AustralieFrV1, PubMed, Curation, bibRecord, 003075

Time course of safety and efficacy of aflibercept in combination with FOLFIRI in patients with metastatic colorectal cancer who progressed on previous oxaliplatin-based therapy.

Identifieur interne : 003075 ( PubMed/Curation ); précédent : 003074; suivant : 003076

Time course of safety and efficacy of aflibercept in combination with FOLFIRI in patients with metastatic colorectal cancer who progressed on previous oxaliplatin-based therapy.

Auteurs : Paul Ruff [Afrique du Sud] ; David R. Ferry [Royaume-Uni] ; Radek Lakom [République tchèque] ; Jana Prausová [République tchèque] ; Guy A. Van Hazel [Australie] ; Paulo M. Hoff [Brésil] ; David Cunningham [Royaume-Uni] ; Dirk Arnold [Allemagne] ; Hans J. Schmoll [Allemagne] ; Vladimir M. Moiseyenko [Russie] ; Joseph J. Mckendrick [Australie] ; Albert J. Ten Tije [Pays-Bas] ; Raghu L. Vishwanath [États-Unis] ; Pankaj Bhargava [États-Unis] ; Soazig Chevalier [France] ; Teresa Macarulla [Espagne] ; Eric Van Cutsem [Belgique]

Source :

European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2015.

RBID : pubmed:25466509

Descripteurs français

English descriptors

KwdEn :
- Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (pharmacology), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Biomarkers, Pharmacological, Camptothecin (adverse effects), Camptothecin (analogs & derivatives), Camptothecin (pharmacology), Camptothecin (therapeutic use), Colorectal Neoplasms (pathology), Disease Progression, Disease-Free Survival, Female, Fluorouracil (adverse effects), Fluorouracil (pharmacology), Fluorouracil (therapeutic use), Humans, Leucovorin (adverse effects), Leucovorin (pharmacology), Leucovorin (therapeutic use), Male, Neoplasm Metastasis, Organoplatinum Compounds (therapeutic use), Proportional Hazards Models, Receptors, Vascular Endothelial Growth Factor (adverse effects), Receptors, Vascular Endothelial Growth Factor (pharmacology), Receptors, Vascular Endothelial Growth Factor (therapeutic use), Recombinant Fusion Proteins (adverse effects), Recombinant Fusion Proteins (therapeutic use).
MESH :
- chemical , adverse effects : Camptothecin, Fluorouracil, Leucovorin, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- chemical , analogs & derivatives : Camptothecin.
- chemical , pharmacology : Camptothecin, Fluorouracil, Leucovorin, Receptors, Vascular Endothelial Growth Factor.
- chemical , therapeutic use : Camptothecin, Fluorouracil, Leucovorin, Organoplatinum Compounds, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- chemical : Biomarkers, Pharmacological.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- pathology : Colorectal Neoplasms.
- pharmacology : Antineoplastic Combined Chemotherapy Protocols.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Disease Progression, Disease-Free Survival, Female, Humans, Male, Neoplasm Metastasis, Proportional Hazards Models.

Abstract

Patients with metastatic colorectal cancer (mCRC) previously-treated with oxaliplatin benefit significantly from the addition of aflibercept to FOLFIRI in relation to overall survival, progression-free survival and response rate.

DOI: 10.1016/j.ejca.2014.10.019
PubMed: 25466509

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Le document en format XML

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<term>Leucovorine (usage thérapeutique)</term>
<term>Modèles de hasards proportionnels</term>
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<term>Protéines de fusion recombinantes</term>
<term>Récepteurs aux facteurs de croissance endothéliale vasculaire</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Colorectal Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Camptothécine</term>
<term>Fluorouracil</term>
<term>Leucovorine</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
<term>Récepteurs aux facteurs de croissance endothéliale vasculaire</term>
</keywords>
<keywords scheme="MESH" qualifier="pharmacology" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Camptothécine</term>
<term>Composés organiques du platine</term>
<term>Fluorouracil</term>
<term>Leucovorine</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
<term>Protéines de fusion recombinantes</term>
<term>Récepteurs aux facteurs de croissance endothéliale vasculaire</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Disease Progression</term>
<term>Disease-Free Survival</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Neoplasm Metastasis</term>
<term>Proportional Hazards Models</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Biomarqueurs pharmacologiques</term>
<term>Femelle</term>
<term>Humains</term>
<term>Modèles de hasards proportionnels</term>
<term>Mâle</term>
<term>Métastase tumorale</term>
<term>Survie sans rechute</term>
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<front><div type="abstract" xml:lang="en">Patients with metastatic colorectal cancer (mCRC) previously-treated with oxaliplatin benefit significantly from the addition of aflibercept to FOLFIRI in relation to overall survival, progression-free survival and response rate.</div>
</front>
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<DateCreated><Year>2014</Year>
<Month>12</Month>
<Day>26</Day>
</DateCreated>
<DateCompleted><Year>2015</Year>
<Month>04</Month>
<Day>17</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>51</Volume>
<Issue>1</Issue>
<PubDate><Year>2015</Year>
<Month>Jan</Month>
</PubDate>
</JournalIssue>
<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Time course of safety and efficacy of aflibercept in combination with FOLFIRI in patients with metastatic colorectal cancer who progressed on previous oxaliplatin-based therapy.</ArticleTitle>
<Pagination><MedlinePgn>18-26</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2014.10.019</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0959-8049(14)01055-7</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Patients with metastatic colorectal cancer (mCRC) previously-treated with oxaliplatin benefit significantly from the addition of aflibercept to FOLFIRI in relation to overall survival, progression-free survival and response rate.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">The results for efficacy and safety over the time course of the VEGF Trap (aflibercept) with irinotecan in colorectal cancer after failure of oxaliplatin regimen trial were analysed based on data from 1226 patients randomised to receive FOLFIRI plus either aflibercept (n=612) or placebo (n=614). Hazard ratios (HR) by 6-month time period were estimated using a piecewise Cox proportional hazard model. Severity of adverse events (AEs) was graded using National Cancer Institute Common Terminology Criteria, version 3.0.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The estimated probabilities of survival were 38.5% versus 30.9% at 18 months, 28.0% versus 18.7% at 24 months and 22.3% versus 12.0% at 30 months, for the aflibercept- and placebo-treated arms, respectively. The proportional improvement in the HR over time was consistent with the survival probability results; survival at 24 months was improved by 50% and almost doubled at 30 months. The majority of worst-grade AEs occurred within the first four cycles of treatment and in a small percent of treatment cycles and were mostly reversible. Common chemotherapy- and anti-vascular epithelial growth factor (VEGF)-associated AEs occurred rarely and in a small proportion of cycles with the majority being of single occurrence.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The addition of aflibercept to FOLFIRI showed a continued and persistent improvement in overall survival over time in patients with mCRC. Although grade 3-4 AEs were more frequent in the aflibercept arm, they occurred in early treatment cycles and decreased sharply following initial presentation.</AbstractText>
<CopyrightInformation>Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ruff</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>University of Witwatersrand, Faculty of Health Sciences, Johannesburg, South Africa. Electronic address: pruff@iafrica.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ferry</LastName>
<ForeName>David R</ForeName>
<Initials>DR</Initials>
<AffiliationInfo><Affiliation>Russells Hall Hospital, Dudley, UK.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Lakomỳ</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>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>Hoff</LastName>
<ForeName>Paulo M</ForeName>
<Initials>PM</Initials>
<AffiliationInfo><Affiliation>Centro De Oncologia/Hospital Sirio Libanes, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cunningham</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>The Royal Marsden Hospital, Sutton, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Arnold</LastName>
<ForeName>Dirk</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, Tumor Biology Center, Freiburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schmoll</LastName>
<ForeName>Hans J</ForeName>
<Initials>HJ</Initials>
<AffiliationInfo><Affiliation>Martin Luther University Halle-Wittenberg, Germany.</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>McKendrick</LastName>
<ForeName>Joseph J</ForeName>
<Initials>JJ</Initials>
<AffiliationInfo><Affiliation>Monash University, Victoria, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ten Tije</LastName>
<ForeName>Albert J</ForeName>
<Initials>AJ</Initials>
<AffiliationInfo><Affiliation>Amphia Hospital, Breda, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Vishwanath</LastName>
<ForeName>Raghu L</ForeName>
<Initials>RL</Initials>
<AffiliationInfo><Affiliation>Sanofi Global Oncology Medical Affairs, Cambridge, MA, United States.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bhargava</LastName>
<ForeName>Pankaj</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Sanofi Global Oncology Research and Development, Cambridge, MA, United States.</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>Macarulla</LastName>
<ForeName>Teresa</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.</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>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2014</Year>
<Month>11</Month>
<Day>14</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="D054316">Biomarkers, Pharmacological</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D009944">Organoplatinum Compounds</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D011993">Recombinant Fusion Proteins</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>04ZR38536J</RegistryNumber>
<NameOfSubstance UI="C030110">oxaliplatin</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0H43101T0J</RegistryNumber>
<NameOfSubstance UI="C051890">irinotecan</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>15C2VL427D</RegistryNumber>
<NameOfSubstance UI="C533178">aflibercept</NameOfSubstance>
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<Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber>
<NameOfSubstance UI="D040262">Receptors, Vascular Endothelial Growth Factor</NameOfSubstance>
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<Chemical><RegistryNumber>Q573I9DVLP</RegistryNumber>
<NameOfSubstance UI="D002955">Leucovorin</NameOfSubstance>
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<Chemical><RegistryNumber>U3P01618RT</RegistryNumber>
<NameOfSubstance UI="D005472">Fluorouracil</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>XT3Z54Z28A</RegistryNumber>
<NameOfSubstance UI="D002166">Camptothecin</NameOfSubstance>
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<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName>
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<MeshHeading><DescriptorName UI="D054316" MajorTopicYN="N">Biomarkers, Pharmacological</DescriptorName>
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<MeshHeading><DescriptorName UI="D002166" MajorTopicYN="N">Camptothecin</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName>
<QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D015179" MajorTopicYN="N">Colorectal Neoplasms</DescriptorName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018450" MajorTopicYN="N">Disease Progression</DescriptorName>
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<MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName>
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<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
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<QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName>
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<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
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<MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName>
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<QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D011993" MajorTopicYN="N">Recombinant Fusion Proteins</DescriptorName>
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<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Aflibercept</Keyword>
<Keyword MajorTopicYN="N">Colorectal cancer</Keyword>
<Keyword MajorTopicYN="N">Efficacy</Keyword>
<Keyword MajorTopicYN="N">PlGF</Keyword>
<Keyword MajorTopicYN="N">Safety</Keyword>
<Keyword MajorTopicYN="N">VEGF-A</Keyword>
<Keyword MajorTopicYN="N">VEGF-B</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year>
<Month>03</Month>
<Day>17</Day>
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<PubMedPubDate PubStatus="revised"><Year>2014</Year>
<Month>08</Month>
<Day>12</Day>
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Time course of safety and efficacy of aflibercept in combination with FOLFIRI in patients with metastatic colorectal cancer who progressed on previous oxaliplatin-based therapy.

Time course of safety and efficacy of aflibercept in combination with FOLFIRI in patients with metastatic colorectal cancer who progressed on previous oxaliplatin-based therapy.

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