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Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial.

Identifieur interne : 001250 ( PubMed/Corpus ); précédent : 001249; suivant : 001251

Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial.

Auteurs : Roberto Sorio ; Célia Roemer-Becuwe ; Felix Hilpert ; Emma Gibbs ; Yolanda García ; Janne Kaern ; Manon Huizing ; Petronella Witteveen ; Flora Zagouri ; David Coeffic ; Hans-Joachim Lück ; Antonio González-Martín ; Gunnar Kristensen ; Charles-Briac Levaché ; Chee Khoon Lee ; Val Gebski ; Eric Pujade-Lauraine

Source :

RBID : pubmed:27871723

English descriptors

Abstract

The AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC).

DOI: 10.1016/j.ygyno.2016.11.006
PubMed: 27871723

Links to Exploration step

pubmed:27871723

Le document en format XML

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<name sortKey="Kaern, Janne" sort="Kaern, Janne" uniqKey="Kaern J" first="Janne" last="Kaern">Janne Kaern</name>
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<nlm:affiliation>NSGO and Oslo University Hospital HF, Radiumhospitalet, Postboks 4950, Nydalen, N-0424 Oslo, Norway.</nlm:affiliation>
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<name sortKey="Huizing, Manon" sort="Huizing, Manon" uniqKey="Huizing M" first="Manon" last="Huizing">Manon Huizing</name>
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<nlm:affiliation>BGOG and Universitair Ziekenhuis Antwerpen, Wilrijkstraat 10, 2650 Edegem, Belgium.</nlm:affiliation>
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<name sortKey="Witteveen, Petronella" sort="Witteveen, Petronella" uniqKey="Witteveen P" first="Petronella" last="Witteveen">Petronella Witteveen</name>
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<nlm:affiliation>DGOG and University Medical Center Utrecht, F02.126, PO Box 85500, 3508 GA Utrecht, The Netherlands.</nlm:affiliation>
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<name sortKey="Zagouri, Flora" sort="Zagouri, Flora" uniqKey="Zagouri F" first="Flora" last="Zagouri">Flora Zagouri</name>
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<nlm:affiliation>HECOG and Department of Clinical Therapeutics, Medical School, University of Athens, 133, Vas Sofias Av, 11528 Athens, Greece.</nlm:affiliation>
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<name sortKey="Coeffic, David" sort="Coeffic, David" uniqKey="Coeffic D" first="David" last="Coeffic">David Coeffic</name>
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<nlm:affiliation>GINECO and Polyclinique Courlancy, 38 rue de Courlancy, 51100 Reims, France.</nlm:affiliation>
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<name sortKey="Luck, Hans Joachim" sort="Luck, Hans Joachim" uniqKey="Luck H" first="Hans-Joachim" last="Lück">Hans-Joachim Lück</name>
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<nlm:affiliation>AGO and Gynäkologisch-Onkologische Praxis am Pelikanplatz, Pelikanplatz 23, D30177 Hannover, Germany.</nlm:affiliation>
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<name sortKey="Gonzalez Martin, Antonio" sort="Gonzalez Martin, Antonio" uniqKey="Gonzalez Martin A" first="Antonio" last="González-Martín">Antonio González-Martín</name>
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<nlm:affiliation>GEICO and MD Anderson Cancer Center Spain, C/Arturo Soria 270, 28033 Madrid, Spain.</nlm:affiliation>
</affiliation>
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<name sortKey="Kristensen, Gunnar" sort="Kristensen, Gunnar" uniqKey="Kristensen G" first="Gunnar" last="Kristensen">Gunnar Kristensen</name>
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<nlm:affiliation>NSGO and Department of Gynecological Cancer and Institute for Cancer Genetics and Informatics, The Norwegian Radium Hospital, Oslo University Hospital and Institute for Clinical Medicine, Oslo University, Postboks 4950, Nydalen, N-0424 Oslo, Norway.</nlm:affiliation>
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<name sortKey="Levache, Charles Briac" sort="Levache, Charles Briac" uniqKey="Levache C" first="Charles-Briac" last="Levaché">Charles-Briac Levaché</name>
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<nlm:affiliation>GINECO and Clinique Francheville, 38 Boulevard de Vésone, BP 4063, 24000 Périgueux, France.</nlm:affiliation>
</affiliation>
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<name sortKey="Lee, Chee Khoon" sort="Lee, Chee Khoon" uniqKey="Lee C" first="Chee Khoon" last="Lee">Chee Khoon Lee</name>
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<nlm:affiliation>National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name>
<affiliation>
<nlm:affiliation>National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia.</nlm:affiliation>
</affiliation>
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<name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name>
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<nlm:affiliation>GINECO and Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu - Oncologie, 1 Place du Parvis Notre-Dame - Place Jean-Paul II, 75004 Paris, France.</nlm:affiliation>
</affiliation>
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<series>
<title level="j">Gynecologic oncology</title>
<idno type="eISSN">1095-6859</idno>
<imprint>
<date when="2017" type="published">2017</date>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Adult</term>
<term>Age Factors</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Bevacizumab (administration & dosage)</term>
<term>Bevacizumab (adverse effects)</term>
<term>Disease-Free Survival</term>
<term>Doxorubicin (administration & dosage)</term>
<term>Doxorubicin (analogs & derivatives)</term>
<term>Drug Resistance, Neoplasm</term>
<term>Female</term>
<term>Humans</term>
<term>Hypertension (chemically induced)</term>
<term>Hypertension (physiopathology)</term>
<term>Middle Aged</term>
<term>Neoplasm Recurrence, Local (drug therapy)</term>
<term>Ovarian Neoplasms (drug therapy)</term>
<term>Paclitaxel (administration & dosage)</term>
<term>Patient Selection</term>
<term>Platinum Compounds</term>
<term>Polyethylene Glycols (administration & dosage)</term>
<term>Topotecan (administration & dosage)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Bevacizumab</term>
<term>Doxorubicin</term>
<term>Paclitaxel</term>
<term>Polyethylene Glycols</term>
<term>Topotecan</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
<term>Bevacizumab</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en">
<term>Doxorubicin</term>
</keywords>
<keywords scheme="MESH" qualifier="chemically induced" xml:lang="en">
<term>Hypertension</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Neoplasm Recurrence, Local</term>
<term>Ovarian Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en">
<term>Hypertension</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Age Factors</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Drug Resistance, Neoplasm</term>
<term>Female</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Patient Selection</term>
<term>Platinum Compounds</term>
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<front>
<div type="abstract" xml:lang="en">The AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC).</div>
</front>
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<DateCreated>
<Year>2016</Year>
<Month>11</Month>
<Day>22</Day>
</DateCreated>
<DateCompleted>
<Year>2017</Year>
<Month>05</Month>
<Day>30</Day>
</DateCompleted>
<DateRevised>
<Year>2017</Year>
<Month>05</Month>
<Day>30</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1095-6859</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>144</Volume>
<Issue>1</Issue>
<PubDate>
<Year>2017</Year>
<Month>Jan</Month>
</PubDate>
</JournalIssue>
<Title>Gynecologic oncology</Title>
<ISOAbbreviation>Gynecol. Oncol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial.</ArticleTitle>
<Pagination>
<MedlinePgn>65-71</MedlinePgn>
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<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC).</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients with PROC were randomised to receive investigator-selected single-agent chemotherapy alone or with bevacizumab. Post-hoc exploratory analyses assessed efficacy, safety and patient-reported outcomes according to age <65 versus ≥65years.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">In the 133 patients (37%) aged ≥65years, baseline hypertension was more frequent and ascites was less common than in patients <65years. The magnitude of PFS benefit from bevacizumab was similar in patients ≥65 versus <65years (hazard ratio 0.44 [95% CI, 0.31-0.64] versus 0.49 [95% CI, 0.37-0.64], respectively, treatment-age interaction p=0.58), with similar improvements in response rates. Grade≥3 hypertension was more common with bevacizumab than chemotherapy alone in both subgroups, and more common in older than younger patients irrespective of treatment. However, there was no excess of other adverse events of specific interest for bevacizumab, including venous thromboembolic events, in older patients. More patients receiving bevacizumab in the younger but not the older subgroup showed improved gastrointestinal/abdominal symptoms.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">In exploratory analyses, PFS and response rate improvement with bevacizumab were consistent in older and younger patients. Grade≥3 hypertension was more common in elderly bevacizumab-treated patients; careful monitoring is recommended. Overall, bevacizumab-containing therapy was well tolerated in a selected population aged ≥65years, suggesting a favourable benefit:risk profile. However, geriatric assessments are needed to improve selection of elderly patients potentially gaining symptom and quality of life improvements from bevacizumab-containing therapy.</AbstractText>
<AbstractText Label="CLINICAL TRIALS REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.govNCT00976911.</AbstractText>
<CopyrightInformation>Copyright © 2016 Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
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<LastName>Sorio</LastName>
<ForeName>Roberto</ForeName>
<Initials>R</Initials>
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<Affiliation>MITO and Centro di Riferimento Oncologico, CRO-IRCCS, Via F. Gallini, 2 - 33081 Aviano, PN, Italy. Electronic address: rsorio@cro.it.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Roemer-Becuwe</LastName>
<ForeName>Célia</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>GINECO and Centre d'Oncologie de Gentilly, 2 rue Marie Marvingt, 54000 Nancy, France.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Hilpert</LastName>
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<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>AGO and Onkologisches Therapiezentrum am Krankenhaus Jerusalem Hamburg, Moorkamp 2-6, 20357 Hamburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Gibbs</LastName>
<ForeName>Emma</ForeName>
<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>García</LastName>
<ForeName>Yolanda</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>GEICO and Hospital Universitari Parc Taulí, Parc Taulí 1, 08208 Sabadell, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Kaern</LastName>
<ForeName>Janne</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>NSGO and Oslo University Hospital HF, Radiumhospitalet, Postboks 4950, Nydalen, N-0424 Oslo, Norway.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Huizing</LastName>
<ForeName>Manon</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>BGOG and Universitair Ziekenhuis Antwerpen, Wilrijkstraat 10, 2650 Edegem, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Witteveen</LastName>
<ForeName>Petronella</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>DGOG and University Medical Center Utrecht, F02.126, PO Box 85500, 3508 GA Utrecht, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Zagouri</LastName>
<ForeName>Flora</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>HECOG and Department of Clinical Therapeutics, Medical School, University of Athens, 133, Vas Sofias Av, 11528 Athens, Greece.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y">
<LastName>Coeffic</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
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<Affiliation>GINECO and Polyclinique Courlancy, 38 rue de Courlancy, 51100 Reims, France.</Affiliation>
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<LastName>Lück</LastName>
<ForeName>Hans-Joachim</ForeName>
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<Affiliation>AGO and Gynäkologisch-Onkologische Praxis am Pelikanplatz, Pelikanplatz 23, D30177 Hannover, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>González-Martín</LastName>
<ForeName>Antonio</ForeName>
<Initials>A</Initials>
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<Affiliation>GEICO and MD Anderson Cancer Center Spain, C/Arturo Soria 270, 28033 Madrid, Spain.</Affiliation>
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