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 : 002884 ( PubMed/Curation ); précédent : 002883; suivant : 002885Vosaroxin 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 [États-Unis] ; Ellen K. Ritchie [États-Unis] ; Hamid Sayar [États-Unis] ; Jeffrey E. Lancet [États-Unis] ; Michael D. Craig [États-Unis] ; Norbert Vey [France] ; Stephen A. Strickland [États-Unis] ; Gary J. Schiller [États-Unis] ; Elias Jabbour [États-Unis] ; Harry P. Erba [États-Unis] ; Arnaud Pigneux [France] ; Heinz-August Horst [Allemagne] ; Christian Recher [France] ; Virginia M. Klimek [États-Unis] ; Jorge Cortes [États-Unis] ; Gail J. Roboz [États-Unis] ; Olatoyosi Odenike [États-Unis] ; Xavier Thomas [France] ; Violaine Havelange [Belgique] ; Johan Maertens [Belgique] ; Hans-Günter Derigs [Allemagne] ; Michael Heuser [Allemagne] ; Lloyd Damon [États-Unis] ; Bayard L. Powell [États-Unis] ; Gianluca Gaidano [Italie] ; Angelo-Michele Carella [Italie] ; Andrew Wei [Australie] ; Donna Hogge [Canada] ; Adam R. Craig [États-Unis] ; Judith A. Fox [États-Unis] ; Renee Ward [États-Unis] ; Jennifer A. Smith [États-Unis] ; Gary Acton [États-Unis] ; Cyrus Mehta [États-Unis] ; Robert K. Stuart [États-Unis] ; Hagop M. Kantarjian [États-Unis]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Cytarabine (administration et posologie), Estimation de Kaplan-Meier, Femelle, Humains, Induction de rémission, Leucémie aigüe myéloïde (anatomopathologie), Leucémie aigüe myéloïde (traitement médicamenteux), Mâle, Méthode en double aveugle, Naphtyridines (administration et posologie), Protocoles de polychimiothérapie antinéoplasique, Récidive tumorale locale (anatomopathologie), Récidive tumorale locale (traitement médicamenteux), Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Thiazoles (administration et posologie).
- MESH :
- administration et posologie : Cytarabine, Naphtyridines, Thiazoles.
- anatomopathologie : Leucémie aigüe myéloïde, Récidive tumorale locale.
- traitement médicamenteux : Leucémie aigüe myéloïde, Récidive tumorale locale.
- Adulte, Adulte d'âge moyen, Estimation de Kaplan-Meier, Femelle, Humains, Induction de rémission, Mâle, Méthode en double aveugle, Protocoles de polychimiothérapie antinéoplasique, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute.
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
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pubmed:26234174Le document en format XML
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<author><name sortKey="Vey, Norbert" sort="Vey, Norbert" uniqKey="Vey N" first="Norbert" last="Vey">Norbert Vey</name>
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<author><name sortKey="Schiller, Gary J" sort="Schiller, Gary J" uniqKey="Schiller G" first="Gary J" last="Schiller">Gary J. Schiller</name>
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<author><name sortKey="Jabbour, Elias" sort="Jabbour, Elias" uniqKey="Jabbour E" first="Elias" last="Jabbour">Elias Jabbour</name>
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<author><name sortKey="Erba, Harry P" sort="Erba, Harry P" uniqKey="Erba H" first="Harry P" last="Erba">Harry P. Erba</name>
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<author><name sortKey="Horst, Heinz August" sort="Horst, Heinz August" uniqKey="Horst H" first="Heinz-August" last="Horst">Heinz-August Horst</name>
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<author><name sortKey="Recher, Christian" sort="Recher, Christian" uniqKey="Recher C" first="Christian" last="Recher">Christian Recher</name>
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<author><name sortKey="Klimek, Virginia M" sort="Klimek, Virginia M" uniqKey="Klimek V" first="Virginia M" last="Klimek">Virginia M. Klimek</name>
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<author><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name>
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<author><name sortKey="Maertens, Johan" sort="Maertens, Johan" uniqKey="Maertens J" first="Johan" last="Maertens">Johan Maertens</name>
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<author><name sortKey="Heuser, Michael" sort="Heuser, Michael" uniqKey="Heuser M" first="Michael" last="Heuser">Michael Heuser</name>
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<wicri:regionArea>Hannover Medical School, Hannover</wicri:regionArea>
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<author><name sortKey="Damon, Lloyd" sort="Damon, Lloyd" uniqKey="Damon L" first="Lloyd" last="Damon">Lloyd Damon</name>
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<author><name sortKey="Powell, Bayard L" sort="Powell, Bayard L" uniqKey="Powell B" first="Bayard L" last="Powell">Bayard L. Powell</name>
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<author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name>
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<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara</wicri:regionArea>
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<author><name sortKey="Carella, Angelo Michele" sort="Carella, Angelo Michele" uniqKey="Carella A" first="Angelo-Michele" last="Carella">Angelo-Michele Carella</name>
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<author><name sortKey="Wei, Andrew" sort="Wei, Andrew" uniqKey="Wei A" first="Andrew" last="Wei">Andrew Wei</name>
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<author><name sortKey="Hogge, Donna" sort="Hogge, Donna" uniqKey="Hogge D" first="Donna" last="Hogge">Donna Hogge</name>
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<author><name sortKey="Craig, Adam R" sort="Craig, Adam R" uniqKey="Craig A" first="Adam R" last="Craig">Adam R. Craig</name>
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</affiliation>
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<author><name sortKey="Fox, Judith A" sort="Fox, Judith A" uniqKey="Fox J" first="Judith A" last="Fox">Judith A. Fox</name>
<affiliation wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</affiliation>
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<author><name sortKey="Ward, Renee" sort="Ward, Renee" uniqKey="Ward R" first="Renee" last="Ward">Renee Ward</name>
<affiliation wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Smith, Jennifer A" sort="Smith, Jennifer A" uniqKey="Smith J" first="Jennifer A" last="Smith">Jennifer A. Smith</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</affiliation>
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<author><name sortKey="Acton, Gary" sort="Acton, Gary" uniqKey="Acton G" first="Gary" last="Acton">Gary Acton</name>
<affiliation wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mehta, Cyrus" sort="Mehta, Cyrus" uniqKey="Mehta C" first="Cyrus" last="Mehta">Cyrus Mehta</name>
<affiliation wicri:level="1"><nlm:affiliation>Cytel, Cambridge, MA, USA; Harvard School of Public Health, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cytel, Cambridge, MA, USA; Harvard School of Public Health, Cambridge, MA</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Medical University of South Carolina, Charleston, SC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Medical University of South Carolina, Charleston, SC</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
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<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 wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: fravandi@mdanderson.org.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Weill Cornell Medical Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Weill Cornell Medical Center, New York, NY</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Sayar, Hamid" sort="Sayar, Hamid" uniqKey="Sayar H" first="Hamid" last="Sayar">Hamid Sayar</name>
<affiliation wicri:level="1"><nlm:affiliation>Indiana University Cancer Center, Indianapolis, IN, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Indiana University Cancer Center, Indianapolis, IN</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Moffitt Cancer Center, Tampa, FL</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>West Virginia University, Morgantown, WV, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>West Virginia University, Morgantown, WV</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Vey, Norbert" sort="Vey, Norbert" uniqKey="Vey N" first="Norbert" last="Vey">Norbert Vey</name>
<affiliation wicri:level="1"><nlm:affiliation>Institut Paoli-Calmettes and Aix-Marseille University, Marseille, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Institut Paoli-Calmettes and Aix-Marseille University, Marseille</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vanderbilt-Ingram Cancer Center, Nashville, TN</wicri:regionArea>
</affiliation>
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<author><name sortKey="Schiller, Gary J" sort="Schiller, Gary J" uniqKey="Schiller G" first="Gary J" last="Schiller">Gary J. Schiller</name>
<affiliation wicri:level="1"><nlm:affiliation>University of California, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of California, Los Angeles, CA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Jabbour, Elias" sort="Jabbour, Elias" uniqKey="Jabbour E" first="Elias" last="Jabbour">Elias Jabbour</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Division of Hematology and Oncology, University of Alabama, Birmingham, AL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Hematology and Oncology, University of Alabama, Birmingham, AL</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Pigneux, Arnaud" sort="Pigneux, Arnaud" uniqKey="Pigneux A" first="Arnaud" last="Pigneux">Arnaud Pigneux</name>
<affiliation wicri:level="1"><nlm:affiliation>Université de Bordeaux, CHU de Bordeaux, Bordeaux, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université de Bordeaux, CHU de Bordeaux, Bordeaux</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Medizinische Klinik und Poliklinik, University Hospital Schleswig-Holstein, Kiel, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Medizinische Klinik und Poliklinik, University Hospital Schleswig-Holstein, Kiel</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Recher, Christian" sort="Recher, Christian" uniqKey="Recher C" first="Christian" last="Recher">Christian Recher</name>
<affiliation wicri:level="1"><nlm:affiliation>Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III, CHU de Toulouse, Toulouse, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III, CHU de Toulouse, Toulouse</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memorial Sloan-Kettering Cancer Center, New York, NY</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Weill Cornell Medical Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Weill Cornell Medical Center, New York, NY</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Odenike, Olatoyosi" sort="Odenike, Olatoyosi" uniqKey="Odenike O" first="Olatoyosi" last="Odenike">Olatoyosi Odenike</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Chicago, Chicago, IL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Chicago, Chicago, IL</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Thomas, Xavier" sort="Thomas, Xavier" uniqKey="Thomas X" first="Xavier" last="Thomas">Xavier Thomas</name>
<affiliation wicri:level="1"><nlm:affiliation>Hôpital Edouard Herriot, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hôpital Edouard Herriot, Lyon</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Havelange, Violaine" sort="Havelange, Violaine" uniqKey="Havelange V" first="Violaine" last="Havelange">Violaine Havelange</name>
<affiliation wicri:level="1"><nlm:affiliation>Cliniques Universitaires Saint-Luc, Brussels, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Cliniques Universitaires Saint-Luc, Brussels</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Maertens, Johan" sort="Maertens, Johan" uniqKey="Maertens J" first="Johan" last="Maertens">Johan Maertens</name>
<affiliation wicri:level="1"><nlm:affiliation>Universitair Ziekenhuis, Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Universitair Ziekenhuis, Leuven</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Klinikum Frankfurt Main, Frankfurt, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Klinikum Frankfurt Main, Frankfurt</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Heuser, Michael" sort="Heuser, Michael" uniqKey="Heuser M" first="Michael" last="Heuser">Michael Heuser</name>
<affiliation wicri:level="1"><nlm:affiliation>Hannover Medical School, Hannover, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Hannover Medical School, Hannover</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Damon, Lloyd" sort="Damon, Lloyd" uniqKey="Damon L" first="Lloyd" last="Damon">Lloyd Damon</name>
<affiliation wicri:level="1"><nlm:affiliation>UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Wake Forest University Baptist Medical Center-Comprehensive Cancer Center, Winston-Salem, NC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Wake Forest University Baptist Medical Center-Comprehensive Cancer Center, Winston-Salem, NC</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Hematology Unit, IRCCS AOU San Martino-IST, Genova, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Hematology Unit, IRCCS AOU San Martino-IST, Genova</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Wei, Andrew" sort="Wei, Andrew" uniqKey="Wei A" first="Andrew" last="Wei">Andrew Wei</name>
<affiliation wicri:level="1"><nlm:affiliation>The Alfred Hospital and Monash University, Melbourne, VIC, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>The Alfred Hospital and Monash University, Melbourne, VIC</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Hogge, Donna" sort="Hogge, Donna" uniqKey="Hogge D" first="Donna" last="Hogge">Donna Hogge</name>
<affiliation wicri:level="1"><nlm:affiliation>Vancouver General Hospital, Vancouver, BC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Vancouver General Hospital, Vancouver, BC</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Ward, Renee" sort="Ward, Renee" uniqKey="Ward R" first="Renee" last="Ward">Renee Ward</name>
<affiliation wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Acton, Gary" sort="Acton, Gary" uniqKey="Acton G" first="Gary" last="Acton">Gary Acton</name>
<affiliation wicri:level="1"><nlm:affiliation>Sunesis Pharmaceuticals, South San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sunesis Pharmaceuticals, South San Francisco, CA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mehta, Cyrus" sort="Mehta, Cyrus" uniqKey="Mehta C" first="Cyrus" last="Mehta">Cyrus Mehta</name>
<affiliation wicri:level="1"><nlm:affiliation>Cytel, Cambridge, MA, USA; Harvard School of Public Health, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cytel, Cambridge, MA, USA; Harvard School of Public Health, Cambridge, MA</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Medical University of South Carolina, Charleston, SC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Medical University of South Carolina, Charleston, SC</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
</affiliation>
</author>
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<series><title level="j">The Lancet. Oncology</title>
<idno type="eISSN">1474-5488</idno>
<imprint><date when="2015" type="published">2015</date>
</imprint>
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<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>
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<term>Adulte d'âge moyen</term>
<term>Cytarabine (administration et posologie)</term>
<term>Estimation de Kaplan-Meier</term>
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<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>
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