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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study</title><author><name sortKey="Fenaux, Pierre" sort="Fenaux, Pierre" uniqKey="Fenaux P" first="Pierre" last="Fenaux">Pierre Fenaux</name></author><author><name sortKey="Mufti, Ghulam J" sort="Mufti, Ghulam J" uniqKey="Mufti G" first="Ghulam J" last="Mufti">Ghulam J. Mufti</name></author><author><name sortKey="Hellstrom Lindberg, Eva" sort="Hellstrom Lindberg, Eva" uniqKey="Hellstrom Lindberg E" first="Eva" last="Hellstrom-Lindberg">Eva Hellstrom-Lindberg</name></author><author><name sortKey="Santini, Valeria" sort="Santini, Valeria" uniqKey="Santini V" first="Valeria" last="Santini">Valeria Santini</name></author><author><name sortKey="Finelli, Carlo" sort="Finelli, Carlo" uniqKey="Finelli C" first="Carlo" last="Finelli">Carlo Finelli</name></author><author><name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name></author><author><name sortKey="Schoch, Robert" sort="Schoch, Robert" uniqKey="Schoch R" first="Robert" last="Schoch">Robert Schoch</name></author><author><name sortKey="Gattermann, Norbert" sort="Gattermann, Norbert" uniqKey="Gattermann N" first="Norbert" last="Gattermann">Norbert Gattermann</name></author><author><name sortKey="Sanz, Guillermo" sort="Sanz, Guillermo" uniqKey="Sanz G" first="Guillermo" last="Sanz">Guillermo Sanz</name></author><author><name sortKey="List, Alan" sort="List, Alan" uniqKey="List A" first="Alan" last="List">Alan List</name></author><author><name sortKey="Gore, Steven D" sort="Gore, Steven D" uniqKey="Gore S" first="Steven D" last="Gore">Steven D. Gore</name></author><author><name sortKey="Seymour, John F" sort="Seymour, John F" uniqKey="Seymour J" first="John F" last="Seymour">John F. Seymour</name></author><author><name sortKey="Bennett, John M" sort="Bennett, John M" uniqKey="Bennett J" first="John M" last="Bennett">John M. Bennett</name></author><author><name sortKey="Byrd, John" sort="Byrd, John" uniqKey="Byrd J" first="John" last="Byrd">John Byrd</name></author><author><name sortKey="Backstrom, Jay" sort="Backstrom, Jay" uniqKey="Backstrom J" first="Jay" last="Backstrom">Jay Backstrom</name></author><author><name sortKey="Zimmerman, Linda" sort="Zimmerman, Linda" uniqKey="Zimmerman L" first="Linda" last="Zimmerman">Linda Zimmerman</name></author><author><name sortKey="Mckenzie, David" sort="Mckenzie, David" uniqKey="Mckenzie D" first="David" last="Mckenzie">David Mckenzie</name></author><author><name sortKey="Beach, C L" sort="Beach, C L" uniqKey="Beach C" first="C L" last="Beach">C L Beach</name></author><author><name sortKey="Silverman, Lewis R" sort="Silverman, Lewis R" uniqKey="Silverman L" first="Lewis R" last="Silverman">Lewis R. Silverman</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">19230772</idno><idno type="pmc">4086808</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4086808</idno><idno type="RBID">PMC:4086808</idno><idno type="doi">10.1016/S1470-2045(09)70003-8</idno><date when="2009">2009</date><idno type="wicri:Area/Pmc/Corpus">001D86</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001D86</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study</title><author><name sortKey="Fenaux, Pierre" sort="Fenaux, Pierre" uniqKey="Fenaux P" first="Pierre" last="Fenaux">Pierre Fenaux</name></author><author><name sortKey="Mufti, Ghulam J" sort="Mufti, Ghulam J" uniqKey="Mufti G" first="Ghulam J" last="Mufti">Ghulam J. Mufti</name></author><author><name sortKey="Hellstrom Lindberg, Eva" sort="Hellstrom Lindberg, Eva" uniqKey="Hellstrom Lindberg E" first="Eva" last="Hellstrom-Lindberg">Eva Hellstrom-Lindberg</name></author><author><name sortKey="Santini, Valeria" sort="Santini, Valeria" uniqKey="Santini V" first="Valeria" last="Santini">Valeria Santini</name></author><author><name sortKey="Finelli, Carlo" sort="Finelli, Carlo" uniqKey="Finelli C" first="Carlo" last="Finelli">Carlo Finelli</name></author><author><name sortKey="Giagounidis, Aristoteles" sort="Giagounidis, Aristoteles" uniqKey="Giagounidis A" first="Aristoteles" last="Giagounidis">Aristoteles Giagounidis</name></author><author><name sortKey="Schoch, Robert" sort="Schoch, Robert" uniqKey="Schoch R" first="Robert" last="Schoch">Robert Schoch</name></author><author><name sortKey="Gattermann, Norbert" sort="Gattermann, Norbert" uniqKey="Gattermann N" first="Norbert" last="Gattermann">Norbert Gattermann</name></author><author><name sortKey="Sanz, Guillermo" sort="Sanz, Guillermo" uniqKey="Sanz G" first="Guillermo" last="Sanz">Guillermo Sanz</name></author><author><name sortKey="List, Alan" sort="List, Alan" uniqKey="List A" first="Alan" last="List">Alan List</name></author><author><name sortKey="Gore, Steven D" sort="Gore, Steven D" uniqKey="Gore S" first="Steven D" last="Gore">Steven D. Gore</name></author><author><name sortKey="Seymour, John F" sort="Seymour, John F" uniqKey="Seymour J" first="John F" last="Seymour">John F. Seymour</name></author><author><name sortKey="Bennett, John M" sort="Bennett, John M" uniqKey="Bennett J" first="John M" last="Bennett">John M. Bennett</name></author><author><name sortKey="Byrd, John" sort="Byrd, John" uniqKey="Byrd J" first="John" last="Byrd">John Byrd</name></author><author><name sortKey="Backstrom, Jay" sort="Backstrom, Jay" uniqKey="Backstrom J" first="Jay" last="Backstrom">Jay Backstrom</name></author><author><name sortKey="Zimmerman, Linda" sort="Zimmerman, Linda" uniqKey="Zimmerman L" first="Linda" last="Zimmerman">Linda Zimmerman</name></author><author><name sortKey="Mckenzie, David" sort="Mckenzie, David" uniqKey="Mckenzie D" first="David" last="Mckenzie">David Mckenzie</name></author><author><name sortKey="Beach, C L" sort="Beach, C L" uniqKey="Beach C" first="C L" last="Beach">C L Beach</name></author><author><name sortKey="Silverman, Lewis R" sort="Silverman, Lewis R" uniqKey="Silverman L" first="Lewis R" last="Silverman">Lewis R. Silverman</name></author></analytic><series><title level="j">The lancet oncology</title><idno type="ISSN">1470-2045</idno><idno type="eISSN">1474-5488</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><sec id="S1"><title>Background</title><p id="P1">Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens.</p></sec><sec id="S2"><title>Methods</title><p id="P2">In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m² per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French–American–British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov, number NCT00071799.</p></sec><sec id="S3"><title>Findings</title><p id="P3">Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21·1 months (IQR 15·1–26·9), median overall survival was 24·5 months (9·9–not reached) for the azacitidine group versus 15·0 months (5·6–24·1) for the conventional care group (hazard ratio 0·58; 95% CI 0·43–0·77; stratified log-rank p=0·0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50·8% (95% CI 42·1–58·8) of patients in the azacitidine group were alive compared with 26·2% (18·7–34·3) in the conventional care group (p<0·0001). Peripheral cytopenias were the most common grade 3–4 adverse events for all treatments.</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care.</p></sec></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>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">100957246</journal-id><journal-id journal-id-type="pubmed-jr-id">27004</journal-id><journal-id journal-id-type="nlm-ta">Lancet Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Lancet Oncol.</journal-id><journal-title-group><journal-title>The lancet oncology</journal-title></journal-title-group><issn pub-type="ppub">1470-2045</issn><issn pub-type="epub">1474-5488</issn></journal-meta><article-meta><article-id pub-id-type="pmid">19230772</article-id><article-id pub-id-type="pmc">4086808</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(09)70003-8</article-id><article-id pub-id-type="manuscript">NIHMS428850</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Fenaux</surname><given-names>Pierre</given-names></name></contrib><contrib contrib-type="author"><name><surname>Mufti</surname><given-names>Ghulam J</given-names></name></contrib><contrib contrib-type="author"><name><surname>Hellstrom-Lindberg</surname><given-names>Eva</given-names></name></contrib><contrib contrib-type="author"><name><surname>Santini</surname><given-names>Valeria</given-names></name></contrib><contrib contrib-type="author"><name><surname>Finelli</surname><given-names>Carlo</given-names></name></contrib><contrib contrib-type="author"><name><surname>Giagounidis</surname><given-names>Aristoteles</given-names></name></contrib><contrib contrib-type="author"><name><surname>Schoch</surname><given-names>Robert</given-names></name></contrib><contrib contrib-type="author"><name><surname>Gattermann</surname><given-names>Norbert</given-names></name></contrib><contrib contrib-type="author"><name><surname>Sanz</surname><given-names>Guillermo</given-names></name></contrib><contrib contrib-type="author"><name><surname>List</surname><given-names>Alan</given-names></name></contrib><contrib contrib-type="author"><name><surname>Gore</surname><given-names>Steven D</given-names></name></contrib><contrib contrib-type="author"><name><surname>Seymour</surname><given-names>John F</given-names></name></contrib><contrib contrib-type="author"><name><surname>Bennett</surname><given-names>John M</given-names></name></contrib><contrib contrib-type="author"><name><surname>Byrd</surname><given-names>John</given-names></name></contrib><contrib contrib-type="author"><name><surname>Backstrom</surname><given-names>Jay</given-names></name></contrib><contrib contrib-type="author"><name><surname>Zimmerman</surname><given-names>Linda</given-names></name></contrib><contrib contrib-type="author"><name><surname>McKenzie</surname><given-names>David</given-names></name></contrib><contrib contrib-type="author"><name><surname>Beach</surname><given-names>C L</given-names></name></contrib><contrib contrib-type="author"><name><surname>Silverman</surname><given-names>Lewis R</given-names></name></contrib><contrib contrib-type="author"><collab>for the International Vidaza High-Risk MDS Survival Study Group</collab></contrib><aff id="A1">Hôpital Avicenne, Université Paris XIII, Bobigny, France (Prof P Fenaux MD); King’s College Hospital, London, UK (Prof G J Mufti MD); Karolinska University Hospital, Stockholm, Sweden (Prof E Hellstrom-Lindberg MD); Azienda Ospedaliera Universitaria Careggi, Florence, Italy (V Santini MD); Institute of Hematology “Seràgnoli”, Bologna, Italy (C Finelli MD); St Johannes Hospital, Duisburg, Germany (A Giagounidis MD); Universitätsklinikum Schleswig-Holstein, Kiel, Germany (R Schoch MD); Universitätsklinikum Düsseldorf, Düsseldorf, Germany (N Gattermann MD); Hospital Universitario La Fe, Valencia, Spain (G Sanz MD); H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA (Prof A List MD); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA (Prof S D Gore MD); Peter MacCallum Cancer Centre, East Melbourne, & University of Melbourne, Australia (J F Seymour MBBS); James P Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY, USA (Prof J M Bennett MD); Ohio State University School of Medicine and Public Health, Columbus, OH, USA (Prof J Byrd MD); Celgene Corporation, Summit, NJ, USA (J Backstrom MD, L Zimmerman BSN, D McKenzie MS, C L Beach PharmD); and Mount Sinai School of Medicine, New York, NY, USA (L R Silverman MD); and Mount Sinai School of Medicine, New York, NY, USA (L R Silverman MD)</aff></contrib-group><author-notes><corresp id="cor1">Correspondence to: Prof Pierre Fenaux, Service, d’Hématologie Clinique, Hôpital, Avicenne/Université Paris 13, 125 route de Stalingrad, 93009 Bobigny, France, <email>pierre.fenaux@avc.ap-hop-paris.fr</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>5</day><month>6</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>21</day><month>2</month><year>2009</year></pub-date><pub-date pub-type="ppub"><month>3</month><year>2009</year></pub-date><pub-date pub-type="pmc-release"><day>08</day><month>7</month><year>2014</year></pub-date><volume>10</volume><issue>3</issue><fpage>223</fpage><lpage>232</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S1470-2045(09)70003-8</pmc-comment>
<abstract><title>Summary</title><sec id="S1"><title>Background</title><p id="P1">Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens.</p></sec><sec id="S2"><title>Methods</title><p id="P2">In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m² per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French–American–British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov, number NCT00071799.</p></sec><sec id="S3"><title>Findings</title><p id="P3">Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21·1 months (IQR 15·1–26·9), median overall survival was 24·5 months (9·9–not reached) for the azacitidine group versus 15·0 months (5·6–24·1) for the conventional care group (hazard ratio 0·58; 95% CI 0·43–0·77; stratified log-rank p=0·0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50·8% (95% CI 42·1–58·8) of patients in the azacitidine group were alive compared with 26·2% (18·7–34·3) in the conventional care group (p<0·0001). Peripheral cytopenias were the most common grade 3–4 adverse events for all treatments.</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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