Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer
Identifieur interne : 004025 ( Main/Exploration ); précédent : 004024; suivant : 004026Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer
Auteurs : Martin R. Stockler [Australie] ; Felix Hilpert [Allemagne] ; Michael Friedlander [Australie] ; Madeleine T. King [Australie] ; Lari Wenzel [Canada] ; CHEE KHOON LEE [Australie] ; Florence Joly [France] ; Nikolaus De Gregorio [Allemagne] ; José Angel Arranz [Espagne] ; Mansoor Raza Mirza [Danemark] ; Roberto Sorio [Italie] ; Ulrich Freudensprung [Suisse] ; Vesna Sneller [Australie] ; Gill Hales [Australie] ; Eric Pujade-Lauraine [France]Source :
- Journal of clinical oncology [ 0732-183X ] ; 2014.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Anticorps monoclonaux humanisés (administration et posologie), Anticorps monoclonaux humanisés (effets indésirables), Autorapport, Bévacizumab, Calendrier d'administration des médicaments, Composés organiques du platine (pharmacologie), Doxorubicine (administration et posologie), Doxorubicine (analogues et dérivés), Doxorubicine (effets indésirables), Doxorubicine (usage thérapeutique), Femelle, Humains, Paclitaxel (administration et posologie), Paclitaxel (effets indésirables), Paclitaxel (usage thérapeutique), Polyéthylène glycols (administration et posologie), Polyéthylène glycols (effets indésirables), Polyéthylène glycols (usage thérapeutique), Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Résistance aux médicaments antinéoplasiques, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Topotécane (administration et posologie), Topotécane (effets indésirables), Topotécane (usage thérapeutique), Tumeurs de l'ovaire (traitement médicamenteux).
- MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Doxorubicine, Paclitaxel, Polyéthylène glycols, Topotécane.
- analogues et dérivés : Doxorubicine.
- effets indésirables : Anticorps monoclonaux humanisés, Doxorubicine, Paclitaxel, Polyéthylène glycols, Protocoles de polychimiothérapie antinéoplasique, Topotécane.
- pharmacologie : Composés organiques du platine.
- traitement médicamenteux : Tumeurs de l'ovaire.
- usage thérapeutique : Doxorubicine, Paclitaxel, Polyéthylène glycols, Protocoles de polychimiothérapie antinéoplasique, Topotécane.
- Pascal (Inist)
- Adulte, Adulte d'âge moyen, Autorapport, Bévacizumab, Calendrier d'administration des médicaments, Essai clinique phase III, Femelle, Homme, Humains, Pronostic, Bévacizumab, Evolution, Résistance aux médicaments antinéoplasiques, Résistance traitement, Chimiothérapie, Platine, Cancérologie, Cancer de l'ovaire, Facteur croissance endothélium vasculaire, Anticancéreux, Immunomodulateur, Antiangiogénique, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus.
- Wicri :
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antiangiogenic agent, Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (adverse effects), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Antineoplastic agent, Bevacizumab, Cancerology, Chemotherapy, Doxorubicin (administration & dosage), Doxorubicin (adverse effects), Doxorubicin (analogs & derivatives), Doxorubicin (therapeutic use), Drug Administration Schedule, Drug Resistance, Neoplasm, Evolution, Female, Human, Humans, Immunomodulator, Middle Aged, Organoplatinum Compounds (pharmacology), Ovarian Neoplasms (drug therapy), Ovary cancer, Paclitaxel (administration & dosage), Paclitaxel (adverse effects), Paclitaxel (therapeutic use), Phase III trial, Platinum, Polyethylene Glycols (administration & dosage), Polyethylene Glycols (adverse effects), Polyethylene Glycols (therapeutic use), Prognosis, Self Report, Topotecan (administration & dosage), Topotecan (adverse effects), Topotecan (therapeutic use), Treatment Outcome, Treatment resistance, Vascular endothelium growth factor.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Doxorubicin, Paclitaxel, Polyethylene Glycols, Topotecan.
- chemical , adverse effects : Antibodies, Monoclonal, Humanized, Doxorubicin, Paclitaxel, Polyethylene Glycols, Topotecan.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- chemical , analogs & derivatives : Doxorubicin.
- drug therapy : Ovarian Neoplasms.
- chemical , pharmacology : Organoplatinum Compounds.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Doxorubicin, Paclitaxel, Polyethylene Glycols, Topotecan.
- Adult, Aged, Aged, 80 and over, Bevacizumab, Drug Administration Schedule, Drug Resistance, Neoplasm, Female, Humans, Middle Aged, Self Report, Treatment Outcome.
Abstract
Purpose To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. Patients and Methods Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/Gl symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data. Results Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/Gl symptoms at week 8/9 (primary PRO end point, 21.9% v9.3%; difference, 12.7%; 95% Cl, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% Cl, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1 %; difference, 9.0%; 95% Cl, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions. Conclusion Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/Gl symptoms during chemotherapy for platinum-resistant ovarian cancer.
Url:
Affiliations:
- Allemagne, Australie, Canada, Danemark, Espagne, France, Italie, Suisse
- Bade-Wurtemberg, Basse-Normandie, Communauté de Madrid, District de Tübingen, Hovedstaden, Nouvelle-Galles du Sud, Région Normandie, Schleswig-Holstein, Île-de-France
- Caen, Copenhague, Kiel, Madrid, Paris, Sydney, Ulm
- Université de Sydney
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Le document en format XML
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Hoffmann-La Roche, Basel</wicri:noRegion></affiliation></author><author><name sortKey="Sneller, Vesna" sort="Sneller, Vesna" uniqKey="Sneller V" first="Vesna" last="Sneller">Vesna Sneller</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>The University of Sydney</s1><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Prince of Wales Clinical School, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>3 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Hales, Gill" sort="Hales, Gill" uniqKey="Hales G" first="Gill" last="Hales">Gill Hales</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>The University of Sydney</s1><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Prince of Wales Clinical School, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>3 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>GINECO and Centre Hospitalier Universitaire Hotel Dieu</s1><s2>Paris</s2><s3>FRA</s3><sZ>15 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0144025</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0144025 INIST</idno><idno type="RBID">Pascal:14-0144025</idno><idno type="wicri:Area/PascalFrancis/Corpus">000408</idno><idno type="wicri:Area/PascalFrancis/Curation">005A54</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000161</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000161</idno><idno type="wicri:doubleKey">0732-183X:2014:Stockler M:patient:reported:outcome</idno><idno type="wicri:Area/Main/Merge">004085</idno><idno type="wicri:source">PMC</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876313</idno><idno type="RBID">PMC:4876313</idno><idno type="wicri:Area/Pmc/Corpus">000456</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000456</idno><idno type="wicri:Area/Pmc/Curation">000456</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000456</idno><idno type="wicri:Area/Pmc/Checkpoint">001417</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001417</idno><idno type="wicri:source">PubMed</idno><idno type="wicri:Area/PubMed/Corpus">003780</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003780</idno><idno type="wicri:Area/PubMed/Curation">003666</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">003666</idno><idno type="wicri:Area/PubMed/Checkpoint">003666</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">003666</idno><idno type="wicri:Area/Ncbi/Merge">001919</idno><idno type="wicri:Area/Ncbi/Curation">001919</idno><idno type="wicri:Area/Ncbi/Checkpoint">001919</idno><idno type="wicri:doubleKey">0732-183X:2014:Stockler M:patient:reported:outcome</idno><idno type="wicri:Area/Main/Merge">003667</idno><idno type="wicri:Area/Main/Curation">004025</idno><idno type="wicri:Area/Main/Exploration">004025</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer</title><author><name sortKey="Stockler, Martin R" sort="Stockler, Martin R" uniqKey="Stockler M" first="Martin R." last="Stockler">Martin R. Stockler</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>The University of Sydney</s1><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Hilpert, Felix" sort="Hilpert, Felix" uniqKey="Hilpert F" first="Felix" last="Hilpert">Felix Hilpert</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Klinik für Gynäkologie und Geburtshilfe</s1><s2>Kiel</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author><author><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Prince of Wales Clinical School, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>3 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="King, Madeleine T" sort="King, Madeleine T" uniqKey="King M" first="Madeleine T." last="King">Madeleine T. King</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>The University of Sydney</s1><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Wenzel, Lari" sort="Wenzel, Lari" uniqKey="Wenzel L" first="Lari" last="Wenzel">Lari Wenzel</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>University of California Irvine</s1><s2>Irvine, CA</s2><s3>CAN</s3><sZ>5 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>University of California Irvine</wicri:noRegion></affiliation></author><author><name sortKey="Chee Khoon Lee" sort="Chee Khoon Lee" uniqKey="Chee Khoon Lee" last="Chee Khoon Lee">CHEE KHOON LEE</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>The University of Sydney</s1><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Joly, Florence" sort="Joly, Florence" uniqKey="Joly F" first="Florence" last="Joly">Florence Joly</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Group d'Investigateurs Nationaux pour I'Etude des Cancers Ovariens (GINECO) and Centre François Baclesse</s1><s2>Caen</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Région Normandie</region><region type="old region">Basse-Normandie</region><settlement type="city">Caen</settlement></placeName></affiliation></author><author><name sortKey="De Gregorio, Nikolaus" sort="De Gregorio, Nikolaus" uniqKey="De Gregorio N" first="Nikolaus" last="De Gregorio">Nikolaus De Gregorio</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>AGO and University of Ulm Medical Center</s1><s2>Ulm</s2><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName></affiliation></author><author><name sortKey="Arranz, Jose Angel" sort="Arranz, Jose Angel" uniqKey="Arranz J" first="José Angel" last="Arranz">José Angel Arranz</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Grupo Español de Investigación en Cáncer de Ovario and Hospital General Universitario Gregorio Marañón</s1><s2>Madrid</s2><s3>ESP</s3><sZ>9 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Mirza, Mansoor Raza" sort="Mirza, Mansoor Raza" uniqKey="Mirza M" first="Mansoor Raza" last="Mirza">Mansoor Raza Mirza</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Nordic Society of Gynaecological Oncology and Rigshospitalet, Copenhagen University Hospital</s1><s2>Copenhagen</s2><s3>DNK</s3><sZ>10 aut.</sZ></inist:fA14><country>Danemark</country><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Sorio, Roberto" sort="Sorio, Roberto" uniqKey="Sorio R" first="Roberto" last="Sorio">Roberto Sorio</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Multicenter Italian Trials in Ovarian Cancer and Centro di Riferimento Oncologico-Istituto di Ricovero e Cura a Carattere Scientifico</s1><s2>Aviano</s2><s3>ITA</s3><sZ>11 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Multicenter Italian Trials in Ovarian Cancer and Centro di Riferimento Oncologico-Istituto di Ricovero e Cura a Carattere Scientifico</wicri:noRegion></affiliation></author><author><name sortKey="Freudensprung, Ulrich" sort="Freudensprung, Ulrich" uniqKey="Freudensprung U" first="Ulrich" last="Freudensprung">Ulrich Freudensprung</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Ulrich Freudensprung, Vesna Sneller, 12Gill Hales</s1><s2>F. Hoffmann-La Roche, Basel</s2><s3>CHE</s3><sZ>12 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>F. Hoffmann-La Roche, Basel</wicri:noRegion></affiliation></author><author><name sortKey="Sneller, Vesna" sort="Sneller, Vesna" uniqKey="Sneller V" first="Vesna" last="Sneller">Vesna Sneller</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>The University of Sydney</s1><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Prince of Wales Clinical School, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>3 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Hales, Gill" sort="Hales, Gill" uniqKey="Hales G" first="Gill" last="Hales">Gill Hales</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>The University of Sydney</s1><s3>AUS</s3><sZ>1 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Prince of Wales Clinical School, University of New South Wales</s1><s2>Sydney</s2><s3>AUS</s3><sZ>3 aut.</sZ><sZ>13 aut.</sZ><sZ>14 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>GINECO and Centre Hospitalier Universitaire Hotel Dieu</s1><s2>Paris</s2><s3>FRA</s3><sZ>15 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antiangiogenic agent</term><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Antibodies, Monoclonal, Humanized (adverse effects)</term><term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Antineoplastic agent</term><term>Bevacizumab</term><term>Cancerology</term><term>Chemotherapy</term><term>Doxorubicin (administration & dosage)</term><term>Doxorubicin (adverse effects)</term><term>Doxorubicin (analogs & derivatives)</term><term>Doxorubicin (therapeutic use)</term><term>Drug Administration Schedule</term><term>Drug Resistance, Neoplasm</term><term>Evolution</term><term>Female</term><term>Human</term><term>Humans</term><term>Immunomodulator</term><term>Middle Aged</term><term>Organoplatinum Compounds (pharmacology)</term><term>Ovarian Neoplasms (drug therapy)</term><term>Ovary cancer</term><term>Paclitaxel (administration & dosage)</term><term>Paclitaxel (adverse effects)</term><term>Paclitaxel (therapeutic use)</term><term>Phase III trial</term><term>Platinum</term><term>Polyethylene Glycols (administration & dosage)</term><term>Polyethylene Glycols (adverse effects)</term><term>Polyethylene Glycols (therapeutic use)</term><term>Prognosis</term><term>Self Report</term><term>Topotecan (administration & dosage)</term><term>Topotecan (adverse effects)</term><term>Topotecan (therapeutic use)</term><term>Treatment Outcome</term><term>Treatment resistance</term><term>Vascular endothelium growth factor</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps monoclonaux humanisés (administration et posologie)</term><term>Anticorps monoclonaux humanisés (effets indésirables)</term><term>Autorapport</term><term>Bévacizumab</term><term>Calendrier d'administration des médicaments</term><term>Composés organiques du platine (pharmacologie)</term><term>Doxorubicine (administration et posologie)</term><term>Doxorubicine (analogues et dérivés)</term><term>Doxorubicine (effets indésirables)</term><term>Doxorubicine (usage thérapeutique)</term><term>Femelle</term><term>Humains</term><term>Paclitaxel (administration et posologie)</term><term>Paclitaxel (effets indésirables)</term><term>Paclitaxel (usage thérapeutique)</term><term>Polyéthylène glycols (administration et posologie)</term><term>Polyéthylène glycols (effets indésirables)</term><term>Polyéthylène glycols (usage thérapeutique)</term><term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Résistance aux médicaments antinéoplasiques</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Topotécane (administration et posologie)</term><term>Topotécane (effets indésirables)</term><term>Topotécane (usage thérapeutique)</term><term>Tumeurs de l'ovaire (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Doxorubicin</term><term>Paclitaxel</term><term>Polyethylene Glycols</term><term>Topotecan</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Doxorubicin</term><term>Paclitaxel</term><term>Polyethylene Glycols</term><term>Topotecan</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Doxorubicine</term><term>Paclitaxel</term><term>Polyéthylène glycols</term><term>Topotécane</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Doxorubicin</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Doxorubicine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Doxorubicine</term><term>Paclitaxel</term><term>Polyéthylène glycols</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Topotécane</term></keywords><keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Composés organiques du platine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Organoplatinum Compounds</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Doxorubicin</term><term>Paclitaxel</term><term>Polyethylene Glycols</term><term>Topotecan</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs de l'ovaire</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Doxorubicine</term><term>Paclitaxel</term><term>Polyéthylène glycols</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Topotécane</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Bevacizumab</term><term>Drug Administration Schedule</term><term>Drug Resistance, Neoplasm</term><term>Female</term><term>Humans</term><term>Middle Aged</term><term>Self Report</term><term>Treatment Outcome</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Autorapport</term><term>Bévacizumab</term><term>Calendrier d'administration des médicaments</term><term>Essai clinique phase III</term><term>Femelle</term><term>Homme</term><term>Humains</term><term>Pronostic</term><term>Bévacizumab</term><term>Evolution</term><term>Résistance aux médicaments antinéoplasiques</term><term>Résistance traitement</term><term>Chimiothérapie</term><term>Platine</term><term>Cancérologie</term><term>Cancer de l'ovaire</term><term>Facteur croissance endothélium vasculaire</term><term>Anticancéreux</term><term>Immunomodulateur</term><term>Antiangiogénique</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Platine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. Patients and Methods Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/Gl symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data. Results Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/Gl symptoms at week 8/9 (primary PRO end point, 21.9% v9.3%; difference, 12.7%; 95% Cl, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% Cl, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1 %; difference, 9.0%; 95% Cl, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions. Conclusion Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/Gl symptoms during chemotherapy for platinum-resistant ovarian cancer.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Danemark</li><li>Espagne</li><li>France</li><li>Italie</li><li>Suisse</li></country><region><li>Bade-Wurtemberg</li><li>Basse-Normandie</li><li>Communauté de Madrid</li><li>District de Tübingen</li><li>Hovedstaden</li><li>Nouvelle-Galles du Sud</li><li>Région Normandie</li><li>Schleswig-Holstein</li><li>Île-de-France</li></region><settlement><li>Caen</li><li>Copenhague</li><li>Kiel</li><li>Madrid</li><li>Paris</li><li>Sydney</li><li>Ulm</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Stockler, Martin R" sort="Stockler, Martin R" uniqKey="Stockler M" first="Martin R." last="Stockler">Martin R. Stockler</name></region><name sortKey="Chee Khoon Lee" sort="Chee Khoon Lee" uniqKey="Chee Khoon Lee" last="Chee Khoon Lee">CHEE KHOON LEE</name><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name><name sortKey="Hales, Gill" sort="Hales, Gill" uniqKey="Hales G" first="Gill" last="Hales">Gill Hales</name><name sortKey="Hales, Gill" sort="Hales, Gill" uniqKey="Hales G" first="Gill" last="Hales">Gill Hales</name><name sortKey="King, Madeleine T" sort="King, Madeleine T" uniqKey="King M" first="Madeleine T." last="King">Madeleine T. King</name><name sortKey="Sneller, Vesna" sort="Sneller, Vesna" uniqKey="Sneller V" first="Vesna" last="Sneller">Vesna Sneller</name><name sortKey="Sneller, Vesna" sort="Sneller, Vesna" uniqKey="Sneller V" first="Vesna" last="Sneller">Vesna Sneller</name></country><country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Hilpert, Felix" sort="Hilpert, Felix" uniqKey="Hilpert F" first="Felix" last="Hilpert">Felix Hilpert</name></region><name sortKey="De Gregorio, Nikolaus" sort="De Gregorio, Nikolaus" uniqKey="De Gregorio N" first="Nikolaus" last="De Gregorio">Nikolaus De Gregorio</name></country><country name="Canada"><noRegion><name sortKey="Wenzel, Lari" sort="Wenzel, Lari" uniqKey="Wenzel L" first="Lari" last="Wenzel">Lari Wenzel</name></noRegion></country><country name="France"><region name="Région Normandie"><name sortKey="Joly, Florence" sort="Joly, Florence" uniqKey="Joly F" first="Florence" last="Joly">Florence Joly</name></region><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Arranz, Jose Angel" sort="Arranz, Jose Angel" uniqKey="Arranz J" first="José Angel" last="Arranz">José Angel Arranz</name></region></country><country name="Danemark"><region name="Hovedstaden"><name sortKey="Mirza, Mansoor Raza" sort="Mirza, Mansoor Raza" uniqKey="Mirza M" first="Mansoor Raza" last="Mirza">Mansoor Raza Mirza</name></region></country><country name="Italie"><noRegion><name sortKey="Sorio, Roberto" sort="Sorio, Roberto" uniqKey="Sorio R" first="Roberto" last="Sorio">Roberto Sorio</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Freudensprung, Ulrich" sort="Freudensprung, Ulrich" uniqKey="Freudensprung U" first="Ulrich" last="Freudensprung">Ulrich Freudensprung</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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