AustralieFrV1, Main, Exploration, bibRecord, 002398

Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy.

Identifieur interne : 002398 ( Main/Exploration ); précédent : 002397; suivant : 002399

Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy.

Auteurs : Eric Van Cutsem [Belgique] ; Florence Joulain [France] ; Paulo M. Hoff [Brésil] ; Edith Mitchell [États-Unis] ; Paul Ruff [Afrique du Sud] ; Radek Lakom [République tchèque] ; Jana Prausová [République tchèque] ; Vladimir M. Moiseyenko [Russie] ; Guy Van Hazel [Australie] ; David Cunningham [Royaume-Uni] ; Dirk Arnold [Allemagne] ; Hans-Joachim Schmoll [Allemagne] ; Albert J. Ten Tije [Pays-Bas] ; Joseph Mckendrick [Australie] ; Hendrik Kröning [Allemagne] ; Yves Humblet [Belgique] ; Cristina Grávalos [Espagne] ; Solenn Le-Guennec [France] ; Michael Andria [États-Unis] ; Emmanuelle Dochy [Belgique] ; Raghu L. Vishwanath [États-Unis] ; Teresa Macarulla [Espagne] ; Josep Tabernero [Espagne]

Source :

Targeted oncology [ 1776-260X ] ; 2016.

RBID : pubmed:26706237

Descripteurs français

English descriptors

KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (pharmacology), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Camptothecin (administration & dosage), Camptothecin (analogs & derivatives), Camptothecin (pharmacology), Camptothecin (therapeutic use), Colorectal Neoplasms (drug therapy), Colorectal Neoplasms (mortality), Double-Blind Method, Female, Fluorouracil (administration & dosage), Fluorouracil (pharmacology), Fluorouracil (therapeutic use), Humans, Leucovorin (administration & dosage), Leucovorin (pharmacology), Leucovorin (therapeutic use), Male, Middle Aged, Neoplasm Recurrence, Local (drug therapy), Organoplatinum Compounds (administration & dosage), Organoplatinum Compounds (pharmacology), Organoplatinum Compounds (therapeutic use), Receptors, Vascular Endothelial Growth Factor (administration & dosage), Receptors, Vascular Endothelial Growth Factor (therapeutic use), Recombinant Fusion Proteins (administration & dosage), Recombinant Fusion Proteins (pharmacology), Recombinant Fusion Proteins (therapeutic use), Survival Analysis, Treatment Outcome.
MESH :
- chemical , administration & dosage : Camptothecin, Fluorouracil, Leucovorin, Organoplatinum Compounds, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- chemical , analogs & derivatives : Camptothecin.
- drug therapy : Colorectal Neoplasms, Neoplasm Recurrence, Local.
- mortality : Colorectal Neoplasms.
- pharmacology : Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Fluorouracil, Leucovorin, Organoplatinum Compounds, Recombinant Fusion Proteins.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Fluorouracil, Leucovorin, Organoplatinum Compounds, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Male, Middle Aged, Survival Analysis, Treatment Outcome.

Abstract

The aim of this post hoc analysis of the VELOUR study (ClinicalTrials.gov NCT00561470) was to investigate the treatment effect of adding aflibercept to second-line infusional 5-fluorouracil (5-FU), leucovorin and irinotecan (FOLFIRI) in patients with metastatic colorectal cancer (mCRC) who had failed any prior oxaliplatin-containing regimen. Adjuvant rapid relapsers (ARR), who were enrolled directly following relapse during or within 6 months of completion of oxaliplatin-containing adjuvant chemotherapy (N = 124, including 17 patients who also received bevacizumab as part of their adjuvant therapy), were excluded from the original VELOUR intention-to-treat (ITT) population (N = 1226). After exclusion of the ARR, overall survival (OS) in the ITT minus ARR (ITT-ARR) population (N = 1102) was longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm [hazard ratio (HR) 0.78, 95 % confidence interval (CI) 0.68-0.90; median survival difference 1.87 months]. In the subgroup of patients assigned to the prior bevacizumab stratum at randomization, OS was numerically longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm (HR 0.81; 95 % CI 0.63-1.04; median survival difference 2.14 months). Comparison of the post hoc analysis results with the primary analysis from VELOUR suggests that the inclusion of the directly enrolled ARR may have understated the aflibercept treatment benefit for both bevacizumab-pretreated and bevacizumab-naïve patients in the strictly second-line setting although no definitive conclusion may be inferred. The benefit associated with the addition of aflibercept to second-line FOLFIRI in patients with mCRC was observed whatever the timing of first-line disease progression. There were no unexpected safety concerns.

DOI: 10.1007/s11523-015-0402-9
PubMed: 26706237

Affiliations:

Le document en format XML

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<author><name sortKey="Cunningham, David" sort="Cunningham, David" uniqKey="Cunningham D" first="David" last="Cunningham">David Cunningham</name>
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<author><name sortKey="Arnold, Dirk" sort="Arnold, Dirk" uniqKey="Arnold D" first="Dirk" last="Arnold">Dirk Arnold</name>
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<author><name sortKey="Kroning, Hendrik" sort="Kroning, Hendrik" uniqKey="Kroning H" first="Hendrik" last="Kröning">Hendrik Kröning</name>
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<author><name sortKey="Humblet, Yves" sort="Humblet, Yves" uniqKey="Humblet Y" first="Yves" last="Humblet">Yves Humblet</name>
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</placeName>
</affiliation>
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<author><name sortKey="Gravalos, Cristina" sort="Gravalos, Cristina" uniqKey="Gravalos C" first="Cristina" last="Grávalos">Cristina Grávalos</name>
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<author><name sortKey="Le Guennec, Solenn" sort="Le Guennec, Solenn" uniqKey="Le Guennec S" first="Solenn" last="Le-Guennec">Solenn Le-Guennec</name>
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<author><name sortKey="Andria, Michael" sort="Andria, Michael" uniqKey="Andria M" first="Michael" last="Andria">Michael Andria</name>
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<author><name sortKey="Dochy, Emmanuelle" sort="Dochy, Emmanuelle" uniqKey="Dochy E" first="Emmanuelle" last="Dochy">Emmanuelle Dochy</name>
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<author><name sortKey="Vishwanath, Raghu L" sort="Vishwanath, Raghu L" uniqKey="Vishwanath R" first="Raghu L" last="Vishwanath">Raghu L. Vishwanath</name>
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<author><name sortKey="Macarulla, Teresa" sort="Macarulla, Teresa" uniqKey="Macarulla T" first="Teresa" last="Macarulla">Teresa Macarulla</name>
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<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona</wicri:regionArea>
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</placeName>
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</author>
<author><name sortKey="Tabernero, Josep" sort="Tabernero, Josep" uniqKey="Tabernero J" first="Josep" last="Tabernero">Josep Tabernero</name>
<affiliation wicri:level="3"><nlm:affiliation>Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy.</title>
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<author><name sortKey="Joulain, Florence" sort="Joulain, Florence" uniqKey="Joulain F" first="Florence" last="Joulain">Florence Joulain</name>
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<wicri:noRegion>Chilly Mazarin</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hoff, Paulo M" sort="Hoff, Paulo M" uniqKey="Hoff P" first="Paulo M" last="Hoff">Paulo M. Hoff</name>
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</placeName>
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<author><name sortKey="Mitchell, Edith" sort="Mitchell, Edith" uniqKey="Mitchell E" first="Edith" last="Mitchell">Edith Mitchell</name>
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</placeName>
</affiliation>
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<author><name sortKey="Ruff, Paul" sort="Ruff, Paul" uniqKey="Ruff P" first="Paul" last="Ruff">Paul Ruff</name>
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<author><name sortKey="Lakom, Radek" sort="Lakom, Radek" uniqKey="Lakom R" first="Radek" last="Lakom">Radek Lakom</name>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Prausova, Jana" sort="Prausova, Jana" uniqKey="Prausova J" first="Jana" last="Prausová">Jana Prausová</name>
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<country xml:lang="fr">République tchèque</country>
<wicri:regionArea>Fakultni nemocnice v Motole, Prague</wicri:regionArea>
<placeName><settlement type="city">Prague</settlement>
<region type="région" nuts="2">Bohême centrale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Moiseyenko, Vladimir M" sort="Moiseyenko, Vladimir M" uniqKey="Moiseyenko V" first="Vladimir M" last="Moiseyenko">Vladimir M. Moiseyenko</name>
<affiliation wicri:level="1"><nlm:affiliation>Scientific Research Institute of Oncology n.a. N.N.Petrov, St-Petersburg, Russian Federation.</nlm:affiliation>
<country xml:lang="fr">Russie</country>
<wicri:regionArea>Scientific Research Institute of Oncology n.a. N.N.Petrov, St-Petersburg</wicri:regionArea>
<wicri:noRegion>St-Petersburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Van Hazel, Guy" sort="Van Hazel, Guy" uniqKey="Van Hazel G" first="Guy" last="Van Hazel">Guy Van Hazel</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Western Australia, Perth, Western Australia, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>University of Western Australia, Perth, Western Australia</wicri:regionArea>
<wicri:noRegion>Western Australia</wicri:noRegion>
</affiliation>
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<series><title level="j">Targeted oncology</title>
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<front><div type="abstract" xml:lang="en">The aim of this post hoc analysis of the VELOUR study (ClinicalTrials.gov NCT00561470) was to investigate the treatment effect of adding aflibercept to second-line infusional 5-fluorouracil (5-FU), leucovorin and irinotecan (FOLFIRI) in patients with metastatic colorectal cancer (mCRC) who had failed any prior oxaliplatin-containing regimen. Adjuvant rapid relapsers (ARR), who were enrolled directly following relapse during or within 6 months of completion of oxaliplatin-containing adjuvant chemotherapy (N = 124, including 17 patients who also received bevacizumab as part of their adjuvant therapy), were excluded from the original VELOUR intention-to-treat (ITT) population (N = 1226). After exclusion of the ARR, overall survival (OS) in the ITT minus ARR (ITT-ARR) population (N = 1102) was longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm [hazard ratio (HR) 0.78, 95 % confidence interval (CI) 0.68-0.90; median survival difference 1.87 months]. In the subgroup of patients assigned to the prior bevacizumab stratum at randomization, OS was numerically longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm (HR 0.81; 95 % CI 0.63-1.04; median survival difference 2.14 months). Comparison of the post hoc analysis results with the primary analysis from VELOUR suggests that the inclusion of the directly enrolled ARR may have understated the aflibercept treatment benefit for both bevacizumab-pretreated and bevacizumab-naïve patients in the strictly second-line setting although no definitive conclusion may be inferred. The benefit associated with the addition of aflibercept to second-line FOLFIRI in patients with mCRC was observed whatever the timing of first-line disease progression. There were no unexpected safety concerns.</div>
</front>
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   |texte=   Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy.
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Serveur d'exploration sur les relations entre la France et l'Australie

Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy.

Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy.

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	Serveur d'exploration sur les relations entre la France et l'Australie
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