Kantarjian ; Jorge E. CortesSource :
- Cancer [ 0008-543X ] ; 2017.
Abstract
Effective treatment options for patients with chronic myeloid leukemia (CML) or Philadelphia‐positive (Ph+) acute lymphoblastic leukemia (ALL) who have the threonine to isoleucine mutation at codon 315 (T315I) are few. The objective of this study was to compare overall survival (OS) between patients with CML and those with Ph+ ALL who received treatment with ponatinib versus allogeneic stem cell transplantation (allo‐SCT).
A post hoc, retrospective, indirect comparison of OS among patients who received single‐agent ponatinib in the Ponatinib Ph+ ALL and CML Evaluation (PACE) trial with those who underwent allo‐SCT as reported to the European Bone Marrow Transplant registry, stratified by CML disease phase and Ph+ ALL, was conducted. Kaplan‐Meier survival curves and multivariate Cox proportional‐hazards models were used to compare OS between intervention groups, adjusting for time from diagnosis to intervention, age, sex, and geographic region; 24‐month and 48‐month OS rates and median OS were reported.
After adjustment for potential confounders, 24‐month and 48‐month OS rates were significantly higher in patients with chronic‐phase CML (CP‐CML) who received ponatinib compared with those who underwent allo‐SCT (24 months: 84% vs 60.5%, respectively;
Although allo‐SCT remains an important treatment option for patients with T315I‐positive advanced CML and Ph+ ALL, ponatinib represents a valuable alternative for patients with T315I‐positive CP‐CML.
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DOI: 10.1002/cncr.30558
PubMed: 28387926
PubMed Central: 5573914
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Overall survival with ponatinib versus allogeneic stem cell transplantation in Philadelphia chromosome‐positive leukemias with the T315I mutation</title><author><name sortKey="Nicolini, Franck E" sort="Nicolini, Franck E" uniqKey="Nicolini F" first="Franck E." last="Nicolini">Franck E. Nicolini</name><affiliation><nlm:aff id="cncr30558-aff-0001"></nlm:aff></affiliation></author><author><name sortKey="Basak, Grzegorz W" sort="Basak, Grzegorz W" uniqKey="Basak G" first="Grzegorz W." last="Basak">Grzegorz W. Basak</name><affiliation><nlm:aff id="cncr30558-aff-0002"></nlm:aff></affiliation></author><author><name sortKey="Kim, Dong Ook" sort="Kim, Dong Ook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name><affiliation><nlm:aff id="cncr30558-aff-0003"></nlm:aff></affiliation></author><author><name sortKey="Olavarria, Eduardo" sort="Olavarria, Eduardo" uniqKey="Olavarria E" first="Eduardo" last="Olavarria">Eduardo Olavarria</name><affiliation><nlm:aff id="cncr30558-aff-0004"></nlm:aff></affiliation></author><author><name sortKey="Pinilla Barz, Javier" sort="Pinilla Barz, Javier" uniqKey="Pinilla Barz J" first="Javier" last="Pinilla-Ibarz">Javier Pinilla-Ibarz</name><affiliation><nlm:aff id="cncr30558-aff-0005"></nlm:aff></affiliation></author><author><name sortKey="Apperley, Jane F" sort="Apperley, Jane F" uniqKey="Apperley J" first="Jane F." last="Apperley">Jane F. Apperley</name><affiliation><nlm:aff id="cncr30558-aff-0004"></nlm:aff></affiliation></author><author><name sortKey="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation><nlm:aff id="cncr30558-aff-0006"></nlm:aff></affiliation></author><author><name sortKey="Niederwieser, Dietger" sort="Niederwieser, Dietger" uniqKey="Niederwieser D" first="Dietger" last="Niederwieser">Dietger Niederwieser</name><affiliation><nlm:aff id="cncr30558-aff-0007"></nlm:aff></affiliation></author><author><name sortKey="Mauro, Michael J" sort="Mauro, Michael J" uniqKey="Mauro M" first="Michael J." last="Mauro">Michael J. 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Mcgarry</name><affiliation><nlm:aff id="cncr30558-aff-0013"></nlm:aff></affiliation></author><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="cncr30558-aff-0014"></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="cncr30558-aff-0014"></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">28387926</idno><idno type="pmc">5573914</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5573914</idno><idno type="RBID">PMC:5573914</idno><idno type="doi">10.1002/cncr.30558</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">002364</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002364</idno><idno type="wicri:Area/Pmc/Curation">002214</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002214</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Overall survival with ponatinib versus allogeneic stem cell transplantation in Philadelphia chromosome‐positive leukemias with the T315I mutation</title><author><name sortKey="Nicolini, Franck E" sort="Nicolini, Franck E" uniqKey="Nicolini F" first="Franck E." last="Nicolini">Franck E. Nicolini</name><affiliation><nlm:aff id="cncr30558-aff-0001"></nlm:aff></affiliation></author><author><name sortKey="Basak, Grzegorz W" sort="Basak, Grzegorz W" uniqKey="Basak G" first="Grzegorz W." last="Basak">Grzegorz W. Basak</name><affiliation><nlm:aff id="cncr30558-aff-0002"></nlm:aff></affiliation></author><author><name sortKey="Kim, Dong Ook" sort="Kim, Dong Ook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name><affiliation><nlm:aff id="cncr30558-aff-0003"></nlm:aff></affiliation></author><author><name sortKey="Olavarria, Eduardo" sort="Olavarria, Eduardo" uniqKey="Olavarria E" first="Eduardo" last="Olavarria">Eduardo Olavarria</name><affiliation><nlm:aff id="cncr30558-aff-0004"></nlm:aff></affiliation></author><author><name sortKey="Pinilla Barz, Javier" sort="Pinilla Barz, Javier" uniqKey="Pinilla Barz J" first="Javier" last="Pinilla-Ibarz">Javier Pinilla-Ibarz</name><affiliation><nlm:aff id="cncr30558-aff-0005"></nlm:aff></affiliation></author><author><name sortKey="Apperley, Jane F" sort="Apperley, Jane F" uniqKey="Apperley J" first="Jane F." last="Apperley">Jane F. Apperley</name><affiliation><nlm:aff id="cncr30558-aff-0004"></nlm:aff></affiliation></author><author><name sortKey="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation><nlm:aff id="cncr30558-aff-0006"></nlm:aff></affiliation></author><author><name sortKey="Niederwieser, Dietger" sort="Niederwieser, Dietger" uniqKey="Niederwieser D" first="Dietger" last="Niederwieser">Dietger Niederwieser</name><affiliation><nlm:aff id="cncr30558-aff-0007"></nlm:aff></affiliation></author><author><name sortKey="Mauro, Michael J" sort="Mauro, Michael J" uniqKey="Mauro M" first="Michael J." last="Mauro">Michael J. Mauro</name><affiliation><nlm:aff id="cncr30558-aff-0008"></nlm:aff></affiliation></author><author><name sortKey="Chuah, Charles" sort="Chuah, Charles" uniqKey="Chuah C" first="Charles" last="Chuah">Charles Chuah</name><affiliation><nlm:aff id="cncr30558-aff-0009"></nlm:aff></affiliation></author><author><name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name><affiliation><nlm:aff id="cncr30558-aff-0010"></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="cncr30558-aff-0011"></nlm:aff></affiliation></author><author><name sortKey="Dersarkissian, Maral" sort="Dersarkissian, Maral" uniqKey="Dersarkissian M" first="Maral" last="Dersarkissian">Maral Dersarkissian</name><affiliation><nlm:aff id="cncr30558-aff-0012"></nlm:aff></affiliation></author><author><name sortKey="Duh, Mei Sheng" sort="Duh, Mei Sheng" uniqKey="Duh M" first="Mei Sheng" last="Duh">Mei Sheng Duh</name><affiliation><nlm:aff id="cncr30558-aff-0012"></nlm:aff></affiliation></author><author><name sortKey="Mcgarry, Lisa J" sort="Mcgarry, Lisa J" uniqKey="Mcgarry L" first="Lisa J." last="Mcgarry">Lisa J. Mcgarry</name><affiliation><nlm:aff id="cncr30558-aff-0013"></nlm:aff></affiliation></author><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="cncr30558-aff-0014"></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="cncr30558-aff-0014"></nlm:aff></affiliation></author></analytic><series><title level="j">Cancer</title><idno type="ISSN">0008-543X</idno><idno type="eISSN">1097-0142</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="cncr30558-sec-0001"><title>BACKGROUND</title><p>Effective treatment options for patients with chronic myeloid leukemia (CML) or Philadelphia‐positive (Ph+) acute lymphoblastic leukemia (ALL) who have the threonine to isoleucine mutation at codon 315 (T315I) are few. The objective of this study was to compare overall survival (OS) between patients with CML and those with Ph+ ALL who received treatment with ponatinib versus allogeneic stem cell transplantation (allo‐SCT).</p></sec><sec id="cncr30558-sec-0002"><title>METHODS</title><p>A post hoc, retrospective, indirect comparison of OS among patients who received single‐agent ponatinib in the Ponatinib Ph+ ALL and CML Evaluation (PACE) trial with those who underwent allo‐SCT as reported to the European Bone Marrow Transplant registry, stratified by CML disease phase and Ph+ ALL, was conducted. Kaplan‐Meier survival curves and multivariate Cox proportional‐hazards models were used to compare OS between intervention groups, adjusting for time from diagnosis to intervention, age, sex, and geographic region; 24‐month and 48‐month OS rates and median OS were reported.</p></sec><sec id="cncr30558-sec-0003"><title>RESULTS</title><p>After adjustment for potential confounders, 24‐month and 48‐month OS rates were significantly higher in patients with chronic‐phase CML (CP‐CML) who received ponatinib compared with those who underwent allo‐SCT (24 months: 84% vs 60.5%, respectively; <italic>P</italic> = .004; 48 months: 72.7% vs 55.8%, respectively; <italic>P</italic> = .013), with a hazard ratio (HR) of 0.37 (95% confidence interval [CI], 0.16‐0.84; <italic>P</italic> = .017). In patients who had accelerated‐phase CML, OS rates were not significantly different between the groups (HR, 0.90; 95% CI, 0.20‐4.10; <italic>P</italic> = .889). In patients who had blast‐crisis CML and those with Ph+ ALL, ponatinib was associated with shorter OS compared with allo‐SCT (blast‐crisis CML: HR, 2.29 [95% CI, 1.08‐4.82; <italic>P</italic> = .030]; Ph+ ALL: HR, 2.77 [95% CI, 0.73‐10.56; <italic>P</italic> = .146]).</p></sec><sec id="cncr30558-sec-0004"><title>CONCLUSIONS</title><p>Although allo‐SCT remains an important treatment option for patients with T315I‐positive advanced CML and Ph+ ALL, ponatinib represents a valuable alternative for patients with T315I‐positive CP‐CML. <bold><italic>Cancer</italic> 2017;123:2875–80.</bold> © <italic>2017 American Cancer Society</italic>.</p></sec></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></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">Cancer</journal-id><journal-id journal-id-type="iso-abbrev">Cancer</journal-id><journal-id journal-id-type="doi">10.1002/(ISSN)1097-0142</journal-id><journal-id journal-id-type="publisher-id">CNCR</journal-id><journal-title-group><journal-title>Cancer</journal-title></journal-title-group><issn pub-type="ppub">0008-543X</issn><issn pub-type="epub">1097-0142</issn><publisher><publisher-name>John Wiley and Sons Inc.</publisher-name><publisher-loc>Hoboken</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28387926</article-id><article-id pub-id-type="pmc">5573914</article-id><article-id pub-id-type="doi">10.1002/cncr.30558</article-id><article-id pub-id-type="publisher-id">CNCR30558</article-id><article-categories><subj-group subj-group-type="overline"><subject>Original Article</subject></subj-group><subj-group subj-group-type="heading"><subject>Original Articles</subject><subj-group subj-group-type="heading"><subject>Disease Site</subject><subj-group subj-group-type="heading"><subject>Hematologic Malignancies</subject></subj-group></subj-group></subj-group></article-categories><title-group><article-title>Overall survival with ponatinib versus allogeneic stem cell transplantation in Philadelphia chromosome‐positive leukemias with the T315I mutation</article-title><alt-title alt-title-type="right-running-head">Ponatinib vs Allo‐SCT in T315I Leukemias</alt-title><alt-title alt-title-type="left-running-head">Nicolini et al</alt-title></title-group><contrib-group><contrib id="cncr30558-cr-0001" contrib-type="author" corresp="yes"><name><surname>Nicolini</surname><given-names>Franck E.</given-names></name><degrees>MD, PhD</degrees><address><email>franck-emmanuel.nicolini@chu-lyon.fr</email></address><xref ref-type="aff" rid="cncr30558-aff-0001"><sup>1</sup></xref></contrib><contrib id="cncr30558-cr-0002" contrib-type="author"><name><surname>Basak</surname><given-names>Grzegorz W.</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="cncr30558-aff-0002"><sup>2</sup></xref></contrib><contrib id="cncr30558-cr-0003" contrib-type="author"><name><surname>Kim</surname><given-names>Dong‐Wook</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="cncr30558-aff-0003"><sup>3</sup></xref></contrib><contrib id="cncr30558-cr-0004" contrib-type="author"><name><surname>Olavarria</surname><given-names>Eduardo</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="cncr30558-aff-0004"><sup>4</sup></xref></contrib><contrib id="cncr30558-cr-0005" contrib-type="author"><name><surname>Pinilla‐Ibarz</surname><given-names>Javier</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="cncr30558-aff-0005"><sup>5</sup></xref></contrib><contrib id="cncr30558-cr-0006" contrib-type="author"><name><surname>Apperley</surname><given-names>Jane F.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0004"><sup>4</sup></xref></contrib><contrib id="cncr30558-cr-0007" contrib-type="author"><name><surname>Hughes</surname><given-names>Timothy</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0006"><sup>6</sup></xref></contrib><contrib id="cncr30558-cr-0008" contrib-type="author"><name><surname>Niederwieser</surname><given-names>Dietger</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0007"><sup>7</sup></xref></contrib><contrib id="cncr30558-cr-0009" contrib-type="author"><name><surname>Mauro</surname><given-names>Michael J.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0008"><sup>8</sup></xref></contrib><contrib id="cncr30558-cr-0010" contrib-type="author"><name><surname>Chuah</surname><given-names>Charles</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0009"><sup>9</sup></xref></contrib><contrib id="cncr30558-cr-0011" contrib-type="author"><name><surname>Hochhaus</surname><given-names>Andreas</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0010"><sup>10</sup></xref></contrib><contrib id="cncr30558-cr-0012" contrib-type="author"><name><surname>Martinelli</surname><given-names>Giovanni</given-names></name><degrees>MD, PhD</degrees><xref ref-type="aff" rid="cncr30558-aff-0011"><sup>11</sup></xref></contrib><contrib id="cncr30558-cr-0013" contrib-type="author"><name><surname>DerSarkissian</surname><given-names>Maral</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="cncr30558-aff-0012"><sup>12</sup></xref></contrib><contrib id="cncr30558-cr-0014" contrib-type="author"><name><surname>Duh</surname><given-names>Mei Sheng</given-names></name><degrees>MPH, ScD</degrees><xref ref-type="aff" rid="cncr30558-aff-0012"><sup>12</sup></xref></contrib><contrib id="cncr30558-cr-0015" contrib-type="author"><name><surname>McGarry</surname><given-names>Lisa J.</given-names></name><degrees>MPH</degrees><xref ref-type="aff" rid="cncr30558-aff-0013"><sup>13</sup></xref></contrib><contrib id="cncr30558-cr-0016" contrib-type="author"><name><surname>Kantarjian</surname><given-names>Hagop M.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0014"><sup>14</sup></xref></contrib><contrib id="cncr30558-cr-0017" contrib-type="author"><name><surname>Cortes</surname><given-names>Jorge E.</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="cncr30558-aff-0014"><sup>14</sup></xref></contrib></contrib-group><aff id="cncr30558-aff-0001"><label><sup>1</sup></label><named-content content-type="organisation-division">Hematology Department</named-content><institution>Lyon South‐Pierre‐Bénite Hospital Center and Unit 1052, National Institute of Health and Medical Research Lyon Cancer Research Center/Léon Berard Center</institution><named-content content-type="city">Lyon</named-content><country country="FR">France</country></aff><aff id="cncr30558-aff-0002"><label><sup>2</sup></label><named-content content-type="organisation-division">Department of Hematology</named-content><institution>Oncology and Internal Medicine, Medical University of Warsaw</institution><named-content content-type="city">Warsaw</named-content><country country="PL">Poland</country></aff><aff id="cncr30558-aff-0003"><label><sup>3</sup></label><named-content content-type="organisation-division">Leukemia Research Institute</named-content><institution>Seoul St. Mary's Hospital, The Catholic University of Korea</institution><named-content content-type="city">Seoul</named-content><country country="KR">Korea</country></aff><aff id="cncr30558-aff-0004"><label><sup>4</sup></label><named-content content-type="organisation-division">Department of Haematology</named-content><institution>Imperial College London, Hammersmith Hospital</institution><named-content content-type="city">London</named-content><country country="GB">United Kingdom</country></aff><aff id="cncr30558-aff-0005"><label><sup>5</sup></label><institution>H. Lee Moffitt Cancer Center and Research Institute</institution><named-content content-type="city">Tampa</named-content><named-content content-type="country-part">Florida</named-content></aff><aff id="cncr30558-aff-0006"><label><sup>6</sup></label><named-content content-type="organisation-division">Department of Pathology</named-content><institution>Royal Adelaide Hospital</institution><named-content content-type="city">Adelaide</named-content><named-content content-type="country-part">South Australia</named-content><country country="AU">Australia</country></aff><aff id="cncr30558-aff-0007"><label><sup>7</sup></label><institution>Department of Haematology and Medical Oncology, University of Leipzig</institution><named-content content-type="city">Leipzig</named-content><country country="DE">Germany</country></aff><aff id="cncr30558-aff-0008"><label><sup>8</sup></label><named-content content-type="organisation-division">Department of Leukemia</named-content><institution>Memorial Sloan Kettering Cancer Center</institution><named-content content-type="city">New York</named-content><named-content content-type="country-part">New York</named-content></aff><aff id="cncr30558-aff-0009"><label><sup>9</sup></label><named-content content-type="organisation-division">Department of Haematology</named-content><institution>Singapore General Hospital, Duke‐NUS Medical School</institution><named-content content-type="city">Singapore</named-content></aff><aff id="cncr30558-aff-0010"><label><sup>10</sup></label><named-content content-type="organisation-division">Clinic and Polyclinic for Internal Medicine II, Division of Hematology and Oncology</named-content><institution>Jena University Hospital</institution><named-content content-type="city">Jena</named-content><country country="DE">Germany</country></aff><aff id="cncr30558-aff-0011"><label><sup>11</sup></label><institution>L. e A. Seragnoli Institute of Hematology</institution><named-content content-type="city">Bologna</named-content><country country="IT">Italy</country></aff><aff id="cncr30558-aff-0012"><label><sup>12</sup></label><institution>Analysis Group, Inc</institution><named-content content-type="city">Boston</named-content><named-content content-type="country-part">Massachusetts</named-content></aff><aff id="cncr30558-aff-0013"><label><sup>13</sup></label><institution>ARIAD Pharmaceuticals, Inc</institution><named-content content-type="city">Cambridge</named-content><named-content content-type="country-part">Massachusetts</named-content></aff><aff id="cncr30558-aff-0014"><label><sup>14</sup></label><named-content content-type="organisation-division">Department of Leukemia</named-content><institution>The University of Texas MD Anderson Cancer Center</institution><named-content content-type="city">Houston</named-content><named-content content-type="country-part">Texas</named-content></aff><author-notes><corresp id="correspondenceTo"><label>*</label><bold>Corresponding author</bold>: Franck E. Nicolini, MD, PhD, Hematology Department 1G, Centre Hospitalier Lyon Sud, 165, Chemin du Grand Revoyet, 69495 Pierre Bénite, France; Fax: (011) 33 (0)4 72 67 88 80: <email>franck-emmanuel.nicolini@chu-lyon.fr</email></corresp></author-notes><pub-date pub-type="epub"><day>07</day><month>4</month><year>2017</year></pub-date><pub-date pub-type="ppub"><day>01</day><month>8</month><year>2017</year></pub-date><volume>123</volume><issue>15</issue><issue-id pub-id-type="doi">10.1002/cncr.v123.15</issue-id><fpage>2875</fpage><lpage>2880</lpage><history><date date-type="received"><day>05</day><month>10</month><year>2016</year></date><date date-type="rev-recd"><day>05</day><month>12</month><year>2016</year></date><date date-type="accepted"><day>13</day><month>12</month><year>2016</year></date></history><permissions><pmc-comment> © 2017 American Cancer Society </pmc-comment>
<copyright-statement content-type="article-copyright">© 2017 The Authors. <italic>Cancer</italic> published by Wiley Periodicals, Inc. on behalf of <italic>American Cancer Society</italic></copyright-statement><license license-type="creativeCommonsBy-nc-nd"><license-p>This is an open access article under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution‐NonCommercial‐NoDerivs</ext-link> License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="file:CNCR-123-2875.pdf"></self-uri><abstract><sec id="cncr30558-sec-0001"><title>BACKGROUND</title><p>Effective treatment options for patients with chronic myeloid leukemia (CML) or Philadelphia‐positive (Ph+) acute lymphoblastic leukemia (ALL) who have the threonine to isoleucine mutation at codon 315 (T315I) are few. The objective of this study was to compare overall survival (OS) between patients with CML and those with Ph+ ALL who received treatment with ponatinib versus allogeneic stem cell transplantation (allo‐SCT).</p></sec><sec id="cncr30558-sec-0002"><title>METHODS</title><p>A post hoc, retrospective, indirect comparison of OS among patients who received single‐agent ponatinib in the Ponatinib Ph+ ALL and CML Evaluation (PACE) trial with those who underwent allo‐SCT as reported to the European Bone Marrow Transplant registry, stratified by CML disease phase and Ph+ ALL, was conducted. Kaplan‐Meier survival curves and multivariate Cox proportional‐hazards models were used to compare OS between intervention groups, adjusting for time from diagnosis to intervention, age, sex, and geographic region; 24‐month and 48‐month OS rates and median OS were reported.</p></sec><sec id="cncr30558-sec-0003"><title>RESULTS</title><p>After adjustment for potential confounders, 24‐month and 48‐month OS rates were significantly higher in patients with chronic‐phase CML (CP‐CML) who received ponatinib compared with those who underwent allo‐SCT (24 months: 84% vs 60.5%, respectively; <italic>P</italic> = .004; 48 months: 72.7% vs 55.8%, respectively; <italic>P</italic> = .013), with a hazard ratio (HR) of 0.37 (95% confidence interval [CI], 0.16‐0.84; <italic>P</italic> = .017). In patients who had accelerated‐phase CML, OS rates were not significantly different between the groups (HR, 0.90; 95% CI, 0.20‐4.10; <italic>P</italic> = .889). In patients who had blast‐crisis CML and those with Ph+ ALL, ponatinib was associated with shorter OS compared with allo‐SCT (blast‐crisis CML: HR, 2.29 [95% CI, 1.08‐4.82; <italic>P</italic> = .030]; Ph+ ALL: HR, 2.77 [95% CI, 0.73‐10.56; <italic>P</italic> = .146]).</p></sec><sec id="cncr30558-sec-0004"><title>CONCLUSIONS</title><p>Although allo‐SCT remains an important treatment option for patients with T315I‐positive advanced CML and Ph+ ALL, ponatinib represents a valuable alternative for patients with T315I‐positive CP‐CML. <bold><italic>Cancer</italic> 2017;123:2875–80.</bold> © <italic>2017 American Cancer Society</italic>.</p></sec></abstract><abstract abstract-type="short"><p>In patients who have chronic‐phase chronic myeloid leukemia (CML) with the Philadelphia chromosome threonine to isoleucine mutation at codon 315, single‐agent ponatinib is associated with significantly longer overall survival compared with allogenic stem cell transplantation. In those who have accelerated‐phase CML, blast‐crisis CML, and Philadelphia chromosome‐positive acute lymphoblastic leukemia with the T315I mutation, single‐agent ponatinib is associated with similar or shorter overall survival compared with stem cell transplantation.</p></abstract><kwd-group kwd-group-type="author-generated"><kwd id="cncr30558-kwd-0001">allogeneic stem cell transplantation (allo‐SCT)</kwd><kwd id="cncr30558-kwd-0002">chronic myeloid leukemia (CML)</kwd><kwd id="cncr30558-kwd-0003">Philadelphia chromosome‐positive acute lymphoblastic leukemia (Ph+ ALL)</kwd><kwd id="cncr30558-kwd-0004">ponatinib</kwd><kwd id="cncr30558-kwd-0005">threonine to isoleucine mutation at codon 315 (T315I)</kwd></kwd-group><funding-group><award-group><funding-source>ARIAD Pharmaceuticals, Inc.</funding-source></award-group></funding-group><counts><fig-count count="1"></fig-count><table-count count="1"></table-count><page-count count="7"></page-count><word-count count="3377"></word-count></counts><custom-meta-group><custom-meta><meta-name>source-schema-version-number</meta-name><meta-value>2.0</meta-value></custom-meta><custom-meta><meta-name>component-id</meta-name><meta-value>cncr30558</meta-value></custom-meta><custom-meta><meta-name>cover-date</meta-name><meta-value>August 01, 2017</meta-value></custom-meta><custom-meta><meta-name>details-of-publishers-convertor</meta-name><meta-value>Converter:WILEY_ML3GV2_TO_NLMPMC version:5.1.8 mode:remove_FC converted:29.08.2017</meta-value></custom-meta></custom-meta-group></article-meta><notes><fn-group><fn id="cncr30558-note-0001"><p>Presented in part at the 57th Annual Meeting of the American Society of Hematology; December 5‐8, 2015; Orlando, FL</p></fn><fn id="cncr30558-note-0002"><p>We thank the patients, families, and their caregivers for participating in the Ponatinib Philadelphia‐Positive Acute Lymphoblastic Leukemia and Chronic Myeloid Leukemia Evaluation (PACE) trial and the PACE investigators and team members at each site. In addition, we thank patients for participating in the European Group for Blood and Marrow Transplantation (EBMT) registry, and the investigators, transplantation team members, and clinical research associates who work to maintain the updated database. We also thank Andrew Kageleiry, BS; Rachel Bhak, MS, from Analysis Group Inc. (Boston, MA); and Hui Huang, PhD, MBA, and Mo Yang, PhD, from ARIAD Pharmaceuticals for their contributions and valuable assistance to this study.</p></fn></fn-group></notes></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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