Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial.
Identifieur interne : 000701 ( PubMed/Corpus ); précédent : 000700; suivant : 000702Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial.
Auteurs : Paul Ruff ; Eric Van Cutsem ; Radek Lakomy ; Jana Prausova ; Guy A. Van Hazel ; Vladimir M. Moiseyenko ; Karen Soussan-Lazard ; Emmanuelle Dochy ; Emmanuelle Magherini ; Teresa Macarulla ; Demetris PapamichaelSource :
- Journal of geriatric oncology [ 1879-4076 ] ; 2017.
Abstract
Aflibercept (ziv-aflibercept) significantly improves progression-free (PFS) and overall survival (OS) when added to 5-fluorouracil, leucovorin and irinotecan (FOLFIRI), compared with FOLFIRI alone, in patients with metastatic colorectal cancer previously treated with oxaliplatin-based therapy. This subset analysis of the VELOUR study investigates aflibercept plus FOLFIRI versus placebo plus FOLFIRI according to age.
DOI: 10.1016/j.jgo.2017.07.010
PubMed: 28807738
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial.</title><author><name sortKey="Ruff, Paul" sort="Ruff, Paul" uniqKey="Ruff P" first="Paul" last="Ruff">Paul Ruff</name><affiliation><nlm:affiliation>University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa. Electronic address: pruff@iafrica.com.</nlm:affiliation></affiliation></author><author><name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name><affiliation><nlm:affiliation>University Hospitals Leuven and KU Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Lakomy, Radek" sort="Lakomy, Radek" uniqKey="Lakomy R" first="Radek" last="Lakomy">Radek Lakomy</name><affiliation><nlm:affiliation>Masaryk Memorial Cancer Institute, Brno, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Prausova, Jana" sort="Prausova, Jana" uniqKey="Prausova J" first="Jana" last="Prausova">Jana Prausova</name><affiliation><nlm:affiliation>University Hospital Motol, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Van Hazel, Guy A" sort="Van Hazel, Guy A" uniqKey="Van Hazel G" first="Guy A" last="Van Hazel">Guy A. Van Hazel</name><affiliation><nlm:affiliation>University of Western Australia, Western Australia, Australia.</nlm:affiliation></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><nlm:affiliation>Cancer Center, St-Petersburg, Russian Federation.</nlm:affiliation></affiliation></author><author><name sortKey="Soussan Lazard, Karen" sort="Soussan Lazard, Karen" uniqKey="Soussan Lazard K" first="Karen" last="Soussan-Lazard">Karen Soussan-Lazard</name><affiliation><nlm:affiliation>Sanofi, Vitry-sur-Seine, France.</nlm:affiliation></affiliation></author><author><name sortKey="Dochy, Emmanuelle" sort="Dochy, Emmanuelle" uniqKey="Dochy E" first="Emmanuelle" last="Dochy">Emmanuelle Dochy</name><affiliation><nlm:affiliation>Sanofi, Diegem, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Magherini, Emmanuelle" sort="Magherini, Emmanuelle" uniqKey="Magherini E" first="Emmanuelle" last="Magherini">Emmanuelle Magherini</name><affiliation><nlm:affiliation>Sanofi, Vitry-sur-Seine, France.</nlm:affiliation></affiliation></author><author><name sortKey="Macarulla, Teresa" sort="Macarulla, Teresa" uniqKey="Macarulla T" first="Teresa" last="Macarulla">Teresa Macarulla</name><affiliation><nlm:affiliation>Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Papamichael, Demetris" sort="Papamichael, Demetris" uniqKey="Papamichael D" first="Demetris" last="Papamichael">Demetris Papamichael</name><affiliation><nlm:affiliation>Bank of Cyprus Oncology Centre, Nicosia, Cyprus.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28807738</idno><idno type="pmid">28807738</idno><idno type="doi">10.1016/j.jgo.2017.07.010</idno><idno type="wicri:Area/PubMed/Corpus">000701</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000701</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial.</title><author><name sortKey="Ruff, Paul" sort="Ruff, Paul" uniqKey="Ruff P" first="Paul" last="Ruff">Paul Ruff</name><affiliation><nlm:affiliation>University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa. Electronic address: pruff@iafrica.com.</nlm:affiliation></affiliation></author><author><name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name><affiliation><nlm:affiliation>University Hospitals Leuven and KU Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Lakomy, Radek" sort="Lakomy, Radek" uniqKey="Lakomy R" first="Radek" last="Lakomy">Radek Lakomy</name><affiliation><nlm:affiliation>Masaryk Memorial Cancer Institute, Brno, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Prausova, Jana" sort="Prausova, Jana" uniqKey="Prausova J" first="Jana" last="Prausova">Jana Prausova</name><affiliation><nlm:affiliation>University Hospital Motol, Prague, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Van Hazel, Guy A" sort="Van Hazel, Guy A" uniqKey="Van Hazel G" first="Guy A" last="Van Hazel">Guy A. Van Hazel</name><affiliation><nlm:affiliation>University of Western Australia, Western Australia, Australia.</nlm:affiliation></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><nlm:affiliation>Cancer Center, St-Petersburg, Russian Federation.</nlm:affiliation></affiliation></author><author><name sortKey="Soussan Lazard, Karen" sort="Soussan Lazard, Karen" uniqKey="Soussan Lazard K" first="Karen" last="Soussan-Lazard">Karen Soussan-Lazard</name><affiliation><nlm:affiliation>Sanofi, Vitry-sur-Seine, France.</nlm:affiliation></affiliation></author><author><name sortKey="Dochy, Emmanuelle" sort="Dochy, Emmanuelle" uniqKey="Dochy E" first="Emmanuelle" last="Dochy">Emmanuelle Dochy</name><affiliation><nlm:affiliation>Sanofi, Diegem, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Magherini, Emmanuelle" sort="Magherini, Emmanuelle" uniqKey="Magherini E" first="Emmanuelle" last="Magherini">Emmanuelle Magherini</name><affiliation><nlm:affiliation>Sanofi, Vitry-sur-Seine, France.</nlm:affiliation></affiliation></author><author><name sortKey="Macarulla, Teresa" sort="Macarulla, Teresa" uniqKey="Macarulla T" first="Teresa" last="Macarulla">Teresa Macarulla</name><affiliation><nlm:affiliation>Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Papamichael, Demetris" sort="Papamichael, Demetris" uniqKey="Papamichael D" first="Demetris" last="Papamichael">Demetris Papamichael</name><affiliation><nlm:affiliation>Bank of Cyprus Oncology Centre, Nicosia, Cyprus.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of geriatric oncology</title><idno type="eISSN">1879-4076</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Aflibercept (ziv-aflibercept) significantly improves progression-free (PFS) and overall survival (OS) when added to 5-fluorouracil, leucovorin and irinotecan (FOLFIRI), compared with FOLFIRI alone, in patients with metastatic colorectal cancer previously treated with oxaliplatin-based therapy. This subset analysis of the VELOUR study investigates aflibercept plus FOLFIRI versus placebo plus FOLFIRI according to age.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">28807738</PMID><DateCreated><Year>2017</Year><Month>08</Month><Day>15</Day></DateCreated><DateRevised><Year>2017</Year><Month>08</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-4076</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year><Month>Aug</Month><Day>12</Day></PubDate></JournalIssue><Title>Journal of geriatric oncology</Title><ISOAbbreviation>J Geriatr Oncol</ISOAbbreviation></Journal><ArticleTitle>Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">S1879-4068(17)30140-6</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jgo.2017.07.010</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">Aflibercept (ziv-aflibercept) significantly improves progression-free (PFS) and overall survival (OS) when added to 5-fluorouracil, leucovorin and irinotecan (FOLFIRI), compared with FOLFIRI alone, in patients with metastatic colorectal cancer previously treated with oxaliplatin-based therapy. This subset analysis of the VELOUR study investigates aflibercept plus FOLFIRI versus placebo plus FOLFIRI according to age.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Efficacy and safety were analyzed by treatment arm and age (≥ or <65years).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Overall, 443 patients were ≥65years old (205 in aflibercept arm; 238 in placebo arm) and 783 were <65years old (407 in aflibercept arm; 376 in placebo arm). Median OS was 12.6 versus 11.3months (hazard ratio [HR]: 0.85; 95.34% CI 0.68-1.07) in patients ≥65years old and 14.5 versus 12.5months (HR: 0.80; 95.34% CI 0.67-0.95) in those patients <65years old, for patients receiving FOLFIRI plus aflibercept or placebo, respectively. There was no interaction between treatment and age. Treatment-emergent adverse events (AEs) were comparable for patients <65years and ≥65years old. The incidence of grade 3/4 AEs was higher for patients ≥65years old than for those <65years old in both the aflibercept (89.3% versus 80.5%) and placebo (67.4% versus 59.4%) arms. Interaction tests for grade 3/4 antiangiogenic agent-related AEs suggested no heterogeneity between the older and younger patient populations (p>0.1).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">A limited but consistent benefit on both OS and PFS was associated with the addition of aflibercept to FOLFIRI compared with placebo in patients <65 and ≥65years old, with a marked but manageable increase in the toxicity profile in older patients.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">clinicaltrials.govNCT00561470.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Inc. 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>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>Lakomy</LastName><ForeName>Radek</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Masaryk Memorial Cancer Institute, Brno, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Prausova</LastName><ForeName>Jana</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>University Hospital Motol, Prague, 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>Moiseyenko</LastName><ForeName>Vladimir M</ForeName><Initials>VM</Initials><AffiliationInfo><Affiliation>Cancer Center, St-Petersburg, Russian Federation.</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>Dochy</LastName><ForeName>Emmanuelle</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Sanofi, Diegem, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Magherini</LastName><ForeName>Emmanuelle</ForeName><Initials>E</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), Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Papamichael</LastName><ForeName>Demetris</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Bank of Cyprus Oncology Centre, Nicosia, Cyprus.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>08</Month><Day>12</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>J Geriatr Oncol</MedlineTA><NlmUniqueID>101534770</NlmUniqueID><ISSNLinking>1879-4068</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Aflibercept</Keyword><Keyword MajorTopicYN="N">Elderly</Keyword><Keyword MajorTopicYN="N">Second-line</Keyword><Keyword MajorTopicYN="N">VEGF-Trap</Keyword><Keyword MajorTopicYN="N">VELOUR</Keyword><Keyword MajorTopicYN="N">mCRC</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>01</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>04</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>07</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28807738</ArticleId><ArticleId IdType="pii">S1879-4068(17)30140-6</ArticleId><ArticleId IdType="doi">10.1016/j.jgo.2017.07.010</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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