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 : 003A15 ( Ncbi/Merge ); précédent : 003A14; suivant : 003A16Final 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 :
- Gynecologic oncology [ 1095-6859 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Ascites (étiologie), Femelle, Humains, Méthode en double aveugle, Paclitaxel (administration et posologie), Paclitaxel (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Protéines de fusion recombinantes (administration et posologie), Protéines de fusion recombinantes (effets indésirables), Récidive tumorale locale (mortalité), Récidive tumorale locale (traitement médicamenteux), Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs de l'ovaire (), Tumeurs de l'ovaire (mortalité), Tumeurs de l'ovaire (traitement médicamenteux).
- MESH :
- administration et posologie : Paclitaxel, Protéines de fusion recombinantes.
- effets indésirables : Paclitaxel, Protéines de fusion recombinantes.
- mortalité : Récidive tumorale locale, Tumeurs de l'ovaire.
- traitement médicamenteux : Récidive tumorale locale, Tumeurs de l'ovaire.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- étiologie : Ascites.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Méthode en double aveugle, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs de l'ovaire.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Ascites (etiology), Disease-Free Survival, Double-Blind Method, Female, Humans, Middle Aged, Neoplasm Recurrence, Local (drug therapy), Neoplasm Recurrence, Local (mortality), Ovarian Neoplasms (complications), Ovarian Neoplasms (drug therapy), Ovarian Neoplasms (mortality), Paclitaxel (administration & dosage), Paclitaxel (adverse effects), Recombinant Fusion Proteins (administration & dosage), Recombinant Fusion Proteins (adverse effects).
- MESH :
- chemical , administration & dosage : Paclitaxel, Recombinant Fusion Proteins.
- chemical , adverse effects : Paclitaxel, Recombinant Fusion Proteins.
- complications : Ovarian Neoplasms.
- drug therapy : Neoplasm Recurrence, Local, Ovarian Neoplasms.
- etiology : Ascites.
- mortality : Neoplasm Recurrence, Local, Ovarian Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Double-Blind Method, Female, Humans, Middle Aged.
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
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pubmed:27546885Le document en format XML
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<author><name sortKey="Raspagliesi, Francesco" sort="Raspagliesi, Francesco" uniqKey="Raspagliesi F" first="Francesco" last="Raspagliesi">Francesco Raspagliesi</name>
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<author><name sortKey="Fujiwara, Keiichi" sort="Fujiwara, Keiichi" uniqKey="Fujiwara K" first="Keiichi" last="Fujiwara">Keiichi Fujiwara</name>
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<author><name sortKey="Bae, Duk Soo" sort="Bae, Duk Soo" uniqKey="Bae D" first="Duk-Soo" last="Bae">Duk-Soo Bae</name>
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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>
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<author><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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<author><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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<author><name sortKey="Lhomme, Catherine" sort="Lhomme, Catherine" uniqKey="Lhomme C" first="Catherine" last="Lhommé">Catherine Lhommé</name>
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<author><name sortKey="Richardson, Gary" sort="Richardson, Gary" uniqKey="Richardson G" first="Gary" last="Richardson">Gary Richardson</name>
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<author><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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<author><name sortKey="Coleman, Robert L" sort="Coleman, Robert L" uniqKey="Coleman R" first="Robert L" last="Coleman">Robert L. Coleman</name>
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<author><name sortKey="Marth, Christian" sort="Marth, Christian" uniqKey="Marth C" first="Christian" last="Marth">Christian Marth</name>
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<author><name sortKey="Brize, Arija" sort="Brize, Arija" uniqKey="Brize A" first="Arija" last="Brize">Arija Brize</name>
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<author><name sortKey="Fabbro, Michel" sort="Fabbro, Michel" uniqKey="Fabbro M" first="Michel" last="Fabbro">Michel Fabbro</name>
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<author><name sortKey="Redondo, Andres" sort="Redondo, Andres" uniqKey="Redondo A" first="Andrés" last="Redondo">Andrés Redondo</name>
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<author><name sortKey="Bamias, Aristotelis" sort="Bamias, Aristotelis" uniqKey="Bamias A" first="Aristotelis" last="Bamias">Aristotelis Bamias</name>
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<wicri:regionArea>Alexandra Hospital, Department of Clinical Therapeutics, National & Kapodistrian University of Athens, Athens</wicri:regionArea>
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<author><name sortKey="Ma, Haijun" sort="Ma, Haijun" uniqKey="Ma H" first="Haijun" last="Ma">Haijun Ma</name>
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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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<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>
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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>
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<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>
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<sourceDesc><biblStruct><analytic><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>
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<author><name sortKey="Poveda, Andres" sort="Poveda, Andres" uniqKey="Poveda A" first="Andrés" last="Poveda">Andrés Poveda</name>
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<author><name sortKey="Vergote, Ignace" sort="Vergote, Ignace" uniqKey="Vergote I" first="Ignace" last="Vergote">Ignace Vergote</name>
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<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>
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<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>
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<author><name sortKey="Coleman, Robert L" sort="Coleman, Robert L" uniqKey="Coleman R" first="Robert L" last="Coleman">Robert L. Coleman</name>
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<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>
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<author><name sortKey="Marth, Christian" sort="Marth, Christian" uniqKey="Marth C" first="Christian" last="Marth">Christian Marth</name>
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<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Universitätsklinik für Gynäkologie und Geburtshilfe, Medizinische Universität Innsbruck, Innsbruck</wicri:regionArea>
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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>
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<author><name sortKey="Fabbro, Michel" sort="Fabbro, Michel" uniqKey="Fabbro M" first="Michel" last="Fabbro">Michel Fabbro</name>
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<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>
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<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>
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<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>
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</placeName>
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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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<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>
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<author><name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name>
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<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>
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<series><title level="j">Gynecologic oncology</title>
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<term>Humans</term>
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<term>Neoplasm Recurrence, Local (drug therapy)</term>
<term>Neoplasm Recurrence, Local (mortality)</term>
<term>Ovarian Neoplasms (complications)</term>
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<term>Paclitaxel (administration & dosage)</term>
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<front><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>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27546885</PMID>
<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>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1095-6859</ISSN>
<JournalIssue CitedMedium="Internet"><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>
<ELocationID EIdType="pii" ValidYN="Y">S0090-8258(16)30983-0</ELocationID>
<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>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Monk</LastName>
<ForeName>Bradley J</ForeName>
<Initials>BJ</Initials>
<AffiliationInfo><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>
</Author>
<Author ValidYN="Y"><LastName>Poveda</LastName>
<ForeName>Andrés</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Area Clinica de Oncologia Ginecológica, Fundación Instituto Valenciano de Oncología, Valencia, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Vergote</LastName>
<ForeName>Ignace</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven Cancer Institute, KU Leuven, European Union, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Raspagliesi</LastName>
<ForeName>Francesco</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Gynecologic Oncology Unit, Fondazione IRCCS, Istituto Nazionale per la Cura e lo Studio dei Tumori, Milano, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Fujiwara</LastName>
<ForeName>Keiichi</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka-Shi, Japan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bae</LastName>
<ForeName>Duk-Soo</ForeName>
<Initials>DS</Initials>
<AffiliationInfo><Affiliation>Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Oaknin</LastName>
<ForeName>Ana</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ray-Coquard</LastName>
<ForeName>Isabelle</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Université Lyon-I, Centre Léon Bérard, Lyon, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Provencher</LastName>
<ForeName>Diane M</ForeName>
<Initials>DM</Initials>
<AffiliationInfo><Affiliation>Division of Gynecologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Karlan</LastName>
<ForeName>Beth Y</ForeName>
<Initials>BY</Initials>
<AffiliationInfo><Affiliation>Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lhommé</LastName>
<ForeName>Catherine</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Institut Gustave Roussy, Villejuif, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Richardson</LastName>
<ForeName>Gary</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Academic Haematology and Oncology, Cabrini Hospital, Malvern, VIC, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rincón</LastName>
<ForeName>Dolores Gallardo</ForeName>
<Initials>DG</Initials>
<AffiliationInfo><Affiliation>Subdirección de Medicina Interna, Instituto Nacional de Cancerologia, Mexico City, Mexico.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Coleman</LastName>
<ForeName>Robert L</ForeName>
<Initials>RL</Initials>
<AffiliationInfo><Affiliation>Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Marth</LastName>
<ForeName>Christian</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Universitätsklinik für Gynäkologie und Geburtshilfe, Medizinische Universität Innsbruck, Innsbruck, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Brize</LastName>
<ForeName>Arija</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Latvian Oncology Center, Riga Eastern Clinical University Hospital, Riga, Latvia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Fabbro</LastName>
<ForeName>Michel</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Regional Cancer Institute Montpellier, Montpellier, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Redondo</LastName>
<ForeName>Andrés</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Hospital Universitario La Paz Idi-Paz, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bamias</LastName>
<ForeName>Aristotelis</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Alexandra Hospital, Department of Clinical Therapeutics, National & Kapodistrian University of Athens, Athens, Greece.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ma</LastName>
<ForeName>Haijun</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Vogl</LastName>
<ForeName>Florian D</ForeName>
<Initials>FD</Initials>
<AffiliationInfo><Affiliation>Global Development Oncology, Amgen Inc., Thousand Oaks, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bach</LastName>
<ForeName>Bruce A</ForeName>
<Initials>BA</Initials>
<AffiliationInfo><Affiliation>Global Development Oncology, Amgen Inc., Thousand Oaks, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Oza</LastName>
<ForeName>Amit M</ForeName>
<Initials>AM</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Princess Margaret Hospital, University of Toronto, ON, Canada.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>08</Month>
<Day>18</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Gynecol Oncol</MedlineTA>
<NlmUniqueID>0365304</NlmUniqueID>
<ISSNLinking>0090-8258</ISSNLinking>
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<NameOfSubstance UI="D017239">Paclitaxel</NameOfSubstance>
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<MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName>
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<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009364" MajorTopicYN="N">Neoplasm Recurrence, Local</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010051" MajorTopicYN="N">Ovarian Neoplasms</DescriptorName>
<QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017239" MajorTopicYN="N">Paclitaxel</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011993" MajorTopicYN="N">Recombinant Fusion Proteins</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Ascites</Keyword>
<Keyword MajorTopicYN="Y">Overall survival</Keyword>
<Keyword MajorTopicYN="Y">Recurrent epithelial ovarian cancer</Keyword>
<Keyword MajorTopicYN="Y">TRINOVA-1</Keyword>
<Keyword MajorTopicYN="Y">Time to second disease progression</Keyword>
<Keyword MajorTopicYN="Y">Trebananib</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year>
<Month>05</Month>
<Day>06</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2016</Year>
<Month>07</Month>
<Day>12</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2016</Year>
<Month>07</Month>
<Day>23</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>8</Month>
<Day>23</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>8</Month>
<Day>23</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>5</Month>
<Day>13</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">27546885</ArticleId>
<ArticleId IdType="pii">S0090-8258(16)30983-0</ArticleId>
<ArticleId IdType="doi">10.1016/j.ygyno.2016.07.112</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Australie</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Canada</li>
<li>Corée du Sud</li>
<li>Espagne</li>
<li>France</li>
<li>Grèce</li>
<li>Italie</li>
<li>Japon</li>
<li>Lettonie</li>
<li>Mexique</li>
<li>États-Unis</li>
</country>
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<li>Attique (région)</li>
<li>Auvergne-Rhône-Alpes</li>
<li>Californie</li>
<li>Catalogne</li>
<li>Communauté de Madrid</li>
<li>Languedoc-Roussillon</li>
<li>Occitanie (région administrative)</li>
<li>Ontario</li>
<li>Rhône-Alpes</li>
<li>Région capitale de Séoul</li>
<li>Texas</li>
</region>
<settlement><li>Athènes</li>
<li>Barcelone</li>
<li>Lyon</li>
<li>Madrid</li>
<li>Montpellier</li>
<li>Séoul</li>
<li>Toronto</li>
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<orgName><li>Université de Toronto</li>
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</country>
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</country>
<country name="Belgique"><noRegion><name sortKey="Vergote, Ignace" sort="Vergote, Ignace" uniqKey="Vergote I" first="Ignace" last="Vergote">Ignace Vergote</name>
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</country>
<country name="Italie"><noRegion><name sortKey="Raspagliesi, Francesco" sort="Raspagliesi, Francesco" uniqKey="Raspagliesi F" first="Francesco" last="Raspagliesi">Francesco Raspagliesi</name>
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</country>
<country name="Japon"><noRegion><name sortKey="Fujiwara, Keiichi" sort="Fujiwara, Keiichi" uniqKey="Fujiwara K" first="Keiichi" last="Fujiwara">Keiichi Fujiwara</name>
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</country>
<country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Bae, Duk Soo" sort="Bae, Duk Soo" uniqKey="Bae D" first="Duk-Soo" last="Bae">Duk-Soo Bae</name>
</region>
</country>
<country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Ray Coquard, Isabelle" sort="Ray Coquard, Isabelle" uniqKey="Ray Coquard I" first="Isabelle" last="Ray-Coquard">Isabelle Ray-Coquard</name>
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<name sortKey="Fabbro, Michel" sort="Fabbro, Michel" uniqKey="Fabbro M" first="Michel" last="Fabbro">Michel Fabbro</name>
<name sortKey="Lhomme, Catherine" sort="Lhomme, Catherine" uniqKey="Lhomme C" first="Catherine" last="Lhommé">Catherine Lhommé</name>
</country>
<country name="Canada"><noRegion><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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<name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name>
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<country name="Australie"><noRegion><name sortKey="Richardson, Gary" sort="Richardson, Gary" uniqKey="Richardson G" first="Gary" last="Richardson">Gary Richardson</name>
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<country name="Mexique"><noRegion><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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</country>
<country name="Autriche"><noRegion><name sortKey="Marth, Christian" sort="Marth, Christian" uniqKey="Marth C" first="Christian" last="Marth">Christian Marth</name>
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</country>
<country name="Lettonie"><noRegion><name sortKey="Brize, Arija" sort="Brize, Arija" uniqKey="Brize A" first="Arija" last="Brize">Arija Brize</name>
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</tree>
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</record>
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