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Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study.

Identifieur interne : 000E76 ( Main/Exploration ); précédent : 000E75; suivant : 000E77

Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study.

Auteurs : G V Long [Australie] ; K T Flaherty [États-Unis] ; D. Stroyakovskiy [Russie] ; H. Gogas [Grèce] ; E. Levchenko [Russie] ; F. De Braud [Italie] ; J. Larkin [Royaume-Uni] ; C. Garbe [Allemagne] ; T. Jouary [France] ; A. Hauschild [Allemagne] ; V. Chiarion-Sileni [Italie] ; C. Lebbe [France] ; M. Mandalà [Italie] ; M. Millward [Australie] ; A. Arance [Espagne] ; I. Bondarenko [Ukraine] ; J B A G. Haanen [Pays-Bas] ; J. Hansson [Suède] ; J. Utikal [Allemagne] ; V. Ferraresi [Italie] ; P. Mohr [Allemagne] ; V. Probachai [Ukraine] ; D. Schadendorf [Allemagne] ; P. Nathan [Royaume-Uni] ; C. Robert [France] ; A. Ribas [États-Unis] ; M A Davies [États-Unis] ; S R Lane [États-Unis] ; J J Legos [États-Unis] ; B. Mookerjee [États-Unis] ; J-J Grob [France]

Source :

RBID : pubmed:28475671

Abstract

Previous analysis of COMBI-d (NCT01584648) demonstrated improved progression-free survival (PFS) and overall survival (OS) with combination dabrafenib and trametinib versus dabrafenib monotherapy in BRAF V600E/K-mutant metastatic melanoma. This study was continued to assess 3-year landmark efficacy and safety after ≥36-month follow-up for all living patients.

DOI: 10.1093/annonc/mdx176
PubMed: 28475671


Affiliations:


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Le document en format XML

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<wicri:regionArea>Dipartimento di Medicina Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan</wicri:regionArea>
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<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
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<author>
<name sortKey="Garbe, C" sort="Garbe, C" uniqKey="Garbe C" first="C" last="Garbe">C. Garbe</name>
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<nlm:affiliation>Department of Dermatology, University of Tübingen, Tübingen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Dermatology, University of Tübingen, Tübingen</wicri:regionArea>
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<region type="land" nuts="1">Bade-Wurtemberg</region>
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<settlement type="city">Tübingen</settlement>
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<nlm:affiliation>Service D'oncologie Médicale, Hopital Francois Mitterrand, Pau, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service D'oncologie Médicale, Hopital Francois Mitterrand, Pau</wicri:regionArea>
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<region type="region">Nouvelle-Aquitaine</region>
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<settlement type="city">Pau</settlement>
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<nlm:affiliation>Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Dermatology, University Hospital Schleswig-Holstein, Kiel</wicri:regionArea>
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<region type="land" nuts="2">Schleswig-Holstein</region>
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<nlm:affiliation>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.</nlm:affiliation>
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<wicri:regionArea>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova</wicri:regionArea>
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<nlm:affiliation>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Paris, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Paris</wicri:regionArea>
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<settlement type="city">Paris</settlement>
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<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, Bergamo</wicri:regionArea>
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<name sortKey="Arance, A" sort="Arance, A" uniqKey="Arance A" first="A" last="Arance">A. Arance</name>
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<nlm:affiliation>Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona</wicri:regionArea>
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<settlement type="city">Barcelone</settlement>
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<name sortKey="Bondarenko, I" sort="Bondarenko, I" uniqKey="Bondarenko I" first="I" last="Bondarenko">I. Bondarenko</name>
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<country xml:lang="fr">Ukraine</country>
<wicri:regionArea>Dnipropetrovsk State Medical Academy, Clinical Hospital #4, Dnipropetrovsk</wicri:regionArea>
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<name sortKey="Haanen, J B A G" sort="Haanen, J B A G" uniqKey="Haanen J" first="J B A G" last="Haanen">J B A G. Haanen</name>
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<nlm:affiliation>Netherlands Cancer Institute, Amsterdam, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Netherlands Cancer Institute, Amsterdam</wicri:regionArea>
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<settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
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<name sortKey="Hansson, J" sort="Hansson, J" uniqKey="Hansson J" first="J" last="Hansson">J. Hansson</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Oncology-Pathology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.</nlm:affiliation>
<country xml:lang="fr">Suède</country>
<wicri:regionArea>Department of Oncology-Pathology, Karolinska Institutet, Karolinska University Hospital, Stockholm</wicri:regionArea>
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<settlement type="city">Stockholm</settlement>
<region nuts="2">Svealand</region>
</placeName>
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<name sortKey="Utikal, J" sort="Utikal, J" uniqKey="Utikal J" first="J" last="Utikal">J. Utikal</name>
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<nlm:affiliation>Skin Cancer Unit, German Cancer Research Center (DKFZ) and Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karls University of Heidelberg, Mannheim and Heidelberg, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Skin Cancer Unit, German Cancer Research Center (DKFZ) and Department of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karls University of Heidelberg, Mannheim and Heidelberg</wicri:regionArea>
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<wicri:noRegion>Mannheim and Heidelberg</wicri:noRegion>
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<name sortKey="Ferraresi, V" sort="Ferraresi, V" uniqKey="Ferraresi V" first="V" last="Ferraresi">V. Ferraresi</name>
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<nlm:affiliation>Department of Medical Oncology A, Regina Elena National Cancer Institute, Rome, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Medical Oncology A, Regina Elena National Cancer Institute, Rome</wicri:regionArea>
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<settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
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<name sortKey="Mohr, P" sort="Mohr, P" uniqKey="Mohr P" first="P" last="Mohr">P. Mohr</name>
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<nlm:affiliation>Dermatologisches Zentrum Buxtehude, Elbe Kliniken Buxtehude, Buxtehude, Germany.</nlm:affiliation>
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<wicri:regionArea>Dermatologisches Zentrum Buxtehude, Elbe Kliniken Buxtehude, Buxtehude</wicri:regionArea>
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<name sortKey="Probachai, V" sort="Probachai, V" uniqKey="Probachai V" first="V" last="Probachai">V. Probachai</name>
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<nlm:affiliation>Dnipropetrovsk Clinical Oncology Center of Dnipropetrovsk State Council, Dnipropetrovsk, Ukraine.</nlm:affiliation>
<country xml:lang="fr">Ukraine</country>
<wicri:regionArea>Dnipropetrovsk Clinical Oncology Center of Dnipropetrovsk State Council, Dnipropetrovsk</wicri:regionArea>
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<name sortKey="Schadendorf, D" sort="Schadendorf, D" uniqKey="Schadendorf D" first="D" last="Schadendorf">D. Schadendorf</name>
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<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>
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<name sortKey="Nathan, P" sort="Nathan, P" uniqKey="Nathan P" first="P" last="Nathan">P. Nathan</name>
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<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>
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<author>
<name sortKey="Robert, C" sort="Robert, C" uniqKey="Robert C" first="C" last="Robert">C. Robert</name>
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<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>
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<settlement type="city">Orsay</settlement>
<region type="region" nuts="2">Île-de-France</region>
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<name sortKey="Ribas, A" sort="Ribas, A" uniqKey="Ribas A" first="A" last="Ribas">A. Ribas</name>
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<nlm:affiliation>Department of Medicine, Hematology/Oncology, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Medicine, Hematology/Oncology, UCLA Jonsson Comprehensive Cancer Center, Los Angeles</wicri:regionArea>
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<settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
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<name sortKey="Davies, M A" sort="Davies, M A" uniqKey="Davies M" first="M A" last="Davies">M A Davies</name>
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<nlm:affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, USA.</nlm:affiliation>
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<wicri:regionArea>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston</wicri:regionArea>
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<settlement type="city">Houston</settlement>
<region type="state">Texas</region>
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<name sortKey="Lane, S R" sort="Lane, S R" uniqKey="Lane S" first="S R" last="Lane">S R Lane</name>
<affiliation wicri:level="1">
<nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover</wicri:regionArea>
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<name sortKey="Legos, J J" sort="Legos, J J" uniqKey="Legos J" first="J J" last="Legos">J J Legos</name>
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<nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover</wicri:regionArea>
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<name sortKey="Mookerjee, B" sort="Mookerjee, B" uniqKey="Mookerjee B" first="B" last="Mookerjee">B. Mookerjee</name>
<affiliation wicri:level="1">
<nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover</wicri:regionArea>
<wicri:noRegion>East Hanover</wicri:noRegion>
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<name sortKey="Grob, J J" sort="Grob, J J" uniqKey="Grob J" first="J-J" last="Grob">J-J Grob</name>
<affiliation wicri:level="3">
<nlm:affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix-Marseille Université, Marseille, France.</nlm:affiliation>
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<wicri:regionArea>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix-Marseille Université, Marseille</wicri:regionArea>
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<region type="region">Provence-Alpes-Côte d'Azur</region>
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<title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title>
<idno type="eISSN">1569-8041</idno>
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<date when="2017" type="published">2017</date>
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<div type="abstract" xml:lang="en">Previous analysis of COMBI-d (NCT01584648) demonstrated improved progression-free survival (PFS) and overall survival (OS) with combination dabrafenib and trametinib versus dabrafenib monotherapy in BRAF V600E/K-mutant metastatic melanoma. This study was continued to assess 3-year landmark efficacy and safety after ≥36-month follow-up for all living patients.</div>
</front>
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<name sortKey="Utikal, J" sort="Utikal, J" uniqKey="Utikal J" first="J" last="Utikal">J. Utikal</name>
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<region name="Nouvelle-Aquitaine">
<name sortKey="Jouary, T" sort="Jouary, T" uniqKey="Jouary T" first="T" last="Jouary">T. Jouary</name>
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<name sortKey="Lebbe, C" sort="Lebbe, C" uniqKey="Lebbe C" first="C" last="Lebbe">C. Lebbe</name>
<name sortKey="Robert, C" sort="Robert, C" uniqKey="Robert C" first="C" last="Robert">C. Robert</name>
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<region name="Catalogne">
<name sortKey="Arance, A" sort="Arance, A" uniqKey="Arance A" first="A" last="Arance">A. Arance</name>
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<country name="Ukraine">
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<name sortKey="Probachai, V" sort="Probachai, V" uniqKey="Probachai V" first="V" last="Probachai">V. Probachai</name>
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<country name="Pays-Bas">
<region name="Hollande-Septentrionale">
<name sortKey="Haanen, J B A G" sort="Haanen, J B A G" uniqKey="Haanen J" first="J B A G" last="Haanen">J B A G. Haanen</name>
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<country name="Suède">
<region name="Svealand">
<name sortKey="Hansson, J" sort="Hansson, J" uniqKey="Hansson J" first="J" last="Hansson">J. Hansson</name>
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