AustralieFrV1, PascalFrancis, Curation, bibRecord, 004408

Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

Identifieur interne : 004408 ( PascalFrancis/Curation ); précédent : 004407; suivant : 004409

Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

Auteurs : Paul B. Chapman [États-Unis] ; Axel Hauschild [Allemagne] ; Caroline Robert [France] ; John B. Haanen [Pays-Bas] ; Paolo Ascierto [Italie] ; James Larkin [États-Unis] ; Reinhard Dummer [Suisse] ; Claus Garbe [Allemagne] ; Alessandro Testori [Italie] ; Michele Maio [Italie] ; David Hogg [Canada] ; Paul Lorigan [Royaume-Uni] ; Celeste Lebbe [France] ; Thomas Jouary [France] ; Dirk Schadendorf [Allemagne] ; Antoni Ribas [États-Unis] ; Steven J. O'Day [États-Unis] ; Jeffrey A. Sosman [États-Unis] ; John M. Kirkwood [États-Unis] ; Alexander M. M. Eggermont [France] ; Brigitte Dreno [France] ; Keith Nolop [États-Unis] ; JIANG LI [Royaume-Uni, États-Unis] ; Betty Nelson [États-Unis] ; Jeannie Hou [États-Unis] ; Richard J. Lee [États-Unis] ; Keith T. Flaherty [États-Unis] ; Grant A. Mcarthur [Australie]

Source :

The New England journal of medicine [ 0028-4793 ] ; 2011.

RBID : Pascal:11-0309403

Descripteurs français

Pascal (Inist)
- Mélanome malin, Survie, Protooncogène, Gène onc cellulaire, Mutation, Génétique, Médecine, Gène BRAF.
Wicri :
- topic : Génétique, Médecine.

English descriptors

KwdEn :
- BRAF Gene, C-Onc gene, Genetics, Malignant melanoma, Medicine, Mutation, Protooncogene, Survival.

Abstract

BACKGROUND Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. METHODS We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. RESULTS At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P<0.001 for both comparisons). After review of the interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to vemurafenib was recommended. Response rates were 48% for vemurafenib and 5% for dacarbazine. Common adverse events associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma or squamous-cell carcinoma, photosensitivity, nausea, and diarrhea; 38% of patients required dose modification because of toxic effects. CONCLUSIONS Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation. (Funded by Hoffmann-La Roche; BRIM-3 ClinicalTrials.gov number, NCT01006980.).

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C01	`01`		`ENG`	@0 BACKGROUND Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. METHODS We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. RESULTS At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P<0.001 for both comparisons). After review of the interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to vemurafenib was recommended. Response rates were 48% for vemurafenib and 5% for dacarbazine. Common adverse events associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma or squamous-cell carcinoma, photosensitivity, nausea, and diarrhea; 38% of patients required dose modification because of toxic effects. CONCLUSIONS Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation. (Funded by Hoffmann-La Roche; BRIM-3 ClinicalTrials.gov number, NCT01006980.).
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Le document en format XML

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<author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
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<author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
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<author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
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<author><name sortKey="O Day, Steven J" sort="O Day, Steven J" uniqKey="O Day S" first="Steven J." last="O'Day">Steven J. O'Day</name>
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<author><name sortKey="Sosman, Jeffrey A" sort="Sosman, Jeffrey A" uniqKey="Sosman J" first="Jeffrey A." last="Sosman">Jeffrey A. Sosman</name>
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<author><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name>
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<author><name sortKey="Eggermont, Alexander M M" sort="Eggermont, Alexander M M" uniqKey="Eggermont A" first="Alexander M. M." last="Eggermont">Alexander M. M. Eggermont</name>
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<author><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dreno">Brigitte Dreno</name>
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<author><name sortKey="Nolop, Keith" sort="Nolop, Keith" uniqKey="Nolop K" first="Keith" last="Nolop">Keith Nolop</name>
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<author><name sortKey="Jiang Li" sort="Jiang Li" uniqKey="Jiang Li" last="Jiang Li">JIANG LI</name>
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<country>Royaume-Uni</country>
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<affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Hoffmann-La Roche</s1>
<s2>Nutley, NJ</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
<sZ>26 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Nelson, Betty" sort="Nelson, Betty" uniqKey="Nelson B" first="Betty" last="Nelson">Betty Nelson</name>
<affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Genentech</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Hou, Jeannie" sort="Hou, Jeannie" uniqKey="Hou J" first="Jeannie" last="Hou">Jeannie Hou</name>
<affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Genentech</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Lee, Richard J" sort="Lee, Richard J" uniqKey="Lee R" first="Richard J." last="Lee">Richard J. Lee</name>
<affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Hoffmann-La Roche</s1>
<s2>Nutley, NJ</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
<sZ>26 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Flaherty, Keith T" sort="Flaherty, Keith T" uniqKey="Flaherty K" first="Keith T." last="Flaherty">Keith T. Flaherty</name>
<affiliation wicri:level="1"><inist:fA14 i1="24"><s1>Department of Medicine, Massachusetts General Hospital</s1>
<s2>Boston</s2>
<s3>USA</s3>
<sZ>27 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name>
<affiliation wicri:level="1"><inist:fA14 i1="25"><s1>Peter MacCallum Cancer Center</s1>
<s2>Melbourne, VIC</s2>
<s3>AUS</s3>
<sZ>28 aut.</sZ>
</inist:fA14>
<country>Australie</country>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">11-0309403</idno>
<date when="2011">2011</date>
<idno type="stanalyst">PASCAL 11-0309403 INIST</idno>
<idno type="RBID">Pascal:11-0309403</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">001B36</idno>
<idno type="wicri:Area/PascalFrancis/Curation">004408</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation</title>
<author><name sortKey="Chapman, Paul B" sort="Chapman, Paul B" uniqKey="Chapman P" first="Paul B." last="Chapman">Paul B. Chapman</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Medicine, Memorial Sloan-Kettering Cancer Center</s1>
<s2>New York</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>University of Kiel</s1>
<s2>Kiel</s2>
<s3>DEU</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
</affiliation>
</author>
<author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Institut Gustave Roussy, Hôpital Saint Louis</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author><name sortKey="Haanen, John B" sort="Haanen, John B" uniqKey="Haanen J" first="John B." last="Haanen">John B. Haanen</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Netherlands Cancer Institute</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
</affiliation>
</author>
<author><name sortKey="Ascierto, Paolo" sort="Ascierto, Paolo" uniqKey="Ascierto P" first="Paolo" last="Ascierto">Paolo Ascierto</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Istituto Nazionale Tumori Fondazione Pascale</s1>
<s2>Naples</s2>
<s3>ITA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Italie</country>
</affiliation>
</author>
<author><name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Medicine, Memorial Sloan-Kettering Cancer Center</s1>
<s2>New York</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Department of Dermatology, University of Zurich</s1>
<s2>Zurich</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
</affiliation>
</author>
<author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>University ofTubingen</s1>
<s2>Tübingen</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
</affiliation>
</author>
<author><name sortKey="Testori, Alessandro" sort="Testori, Alessandro" uniqKey="Testori A" first="Alessandro" last="Testori">Alessandro Testori</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Istituto Europeo di Oncologia</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Italie</country>
</affiliation>
</author>
<author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Istituto Toscano Tumori</s1>
<s2>Florence</s2>
<s3>ITA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Italie</country>
</affiliation>
</author>
<author><name sortKey="Hogg, David" sort="Hogg, David" uniqKey="Hogg D" first="David" last="Hogg">David Hogg</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Princess Margaret Hospital and University Health Network</s1>
<s2>Toronto</s2>
<s3>CAN</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Canada</country>
</affiliation>
</author>
<author><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>University of Manchester</s1>
<s2>Manchester</s2>
<s3>GBR</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
</author>
<author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Celeste" last="Lebbe">Celeste Lebbe</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Service de Dermatologie, Hôpital Saint Louis</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author><name sortKey="Jouary, Thomas" sort="Jouary, Thomas" uniqKey="Jouary T" first="Thomas" last="Jouary">Thomas Jouary</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Saint Andre Hospital</s1>
<s2>Bordeaux</s2>
<s3>FRA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>University Hospital Essen</s1>
<s2>Essen</s2>
<s3>DEU</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
</affiliation>
</author>
<author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Department of Medicine, David Geffen School of Medicine at UCLA</s1>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="O Day, Steven J" sort="O Day, Steven J" uniqKey="O Day S" first="Steven J." last="O'Day">Steven J. O'Day</name>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Angeles Clinic and Research Institute</s1>
<s2>Los Angeles</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Sosman, Jeffrey A" sort="Sosman, Jeffrey A" uniqKey="Sosman J" first="Jeffrey A." last="Sosman">Jeffrey A. Sosman</name>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Department of Medicine, Vanderbilt University School of Medicine</s1>
<s2>Nashville</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name>
<affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Department of Medicine, University of Pittsburgh School of Medicine</s1>
<s2>Pittsburgh</s2>
<s3>USA</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Eggermont, Alexander M M" sort="Eggermont, Alexander M M" uniqKey="Eggermont A" first="Alexander M. M." last="Eggermont">Alexander M. M. Eggermont</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Institut Gustave Roussy, Hôpital Saint Louis</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dreno">Brigitte Dreno</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Department of Dermatology, Nantes University Hospital</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>21 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
</author>
<author><name sortKey="Nolop, Keith" sort="Nolop, Keith" uniqKey="Nolop K" first="Keith" last="Nolop">Keith Nolop</name>
<affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Plexxikon</s1>
<s2>Berkeley, CA</s2>
<s3>USA</s3>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Jiang Li" sort="Jiang Li" uniqKey="Jiang Li" last="Jiang Li">JIANG LI</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Medical Oncology, Royal Marsden Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Hoffmann-La Roche</s1>
<s2>Nutley, NJ</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
<sZ>26 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Nelson, Betty" sort="Nelson, Betty" uniqKey="Nelson B" first="Betty" last="Nelson">Betty Nelson</name>
<affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Genentech</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Hou, Jeannie" sort="Hou, Jeannie" uniqKey="Hou J" first="Jeannie" last="Hou">Jeannie Hou</name>
<affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Genentech</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Lee, Richard J" sort="Lee, Richard J" uniqKey="Lee R" first="Richard J." last="Lee">Richard J. Lee</name>
<affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Hoffmann-La Roche</s1>
<s2>Nutley, NJ</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
<sZ>26 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Flaherty, Keith T" sort="Flaherty, Keith T" uniqKey="Flaherty K" first="Keith T." last="Flaherty">Keith T. Flaherty</name>
<affiliation wicri:level="1"><inist:fA14 i1="24"><s1>Department of Medicine, Massachusetts General Hospital</s1>
<s2>Boston</s2>
<s3>USA</s3>
<sZ>27 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name>
<affiliation wicri:level="1"><inist:fA14 i1="25"><s1>Peter MacCallum Cancer Center</s1>
<s2>Melbourne, VIC</s2>
<s3>AUS</s3>
<sZ>28 aut.</sZ>
</inist:fA14>
<country>Australie</country>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint><date when="2011">2011</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>BRAF Gene</term>
<term>C-Onc gene</term>
<term>Genetics</term>
<term>Malignant melanoma</term>
<term>Medicine</term>
<term>Mutation</term>
<term>Protooncogene</term>
<term>Survival</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Mélanome malin</term>
<term>Survie</term>
<term>Protooncogène</term>
<term>Gène onc cellulaire</term>
<term>Mutation</term>
<term>Génétique</term>
<term>Médecine</term>
<term>Gène BRAF</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Génétique</term>
<term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. METHODS We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. RESULTS At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P<0.001 for both comparisons). After review of the interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to vemurafenib was recommended. Response rates were 48% for vemurafenib and 5% for dacarbazine. Common adverse events associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma or squamous-cell carcinoma, photosensitivity, nausea, and diarrhea; 38% of patients required dose modification because of toxic effects. CONCLUSIONS Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation. (Funded by Hoffmann-La Roche; BRIM-3 ClinicalTrials.gov number, NCT01006980.).</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0028-4793</s0>
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<fA02 i1="01"><s0>NEJMAG</s0>
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<fA03 i2="1"><s0>N. Engl. j. med.</s0>
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<fA05><s2>364</s2>
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<fA06><s2>26</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>CHAPMAN (Paul B.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>HAUSCHILD (Axel)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>ROBERT (Caroline)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>HAANEN (John B.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>ASCIERTO (Paolo)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>LARKIN (James)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>DUMMER (Reinhard)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>GARBE (Claus)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>TESTORI (Alessandro)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>MAIO (Michele)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>HOGG (David)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>LORIGAN (Paul)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>LEBBE (Celeste)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>JOUARY (Thomas)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>SCHADENDORF (Dirk)</s1>
</fA11>
<fA11 i1="16" i2="1"><s1>RIBAS (Antoni)</s1>
</fA11>
<fA11 i1="17" i2="1"><s1>O'DAY (Steven J.)</s1>
</fA11>
<fA11 i1="18" i2="1"><s1>SOSMAN (Jeffrey A.)</s1>
</fA11>
<fA11 i1="19" i2="1"><s1>KIRKWOOD (John M.)</s1>
</fA11>
<fA11 i1="20" i2="1"><s1>EGGERMONT (Alexander M. M.)</s1>
</fA11>
<fA11 i1="21" i2="1"><s1>DRENO (Brigitte)</s1>
</fA11>
<fA11 i1="22" i2="1"><s1>NOLOP (Keith)</s1>
</fA11>
<fA11 i1="23" i2="1"><s1>JIANG LI</s1>
</fA11>
<fA11 i1="24" i2="1"><s1>NELSON (Betty)</s1>
</fA11>
<fA11 i1="25" i2="1"><s1>HOU (Jeannie)</s1>
</fA11>
<fA11 i1="26" i2="1"><s1>LEE (Richard J.)</s1>
</fA11>
<fA11 i1="27" i2="1"><s1>FLAHERTY (Keith T.)</s1>
</fA11>
<fA11 i1="28" i2="1"><s1>MCARTHUR (Grant A.)</s1>
</fA11>
<fA14 i1="01"><s1>Department of Medicine, Memorial Sloan-Kettering Cancer Center</s1>
<s2>New York</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>University of Kiel</s1>
<s2>Kiel</s2>
<s3>DEU</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>University Hospital Essen</s1>
<s2>Essen</s2>
<s3>DEU</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>University ofTubingen</s1>
<s2>Tübingen</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Institut Gustave Roussy, Hôpital Saint Louis</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>20 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Service de Dermatologie, Hôpital Saint Louis</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Netherlands Cancer Institute</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Istituto Nazionale Tumori Fondazione Pascale</s1>
<s2>Naples</s2>
<s3>ITA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Istituto Toscano Tumori</s1>
<s2>Florence</s2>
<s3>ITA</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Department of Medical Oncology, Royal Marsden Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>23 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Department of Dermatology, University of Zurich</s1>
<s2>Zurich</s2>
<s3>CHE</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Istituto Europeo di Oncologia</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Princess Margaret Hospital and University Health Network</s1>
<s2>Toronto</s2>
<s3>CAN</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>University of Manchester</s1>
<s2>Manchester</s2>
<s3>GBR</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Saint Andre Hospital</s1>
<s2>Bordeaux</s2>
<s3>FRA</s3>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="16"><s1>Department of Dermatology, Nantes University Hospital</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>21 aut.</sZ>
</fA14>
<fA14 i1="17"><s1>Department of Medicine, David Geffen School of Medicine at UCLA</s1>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="18"><s1>Angeles Clinic and Research Institute</s1>
<s2>Los Angeles</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
</fA14>
<fA14 i1="19"><s1>Department of Medicine, Vanderbilt University School of Medicine</s1>
<s2>Nashville</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</fA14>
<fA14 i1="20"><s1>Department of Medicine, University of Pittsburgh School of Medicine</s1>
<s2>Pittsburgh</s2>
<s3>USA</s3>
<sZ>19 aut.</sZ>
</fA14>
<fA14 i1="21"><s1>Plexxikon</s1>
<s2>Berkeley, CA</s2>
<s3>USA</s3>
<sZ>22 aut.</sZ>
</fA14>
<fA14 i1="22"><s1>Hoffmann-La Roche</s1>
<s2>Nutley, NJ</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
<sZ>26 aut.</sZ>
</fA14>
<fA14 i1="23"><s1>Genentech</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
<sZ>25 aut.</sZ>
</fA14>
<fA14 i1="24"><s1>Department of Medicine, Massachusetts General Hospital</s1>
<s2>Boston</s2>
<s3>USA</s3>
<sZ>27 aut.</sZ>
</fA14>
<fA14 i1="25"><s1>Peter MacCallum Cancer Center</s1>
<s2>Melbourne, VIC</s2>
<s3>AUS</s3>
<sZ>28 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>BRIM-3 Study Group</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>2507-2516</s1>
</fA20>
<fA21><s1>2011</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>6013</s2>
<s5>354000191081910060</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2011 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>28 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>11-0309403</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>The New England journal of medicine</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>BACKGROUND Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. METHODS We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. RESULTS At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P<0.001 for both comparisons). After review of the interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to vemurafenib was recommended. Response rates were 48% for vemurafenib and 5% for dacarbazine. Common adverse events associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma or squamous-cell carcinoma, photosensitivity, nausea, and diarrhea; 38% of patients required dose modification because of toxic effects. CONCLUSIONS Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation. (Funded by Hoffmann-La Roche; BRIM-3 ClinicalTrials.gov number, NCT01006980.).</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B01</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B08A</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Mélanome malin</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Malignant melanoma</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Melanoma maligno</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Survie</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Survival</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Sobrevivencia</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Protooncogène</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Protooncogene</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Protooncogen</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Gène onc cellulaire</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>C-Onc gene</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Gen onc celular</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Mutation</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Mutation</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Mutación</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Génétique</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Genetics</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Genética</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Médecine</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Medicine</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Medicina</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Gène BRAF</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>BRAF Gene</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Gen BRAF</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fN21><s1>213</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

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