Serveur d'exploration sur les relations entre la France et l'Australie

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Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2.

Identifieur interne : 001E42 ( PubMed/Checkpoint ); précédent : 001E41; suivant : 001E43

Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2.

Auteurs : Bradley J. Monk [États-Unis] ; Andrés Poveda [Espagne] ; Ignace Vergote [Belgique] ; Francesco Raspagliesi [Italie] ; Keiichi Fujiwara [Japon] ; Duk-Soo Bae [Corée du Sud] ; Ana Oaknin [Espagne] ; Isabelle Ray-Coquard [France] ; Diane M. Provencher [Canada] ; Beth Y. Karlan [États-Unis] ; Catherine Lhommé [France] ; Gary Richardson [Australie] ; Dolores Gallardo Rinc N [Mexique] ; Robert L. Coleman [États-Unis] ; Christian Marth [Autriche] ; Arija Brize [Lettonie] ; Michel Fabbro [France] ; Andrés Redondo [Espagne] ; Aristotelis Bamias [Grèce] ; Haijun Ma [États-Unis] ; Florian D. Vogl [États-Unis] ; Bruce A. Bach [États-Unis] ; Amit M. Oza [Canada]

Source :

RBID : pubmed:27546885

Descripteurs français

English descriptors

Abstract

Trebananib, a peptibody that blocks binding of angiopoietin-1 and -2 to Tie2, significantly prolonged progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer in the phase 3 TRINOVA-1 study. We report overall survival (OS) in the intent-to-treat population and clinically relevant subgroups and time to second disease progression (PFS-2).

DOI: 10.1016/j.ygyno.2016.07.112
PubMed: 27546885


Affiliations:


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pubmed:27546885

Le document en format XML

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<title xml:lang="en">Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2.</title>
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<name sortKey="Monk, Bradley J" sort="Monk, Bradley J" uniqKey="Monk B" first="Bradley J" last="Monk">Bradley J. Monk</name>
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<nlm:affiliation>Department of Obstetrics and Gynecology, University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA. Electronic address: bradley.monk@chw.edu.</nlm:affiliation>
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<wicri:regionArea>Department of Obstetrics and Gynecology, University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ</wicri:regionArea>
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<nlm:affiliation>Area Clinica de Oncologia Ginecológica, Fundación Instituto Valenciano de Oncología, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<name sortKey="Vergote, Ignace" sort="Vergote, Ignace" uniqKey="Vergote I" first="Ignace" last="Vergote">Ignace Vergote</name>
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<nlm:affiliation>Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven Cancer Institute, KU Leuven, European Union, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven Cancer Institute, KU Leuven, European Union</wicri:regionArea>
<wicri:noRegion>European Union</wicri:noRegion>
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<name sortKey="Raspagliesi, Francesco" sort="Raspagliesi, Francesco" uniqKey="Raspagliesi F" first="Francesco" last="Raspagliesi">Francesco Raspagliesi</name>
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<nlm:affiliation>Gynecologic Oncology Unit, Fondazione IRCCS, Istituto Nazionale per la Cura e lo Studio dei Tumori, Milano, Italy.</nlm:affiliation>
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<name sortKey="Fujiwara, Keiichi" sort="Fujiwara, Keiichi" uniqKey="Fujiwara K" first="Keiichi" last="Fujiwara">Keiichi Fujiwara</name>
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<nlm:affiliation>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi, Japan.</nlm:affiliation>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi</wicri:regionArea>
<wicri:noRegion>Hidaka-Shi</wicri:noRegion>
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<name sortKey="Bae, Duk Soo" sort="Bae, Duk Soo" uniqKey="Bae D" first="Duk-Soo" last="Bae">Duk-Soo Bae</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, South Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul</wicri:regionArea>
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<settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
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<name sortKey="Oaknin, Ana" sort="Oaknin, Ana" uniqKey="Oaknin A" first="Ana" last="Oaknin">Ana Oaknin</name>
<affiliation wicri:level="3">
<nlm:affiliation>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona</wicri:regionArea>
<placeName>
<settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
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<author>
<name sortKey="Ray Coquard, Isabelle" sort="Ray Coquard, Isabelle" uniqKey="Ray Coquard I" first="Isabelle" last="Ray-Coquard">Isabelle Ray-Coquard</name>
<affiliation wicri:level="3">
<nlm:affiliation>Université Lyon-I, Centre Léon Bérard, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Lyon-I, Centre Léon Bérard, Lyon</wicri:regionArea>
<placeName>
<region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
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<name sortKey="Provencher, Diane M" sort="Provencher, Diane M" uniqKey="Provencher D" first="Diane M" last="Provencher">Diane M. Provencher</name>
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<nlm:affiliation>Division of Gynecologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Division of Gynecologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC</wicri:regionArea>
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<name sortKey="Karlan, Beth Y" sort="Karlan, Beth Y" uniqKey="Karlan B" first="Beth Y" last="Karlan">Beth Y. Karlan</name>
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<nlm:affiliation>Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA</wicri:regionArea>
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<region type="state">Californie</region>
</placeName>
</affiliation>
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<name sortKey="Lhomme, Catherine" sort="Lhomme, Catherine" uniqKey="Lhomme C" first="Catherine" last="Lhommé">Catherine Lhommé</name>
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<nlm:affiliation>Department of Medicine, Institut Gustave Roussy, Villejuif, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Medicine, Institut Gustave Roussy, Villejuif</wicri:regionArea>
<wicri:noRegion>Villejuif</wicri:noRegion>
<wicri:noRegion>Villejuif</wicri:noRegion>
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<name sortKey="Richardson, Gary" sort="Richardson, Gary" uniqKey="Richardson G" first="Gary" last="Richardson">Gary Richardson</name>
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<nlm:affiliation>Academic Haematology and Oncology, Cabrini Hospital, Malvern, VIC, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
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<wicri:noRegion>VIC</wicri:noRegion>
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<name sortKey="Rinc N, Dolores Gallardo" sort="Rinc N, Dolores Gallardo" uniqKey="Rinc N D" first="Dolores Gallardo" last="Rinc N">Dolores Gallardo Rinc N</name>
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<nlm:affiliation>Subdirección de Medicina Interna, Instituto Nacional de Cancerologia, Mexico City, Mexico.</nlm:affiliation>
<country xml:lang="fr">Mexique</country>
<wicri:regionArea>Subdirección de Medicina Interna, Instituto Nacional de Cancerologia, Mexico City</wicri:regionArea>
<wicri:noRegion>Mexico City</wicri:noRegion>
</affiliation>
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<name sortKey="Coleman, Robert L" sort="Coleman, Robert L" uniqKey="Coleman R" first="Robert L" last="Coleman">Robert L. Coleman</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
<placeName>
<region type="state">Texas</region>
</placeName>
</affiliation>
</author>
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<name sortKey="Marth, Christian" sort="Marth, Christian" uniqKey="Marth C" first="Christian" last="Marth">Christian Marth</name>
<affiliation wicri:level="1">
<nlm:affiliation>Universitätsklinik für Gynäkologie und Geburtshilfe, Medizinische Universität Innsbruck, Innsbruck, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Universitätsklinik für Gynäkologie und Geburtshilfe, Medizinische Universität Innsbruck, Innsbruck</wicri:regionArea>
<wicri:noRegion>Innsbruck</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Brize, Arija" sort="Brize, Arija" uniqKey="Brize A" first="Arija" last="Brize">Arija Brize</name>
<affiliation wicri:level="1">
<nlm:affiliation>Latvian Oncology Center, Riga Eastern Clinical University Hospital, Riga, Latvia.</nlm:affiliation>
<country xml:lang="fr">Lettonie</country>
<wicri:regionArea>Latvian Oncology Center, Riga Eastern Clinical University Hospital, Riga</wicri:regionArea>
<wicri:noRegion>Riga</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Fabbro, Michel" sort="Fabbro, Michel" uniqKey="Fabbro M" first="Michel" last="Fabbro">Michel Fabbro</name>
<affiliation wicri:level="3">
<nlm:affiliation>Regional Cancer Institute Montpellier, Montpellier, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Regional Cancer Institute Montpellier, Montpellier</wicri:regionArea>
<placeName>
<region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
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<author>
<name sortKey="Redondo, Andres" sort="Redondo, Andres" uniqKey="Redondo A" first="Andrés" last="Redondo">Andrés Redondo</name>
<affiliation wicri:level="3">
<nlm:affiliation>Hospital Universitario La Paz Idi-Paz, Madrid, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitario La Paz Idi-Paz, Madrid</wicri:regionArea>
<placeName>
<settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Bamias, Aristotelis" sort="Bamias, Aristotelis" uniqKey="Bamias A" first="Aristotelis" last="Bamias">Aristotelis Bamias</name>
<affiliation wicri:level="3">
<nlm:affiliation>Alexandra Hospital, Department of Clinical Therapeutics, National & Kapodistrian University of Athens, Athens, Greece.</nlm:affiliation>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea>Alexandra Hospital, Department of Clinical Therapeutics, National & Kapodistrian University of Athens, Athens</wicri:regionArea>
<placeName>
<settlement type="city">Athènes</settlement>
<region nuts="2" type="region">Attique (région)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Ma, Haijun" sort="Ma, Haijun" uniqKey="Ma H" first="Haijun" last="Ma">Haijun Ma</name>
<affiliation wicri:level="2">
<nlm:affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
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<author>
<name sortKey="Vogl, Florian D" sort="Vogl, Florian D" uniqKey="Vogl F" first="Florian D" last="Vogl">Florian D. Vogl</name>
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<nlm:affiliation>Global Development Oncology, Amgen Inc., Thousand Oaks, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Global Development Oncology, Amgen Inc., Thousand Oaks, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
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<author>
<name sortKey="Bach, Bruce A" sort="Bach, Bruce A" uniqKey="Bach B" first="Bruce A" last="Bach">Bruce A. Bach</name>
<affiliation wicri:level="2">
<nlm:affiliation>Global Development Oncology, Amgen Inc., Thousand Oaks, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Global Development Oncology, Amgen Inc., Thousand Oaks, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name>
<affiliation wicri:level="4">
<nlm:affiliation>Department of Medicine, Princess Margaret Hospital, University of Toronto, ON, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Medicine, Princess Margaret Hospital, University of Toronto, ON</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
<placeName>
<settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
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<title xml:lang="en">Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2.</title>
<author>
<name sortKey="Monk, Bradley J" sort="Monk, Bradley J" uniqKey="Monk B" first="Bradley J" last="Monk">Bradley J. Monk</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Obstetrics and Gynecology, University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA. Electronic address: bradley.monk@chw.edu.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Obstetrics and Gynecology, University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ</wicri:regionArea>
<placeName>
<region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
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<name sortKey="Poveda, Andres" sort="Poveda, Andres" uniqKey="Poveda A" first="Andrés" last="Poveda">Andrés Poveda</name>
<affiliation wicri:level="1">
<nlm:affiliation>Area Clinica de Oncologia Ginecológica, Fundación Instituto Valenciano de Oncología, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Area Clinica de Oncologia Ginecológica, Fundación Instituto Valenciano de Oncología, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Vergote, Ignace" sort="Vergote, Ignace" uniqKey="Vergote I" first="Ignace" last="Vergote">Ignace Vergote</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven Cancer Institute, KU Leuven, European Union, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven Cancer Institute, KU Leuven, European Union</wicri:regionArea>
<wicri:noRegion>European Union</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Raspagliesi, Francesco" sort="Raspagliesi, Francesco" uniqKey="Raspagliesi F" first="Francesco" last="Raspagliesi">Francesco Raspagliesi</name>
<affiliation wicri:level="1">
<nlm:affiliation>Gynecologic Oncology Unit, Fondazione IRCCS, Istituto Nazionale per la Cura e lo Studio dei Tumori, Milano, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Gynecologic Oncology Unit, Fondazione IRCCS, Istituto Nazionale per la Cura e lo Studio dei Tumori, Milano</wicri:regionArea>
<wicri:noRegion>Milano</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Fujiwara, Keiichi" sort="Fujiwara, Keiichi" uniqKey="Fujiwara K" first="Keiichi" last="Fujiwara">Keiichi Fujiwara</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi, Japan.</nlm:affiliation>
<country xml:lang="fr">Japon</country>
<wicri:regionArea>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi</wicri:regionArea>
<wicri:noRegion>Hidaka-Shi</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Bae, Duk Soo" sort="Bae, Duk Soo" uniqKey="Bae D" first="Duk-Soo" last="Bae">Duk-Soo Bae</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, South Korea.</nlm:affiliation>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul</wicri:regionArea>
<placeName>
<settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Oaknin, Ana" sort="Oaknin, Ana" uniqKey="Oaknin A" first="Ana" last="Oaknin">Ana Oaknin</name>
<affiliation wicri:level="3">
<nlm:affiliation>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona</wicri:regionArea>
<placeName>
<settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Ray Coquard, Isabelle" sort="Ray Coquard, Isabelle" uniqKey="Ray Coquard I" first="Isabelle" last="Ray-Coquard">Isabelle Ray-Coquard</name>
<affiliation wicri:level="3">
<nlm:affiliation>Université Lyon-I, Centre Léon Bérard, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Lyon-I, Centre Léon Bérard, Lyon</wicri:regionArea>
<placeName>
<region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Provencher, Diane M" sort="Provencher, Diane M" uniqKey="Provencher D" first="Diane M" last="Provencher">Diane M. Provencher</name>
<affiliation wicri:level="1">
<nlm:affiliation>Division of Gynecologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Division of Gynecologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC</wicri:regionArea>
<wicri:noRegion>QC</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Karlan, Beth Y" sort="Karlan, Beth Y" uniqKey="Karlan B" first="Beth Y" last="Karlan">Beth Y. Karlan</name>
<affiliation wicri:level="2">
<nlm:affiliation>Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lhomme, Catherine" sort="Lhomme, Catherine" uniqKey="Lhomme C" first="Catherine" last="Lhommé">Catherine Lhommé</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Medicine, Institut Gustave Roussy, Villejuif, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Medicine, Institut Gustave Roussy, Villejuif</wicri:regionArea>
<wicri:noRegion>Villejuif</wicri:noRegion>
<wicri:noRegion>Villejuif</wicri:noRegion>
</affiliation>
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<term>Neoplasm Recurrence, Local (mortality)</term>
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<term>Recombinant Fusion Proteins (adverse effects)</term>
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<div type="abstract" xml:lang="en">Trebananib, a peptibody that blocks binding of angiopoietin-1 and -2 to Tie2, significantly prolonged progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer in the phase 3 TRINOVA-1 study. We report overall survival (OS) in the intent-to-treat population and clinically relevant subgroups and time to second disease progression (PFS-2).</div>
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<DateCreated>
<Year>2016</Year>
<Month>09</Month>
<Day>21</Day>
</DateCreated>
<DateCompleted>
<Year>2017</Year>
<Month>05</Month>
<Day>12</Day>
</DateCompleted>
<DateRevised>
<Year>2017</Year>
<Month>10</Month>
<Day>21</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1095-6859</ISSN>
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<Volume>143</Volume>
<Issue>1</Issue>
<PubDate>
<Year>2016</Year>
<Month>Oct</Month>
</PubDate>
</JournalIssue>
<Title>Gynecologic oncology</Title>
<ISOAbbreviation>Gynecol. Oncol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2.</ArticleTitle>
<Pagination>
<MedlinePgn>27-34</MedlinePgn>
</Pagination>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ygyno.2016.07.112</ELocationID>
<Abstract>
<AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">Trebananib, a peptibody that blocks binding of angiopoietin-1 and -2 to Tie2, significantly prolonged progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer in the phase 3 TRINOVA-1 study. We report overall survival (OS) in the intent-to-treat population and clinically relevant subgroups and time to second disease progression (PFS-2).</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Women with recurrent disease (platinum-free interval<12months) were randomized to receive intravenous paclitaxel 80mg/m(2) (3weeks on/1week off) plus intravenous trebananib 15mg/kg or placebo, weekly. OS in the intent-to-treat population was a key secondary endpoint. Exploratory analysis of PFS-2 was conducted according to guidance by the European Medicines Agency.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Median OS was not significantly improved with trebananib compared with placebo (19.3 versus 18.3months; HR, 0.95; 95% CI, 0.81-1.11; P=0.52) in the intent-to-treat population (n=919). In subgroup analysis, trebananib improved median OS compared with placebo (14.5 versus 12.3months; HR, 0.72; 95% CI, 0.55-0.93; P=0.011) in patients with ascites at baseline (n=295). In the intent-to-treat population, trebananib significantly improved median PFS-2 compared with placebo (12.5 versus 10.9months; HR, 0.85; 95% CI, 0.74-0.98; P=0.024). The incidence and type of adverse events in this updated analysis was consistent with that described in the primary analysis; no new safety signals were detected.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">OS was not significantly longer in the intent-to-treat population, although there was an improvement in OS in patients with ascites receiving trebananib. PFS-2 confirmed that the PFS benefit associated with trebananib was maintained through the second disease progression independent of the choice of subsequent therapy.</AbstractText>
<CopyrightInformation>Copyright © 2016 Elsevier Inc. All rights reserved.</CopyrightInformation>
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<LastName>Monk</LastName>
<ForeName>Bradley J</ForeName>
<Initials>BJ</Initials>
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<Affiliation>Department of Obstetrics and Gynecology, University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA. Electronic address: bradley.monk@chw.edu.</Affiliation>
</AffiliationInfo>
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<Initials>A</Initials>
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</AffiliationInfo>
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<AffiliationInfo>
<Affiliation>Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven Cancer Institute, KU Leuven, European Union, Belgium.</Affiliation>
</AffiliationInfo>
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<Affiliation>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi, Japan.</Affiliation>
</AffiliationInfo>
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<LastName>Bae</LastName>
<ForeName>Duk-Soo</ForeName>
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<Affiliation>Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, South Korea.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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<Affiliation>Division of Gynecologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.</Affiliation>
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<Affiliation>Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.</Affiliation>
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<LastName>Lhommé</LastName>
<ForeName>Catherine</ForeName>
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<Affiliation>Department of Medicine, Institut Gustave Roussy, Villejuif, France.</Affiliation>
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<LastName>Richardson</LastName>
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<LastName>Fabbro</LastName>
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<Affiliation>Department of Medicine, Princess Margaret Hospital, University of Toronto, ON, Canada.</Affiliation>
</AffiliationInfo>
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