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Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study.

Identifieur interne : 000278 ( PubMed/Corpus ); précédent : 000277; suivant : 000279

Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study.

Auteurs : P B Chapman ; C. Robert ; J. Larkin ; J B Haanen ; A. Ribas ; D. Hogg ; O. Hamid ; P A Ascierto ; A. Testori ; P C Lorigan ; R. Dummer ; J A Sosman ; K T Flaherty ; I. Chang ; S. Coleman ; I. Caro ; A. Hauschild ; G A Mcarthur

Source :

RBID : pubmed:28961848

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

Links to Exploration step

pubmed:28961848

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<name sortKey="Hamid, O" sort="Hamid, O" uniqKey="Hamid O" first="O" last="Hamid">O. Hamid</name>
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<name sortKey="Ascierto, P A" sort="Ascierto, P A" uniqKey="Ascierto P" first="P A" last="Ascierto">P A Ascierto</name>
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<name sortKey="Testori, A" sort="Testori, A" uniqKey="Testori A" first="A" last="Testori">A. Testori</name>
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<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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<name sortKey="Flaherty, K T" sort="Flaherty, K T" uniqKey="Flaherty K" first="K T" last="Flaherty">K T Flaherty</name>
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<name sortKey="Chang, I" sort="Chang, I" uniqKey="Chang I" first="I" last="Chang">I. Chang</name>
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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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<ArticleTitle>Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study.</ArticleTitle>
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<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>
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<AffiliationInfo>
<Affiliation>Department of Medicine, Massachusetts General Hospital, Boston.</Affiliation>
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<LastName>Chang</LastName>
<ForeName>I</ForeName>
<Initials>I</Initials>
<AffiliationInfo>
<Affiliation>Department of Biostatistics in Product Development, Biometrics.</Affiliation>
</AffiliationInfo>
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<LastName>Coleman</LastName>
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<AffiliationInfo>
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<LastName>Caro</LastName>
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<Initials>I</Initials>
<AffiliationInfo>
<Affiliation>Product Development, Oncology, Genentech Inc., South San Francisco, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Hauschild</LastName>
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<AffiliationInfo>
<Affiliation>Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.</Affiliation>
</AffiliationInfo>
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<LastName>McArthur</LastName>
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<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>
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Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024