Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study.
Identifieur interne : 004F57 ( Ncbi/Merge ); précédent : 004F56; suivant : 004F58Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study.
Auteurs : P B Chapman [États-Unis] ; C. Robert [France] ; J. Larkin [Royaume-Uni] ; J B Haanen [Pays-Bas] ; A. Ribas [États-Unis] ; D. Hogg [Canada] ; O. Hamid [États-Unis] ; P A Ascierto ; A. Testori [Italie] ; P C Lorigan [Royaume-Uni] ; R. Dummer [Suisse] ; J A Sosman [États-Unis] ; K T Flaherty [États-Unis] ; I. Chang ; S. Coleman ; I. Caro [États-Unis] ; A. Hauschild [Allemagne] ; G A McarthurSource :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2017.
Abstract
The BRIM-3 trial showed improved progression-free survival (PFS) and overall survival (OS) for vemurafenib compared with dacarbazine in treatment-naive patients with BRAFV600 mutation-positive metastatic melanoma. We present final OS data from BRIM-3.
DOI: 10.1093/annonc/mdx339
PubMed: 28961848
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</affiliation>
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</placeName>
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<front><div type="abstract" xml:lang="en">The BRIM-3 trial showed improved progression-free survival (PFS) and overall survival (OS) for vemurafenib compared with dacarbazine in treatment-naive patients with BRAFV600 mutation-positive metastatic melanoma. We present final OS data from BRIM-3.</div>
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<DateCreated><Year>2017</Year>
<Month>09</Month>
<Day>29</Day>
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<Month>09</Month>
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<Month>Oct</Month>
<Day>01</Day>
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<Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title>
<ISOAbbreviation>Ann. Oncol.</ISOAbbreviation>
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<ArticleTitle>Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study.</ArticleTitle>
<Pagination><MedlinePgn>2581-2587</MedlinePgn>
</Pagination>
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<Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">The BRIM-3 trial showed improved progression-free survival (PFS) and overall survival (OS) for vemurafenib compared with dacarbazine in treatment-naive patients with BRAFV600 mutation-positive metastatic melanoma. We present final OS data from BRIM-3.</AbstractText>
<AbstractText Label="Patients and methods" NlmCategory="UNASSIGNED">Patients were randomly assigned in a 1 : 1 ratio to receive vemurafenib (960 mg twice daily) or dacarbazine (1000 mg/m2 every 3 weeks). OS and PFS were co-primary end points. OS was assessed in the intention-to-treat population, with and without censoring of data for dacarbazine patients who crossed over to vemurafenib.</AbstractText>
<AbstractText Label="Results" NlmCategory="UNASSIGNED">Between 4 January 2010 and 16 December 2010, a total of 675 patients were randomized to vemurafenib (n = 337) or dacarbazine (n = 338, of whom 84 crossed over to vemurafenib). At the time of database lock (14 August 2015), median OS, censored at crossover, was significantly longer for vemurafenib than for dacarbazine {13.6 months [95% confidence interval (CI) 12.0-15.4] versus 9.7 months [95% CI 7.9-12.8; hazard ratio (HR) 0.81 [95% CI 0.67-0.98]; P = 0.03}, as was median OS without censoring at crossover [13.6 months (95% CI 12.0-15.4) versus 10.3 months (95% CI 9.1-12.8); HR 0.81 (95% CI 0.68-0.96); P = 0.01]. Kaplan-Meier estimates of OS rates for vemurafenib versus dacarbazine were 56% versus 46%, 30% versus 24%, 21% versus 19% and 17% versus 16% at 1, 2, 3 and 4 years, respectively. Overall, 173 of the 338 patients (51%) in the dacarbazine arm and 175 of the 337 (52%) of those in the vemurafenib arm received subsequent anticancer therapies, most commonly ipilimumab. Safety data were consistent with the primary analysis.</AbstractText>
<AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">Vemurafenib continues to be associated with improved median OS in the BRIM-3 trial after extended follow-up. OS curves converged after ≈3 years, likely as a result of crossover from dacarbazine to vemurafenib and receipt of subsequent anticancer therapies.</AbstractText>
<AbstractText Label="ClinicalTrials.gov" NlmCategory="UNASSIGNED">NCT01006980.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Chapman</LastName>
<ForeName>P B</ForeName>
<Initials>PB</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Robert</LastName>
<ForeName>C</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Institut Gustave Roussy and Paris Sud University, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Larkin</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, The Royal Marsden NHS Foundation Trust, London, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Haanen</LastName>
<ForeName>J B</ForeName>
<Initials>JB</Initials>
<AffiliationInfo><Affiliation>Division of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ribas</LastName>
<ForeName>A</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Hematology and Oncology, Jonsson Comprehensive Cancer Center at the University of California Los Angeles, Los Angeles, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hogg</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Division of Medical Oncology and Hematology, Princess Margaret Hospital and University Health Network, Toronto, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hamid</LastName>
<ForeName>O</ForeName>
<Initials>O</Initials>
<AffiliationInfo><Affiliation>The Angeles Clinic and Research Institute, Melanoma Therapeutics, Los Angeles, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ascierto</LastName>
<ForeName>P A</ForeName>
<Initials>PA</Initials>
<AffiliationInfo><Affiliation>Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione G. Pascale, Naples.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Testori</LastName>
<ForeName>A</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Melanoma and Sarcoma, Istituto Europeo di Oncologia, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lorigan</LastName>
<ForeName>P C</ForeName>
<Initials>PC</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, University of Manchester, Manchester, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dummer</LastName>
<ForeName>R</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Department of Dermatology, University of Zurich, Zurich, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sosman</LastName>
<ForeName>J A</ForeName>
<Initials>JA</Initials>
<AffiliationInfo><Affiliation>Department of Hematology/Oncology, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Flaherty</LastName>
<ForeName>K T</ForeName>
<Initials>KT</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Massachusetts General Hospital, Boston.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chang</LastName>
<ForeName>I</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Department of Biostatistics in Product Development, Biometrics.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Coleman</LastName>
<ForeName>S</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Clinical Department.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Caro</LastName>
<ForeName>I</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Product Development, Oncology, Genentech Inc., South San Francisco, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hauschild</LastName>
<ForeName>A</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McArthur</LastName>
<ForeName>G A</ForeName>
<Initials>GA</Initials>
<AffiliationInfo><Affiliation>Department of Oncology, Peter MacCallum Cancer Centre, East Melbourne.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Oncology, University of Melbourne, Parkville, Australia.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Ann Oncol</MedlineTA>
<NlmUniqueID>9007735</NlmUniqueID>
<ISSNLinking>0923-7534</ISSNLinking>
</MedlineJournalInfo>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">BRAF mutation</Keyword>
<Keyword MajorTopicYN="N">dacarbazine</Keyword>
<Keyword MajorTopicYN="N">melanoma</Keyword>
<Keyword MajorTopicYN="N">vemurafenib</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2017</Year>
<Month>9</Month>
<Day>30</Day>
<Hour>6</Hour>
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<PubMedPubDate PubStatus="pubmed"><Year>2017</Year>
<Month>9</Month>
<Day>30</Day>
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<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>9</Month>
<Day>30</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">28961848</ArticleId>
<ArticleId IdType="pii">4060460</ArticleId>
<ArticleId IdType="doi">10.1093/annonc/mdx339</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Allemagne</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
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<li>Manchester</li>
<li>Milan</li>
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<orgName><li>Université de Manchester</li>
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<name sortKey="Coleman, S" sort="Coleman, S" uniqKey="Coleman S" first="S" last="Coleman">S. Coleman</name>
<name sortKey="Mcarthur, G A" sort="Mcarthur, G A" uniqKey="Mcarthur G" first="G A" last="Mcarthur">G A Mcarthur</name>
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<country name="États-Unis"><region name="État de New York"><name sortKey="Chapman, P B" sort="Chapman, P B" uniqKey="Chapman P" first="P B" last="Chapman">P B Chapman</name>
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<name sortKey="Hamid, O" sort="Hamid, O" uniqKey="Hamid O" first="O" last="Hamid">O. Hamid</name>
<name sortKey="Ribas, A" sort="Ribas, A" uniqKey="Ribas A" first="A" last="Ribas">A. Ribas</name>
<name sortKey="Sosman, J A" sort="Sosman, J A" uniqKey="Sosman J" first="J A" last="Sosman">J A Sosman</name>
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<country name="France"><region name="Île-de-France"><name sortKey="Robert, C" sort="Robert, C" uniqKey="Robert C" first="C" last="Robert">C. Robert</name>
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<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Larkin, J" sort="Larkin, J" uniqKey="Larkin J" first="J" last="Larkin">J. Larkin</name>
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<name sortKey="Lorigan, P C" sort="Lorigan, P C" uniqKey="Lorigan P" first="P C" last="Lorigan">P C Lorigan</name>
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<country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Haanen, J B" sort="Haanen, J B" uniqKey="Haanen J" first="J B" last="Haanen">J B Haanen</name>
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<country name="Suisse"><region name="Canton de Zurich"><name sortKey="Dummer, R" sort="Dummer, R" uniqKey="Dummer R" first="R" last="Dummer">R. Dummer</name>
</region>
</country>
<country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Hauschild, A" sort="Hauschild, A" uniqKey="Hauschild A" first="A" last="Hauschild">A. Hauschild</name>
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