AustralieFrV1, PubMed, Checkpoint, bibRecord, 003839

Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial.

Identifieur interne : 003839 ( PubMed/Checkpoint ); précédent : 003838; suivant : 003840

Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial.

Auteurs : Josep Tabernero [Espagne] ; Eric Van Cutsem [Belgique] ; Radek Lakom [République tchèque] ; Jana Prausová [République tchèque] ; Paul Ruff [Afrique du Sud] ; Guy A. Van Hazel [Australie] ; Vladimir M. Moiseyenko [Russie] ; David R. Ferry [Royaume-Uni] ; Joseph J. Mckendrick [Australie] ; Karen Soussan-Lazard [France] ; Soazig Chevalier [France] ; Carmen J. Allegra [États-Unis]

Source :

European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2014.

RBID : pubmed:24140268

Descripteurs français

English descriptors

KwdEn :
- Aged, Antibodies, Monoclonal, Humanized (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Bevacizumab, Camptothecin (administration & dosage), Camptothecin (adverse effects), Camptothecin (analogs & derivatives), Colorectal Neoplasms (drug therapy), Colorectal Neoplasms (pathology), Diarrhea (chemically induced), Double-Blind Method, Drug Administration Schedule, Fatigue (chemically induced), Fluorouracil (administration & dosage), Fluorouracil (adverse effects), Humans, Kaplan-Meier Estimate, Leucovorin (administration & dosage), Leucovorin (adverse effects), Middle Aged, Neoplasm Metastasis, Neutropenia (chemically induced), Prospective Studies, Receptors, Vascular Endothelial Growth Factor (administration & dosage), Receptors, Vascular Endothelial Growth Factor (adverse effects), Recombinant Fusion Proteins (administration & dosage), Recombinant Fusion Proteins (adverse effects), Treatment Outcome.
MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Camptothecin, Fluorouracil, Leucovorin, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Fluorouracil, Leucovorin, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- chemical , analogs & derivatives : Camptothecin.
- chemically induced : Diarrhea, Fatigue, Neutropenia.
- drug therapy : Colorectal Neoplasms.
- pathology : Colorectal Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Aged, Bevacizumab, Double-Blind Method, Drug Administration Schedule, Humans, Kaplan-Meier Estimate, Middle Aged, Neoplasm Metastasis, Prospective Studies, Treatment Outcome.

Abstract

The antiangiogenic agent aflibercept (ziv-aflibercept in the United States) in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) significantly improved survival in a phase III study of patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen. In the present analysis, outcomes were evaluated in prespecified subgroups to assess the consistency of the treatment effect.

DOI: 10.1016/j.ejca.2013.09.013
PubMed: 24140268

Affiliations:

Afrique du Sud, Australie, Belgique, Espagne, France, Royaume-Uni, Russie, République tchèque, États-Unis
Bohême centrale, Catalogne, Moravie
Barcelone, Brno, Prague

Links toward previous steps (curation, corpus...)

to stream PubMed, to step Corpus: 003A09
to stream PubMed, to step Curation: 003885

Links to Exploration step

pubmed:24140268

Le document en format XML

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<front><div type="abstract" xml:lang="en">The antiangiogenic agent aflibercept (ziv-aflibercept in the United States) in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) significantly improved survival in a phase III study of patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen. In the present analysis, outcomes were evaluated in prespecified subgroups to assess the consistency of the treatment effect.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24140268</PMID>
<DateCreated><Year>2014</Year>
<Month>01</Month>
<Day>09</Day>
</DateCreated>
<DateCompleted><Year>2014</Year>
<Month>03</Month>
<Day>03</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>11</Month>
<Day>16</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-0852</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>50</Volume>
<Issue>2</Issue>
<PubDate><Year>2014</Year>
<Month>Jan</Month>
</PubDate>
</JournalIssue>
<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial.</ArticleTitle>
<Pagination><MedlinePgn>320-31</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2013.09.013</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0959-8049(13)00853-8</ELocationID>
<Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">The antiangiogenic agent aflibercept (ziv-aflibercept in the United States) in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) significantly improved survival in a phase III study of patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen. In the present analysis, outcomes were evaluated in prespecified subgroups to assess the consistency of the treatment effect.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients were randomised to receive FOLFIRI plus aflibercept or placebo every 2weeks until disease progression or unacceptable toxicity occurred. Efficacy and safety outcomes were analysed with respect to demographic and baseline characteristics, and stratification factors (prior bevacizumab treatment and Eastern Cooperative Oncology Group performance status).</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Median overall survival (OS, months [95.34% confidence interval (CI)]) for aflibercept versus placebo was 12.5 (10.8-15.5) versus 11.7 (9.8-13.8) in patients with prior bevacizumab treatment and 13.9 (12.7-15.6) versus 12.4 (11.2-13.5) in patients with no prior bevacizumab treatment. The p value for interaction was 0.5668, indicating there was no heterogeneity in these subgroups. For OS and progression-free survival (PFS), there was a significantly greater benefit (at the 2-sided 10% level) of treatment for patients with liver only metastases versus patients with no liver metastases/liver metastases with other organ involvement (p value for interaction: 0.0899 [OS]; 0.0076 [PFS]). There was no evidence of heterogeneity in treatment effect in any of the other subgroups examined.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The benefits of aflibercept in combination with FOLFIRI in patients with mCRC previously treated with oxaliplatin were maintained across the specified patient subgroups, including in patients with or without prior bevacizumab treatment.</AbstractText>
<CopyrightInformation>Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Tabernero</LastName>
<ForeName>Josep</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: jtabernero@vhio.net.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Van Cutsem</LastName>
<ForeName>Eric</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>University Hospitals Leuven and KU Leuven, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lakomý</LastName>
<ForeName>Radek</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Masaryk Memorial Cancer Institute, Brno, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Prausová</LastName>
<ForeName>Jana</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Fakultni nemocnice v Motole, Praha, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ruff</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>van Hazel</LastName>
<ForeName>Guy A</ForeName>
<Initials>GA</Initials>
<AffiliationInfo><Affiliation>University of Western Australia, Western Australia, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Moiseyenko</LastName>
<ForeName>Vladimir M</ForeName>
<Initials>VM</Initials>
<AffiliationInfo><Affiliation>Oncology Research Institute Na.NN.Petrov, St-Petersburg, Russian Federation.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ferry</LastName>
<ForeName>David R</ForeName>
<Initials>DR</Initials>
<AffiliationInfo><Affiliation>Russells Hall Hospital, Dudley, West Midlands, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McKendrick</LastName>
<ForeName>Joseph J</ForeName>
<Initials>JJ</Initials>
<AffiliationInfo><Affiliation>Monash University, Victoria, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Soussan-Lazard</LastName>
<ForeName>Karen</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Sanofi, Vitry-sur-Seine, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chevalier</LastName>
<ForeName>Soazig</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Sanofi, Vitry-sur-Seine, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Allegra</LastName>
<ForeName>Carmen J</ForeName>
<Initials>CJ</Initials>
<AffiliationInfo><Affiliation>University of Florida, Gainesville, United States.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT00561470</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2013</Year>
<Month>10</Month>
<Day>16</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Eur J Cancer</MedlineTA>
<NlmUniqueID>9005373</NlmUniqueID>
<ISSNLinking>0959-8049</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D011993">Recombinant Fusion Proteins</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0H43101T0J</RegistryNumber>
<NameOfSubstance UI="C051890">irinotecan</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>15C2VL427D</RegistryNumber>
<NameOfSubstance UI="C533178">aflibercept</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>2S9ZZM9Q9V</RegistryNumber>
<NameOfSubstance UI="D000068258">Bevacizumab</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber>
<NameOfSubstance UI="D040262">Receptors, Vascular Endothelial Growth Factor</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>Q573I9DVLP</RegistryNumber>
<NameOfSubstance UI="D002955">Leucovorin</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>U3P01618RT</RegistryNumber>
<NameOfSubstance UI="D005472">Fluorouracil</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>XT3Z54Z28A</RegistryNumber>
<NameOfSubstance UI="D002166">Camptothecin</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D000068258" MajorTopicYN="N">Bevacizumab</DescriptorName>
</MeshHeading>
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<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000031" MajorTopicYN="N">analogs & derivatives</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015179" MajorTopicYN="N">Colorectal Neoplasms</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
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<MeshHeading><DescriptorName UI="D003967" MajorTopicYN="N">Diarrhea</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005221" MajorTopicYN="N">Fatigue</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005472" MajorTopicYN="N">Fluorouracil</DescriptorName>
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<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName>
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<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
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<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009362" MajorTopicYN="N">Neoplasm Metastasis</DescriptorName>
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<MeshHeading><DescriptorName UI="D009503" MajorTopicYN="N">Neutropenia</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName>
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<MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D040262" MajorTopicYN="N">Receptors, Vascular Endothelial Growth Factor</DescriptorName>
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<MeshHeading><DescriptorName UI="D011993" MajorTopicYN="N">Recombinant Fusion Proteins</DescriptorName>
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<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
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<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
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<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Aflibercept</Keyword>
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<Keyword MajorTopicYN="N">Metastatic colorectal cancer</Keyword>
<Keyword MajorTopicYN="N">Performance status</Keyword>
<Keyword MajorTopicYN="N">Subgroup analysis</Keyword>
<Keyword MajorTopicYN="N">VEGF Trap</Keyword>
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</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year>
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Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial.

Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial.

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