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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial</title><author><name sortKey="Gore, Steven D" sort="Gore, Steven D" uniqKey="Gore S" first="Steven D." last="Gore">Steven D. Gore</name><affiliation><nlm:aff id="af1-0981067">Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Fenaux, Pierre" sort="Fenaux, Pierre" uniqKey="Fenaux P" first="Pierre" last="Fenaux">Pierre Fenaux</name><affiliation><nlm:aff id="af2-0981067">Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP) and Paris 13 Université, Bobigny, France</nlm:aff></affiliation></author><author><name sortKey="Santini, Valeria" sort="Santini, Valeria" uniqKey="Santini V" first="Valeria" last="Santini">Valeria Santini</name><affiliation><nlm:aff id="af3-0981067">AOU Careggi, University of Florence, Italy</nlm:aff></affiliation></author><author><name sortKey="Bennett, John M" sort="Bennett, John M" uniqKey="Bennett J" first="John M." last="Bennett">John M. Bennett</name><affiliation><nlm:aff id="af4-0981067">James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Silverman, Lewis R" sort="Silverman, Lewis R" uniqKey="Silverman L" first="Lewis R." last="Silverman">Lewis R. Silverman</name><affiliation><nlm:aff id="af5-0981067">Mount Sinai School of Medicine, New York, NY, USA</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="af6-0981067">Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Hellstrom Lindberg, Eva" sort="Hellstrom Lindberg, Eva" uniqKey="Hellstrom Lindberg E" first="Eva" last="Hellström-Lindberg">Eva Hellström-Lindberg</name><affiliation><nlm:aff id="af7-0981067">Karolinska University Hospital, Stockholm, Sweden</nlm:aff></affiliation></author><author><name sortKey="Swern, Arlene S" sort="Swern, Arlene S" uniqKey="Swern A" first="Arlene S." last="Swern">Arlene S. Swern</name><affiliation><nlm:aff id="af8-0981067">Celgene Corporation, Summit, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Beach, Charles L" sort="Beach, Charles L" uniqKey="Beach C" first="Charles. L." last="Beach">Charles. L. Beach</name><affiliation><nlm:aff id="af8-0981067">Celgene Corporation, Summit, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="List, Alan F" sort="List, Alan F" uniqKey="List A" first="Alan. F." last="List">Alan. F. List</name><affiliation><nlm:aff id="af9-0981067">Moffitt Cancer Center, Tampa, FL, USA</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23585522</idno><idno type="pmc">3696610</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3696610</idno><idno type="RBID">PMC:3696610</idno><idno type="doi">10.3324/haematol.2012.074831</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">001855</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001855</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial</title><author><name sortKey="Gore, Steven D" sort="Gore, Steven D" uniqKey="Gore S" first="Steven D." last="Gore">Steven D. Gore</name><affiliation><nlm:aff id="af1-0981067">Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Fenaux, Pierre" sort="Fenaux, Pierre" uniqKey="Fenaux P" first="Pierre" last="Fenaux">Pierre Fenaux</name><affiliation><nlm:aff id="af2-0981067">Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP) and Paris 13 Université, Bobigny, France</nlm:aff></affiliation></author><author><name sortKey="Santini, Valeria" sort="Santini, Valeria" uniqKey="Santini V" first="Valeria" last="Santini">Valeria Santini</name><affiliation><nlm:aff id="af3-0981067">AOU Careggi, University of Florence, Italy</nlm:aff></affiliation></author><author><name sortKey="Bennett, John M" sort="Bennett, John M" uniqKey="Bennett J" first="John M." last="Bennett">John M. Bennett</name><affiliation><nlm:aff id="af4-0981067">James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Silverman, Lewis R" sort="Silverman, Lewis R" uniqKey="Silverman L" first="Lewis R." last="Silverman">Lewis R. Silverman</name><affiliation><nlm:aff id="af5-0981067">Mount Sinai School of Medicine, New York, NY, USA</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="af6-0981067">Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Hellstrom Lindberg, Eva" sort="Hellstrom Lindberg, Eva" uniqKey="Hellstrom Lindberg E" first="Eva" last="Hellström-Lindberg">Eva Hellström-Lindberg</name><affiliation><nlm:aff id="af7-0981067">Karolinska University Hospital, Stockholm, Sweden</nlm:aff></affiliation></author><author><name sortKey="Swern, Arlene S" sort="Swern, Arlene S" uniqKey="Swern A" first="Arlene S." last="Swern">Arlene S. Swern</name><affiliation><nlm:aff id="af8-0981067">Celgene Corporation, Summit, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Beach, Charles L" sort="Beach, Charles L" uniqKey="Beach C" first="Charles. L." last="Beach">Charles. L. Beach</name><affiliation><nlm:aff id="af8-0981067">Celgene Corporation, Summit, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="List, Alan F" sort="List, Alan F" uniqKey="List A" first="Alan. F." last="List">Alan. F. List</name><affiliation><nlm:aff id="af9-0981067">Moffitt Cancer Center, Tampa, FL, USA</nlm:aff></affiliation></author></analytic><series><title level="j">Haematologica</title><idno type="ISSN">0390-6078</idno><idno type="eISSN">1592-8721</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>The phase III AZA-001 study established that azacitidine significantly improves overall survival compared with conventional care regimens (hazard ratio 0.58 [95% confidence interval 0.43–0.77], <italic>P</italic><0.001). This analysis was conducted to investigate the relationship between treatment response and overall survival. AZA-001 data were analyzed in a multivariate Cox regression analysis with response as a time-varying covariate. Response categories were “Overall Response” (defined as complete remission, partial remission, or any hematologic improvement) and “Stable Disease” (no complete or partial remission, hematologic improvement, or progression) or “Other” (e.g. disease progression). Achieving an Overall Response with azacitidine reduced risk of death by 95% compared with achieving an Overall Response with the conventional care regimens (hazard ratio 0.05 [95%CI: 0.01–0.43], <italic>P</italic>=0.006). Sensitivity analyses indicated that significantly improved overall survival remained manifest for patients with a hematologic improvement who had never achieved complete or partial remission (hazard ratio 0.19 [95%CI: 0.08–0.46], <italic>P</italic><0.001). Stable Disease in both azacitidine-treated and conventional care-treated patients was also associated with a significantly reduced risk of death (hazard ratio 0.09, [95%CI: 0.06–0.15]; <italic>P</italic><0.001). These results demonstrate azacitidine benefit on overall survival compared with conventional care regimens in patients with higher-risk myelodysplastic syndromes who achieve hematologic response but never attain complete or partial remission, in addition to the survival advantage conferred by achievement of complete or partial remission. <italic>This study was registered with <ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link> (NCT00071799).</italic></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">Haematologica</journal-id><journal-id journal-id-type="iso-abbrev">Haematologica</journal-id><journal-id journal-id-type="hwp">haematol</journal-id><journal-id journal-id-type="publisher-id">Haematologica</journal-id><journal-title-group><journal-title>Haematologica</journal-title></journal-title-group><issn pub-type="ppub">0390-6078</issn><issn pub-type="epub">1592-8721</issn><publisher><publisher-name>Ferrata Storti Foundation</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">23585522</article-id><article-id pub-id-type="pmc">3696610</article-id><article-id pub-id-type="doi">10.3324/haematol.2012.074831</article-id><article-id pub-id-type="publisher-id">0981067</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Articles and Brief Reports</subject><subj-group><subject>Myelodysplastic Syndromes</subject></subj-group></subj-group></article-categories><title-group><article-title>A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Gore</surname><given-names>Steven D.</given-names></name><xref ref-type="aff" rid="af1-0981067">1</xref><xref ref-type="corresp" rid="c1-0981067"></xref></contrib><contrib contrib-type="author"><name><surname>Fenaux</surname><given-names>Pierre</given-names></name><xref ref-type="aff" rid="af2-0981067">2</xref></contrib><contrib contrib-type="author"><name><surname>Santini</surname><given-names>Valeria</given-names></name><xref ref-type="aff" rid="af3-0981067">3</xref></contrib><contrib contrib-type="author"><name><surname>Bennett</surname><given-names>John M.</given-names></name><xref ref-type="aff" rid="af4-0981067">4</xref></contrib><contrib contrib-type="author"><name><surname>Silverman</surname><given-names>Lewis R.</given-names></name><xref ref-type="aff" rid="af5-0981067">5</xref></contrib><contrib contrib-type="author"><name><surname>Seymour</surname><given-names>John F.</given-names></name><xref ref-type="aff" rid="af6-0981067">6</xref></contrib><contrib contrib-type="author"><name><surname>Hellström-Lindberg</surname><given-names>Eva</given-names></name><xref ref-type="aff" rid="af7-0981067">7</xref></contrib><contrib contrib-type="author"><name><surname>Swern</surname><given-names>Arlene S.</given-names></name><xref ref-type="aff" rid="af8-0981067">8</xref></contrib><contrib contrib-type="author"><name><surname>Beach</surname><given-names>Charles. L.</given-names></name><xref ref-type="aff" rid="af8-0981067">8</xref></contrib><contrib contrib-type="author"><name><surname>List</surname><given-names>Alan. F.</given-names></name><xref ref-type="aff" rid="af9-0981067">9</xref></contrib></contrib-group><aff id="af1-0981067"><label>1</label>Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD, USA</aff><aff id="af2-0981067"><label>2</label>Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP) and Paris 13 Université, Bobigny, France</aff><aff id="af3-0981067"><label>3</label>AOU Careggi, University of Florence, Italy</aff><aff id="af4-0981067"><label>4</label>James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY, USA</aff><aff id="af5-0981067"><label>5</label>Mount Sinai School of Medicine, New York, NY, USA</aff><aff id="af6-0981067"><label>6</label>Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia</aff><aff id="af7-0981067"><label>7</label>Karolinska University Hospital, Stockholm, Sweden</aff><aff id="af8-0981067"><label>8</label>Celgene Corporation, Summit, NJ, USA</aff><aff id="af9-0981067"><label>9</label>Moffitt Cancer Center, Tampa, FL, USA</aff><author-notes><corresp id="c1-0981067">Correspondence: <email>gorest@jhmi.edu</email></corresp></author-notes><pub-date pub-type="ppub"><month>7</month><year>2013</year></pub-date><volume>98</volume><issue>7</issue><fpage>1067</fpage><lpage>1072</lpage><history><date date-type="received"><day>26</day><month>7</month><year>2012</year></date><date date-type="accepted"><day>22</day><month>3</month><year>2013</year></date></history><permissions><copyright-statement>Copyright© Ferrata Storti Foundation</copyright-statement><copyright-year>2013</copyright-year></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="981067.pdf"></self-uri><abstract><p>The phase III AZA-001 study established that azacitidine significantly improves overall survival compared with conventional care regimens (hazard ratio 0.58 [95% confidence interval 0.43–0.77], <italic>P</italic><0.001). This analysis was conducted to investigate the relationship between treatment response and overall survival. AZA-001 data were analyzed in a multivariate Cox regression analysis with response as a time-varying covariate. Response categories were “Overall Response” (defined as complete remission, partial remission, or any hematologic improvement) and “Stable Disease” (no complete or partial remission, hematologic improvement, or progression) or “Other” (e.g. disease progression). Achieving an Overall Response with azacitidine reduced risk of death by 95% compared with achieving an Overall Response with the conventional care regimens (hazard ratio 0.05 [95%CI: 0.01–0.43], <italic>P</italic>=0.006). Sensitivity analyses indicated that significantly improved overall survival remained manifest for patients with a hematologic improvement who had never achieved complete or partial remission (hazard ratio 0.19 [95%CI: 0.08–0.46], <italic>P</italic><0.001). Stable Disease in both azacitidine-treated and conventional care-treated patients was also associated with a significantly reduced risk of death (hazard ratio 0.09, [95%CI: 0.06–0.15]; <italic>P</italic><0.001). These results demonstrate azacitidine benefit on overall survival compared with conventional care regimens in patients with higher-risk myelodysplastic syndromes who achieve hematologic response but never attain complete or partial remission, in addition to the survival advantage conferred by achievement of complete or partial remission. <italic>This study was registered with <ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link> (NCT00071799).</italic></p></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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