AustralieFrV1, Main, Exploration, bibRecord, 003011

Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial.

Identifieur interne : 003011 ( Main/Exploration ); précédent : 003010; suivant : 003012

Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial.

Auteurs : Jean Jacques Grob [France] ; Mayur M. Amonkar [États-Unis] ; Boguslawa Karaszewska [Pologne] ; Jacob Schachter [Israël] ; Reinhard Dummer [Suisse] ; Andrzej Mackiewicz [Pologne] ; Daniil Stroyakovskiy [Russie] ; Kamil Drucis [Pologne] ; Florent Grange [France] ; Vanna Chiarion-Sileni [Italie] ; Piotr Rutkowski [Pologne] ; Mikhail Lichinitser [Russie] ; Evgeny Levchenko [Russie] ; Pascal Wolter [Belgique] ; Axel Hauschild [Allemagne] ; Georgina V. Long [Australie] ; Paul Nathan [Royaume-Uni] ; Antoni Ribas [États-Unis] ; Keith Flaherty [États-Unis] ; Peng Sun [États-Unis] ; Jeffrey J. Legos [États-Unis] ; Diane Opatt Mcdowell [États-Unis] ; Bijoyesh Mookerjee [États-Unis] ; Dirk Schadendorf [Allemagne] ; Caroline Robert [France]

Source :

The Lancet. Oncology [ 1474-5488 ] ; 2015.

RBID : pubmed:26433819

Descripteurs français

English descriptors

KwdEn :
- Administration, Oral, Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Biomarkers, Tumor (genetics), DNA Mutational Analysis, Disease Progression, Disease-Free Survival, Drug Administration Schedule, Genetic Predisposition to Disease, Humans, Imidazoles (administration & dosage), Imidazoles (adverse effects), Imidazoles (therapeutic use), Indoles (administration & dosage), Indoles (adverse effects), Indoles (therapeutic use), Intention to Treat Analysis, MAP Kinase Kinase Kinases (antagonists & inhibitors), MAP Kinase Kinase Kinases (metabolism), Melanoma (drug therapy), Melanoma (genetics), Melanoma (mortality), Melanoma (secondary), Mutation, Oximes (administration & dosage), Oximes (adverse effects), Oximes (therapeutic use), Phenotype, Prospective Studies, Protein Kinase Inhibitors (administration & dosage), Protein Kinase Inhibitors (adverse effects), Protein Kinase Inhibitors (therapeutic use), Proto-Oncogene Proteins B-raf (antagonists & inhibitors), Proto-Oncogene Proteins B-raf (genetics), Pyridones (administration & dosage), Pyridones (adverse effects), Pyridones (therapeutic use), Pyrimidinones (administration & dosage), Pyrimidinones (adverse effects), Pyrimidinones (therapeutic use), Quality of Life, Risk Factors, Skin Neoplasms (drug therapy), Skin Neoplasms (genetics), Skin Neoplasms (mortality), Skin Neoplasms (pathology), Sulfonamides (administration & dosage), Sulfonamides (adverse effects), Sulfonamides (therapeutic use), Surveys and Questionnaires, Time Factors, Treatment Outcome.
MESH :
- chemical , administration & dosage : Imidazoles, Indoles, Oximes, Protein Kinase Inhibitors, Pyridones, Pyrimidinones, Sulfonamides.
- chemical , adverse effects : Imidazoles, Indoles, Oximes, Protein Kinase Inhibitors, Pyridones, Pyrimidinones, Sulfonamides.
- chemical , antagonists & inhibitors : MAP Kinase Kinase Kinases, Proto-Oncogene Proteins B-raf.
- chemical , genetics : Biomarkers, Tumor, Proto-Oncogene Proteins B-raf.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- drug therapy : Melanoma, Skin Neoplasms.
- genetics : Melanoma, Skin Neoplasms.
- chemical , metabolism : MAP Kinase Kinase Kinases.
- mortality : Melanoma, Skin Neoplasms.
- pathology : Skin Neoplasms.
- secondary : Melanoma.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Imidazoles, Indoles, Oximes, Protein Kinase Inhibitors, Pyridones, Pyrimidinones, Sulfonamides.
- Administration, Oral, DNA Mutational Analysis, Disease Progression, Disease-Free Survival, Drug Administration Schedule, Genetic Predisposition to Disease, Humans, Intention to Treat Analysis, Mutation, Phenotype, Prospective Studies, Quality of Life, Risk Factors, Surveys and Questionnaires, Time Factors, Treatment Outcome.

Abstract

In the COMBI-v trial, patients with previously untreated BRAF Val600Glu or Val600Lys mutant unresectable or metastatic melanoma who were treated with the combination of dabrafenib and trametinib had significantly longer overall and progression-free survival than those treated with vemurafenib alone. Here, we present the effects of treatments on health-related quality of life (HRQoL), an exploratory endpoint in the COMBI-v study.

DOI: 10.1016/S1470-2045(15)00087-X
PubMed: 26433819

Affiliations:

Le document en format XML

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<author><name sortKey="Mackiewicz, Andrzej" sort="Mackiewicz, Andrzej" uniqKey="Mackiewicz A" first="Andrzej" last="Mackiewicz">Andrzej Mackiewicz</name>
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<author><name sortKey="Stroyakovskiy, Daniil" sort="Stroyakovskiy, Daniil" uniqKey="Stroyakovskiy D" first="Daniil" last="Stroyakovskiy">Daniil Stroyakovskiy</name>
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<author><name sortKey="Sun, Peng" sort="Sun, Peng" uniqKey="Sun P" first="Peng" last="Sun">Peng Sun</name>
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<author><name sortKey="Legos, Jeffrey J" sort="Legos, Jeffrey J" uniqKey="Legos J" first="Jeffrey J" last="Legos">Jeffrey J. Legos</name>
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<author><name sortKey="Mcdowell, Diane Opatt" sort="Mcdowell, Diane Opatt" uniqKey="Mcdowell D" first="Diane Opatt" last="Mcdowell">Diane Opatt Mcdowell</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline Oncology Research and Development, Collegeville, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mookerjee, Bijoyesh" sort="Mookerjee, Bijoyesh" uniqKey="Mookerjee B" first="Bijoyesh" last="Mookerjee">Bijoyesh Mookerjee</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline Oncology Research and Development, Collegeville, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Dermatology, University Hospital Essen, Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Dermatology, University Hospital Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<affiliation wicri:level="4"><nlm:affiliation>Gustave Roussy, Département de Médecine oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Gustave Roussy, Département de Médecine oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif</wicri:regionArea>
<wicri:noRegion>Villejuif</wicri:noRegion>
<orgName type="university">Université Paris-Sud</orgName>
<placeName><settlement type="city">Orsay</settlement>
<region type="region" nuts="2">Île-de-France</region>
</placeName>
</affiliation>
</author>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial.</title>
<author><name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean Jacques" last="Grob">Jean Jacques Grob</name>
<affiliation wicri:level="3"><nlm:affiliation>Service de Dermatologie, Aix Marseille University, and Assistance Publique Hôpitaux de Marseille (APHM), University Hospital Timone, Marseille, France. Electronic address: jean-jacques.grob@ap-hm.fr.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service de Dermatologie, Aix Marseille University, and Assistance Publique Hôpitaux de Marseille (APHM), University Hospital Timone, Marseille</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
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</placeName>
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<author><name sortKey="Amonkar, Mayur M" sort="Amonkar, Mayur M" uniqKey="Amonkar M" first="Mayur M" last="Amonkar">Mayur M. Amonkar</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline Oncology Research and Development, Collegeville, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Karaszewska, Boguslawa" sort="Karaszewska, Boguslawa" uniqKey="Karaszewska B" first="Boguslawa" last="Karaszewska">Boguslawa Karaszewska</name>
<affiliation wicri:level="1"><nlm:affiliation>Przychodnia Lekarska Komed, Konin, Poland.</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Przychodnia Lekarska Komed, Konin</wicri:regionArea>
<wicri:noRegion>Konin</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Schachter, Jacob" sort="Schachter, Jacob" uniqKey="Schachter J" first="Jacob" last="Schachter">Jacob Schachter</name>
<affiliation wicri:level="1"><nlm:affiliation>Sheba Medical Center, Ramat Gan, Ramat, Israel.</nlm:affiliation>
<country xml:lang="fr">Israël</country>
<wicri:regionArea>Sheba Medical Center, Ramat Gan, Ramat</wicri:regionArea>
<wicri:noRegion>Ramat</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Dermatology, Universität Zürich, Zurich, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Dermatology, Universität Zürich, Zurich</wicri:regionArea>
<wicri:noRegion>Zurich</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mackiewicz, Andrzej" sort="Mackiewicz, Andrzej" uniqKey="Mackiewicz A" first="Andrzej" last="Mackiewicz">Andrzej Mackiewicz</name>
<affiliation wicri:level="1"><nlm:affiliation>Oncology Division, Poznan University of Medical Sciences, Med-Polonia, Poznan, Poland.</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Oncology Division, Poznan University of Medical Sciences, Med-Polonia, Poznan</wicri:regionArea>
<wicri:noRegion>Poznan</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Stroyakovskiy, Daniil" sort="Stroyakovskiy, Daniil" uniqKey="Stroyakovskiy D" first="Daniil" last="Stroyakovskiy">Daniil Stroyakovskiy</name>
<affiliation wicri:level="3"><nlm:affiliation>Moscow City Oncology Hospital #62, Stepanovskoye, Moscow, Russia.</nlm:affiliation>
<country xml:lang="fr">Russie</country>
<wicri:regionArea>Moscow City Oncology Hospital #62, Stepanovskoye, Moscow</wicri:regionArea>
<placeName><settlement type="city">Moscou</settlement>
<region>District fédéral central</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Drucis, Kamil" sort="Drucis, Kamil" uniqKey="Drucis K" first="Kamil" last="Drucis">Kamil Drucis</name>
<affiliation wicri:level="1"><nlm:affiliation>Swissmed Centrum Zdrowia and Gdansk Medical University, Gdansk, Poland.</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Swissmed Centrum Zdrowia and Gdansk Medical University, Gdansk</wicri:regionArea>
<wicri:noRegion>Gdansk</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Grange, Florent" sort="Grange, Florent" uniqKey="Grange F" first="Florent" last="Grange">Florent Grange</name>
<affiliation wicri:level="3"><nlm:affiliation>Centre Hospitalier Universitairede Reims-Hôpital Robert Debré, Reims, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Centre Hospitalier Universitairede Reims-Hôpital Robert Debré, Reims</wicri:regionArea>
<placeName><region type="region">Grand Est</region>
<region type="old region">Champagne-Ardenne</region>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name>
<affiliation wicri:level="1"><nlm:affiliation>Istituto Oncologico Veneto Istituto Di Ricovero e Cura a Carattere Scientifico, Padua, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Istituto Oncologico Veneto Istituto Di Ricovero e Cura a Carattere Scientifico, Padua</wicri:regionArea>
<wicri:noRegion>Padua</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rutkowski, Piotr" sort="Rutkowski, Piotr" uniqKey="Rutkowski P" first="Piotr" last="Rutkowski">Piotr Rutkowski</name>
<affiliation wicri:level="1"><nlm:affiliation>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw</wicri:regionArea>
<wicri:noRegion>Warsaw</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lichinitser, Mikhail" sort="Lichinitser, Mikhail" uniqKey="Lichinitser M" first="Mikhail" last="Lichinitser">Mikhail Lichinitser</name>
<affiliation wicri:level="3"><nlm:affiliation>N N Blokhin Russian Cancer Research Center, Moscow, Russia.</nlm:affiliation>
<country xml:lang="fr">Russie</country>
<wicri:regionArea>N N Blokhin Russian Cancer Research Center, Moscow</wicri:regionArea>
<placeName><settlement type="city">Moscou</settlement>
<region>District fédéral central</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Levchenko, Evgeny" sort="Levchenko, Evgeny" uniqKey="Levchenko E" first="Evgeny" last="Levchenko">Evgeny Levchenko</name>
<affiliation wicri:level="1"><nlm:affiliation>Petrov Research Institute of Oncology, Saint Petersburg, Russia.</nlm:affiliation>
<country xml:lang="fr">Russie</country>
<wicri:regionArea>Petrov Research Institute of Oncology, Saint Petersburg</wicri:regionArea>
<wicri:noRegion>Saint Petersburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wolter, Pascal" sort="Wolter, Pascal" uniqKey="Wolter P" first="Pascal" last="Wolter">Pascal Wolter</name>
<affiliation wicri:level="1"><nlm:affiliation>University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>University Hospitals Leuven, Leuven Cancer Institute, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<affiliation wicri:level="3"><nlm:affiliation>Universitätsklinikum Schleswig-Holstein (UKSH), Department of Dermatology, Kiel, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Universitätsklinikum Schleswig-Holstein (UKSH), Department of Dermatology, Kiel</wicri:regionArea>
<placeName><region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name>
<affiliation wicri:level="3"><nlm:affiliation>Melanoma Institute Australia, The University of Sydney and The Mater Hospital, Sydney, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Melanoma Institute Australia, The University of Sydney and The Mater Hospital, Sydney</wicri:regionArea>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nathan, Paul" sort="Nathan, Paul" uniqKey="Nathan P" first="Paul" last="Nathan">Paul Nathan</name>
<affiliation wicri:level="1"><nlm:affiliation>Mount Vernon Cancer Centre, Northwood, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Mount Vernon Cancer Centre, Northwood</wicri:regionArea>
<wicri:noRegion>Northwood</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<affiliation wicri:level="2"><nlm:affiliation>University of California Los Angeles (UCLA) Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of California Los Angeles (UCLA) Jonsson Comprehensive Cancer Center, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Flaherty, Keith" sort="Flaherty, Keith" uniqKey="Flaherty K" first="Keith" last="Flaherty">Keith Flaherty</name>
<affiliation wicri:level="2"><nlm:affiliation>Massachusetts General Hospital Cancer Center, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Massachusetts General Hospital Cancer Center, Boston, MA</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sun, Peng" sort="Sun, Peng" uniqKey="Sun P" first="Peng" last="Sun">Peng Sun</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Oncology Research and Development, Collegeville, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline Oncology Research and Development, Collegeville, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Legos, Jeffrey J" sort="Legos, Jeffrey J" uniqKey="Legos J" first="Jeffrey J" last="Legos">Jeffrey J. Legos</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Oncology Research and Development, Collegeville, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline Oncology Research and Development, Collegeville, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mcdowell, Diane Opatt" sort="Mcdowell, Diane Opatt" uniqKey="Mcdowell D" first="Diane Opatt" last="Mcdowell">Diane Opatt Mcdowell</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Oncology Research and Development, Collegeville, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline Oncology Research and Development, Collegeville, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mookerjee, Bijoyesh" sort="Mookerjee, Bijoyesh" uniqKey="Mookerjee B" first="Bijoyesh" last="Mookerjee">Bijoyesh Mookerjee</name>
<affiliation wicri:level="2"><nlm:affiliation>GlaxoSmithKline Oncology Research and Development, Collegeville, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GlaxoSmithKline Oncology Research and Development, Collegeville, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Dermatology, University Hospital Essen, Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Dermatology, University Hospital Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<affiliation wicri:level="4"><nlm:affiliation>Gustave Roussy, Département de Médecine oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Gustave Roussy, Département de Médecine oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif</wicri:regionArea>
<wicri:noRegion>Villejuif</wicri:noRegion>
<orgName type="university">Université Paris-Sud</orgName>
<placeName><settlement type="city">Orsay</settlement>
<region type="region" nuts="2">Île-de-France</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">The Lancet. Oncology</title>
<idno type="eISSN">1474-5488</idno>
<imprint><date when="2015" type="published">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term>
<term>Antineoplastic Combined Chemotherapy Protocols (administration & dosage)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Biomarkers, Tumor (genetics)</term>
<term>DNA Mutational Analysis</term>
<term>Disease Progression</term>
<term>Disease-Free Survival</term>
<term>Drug Administration Schedule</term>
<term>Genetic Predisposition to Disease</term>
<term>Humans</term>
<term>Imidazoles (administration & dosage)</term>
<term>Imidazoles (adverse effects)</term>
<term>Imidazoles (therapeutic use)</term>
<term>Indoles (administration & dosage)</term>
<term>Indoles (adverse effects)</term>
<term>Indoles (therapeutic use)</term>
<term>Intention to Treat Analysis</term>
<term>MAP Kinase Kinase Kinases (antagonists & inhibitors)</term>
<term>MAP Kinase Kinase Kinases (metabolism)</term>
<term>Melanoma (drug therapy)</term>
<term>Melanoma (genetics)</term>
<term>Melanoma (mortality)</term>
<term>Melanoma (secondary)</term>
<term>Mutation</term>
<term>Oximes (administration & dosage)</term>
<term>Oximes (adverse effects)</term>
<term>Oximes (therapeutic use)</term>
<term>Phenotype</term>
<term>Prospective Studies</term>
<term>Protein Kinase Inhibitors (administration & dosage)</term>
<term>Protein Kinase Inhibitors (adverse effects)</term>
<term>Protein Kinase Inhibitors (therapeutic use)</term>
<term>Proto-Oncogene Proteins B-raf (antagonists & inhibitors)</term>
<term>Proto-Oncogene Proteins B-raf (genetics)</term>
<term>Pyridones (administration & dosage)</term>
<term>Pyridones (adverse effects)</term>
<term>Pyridones (therapeutic use)</term>
<term>Pyrimidinones (administration & dosage)</term>
<term>Pyrimidinones (adverse effects)</term>
<term>Pyrimidinones (therapeutic use)</term>
<term>Quality of Life</term>
<term>Risk Factors</term>
<term>Skin Neoplasms (drug therapy)</term>
<term>Skin Neoplasms (genetics)</term>
<term>Skin Neoplasms (mortality)</term>
<term>Skin Neoplasms (pathology)</term>
<term>Sulfonamides (administration & dosage)</term>
<term>Sulfonamides (adverse effects)</term>
<term>Sulfonamides (therapeutic use)</term>
<term>Surveys and Questionnaires</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Administration par voie orale</term>
<term>Analyse de l'intention de traiter</term>
<term>Analyse de mutations d'ADN</term>
<term>Calendrier d'administration des médicaments</term>
<term>Enquêtes et questionnaires</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Humains</term>
<term>Imidazoles (administration et posologie)</term>
<term>Imidazoles (effets indésirables)</term>
<term>Imidazoles (usage thérapeutique)</term>
<term>Indoles (administration et posologie)</term>
<term>Indoles (effets indésirables)</term>
<term>Indoles (usage thérapeutique)</term>
<term>Inhibiteurs de protéines kinases (administration et posologie)</term>
<term>Inhibiteurs de protéines kinases (effets indésirables)</term>
<term>Inhibiteurs de protéines kinases (usage thérapeutique)</term>
<term>MAP Kinase Kinase Kinases (antagonistes et inhibiteurs)</term>
<term>MAP Kinase Kinase Kinases (métabolisme)</term>
<term>Marqueurs biologiques tumoraux (génétique)</term>
<term>Mutation</term>
<term>Mélanome (génétique)</term>
<term>Mélanome (mortalité)</term>
<term>Mélanome (secondaire)</term>
<term>Mélanome (traitement médicamenteux)</term>
<term>Oximes (administration et posologie)</term>
<term>Oximes (effets indésirables)</term>
<term>Oximes (usage thérapeutique)</term>
<term>Phénotype</term>
<term>Protocoles de polychimiothérapie antinéoplasique (administration et posologie)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Protéines proto-oncogènes B-raf (antagonistes et inhibiteurs)</term>
<term>Protéines proto-oncogènes B-raf (génétique)</term>
<term>Prédisposition génétique à une maladie</term>
<term>Pyridones (administration et posologie)</term>
<term>Pyridones (effets indésirables)</term>
<term>Pyridones (usage thérapeutique)</term>
<term>Pyrimidinones (administration et posologie)</term>
<term>Pyrimidinones (effets indésirables)</term>
<term>Pyrimidinones (usage thérapeutique)</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>Sulfonamides (administration et posologie)</term>
<term>Sulfonamides (effets indésirables)</term>
<term>Sulfonamides (usage thérapeutique)</term>
<term>Survie sans rechute</term>
<term>Tumeurs cutanées (anatomopathologie)</term>
<term>Tumeurs cutanées (génétique)</term>
<term>Tumeurs cutanées (mortalité)</term>
<term>Tumeurs cutanées (traitement médicamenteux)</term>
<term>Études prospectives</term>
<term>Évolution de la maladie</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Imidazoles</term>
<term>Indoles</term>
<term>Oximes</term>
<term>Protein Kinase Inhibitors</term>
<term>Pyridones</term>
<term>Pyrimidinones</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Imidazoles</term>
<term>Indoles</term>
<term>Oximes</term>
<term>Protein Kinase Inhibitors</term>
<term>Pyridones</term>
<term>Pyrimidinones</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>MAP Kinase Kinase Kinases</term>
<term>Proto-Oncogene Proteins B-raf</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Biomarkers, Tumor</term>
<term>Proto-Oncogene Proteins B-raf</term>
</keywords>
<keywords scheme="MESH" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Imidazoles</term>
<term>Indoles</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Oximes</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
<term>Pyridones</term>
<term>Pyrimidinones</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Tumeurs cutanées</term>
</keywords>
<keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>MAP Kinase Kinase Kinases</term>
<term>Protéines proto-oncogènes B-raf</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Melanoma</term>
<term>Skin Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Imidazoles</term>
<term>Indoles</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Oximes</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
<term>Pyridones</term>
<term>Pyrimidinones</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Melanoma</term>
<term>Skin Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Marqueurs biologiques tumoraux</term>
<term>Mélanome</term>
<term>Protéines proto-oncogènes B-raf</term>
<term>Tumeurs cutanées</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>MAP Kinase Kinase Kinases</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Melanoma</term>
<term>Skin Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Mélanome</term>
<term>Tumeurs cutanées</term>
</keywords>
<keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>MAP Kinase Kinase Kinases</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Skin Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="secondaire" xml:lang="fr"><term>Mélanome</term>
</keywords>
<keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Melanoma</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
<term>Imidazoles</term>
<term>Indoles</term>
<term>Oximes</term>
<term>Protein Kinase Inhibitors</term>
<term>Pyridones</term>
<term>Pyrimidinones</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Mélanome</term>
<term>Tumeurs cutanées</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Imidazoles</term>
<term>Indoles</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Oximes</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
<term>Pyridones</term>
<term>Pyrimidinones</term>
<term>Sulfonamides</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term>
<term>DNA Mutational Analysis</term>
<term>Disease Progression</term>
<term>Disease-Free Survival</term>
<term>Drug Administration Schedule</term>
<term>Genetic Predisposition to Disease</term>
<term>Humans</term>
<term>Intention to Treat Analysis</term>
<term>Mutation</term>
<term>Phenotype</term>
<term>Prospective Studies</term>
<term>Quality of Life</term>
<term>Risk Factors</term>
<term>Surveys and Questionnaires</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Administration par voie orale</term>
<term>Analyse de l'intention de traiter</term>
<term>Analyse de mutations d'ADN</term>
<term>Calendrier d'administration des médicaments</term>
<term>Enquêtes et questionnaires</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Humains</term>
<term>Mutation</term>
<term>Phénotype</term>
<term>Prédisposition génétique à une maladie</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>Survie sans rechute</term>
<term>Études prospectives</term>
<term>Évolution de la maladie</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">In the COMBI-v trial, patients with previously untreated BRAF Val600Glu or Val600Lys mutant unresectable or metastatic melanoma who were treated with the combination of dabrafenib and trametinib had significantly longer overall and progression-free survival than those treated with vemurafenib alone. Here, we present the effects of treatments on health-related quality of life (HRQoL), an exploratory endpoint in the COMBI-v study.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>France</li>
<li>Israël</li>
<li>Italie</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>Russie</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Champagne-Ardenne</li>
<li>District fédéral central</li>
<li>Grand Est</li>
<li>Massachusetts</li>
<li>Nouvelle-Galles du Sud</li>
<li>Pennsylvanie</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Schleswig-Holstein</li>
<li>Île-de-France</li>
</region>
<settlement><li>Kiel</li>
<li>Marseille</li>
<li>Moscou</li>
<li>Orsay</li>
<li>Reims</li>
<li>Sydney</li>
</settlement>
<orgName><li>Université Paris-Sud</li>
</orgName>
</list>
<tree><country name="France"><region name="Provence-Alpes-Côte d'Azur"><name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean Jacques" last="Grob">Jean Jacques Grob</name>
</region>
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<country name="Israël"><noRegion><name sortKey="Schachter, Jacob" sort="Schachter, Jacob" uniqKey="Schachter J" first="Jacob" last="Schachter">Jacob Schachter</name>
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<country name="Suisse"><noRegion><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
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<country name="Russie"><region name="District fédéral central"><name sortKey="Stroyakovskiy, Daniil" sort="Stroyakovskiy, Daniil" uniqKey="Stroyakovskiy D" first="Daniil" last="Stroyakovskiy">Daniil Stroyakovskiy</name>
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<country name="Italie"><noRegion><name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name>
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<country name="Belgique"><noRegion><name sortKey="Wolter, Pascal" sort="Wolter, Pascal" uniqKey="Wolter P" first="Pascal" last="Wolter">Pascal Wolter</name>
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<country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
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<name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
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<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name>
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<country name="Royaume-Uni"><noRegion><name sortKey="Nathan, Paul" sort="Nathan, Paul" uniqKey="Nathan P" first="Paul" last="Nathan">Paul Nathan</name>
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   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
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   |texte=   Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial.
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Serveur d'exploration sur les relations entre la France et l'Australie

Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial.

Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial.

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	Serveur d'exploration sur les relations entre la France et l'Australie
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