Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer.
Identifieur interne : 002625 ( PubMed/Corpus ); précédent : 002624; suivant : 002626Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer.
Auteurs : Marc Peeters ; Kelly S. Oliner ; Timothy J. Price ; Andrés Cervantes ; Alberto F. Sobrero ; Michel Ducreux ; Yevhen Hotko ; Thierry André ; Emily Chan ; Florian Lordick ; Cornelis J A. Punt ; Andrew H. Strickland ; Gregory Wilson ; Tudor E. Ciuleanu ; Laslo Roman ; Eric Van Cutsem ; Pei He ; Hua Yu ; Reija Koukakis ; Jan-Henrik Terwey ; Andre S. Jung ; Roger Sidhu ; Scott D. PattersonSource :
- Clinical cancer research : an official journal of the American Association for Cancer Research [ 1078-0432 ] ; 2015.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Camptothecin (adverse effects), Camptothecin (analogs & derivatives), Camptothecin (therapeutic use), Colorectal Neoplasms (drug therapy), Colorectal Neoplasms (genetics), Colorectal Neoplasms (mortality), Colorectal Neoplasms (pathology), DNA Mutational Analysis, Exons, Female, Fluorouracil (adverse effects), Fluorouracil (therapeutic use), Genes, ras, Humans, Leucovorin (adverse effects), Leucovorin (therapeutic use), Male, Middle Aged, Mutation, Neoplasm Metastasis, Proportional Hazards Models, Proto-Oncogene Proteins B-raf (genetics), Retreatment, Survival Analysis, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Fluorouracil, Leucovorin.
- chemical , analogs & derivatives : Camptothecin.
- drug therapy : Colorectal Neoplasms.
- genetics : Colorectal Neoplasms, Proto-Oncogene Proteins B-raf.
- mortality : Colorectal Neoplasms.
- pathology : Colorectal Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Fluorouracil, Leucovorin.
- Adult, Aged, Aged, 80 and over, DNA Mutational Analysis, Exons, Female, Genes, ras, Humans, Male, Middle Aged, Mutation, Neoplasm Metastasis, Proportional Hazards Models, Retreatment, Survival Analysis, Treatment Outcome.
Abstract
We evaluated the influence of RAS mutation status on the treatment effect of panitumumab in a prospective-retrospective analysis of a randomized, multicenter phase III study of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) versus FOLFIRI alone as second-line therapy in patients with metastatic colorectal cancer (mCRC; ClinicalTrials.gov, NCT0039183).
DOI: 10.1158/1078-0432.CCR-15-0526
PubMed: 26341920
Links to Exploration step
pubmed:26341920Le document en format XML
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<author><name sortKey="Sobrero, Alberto F" sort="Sobrero, Alberto F" uniqKey="Sobrero A" first="Alberto F" last="Sobrero">Alberto F. Sobrero</name>
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<author><name sortKey="Andre, Thierry" sort="Andre, Thierry" uniqKey="Andre T" first="Thierry" last="André">Thierry André</name>
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<author><name sortKey="Chan, Emily" sort="Chan, Emily" uniqKey="Chan E" first="Emily" last="Chan">Emily Chan</name>
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<author><name sortKey="Lordick, Florian" sort="Lordick, Florian" uniqKey="Lordick F" first="Florian" last="Lordick">Florian Lordick</name>
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</affiliation>
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<author><name sortKey="Roman, Laslo" sort="Roman, Laslo" uniqKey="Roman L" first="Laslo" last="Roman">Laslo Roman</name>
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<front><div type="abstract" xml:lang="en">We evaluated the influence of RAS mutation status on the treatment effect of panitumumab in a prospective-retrospective analysis of a randomized, multicenter phase III study of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) versus FOLFIRI alone as second-line therapy in patients with metastatic colorectal cancer (mCRC; ClinicalTrials.gov, NCT0039183).</div>
</front>
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<DateCreated><Year>2015</Year>
<Month>12</Month>
<Day>16</Day>
</DateCreated>
<DateCompleted><Year>2016</Year>
<Month>09</Month>
<Day>15</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>03</Month>
<Day>22</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">1078-0432</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>21</Volume>
<Issue>24</Issue>
<PubDate><Year>2015</Year>
<Month>12</Month>
<Day>15</Day>
</PubDate>
</JournalIssue>
<Title>Clinical cancer research : an official journal of the American Association for Cancer Research</Title>
<ISOAbbreviation>Clin. Cancer Res.</ISOAbbreviation>
</Journal>
<ArticleTitle>Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer.</ArticleTitle>
<Pagination><MedlinePgn>5469-79</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1158/1078-0432.CCR-15-0526</ELocationID>
<Abstract><AbstractText Label="PURPOSE">We evaluated the influence of RAS mutation status on the treatment effect of panitumumab in a prospective-retrospective analysis of a randomized, multicenter phase III study of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) versus FOLFIRI alone as second-line therapy in patients with metastatic colorectal cancer (mCRC; ClinicalTrials.gov, NCT0039183).</AbstractText>
<AbstractText Label="EXPERIMENTAL DESIGN">Outcomes were from the study's primary analysis. RAS mutations beyond KRAS exon 2 (KRAS exons 3, 4; NRAS exons 2, 3, 4; BRAF exon 15) were detected by bidirectional Sanger sequencing in wild-type KRAS exon 2 tumor specimens. Progression-free survival (PFS) and overall survival (OS) were coprimary endpoints.</AbstractText>
<AbstractText Label="RESULTS">The RAS ascertainment rate was 85%; 18% of wild-type KRAS exon 2 tumors harbored other RAS mutations. For PFS and OS, the hazard ratio (HR) for panitumumab plus FOLFIRI versus FOLFIRI alone more strongly favored panitumumab in the wild-type RAS population than in the wild-type KRAS exon 2 population [PFS HR, 0.70 (95% confidence interval [CI], 0.54-0.91); P = 0.007 vs. 0.73 (95% CI, 0.59-0.90); P = 0.004; OS HR, 0.81 (95% CI, 0.63-1.03); P = 0.08 vs. 0.85 (95% CI, 0.70-1.04); P = 0.12]. Patients with RAS mutations were unlikely to benefit from panitumumab. Among RAS wild-type patients, the objective response rate was 41% in the panitumumab-FOLFIRI group versus 10% in the FOLFIRI group.</AbstractText>
<AbstractText Label="CONCLUSIONS">Patients with RAS mutations were unlikely to benefit from panitumumab-FOLFIRI and the benefit-risk of panitumumab-FOLFIRI was improved in the wild-type RAS population compared with the wild-type KRAS exon 2 population. These findings support RAS testing for patients with mCRC. Clin Cancer Res; 21(24); 5469-79. ©2015 AACR.See related commentary by Salazar and Ciardiello, p. 5415.</AbstractText>
<CopyrightInformation>©2015 American Association for Cancer Research.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Peeters</LastName>
<ForeName>Marc</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Antwerp University Hospital and University of Antwerp, Edegem, Belgium. Marc.Peeters@uza.be.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Oliner</LastName>
<ForeName>Kelly S</ForeName>
<Initials>KS</Initials>
<AffiliationInfo><Affiliation>Amgen Inc., Thousand Oaks, California, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Price</LastName>
<ForeName>Timothy J</ForeName>
<Initials>TJ</Initials>
<AffiliationInfo><Affiliation>Queen Elizabeth Hospital and University of Adelaide, Woodville, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cervantes</LastName>
<ForeName>Andrés</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Biomedical Research Institute INCLIVA, University of Valencia, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sobrero</LastName>
<ForeName>Alberto F</ForeName>
<Initials>AF</Initials>
<AffiliationInfo><Affiliation>Ospedale San Martino, Genova, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ducreux</LastName>
<ForeName>Michel</ForeName>
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