Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study.
Identifieur interne : 002953 ( PubMed/Corpus ); précédent : 002952; suivant : 002954Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study.
Auteurs : Farhad Ravandi ; Ellen K. Ritchie ; Hamid Sayar ; Jeffrey E. Lancet ; Michael D. Craig ; Norbert Vey ; Stephen A. Strickland ; Gary J. Schiller ; Elias Jabbour ; Harry P. Erba ; Arnaud Pigneux ; Heinz-August Horst ; Christian Recher ; Virginia M. Klimek ; Jorge Cortes ; Gail J. Roboz ; Olatoyosi Odenike ; Xavier Thomas ; Violaine Havelange ; Johan Maertens ; Hans-Günter Derigs ; Michael Heuser ; Lloyd Damon ; Bayard L. Powell ; Gianluca Gaidano ; Angelo-Michele Carella ; Andrew Wei ; Donna Hogge ; Adam R. Craig ; Judith A. Fox ; Renee Ward ; Jennifer A. Smith ; Gary Acton ; Cyrus Mehta ; Robert K. Stuart ; Hagop M. KantarjianSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2015.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Cytarabine (administration & dosage), Disease-Free Survival, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Leukemia, Myeloid, Acute (drug therapy), Leukemia, Myeloid, Acute (pathology), Male, Middle Aged, Naphthyridines (administration & dosage), Neoplasm Recurrence, Local (drug therapy), Neoplasm Recurrence, Local (pathology), Remission Induction, Thiazoles (administration & dosage), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Cytarabine, Naphthyridines, Thiazoles.
- drug therapy : Leukemia, Myeloid, Acute, Neoplasm Recurrence, Local.
- pathology : Leukemia, Myeloid, Acute, Neoplasm Recurrence, Local.
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Remission Induction, Treatment Outcome.
Abstract
Safe and effective treatments are urgently needed for patients with relapsed or refractory acute myeloid leukaemia. We investigated the efficacy and safety of vosaroxin, a first-in-class anticancer quinolone derivative, plus cytarabine in patients with relapsed or refractory acute myeloid leukaemia.
DOI: 10.1016/S1470-2045(15)00201-6
PubMed: 26234174
Links to Exploration step
pubmed:26234174Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study.</title><author><name sortKey="Ravandi, Farhad" sort="Ravandi, Farhad" uniqKey="Ravandi F" first="Farhad" last="Ravandi">Farhad Ravandi</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: fravandi@mdanderson.org.</nlm:affiliation></affiliation></author><author><name sortKey="Ritchie, Ellen K" sort="Ritchie, Ellen K" uniqKey="Ritchie E" first="Ellen K" last="Ritchie">Ellen K. Ritchie</name><affiliation><nlm:affiliation>Weill Cornell Medical Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sayar, Hamid" sort="Sayar, Hamid" uniqKey="Sayar H" first="Hamid" last="Sayar">Hamid Sayar</name><affiliation><nlm:affiliation>Indiana University Cancer Center, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lancet, Jeffrey E" sort="Lancet, Jeffrey E" uniqKey="Lancet J" first="Jeffrey E" last="Lancet">Jeffrey E. Lancet</name><affiliation><nlm:affiliation>Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Craig, Michael D" sort="Craig, Michael D" uniqKey="Craig M" first="Michael D" last="Craig">Michael D. Craig</name><affiliation><nlm:affiliation>West Virginia University, Morgantown, WV, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Vey, Norbert" sort="Vey, Norbert" uniqKey="Vey N" first="Norbert" last="Vey">Norbert Vey</name><affiliation><nlm:affiliation>Institut Paoli-Calmettes and Aix-Marseille University, Marseille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Strickland, Stephen A" sort="Strickland, Stephen A" uniqKey="Strickland S" first="Stephen A" last="Strickland">Stephen A. Strickland</name><affiliation><nlm:affiliation>Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Schiller, Gary J" sort="Schiller, Gary J" uniqKey="Schiller G" first="Gary J" last="Schiller">Gary J. Schiller</name><affiliation><nlm:affiliation>University of California, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jabbour, Elias" sort="Jabbour, Elias" uniqKey="Jabbour E" first="Elias" last="Jabbour">Elias Jabbour</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Erba, Harry P" sort="Erba, Harry P" uniqKey="Erba H" first="Harry P" last="Erba">Harry P. Erba</name><affiliation><nlm:affiliation>Division of Hematology and Oncology, University of Alabama, Birmingham, AL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pigneux, Arnaud" sort="Pigneux, Arnaud" uniqKey="Pigneux A" first="Arnaud" last="Pigneux">Arnaud Pigneux</name><affiliation><nlm:affiliation>Université de Bordeaux, CHU de Bordeaux, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Horst, Heinz August" sort="Horst, Heinz August" uniqKey="Horst H" first="Heinz-August" last="Horst">Heinz-August Horst</name><affiliation><nlm:affiliation>Medizinische Klinik und Poliklinik, University Hospital Schleswig-Holstein, Kiel, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Recher, Christian" sort="Recher, Christian" uniqKey="Recher C" first="Christian" last="Recher">Christian Recher</name><affiliation><nlm:affiliation>Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III, CHU de Toulouse, Toulouse, France.</nlm:affiliation></affiliation></author><author><name sortKey="Klimek, Virginia M" sort="Klimek, Virginia M" uniqKey="Klimek V" first="Virginia M" last="Klimek">Virginia M. Klimek</name><affiliation><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Roboz, Gail J" sort="Roboz, Gail J" uniqKey="Roboz G" first="Gail J" last="Roboz">Gail J. Roboz</name><affiliation><nlm:affiliation>Weill Cornell Medical Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Odenike, Olatoyosi" sort="Odenike, Olatoyosi" uniqKey="Odenike O" first="Olatoyosi" last="Odenike">Olatoyosi Odenike</name><affiliation><nlm:affiliation>University of Chicago, Chicago, IL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Thomas, Xavier" sort="Thomas, Xavier" uniqKey="Thomas X" first="Xavier" last="Thomas">Xavier Thomas</name><affiliation><nlm:affiliation>Hôpital Edouard Herriot, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Havelange, Violaine" sort="Havelange, Violaine" uniqKey="Havelange V" first="Violaine" last="Havelange">Violaine Havelange</name><affiliation><nlm:affiliation>Cliniques Universitaires Saint-Luc, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Maertens, Johan" sort="Maertens, Johan" uniqKey="Maertens J" first="Johan" last="Maertens">Johan Maertens</name><affiliation><nlm:affiliation>Universitair Ziekenhuis, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Derigs, Hans Gunter" sort="Derigs, Hans Gunter" uniqKey="Derigs H" first="Hans-Günter" last="Derigs">Hans-Günter Derigs</name><affiliation><nlm:affiliation>Klinikum Frankfurt Main, Frankfurt, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Heuser, Michael" sort="Heuser, Michael" uniqKey="Heuser M" first="Michael" last="Heuser">Michael Heuser</name><affiliation><nlm:affiliation>Hannover Medical School, Hannover, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Damon, Lloyd" sort="Damon, Lloyd" uniqKey="Damon L" first="Lloyd" last="Damon">Lloyd Damon</name><affiliation><nlm:affiliation>UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Powell, Bayard L" sort="Powell, Bayard L" uniqKey="Powell B" first="Bayard L" last="Powell">Bayard L. Powell</name><affiliation><nlm:affiliation>Wake Forest University Baptist Medical Center-Comprehensive Cancer Center, Winston-Salem, NC, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name><affiliation><nlm:affiliation>Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Carella, Angelo Michele" sort="Carella, Angelo Michele" uniqKey="Carella A" first="Angelo-Michele" last="Carella">Angelo-Michele Carella</name><affiliation><nlm:affiliation>Hematology Unit, IRCCS AOU San Martino-IST, Genova, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Wei, Andrew" sort="Wei, Andrew" uniqKey="Wei A" first="Andrew" last="Wei">Andrew Wei</name><affiliation><nlm:affiliation>The Alfred Hospital and Monash University, Melbourne, VIC, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Hogge, Donna" sort="Hogge, Donna" uniqKey="Hogge D" first="Donna" last="Hogge">Donna Hogge</name><affiliation><nlm:affiliation>Vancouver General Hospital, Vancouver, BC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Craig, Adam R" sort="Craig, Adam R" uniqKey="Craig A" first="Adam R" last="Craig">Adam R. Craig</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fox, Judith A" sort="Fox, Judith A" uniqKey="Fox J" first="Judith A" last="Fox">Judith A. Fox</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ward, Renee" sort="Ward, Renee" uniqKey="Ward R" first="Renee" last="Ward">Renee Ward</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Smith, Jennifer A" sort="Smith, Jennifer A" uniqKey="Smith J" first="Jennifer A" last="Smith">Jennifer A. Smith</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Acton, Gary" sort="Acton, Gary" uniqKey="Acton G" first="Gary" last="Acton">Gary Acton</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mehta, Cyrus" sort="Mehta, Cyrus" uniqKey="Mehta C" first="Cyrus" last="Mehta">Cyrus Mehta</name><affiliation><nlm:affiliation>Cytel, Cambridge, MA, USA; Harvard School of Public Health, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Stuart, Robert K" sort="Stuart, Robert K" uniqKey="Stuart R" first="Robert K" last="Stuart">Robert K. Stuart</name><affiliation><nlm:affiliation>Medical University of South Carolina, Charleston, SC, USA.</nlm:affiliation></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:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26234174</idno><idno type="pmid">26234174</idno><idno type="doi">10.1016/S1470-2045(15)00201-6</idno><idno type="wicri:Area/PubMed/Corpus">002953</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002953</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study.</title><author><name sortKey="Ravandi, Farhad" sort="Ravandi, Farhad" uniqKey="Ravandi F" first="Farhad" last="Ravandi">Farhad Ravandi</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: fravandi@mdanderson.org.</nlm:affiliation></affiliation></author><author><name sortKey="Ritchie, Ellen K" sort="Ritchie, Ellen K" uniqKey="Ritchie E" first="Ellen K" last="Ritchie">Ellen K. Ritchie</name><affiliation><nlm:affiliation>Weill Cornell Medical Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sayar, Hamid" sort="Sayar, Hamid" uniqKey="Sayar H" first="Hamid" last="Sayar">Hamid Sayar</name><affiliation><nlm:affiliation>Indiana University Cancer Center, Indianapolis, IN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lancet, Jeffrey E" sort="Lancet, Jeffrey E" uniqKey="Lancet J" first="Jeffrey E" last="Lancet">Jeffrey E. Lancet</name><affiliation><nlm:affiliation>Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Craig, Michael D" sort="Craig, Michael D" uniqKey="Craig M" first="Michael D" last="Craig">Michael D. Craig</name><affiliation><nlm:affiliation>West Virginia University, Morgantown, WV, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Vey, Norbert" sort="Vey, Norbert" uniqKey="Vey N" first="Norbert" last="Vey">Norbert Vey</name><affiliation><nlm:affiliation>Institut Paoli-Calmettes and Aix-Marseille University, Marseille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Strickland, Stephen A" sort="Strickland, Stephen A" uniqKey="Strickland S" first="Stephen A" last="Strickland">Stephen A. Strickland</name><affiliation><nlm:affiliation>Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Schiller, Gary J" sort="Schiller, Gary J" uniqKey="Schiller G" first="Gary J" last="Schiller">Gary J. Schiller</name><affiliation><nlm:affiliation>University of California, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jabbour, Elias" sort="Jabbour, Elias" uniqKey="Jabbour E" first="Elias" last="Jabbour">Elias Jabbour</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Erba, Harry P" sort="Erba, Harry P" uniqKey="Erba H" first="Harry P" last="Erba">Harry P. Erba</name><affiliation><nlm:affiliation>Division of Hematology and Oncology, University of Alabama, Birmingham, AL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pigneux, Arnaud" sort="Pigneux, Arnaud" uniqKey="Pigneux A" first="Arnaud" last="Pigneux">Arnaud Pigneux</name><affiliation><nlm:affiliation>Université de Bordeaux, CHU de Bordeaux, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Horst, Heinz August" sort="Horst, Heinz August" uniqKey="Horst H" first="Heinz-August" last="Horst">Heinz-August Horst</name><affiliation><nlm:affiliation>Medizinische Klinik und Poliklinik, University Hospital Schleswig-Holstein, Kiel, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Recher, Christian" sort="Recher, Christian" uniqKey="Recher C" first="Christian" last="Recher">Christian Recher</name><affiliation><nlm:affiliation>Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III, CHU de Toulouse, Toulouse, France.</nlm:affiliation></affiliation></author><author><name sortKey="Klimek, Virginia M" sort="Klimek, Virginia M" uniqKey="Klimek V" first="Virginia M" last="Klimek">Virginia M. Klimek</name><affiliation><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Roboz, Gail J" sort="Roboz, Gail J" uniqKey="Roboz G" first="Gail J" last="Roboz">Gail J. Roboz</name><affiliation><nlm:affiliation>Weill Cornell Medical Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Odenike, Olatoyosi" sort="Odenike, Olatoyosi" uniqKey="Odenike O" first="Olatoyosi" last="Odenike">Olatoyosi Odenike</name><affiliation><nlm:affiliation>University of Chicago, Chicago, IL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Thomas, Xavier" sort="Thomas, Xavier" uniqKey="Thomas X" first="Xavier" last="Thomas">Xavier Thomas</name><affiliation><nlm:affiliation>Hôpital Edouard Herriot, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Havelange, Violaine" sort="Havelange, Violaine" uniqKey="Havelange V" first="Violaine" last="Havelange">Violaine Havelange</name><affiliation><nlm:affiliation>Cliniques Universitaires Saint-Luc, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Maertens, Johan" sort="Maertens, Johan" uniqKey="Maertens J" first="Johan" last="Maertens">Johan Maertens</name><affiliation><nlm:affiliation>Universitair Ziekenhuis, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Derigs, Hans Gunter" sort="Derigs, Hans Gunter" uniqKey="Derigs H" first="Hans-Günter" last="Derigs">Hans-Günter Derigs</name><affiliation><nlm:affiliation>Klinikum Frankfurt Main, Frankfurt, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Heuser, Michael" sort="Heuser, Michael" uniqKey="Heuser M" first="Michael" last="Heuser">Michael Heuser</name><affiliation><nlm:affiliation>Hannover Medical School, Hannover, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Damon, Lloyd" sort="Damon, Lloyd" uniqKey="Damon L" first="Lloyd" last="Damon">Lloyd Damon</name><affiliation><nlm:affiliation>UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Powell, Bayard L" sort="Powell, Bayard L" uniqKey="Powell B" first="Bayard L" last="Powell">Bayard L. Powell</name><affiliation><nlm:affiliation>Wake Forest University Baptist Medical Center-Comprehensive Cancer Center, Winston-Salem, NC, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name><affiliation><nlm:affiliation>Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Carella, Angelo Michele" sort="Carella, Angelo Michele" uniqKey="Carella A" first="Angelo-Michele" last="Carella">Angelo-Michele Carella</name><affiliation><nlm:affiliation>Hematology Unit, IRCCS AOU San Martino-IST, Genova, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Wei, Andrew" sort="Wei, Andrew" uniqKey="Wei A" first="Andrew" last="Wei">Andrew Wei</name><affiliation><nlm:affiliation>The Alfred Hospital and Monash University, Melbourne, VIC, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Hogge, Donna" sort="Hogge, Donna" uniqKey="Hogge D" first="Donna" last="Hogge">Donna Hogge</name><affiliation><nlm:affiliation>Vancouver General Hospital, Vancouver, BC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Craig, Adam R" sort="Craig, Adam R" uniqKey="Craig A" first="Adam R" last="Craig">Adam R. Craig</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Fox, Judith A" sort="Fox, Judith A" uniqKey="Fox J" first="Judith A" last="Fox">Judith A. Fox</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ward, Renee" sort="Ward, Renee" uniqKey="Ward R" first="Renee" last="Ward">Renee Ward</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Smith, Jennifer A" sort="Smith, Jennifer A" uniqKey="Smith J" first="Jennifer A" last="Smith">Jennifer A. Smith</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Acton, Gary" sort="Acton, Gary" uniqKey="Acton G" first="Gary" last="Acton">Gary Acton</name><affiliation><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mehta, Cyrus" sort="Mehta, Cyrus" uniqKey="Mehta C" first="Cyrus" last="Mehta">Cyrus Mehta</name><affiliation><nlm:affiliation>Cytel, Cambridge, MA, USA; Harvard School of Public Health, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Stuart, Robert K" sort="Stuart, Robert K" uniqKey="Stuart R" first="Robert K" last="Stuart">Robert K. Stuart</name><affiliation><nlm:affiliation>Medical University of South Carolina, Charleston, SC, USA.</nlm:affiliation></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:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Cytarabine (administration & dosage)</term><term>Disease-Free Survival</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Leukemia, Myeloid, Acute (drug therapy)</term><term>Leukemia, Myeloid, Acute (pathology)</term><term>Male</term><term>Middle Aged</term><term>Naphthyridines (administration & dosage)</term><term>Neoplasm Recurrence, Local (drug therapy)</term><term>Neoplasm Recurrence, Local (pathology)</term><term>Remission Induction</term><term>Thiazoles (administration & dosage)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Cytarabine</term><term>Naphthyridines</term><term>Thiazoles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myeloid, Acute</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Leukemia, Myeloid, Acute</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Disease-Free Survival</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Remission Induction</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Safe and effective treatments are urgently needed for patients with relapsed or refractory acute myeloid leukaemia. We investigated the efficacy and safety of vosaroxin, a first-in-class anticancer quinolone derivative, plus cytarabine in patients with relapsed or refractory acute myeloid leukaemia.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26234174</PMID><DateCreated><Year>2015</Year><Month>09</Month><Day>15</Day></DateCreated><DateCompleted><Year>2015</Year><Month>12</Month><Day>14</Day></DateCompleted><DateRevised><Year>2017</Year><Month>08</Month><Day>23</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><Issue>9</Issue><PubDate><Year>2015</Year><Month>Sep</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study.</ArticleTitle><Pagination><MedlinePgn>1025-1036</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(15)00201-6</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(15)00201-6</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Safe and effective treatments are urgently needed for patients with relapsed or refractory acute myeloid leukaemia. We investigated the efficacy and safety of vosaroxin, a first-in-class anticancer quinolone derivative, plus cytarabine in patients with relapsed or refractory acute myeloid leukaemia.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This phase 3, double-blind, placebo-controlled trial was undertaken at 101 international sites. Eligible patients with acute myeloid leukaemia were aged 18 years of age or older and had refractory disease or were in first relapse after one or two cycles of previous induction chemotherapy, including at least one cycle of anthracycline (or anthracenedione) plus cytarabine. Patients were randomly assigned 1:1 to vosaroxin (90 mg/m(2) intravenously on days 1 and 4 in a first cycle; 70 mg/m(2) in subsequent cycles) plus cytarabine (1 g/m(2) intravenously on days 1-5) or placebo plus cytarabine through a central interactive voice system with a permuted block procedure stratified by disease status, age, and geographical location. All participants were masked to treatment assignment. The primary efficacy endpoint was overall survival and the primary safety endpoint was 30-day and 60-day all-cause mortality. Efficacy analyses were done by intention to treat; safety analyses included all treated patients. This study is registered with ClinicalTrials.gov, number NCT01191801.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Dec 17, 2010, and Sept 25, 2013, 711 patients were randomly assigned to vosaroxin plus cytarabine (n=356) or placebo plus cytarabine (n=355). At the final analysis, median overall survival was 7·5 months (95% CI 6·4-8·5) in the vosaroxin plus cytarabine group and 6·1 months (5·2-7·1) in the placebo plus cytarabine group (hazard ratio 0·87, 95% CI 0·73-1·02; unstratified log-rank p=0·061; stratified p=0·024). A higher proportion of patients achieved complete remission in the vosaroxin plus cytarabine group than in the placebo plus cytarabine group (107 [30%] of 356 patients vs 58 [16%] of 355 patients, p<0·0001). Early mortality was similar between treatment groups (30-day: 28 [8%] of 355 patients in the vosaroxin plus cytarabine group vs 23 [7%] of 350 in the placebo plus cytarabine group; 60-day: 70 [20%] vs 68 [19%]). Treatment-related deaths occurred at any time in 20 (6%) of 355 patients given vosaroxin plus cytarabine and in eight (2%) of 350 patients given placebo plus cytarabine. Treatment-related serious adverse events occurred in 116 (33%) and 58 (17%) patients in each group, respectively. Grade 3 or worse adverse events that were more frequent in the vosaroxin plus cytarabine group than in the placebo plus cytarabine group included febrile neutropenia (167 [47%] vs 117 [33%]), neutropenia (66 [19%] vs 49 [14%]), stomatitis (54 [15%] vs 10 [3%]), hypokalaemia (52 [15%] vs 21 [6%]), bacteraemia (43 [12%] vs 16 [5%]), sepsis (42 [12%] vs 18 [5%]), and pneumonia (39 [11%] vs 26 [7%]).</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Although there was no significant difference in the primary endpoint between groups, the prespecified secondary analysis stratified by randomisation factors suggests that the addition of vosaroxin to cytarabine might be of clinical benefit to some patients with relapsed or refractory acute myeloid leukaemia.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Sunesis Pharmaceuticals.</AbstractText><CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ravandi</LastName><ForeName>Farhad</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: fravandi@mdanderson.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ritchie</LastName><ForeName>Ellen K</ForeName><Initials>EK</Initials><AffiliationInfo><Affiliation>Weill Cornell Medical Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sayar</LastName><ForeName>Hamid</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Indiana University Cancer Center, Indianapolis, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lancet</LastName><ForeName>Jeffrey E</ForeName><Initials>JE</Initials><AffiliationInfo><Affiliation>Moffitt Cancer Center, Tampa, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Craig</LastName><ForeName>Michael D</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>West Virginia University, Morgantown, WV, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vey</LastName><ForeName>Norbert</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Institut Paoli-Calmettes and Aix-Marseille University, Marseille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Strickland</LastName><ForeName>Stephen A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schiller</LastName><ForeName>Gary J</ForeName><Initials>GJ</Initials><AffiliationInfo><Affiliation>University of California, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jabbour</LastName><ForeName>Elias</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Erba</LastName><ForeName>Harry P</ForeName><Initials>HP</Initials><AffiliationInfo><Affiliation>Division of Hematology and Oncology, University of Alabama, Birmingham, AL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pigneux</LastName><ForeName>Arnaud</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Université de Bordeaux, CHU de Bordeaux, Bordeaux, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Horst</LastName><ForeName>Heinz-August</ForeName><Initials>HA</Initials><AffiliationInfo><Affiliation>Medizinische Klinik und Poliklinik, University Hospital Schleswig-Holstein, Kiel, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Recher</LastName><ForeName>Christian</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III, CHU de Toulouse, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Klimek</LastName><ForeName>Virginia M</ForeName><Initials>VM</Initials><AffiliationInfo><Affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cortes</LastName><ForeName>Jorge</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Roboz</LastName><ForeName>Gail J</ForeName><Initials>GJ</Initials><AffiliationInfo><Affiliation>Weill Cornell Medical Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Odenike</LastName><ForeName>Olatoyosi</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>University of Chicago, Chicago, IL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thomas</LastName><ForeName>Xavier</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Hôpital Edouard Herriot, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Havelange</LastName><ForeName>Violaine</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Cliniques Universitaires Saint-Luc, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maertens</LastName><ForeName>Johan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Universitair Ziekenhuis, Leuven, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Derigs</LastName><ForeName>Hans-Günter</ForeName><Initials>HG</Initials><AffiliationInfo><Affiliation>Klinikum Frankfurt Main, Frankfurt, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Heuser</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Hannover Medical School, Hannover, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Damon</LastName><ForeName>Lloyd</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Powell</LastName><ForeName>Bayard L</ForeName><Initials>BL</Initials><AffiliationInfo><Affiliation>Wake Forest University Baptist Medical Center-Comprehensive Cancer Center, Winston-Salem, NC, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gaidano</LastName><ForeName>Gianluca</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carella</LastName><ForeName>Angelo-Michele</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Hematology Unit, IRCCS AOU San Martino-IST, Genova, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wei</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>The Alfred Hospital and Monash University, Melbourne, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hogge</LastName><ForeName>Donna</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Vancouver General Hospital, Vancouver, BC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Craig</LastName><ForeName>Adam R</ForeName><Initials>AR</Initials><AffiliationInfo><Affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fox</LastName><ForeName>Judith A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ward</LastName><ForeName>Renee</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Jennifer A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Acton</LastName><ForeName>Gary</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mehta</LastName><ForeName>Cyrus</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Cytel, Cambridge, MA, USA; Harvard School of Public Health, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stuart</LastName><ForeName>Robert K</ForeName><Initials>RK</Initials><AffiliationInfo><Affiliation>Medical University of South Carolina, Charleston, SC, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kantarjian</LastName><ForeName>Hagop M</ForeName><Initials>HM</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01191801</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>P30 CA016672</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>07</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Oncol</MedlineTA><NlmUniqueID>100957246</NlmUniqueID><ISSNLinking>1470-2045</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D009287">Naphthyridines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013844">Thiazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>04079A1RDZ</RegistryNumber><NameOfSubstance UI="D003561">Cytarabine</NameOfSubstance></Chemical><Chemical><RegistryNumber>K6A90IIZ19</RegistryNumber><NameOfSubstance 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Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015470" MajorTopicYN="N">Leukemia, Myeloid, Acute</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009287" MajorTopicYN="N">Naphthyridines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009364" MajorTopicYN="N">Neoplasm Recurrence, Local</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012074" MajorTopicYN="N">Remission Induction</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013844" MajorTopicYN="N">Thiazoles</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">NIHMS769284</OtherID><OtherID Source="NLM">PMC4822512</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>04</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2015</Year><Month>05</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>05</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>8</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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