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 : 000904 ( PubMed/Curation ); précédent : 000903; suivant : 000905Dabrafenib 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 :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2017.
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
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Stroyakovskiy</name><affiliation wicri:level="1"><nlm:affiliation>Moscow City Oncology Hospital #62, Moscow, Russia.</nlm:affiliation><country xml:lang="fr">Russie</country><wicri:regionArea>Moscow City Oncology Hospital #62, Moscow</wicri:regionArea></affiliation></author><author><name sortKey="Gogas, H" sort="Gogas, H" uniqKey="Gogas H" first="H" last="Gogas">H. Gogas</name><affiliation wicri:level="1"><nlm:affiliation>First Department of Medicine, "Laiko" General Hospital, National and Kapodistrian University of Athens, Athens, Greece.</nlm:affiliation><country xml:lang="fr">Grèce</country><wicri:regionArea>First Department of Medicine, "Laiko" General Hospital, National and Kapodistrian University of Athens, Athens</wicri:regionArea></affiliation></author><author><name sortKey="Levchenko, E" sort="Levchenko, E" uniqKey="Levchenko E" first="E" last="Levchenko">E. 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Larkin</name><affiliation wicri:level="1"><nlm:affiliation>Royal Marsden NHS Foundation Trust, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Marsden NHS Foundation Trust, London</wicri:regionArea></affiliation></author><author><name sortKey="Garbe, C" sort="Garbe, C" uniqKey="Garbe C" first="C" last="Garbe">C. Garbe</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Jouary, T" sort="Jouary, T" uniqKey="Jouary T" first="T" last="Jouary">T. Jouary</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Hauschild, A" sort="Hauschild, A" uniqKey="Hauschild A" first="A" last="Hauschild">A. Hauschild</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Chiarion Sileni, V" sort="Chiarion Sileni, V" uniqKey="Chiarion Sileni V" first="V" last="Chiarion-Sileni">V. Chiarion-Sileni</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova</wicri:regionArea></affiliation></author><author><name sortKey="Lebbe, C" sort="Lebbe, C" uniqKey="Lebbe C" first="C" last="Lebbe">C. Lebbe</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Mandala, M" sort="Mandala, M" uniqKey="Mandala M" first="M" last="Mandalà">M. Mandalà</name><affiliation wicri:level="1"><nlm:affiliation>Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, Bergamo, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, Bergamo</wicri:regionArea></affiliation></author><author><name sortKey="Millward, M" sort="Millward, M" uniqKey="Millward M" first="M" last="Millward">M. Millward</name><affiliation wicri:level="1"><nlm:affiliation>Medical Oncology Department, Sir Charles Gairdner Hospital, Perth, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Medical Oncology Department, Sir Charles Gairdner Hospital, Perth</wicri:regionArea></affiliation></author><author><name sortKey="Arance, A" sort="Arance, A" uniqKey="Arance A" first="A" last="Arance">A. Arance</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Bondarenko, I" sort="Bondarenko, I" uniqKey="Bondarenko I" first="I" last="Bondarenko">I. Bondarenko</name><affiliation wicri:level="1"><nlm:affiliation>Dnipropetrovsk State Medical Academy, Clinical Hospital #4, Dnipropetrovsk, Ukraine.</nlm:affiliation><country xml:lang="fr">Ukraine</country><wicri:regionArea>Dnipropetrovsk State Medical Academy, Clinical Hospital #4, Dnipropetrovsk</wicri:regionArea></affiliation></author><author><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><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Hansson, J" sort="Hansson, J" uniqKey="Hansson J" first="J" last="Hansson">J. Hansson</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Utikal, J" sort="Utikal, J" uniqKey="Utikal J" first="J" last="Utikal">J. Utikal</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Ferraresi, V" sort="Ferraresi, V" uniqKey="Ferraresi V" first="V" last="Ferraresi">V. Ferraresi</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Mohr, P" sort="Mohr, P" uniqKey="Mohr P" first="P" last="Mohr">P. Mohr</name><affiliation wicri:level="1"><nlm:affiliation>Dermatologisches Zentrum Buxtehude, Elbe Kliniken Buxtehude, Buxtehude, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Dermatologisches Zentrum Buxtehude, Elbe Kliniken Buxtehude, Buxtehude</wicri:regionArea></affiliation></author><author><name sortKey="Probachai, V" sort="Probachai, V" uniqKey="Probachai V" first="V" last="Probachai">V. Probachai</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Schadendorf, D" sort="Schadendorf, D" uniqKey="Schadendorf D" first="D" last="Schadendorf">D. 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></affiliation></author><author><name sortKey="Nathan, P" sort="Nathan, P" uniqKey="Nathan P" first="P" last="Nathan">P. 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></affiliation></author><author><name sortKey="Robert, C" sort="Robert, C" uniqKey="Robert C" first="C" last="Robert">C. Robert</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Ribas, A" sort="Ribas, A" uniqKey="Ribas A" first="A" last="Ribas">A. Ribas</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Davies, M A" sort="Davies, M A" uniqKey="Davies M" first="M A" last="Davies">M A Davies</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston</wicri:regionArea></affiliation></author><author><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></affiliation></author><author><name sortKey="Legos, J J" sort="Legos, J J" uniqKey="Legos J" first="J J" last="Legos">J J Legos</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></affiliation></author><author><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></affiliation></author><author><name sortKey="Grob, J J" sort="Grob, J J" uniqKey="Grob J" first="J-J" last="Grob">J-J Grob</name><affiliation wicri:level="1"><nlm:affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix-Marseille Université, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix-Marseille Université, Marseille</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28475671</idno><idno type="pmid">28475671</idno><idno type="doi">10.1093/annonc/mdx176</idno><idno type="wicri:Area/PubMed/Corpus">000907</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000907</idno><idno type="wicri:Area/PubMed/Curation">000904</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000904</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title><author><name sortKey="Long, G V" sort="Long, G V" uniqKey="Long G" first="G V" last="Long">G V Long</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney</wicri:regionArea></affiliation></author><author><name sortKey="Flaherty, K T" sort="Flaherty, K T" uniqKey="Flaherty K" first="K T" last="Flaherty">K T Flaherty</name><affiliation wicri:level="1"><nlm:affiliation>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston</wicri:regionArea></affiliation></author><author><name sortKey="Stroyakovskiy, D" sort="Stroyakovskiy, D" uniqKey="Stroyakovskiy D" first="D" last="Stroyakovskiy">D. Stroyakovskiy</name><affiliation wicri:level="1"><nlm:affiliation>Moscow City Oncology Hospital #62, Moscow, Russia.</nlm:affiliation><country xml:lang="fr">Russie</country><wicri:regionArea>Moscow City Oncology Hospital #62, Moscow</wicri:regionArea></affiliation></author><author><name sortKey="Gogas, H" sort="Gogas, H" uniqKey="Gogas H" first="H" last="Gogas">H. Gogas</name><affiliation wicri:level="1"><nlm:affiliation>First Department of Medicine, "Laiko" General Hospital, National and Kapodistrian University of Athens, Athens, Greece.</nlm:affiliation><country xml:lang="fr">Grèce</country><wicri:regionArea>First Department of Medicine, "Laiko" General Hospital, National and Kapodistrian University of Athens, Athens</wicri:regionArea></affiliation></author><author><name sortKey="Levchenko, E" sort="Levchenko, E" uniqKey="Levchenko E" first="E" last="Levchenko">E. 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></affiliation></author><author><name sortKey="De Braud, F" sort="De Braud, F" uniqKey="De Braud F" first="F" last="De Braud">F. De Braud</name><affiliation wicri:level="1"><nlm:affiliation>Dipartimento di Medicina Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Dipartimento di Medicina Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan</wicri:regionArea></affiliation></author><author><name sortKey="Larkin, J" sort="Larkin, J" uniqKey="Larkin J" first="J" last="Larkin">J. Larkin</name><affiliation wicri:level="1"><nlm:affiliation>Royal Marsden NHS Foundation Trust, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Marsden NHS Foundation Trust, London</wicri:regionArea></affiliation></author><author><name sortKey="Garbe, C" sort="Garbe, C" uniqKey="Garbe C" first="C" last="Garbe">C. Garbe</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Jouary, T" sort="Jouary, T" uniqKey="Jouary T" first="T" last="Jouary">T. Jouary</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Hauschild, A" sort="Hauschild, A" uniqKey="Hauschild A" first="A" last="Hauschild">A. Hauschild</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Chiarion Sileni, V" sort="Chiarion Sileni, V" uniqKey="Chiarion Sileni V" first="V" last="Chiarion-Sileni">V. Chiarion-Sileni</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova</wicri:regionArea></affiliation></author><author><name sortKey="Lebbe, C" sort="Lebbe, C" uniqKey="Lebbe C" first="C" last="Lebbe">C. Lebbe</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Mandala, M" sort="Mandala, M" uniqKey="Mandala M" first="M" last="Mandalà">M. Mandalà</name><affiliation wicri:level="1"><nlm:affiliation>Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, Bergamo, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, Bergamo</wicri:regionArea></affiliation></author><author><name sortKey="Millward, M" sort="Millward, M" uniqKey="Millward M" first="M" last="Millward">M. Millward</name><affiliation wicri:level="1"><nlm:affiliation>Medical Oncology Department, Sir Charles Gairdner Hospital, Perth, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Medical Oncology Department, Sir Charles Gairdner Hospital, Perth</wicri:regionArea></affiliation></author><author><name sortKey="Arance, A" sort="Arance, A" uniqKey="Arance A" first="A" last="Arance">A. Arance</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Bondarenko, I" sort="Bondarenko, I" uniqKey="Bondarenko I" first="I" last="Bondarenko">I. Bondarenko</name><affiliation wicri:level="1"><nlm:affiliation>Dnipropetrovsk State Medical Academy, Clinical Hospital #4, Dnipropetrovsk, Ukraine.</nlm:affiliation><country xml:lang="fr">Ukraine</country><wicri:regionArea>Dnipropetrovsk State Medical Academy, Clinical Hospital #4, Dnipropetrovsk</wicri:regionArea></affiliation></author><author><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><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Hansson, J" sort="Hansson, J" uniqKey="Hansson J" first="J" last="Hansson">J. Hansson</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Utikal, J" sort="Utikal, J" uniqKey="Utikal J" first="J" last="Utikal">J. Utikal</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Ferraresi, V" sort="Ferraresi, V" uniqKey="Ferraresi V" first="V" last="Ferraresi">V. Ferraresi</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Mohr, P" sort="Mohr, P" uniqKey="Mohr P" first="P" last="Mohr">P. Mohr</name><affiliation wicri:level="1"><nlm:affiliation>Dermatologisches Zentrum Buxtehude, Elbe Kliniken Buxtehude, Buxtehude, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Dermatologisches Zentrum Buxtehude, Elbe Kliniken Buxtehude, Buxtehude</wicri:regionArea></affiliation></author><author><name sortKey="Probachai, V" sort="Probachai, V" uniqKey="Probachai V" first="V" last="Probachai">V. Probachai</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Schadendorf, D" sort="Schadendorf, D" uniqKey="Schadendorf D" first="D" last="Schadendorf">D. 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></affiliation></author><author><name sortKey="Nathan, P" sort="Nathan, P" uniqKey="Nathan P" first="P" last="Nathan">P. 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></affiliation></author><author><name sortKey="Robert, C" sort="Robert, C" uniqKey="Robert C" first="C" last="Robert">C. Robert</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Ribas, A" sort="Ribas, A" uniqKey="Ribas A" first="A" last="Ribas">A. Ribas</name><affiliation wicri:level="1"><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></affiliation></author><author><name sortKey="Davies, M A" sort="Davies, M A" uniqKey="Davies M" first="M A" last="Davies">M A Davies</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston</wicri:regionArea></affiliation></author><author><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></affiliation></author><author><name sortKey="Legos, J J" sort="Legos, J J" uniqKey="Legos J" first="J J" last="Legos">J J Legos</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></affiliation></author><author><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></affiliation></author><author><name sortKey="Grob, J J" sort="Grob, J J" uniqKey="Grob J" first="J-J" last="Grob">J-J Grob</name><affiliation wicri:level="1"><nlm:affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix-Marseille Université, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix-Marseille Université, Marseille</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title><idno type="eISSN">1569-8041</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><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></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28475671</PMID><DateCreated><Year>2017</Year><Month>05</Month><Day>05</Day></DateCreated><DateRevised><Year>2017</Year><Month>09</Month><Day>02</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1569-8041</ISSN><JournalIssue CitedMedium="Internet"><Volume>28</Volume><Issue>7</Issue><PubDate><Year>2017</Year><Month>Jul</Month><Day>01</Day></PubDate></JournalIssue><Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title><ISOAbbreviation>Ann. Oncol.</ISOAbbreviation></Journal><ArticleTitle>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.</ArticleTitle><Pagination><MedlinePgn>1631-1639</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdx176</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">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.</AbstractText><AbstractText Label="Patients and methods" NlmCategory="UNASSIGNED">This double-blind, phase 3 study enrolled previously untreated patients with BRAF V600E/K-mutant unresectable stage IIIC or stage IV melanoma. Patients were randomized to receive dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) or dabrafenib plus placebo. The primary endpoint was PFS; secondary endpoints were OS, overall response, duration of response, safety, and pharmacokinetics.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">Between 4 May and 30 November 2012, a total of 423 of 947 screened patients were randomly assigned to receive dabrafenib plus trametinib (n = 211) or dabrafenib monotherapy (n = 212). At data cut-off (15 February 2016), outcomes remained superior with the combination: 3-year PFS was 22% with dabrafenib plus trametinib versus 12% with monotherapy, and 3-year OS was 44% versus 32%, respectively. Twenty-five patients receiving monotherapy crossed over to combination therapy, with continued follow-up under the monotherapy arm (per intent-to-treat principle). Of combination-arm patients alive at 3 years, 58% remained on dabrafenib plus trametinib. Three-year OS with the combination reached 62% in the most favourable subgroup (normal lactate dehydrogenase and <3 organ sites with metastasis) versus only 25% in the unfavourable subgroup (elevated lactate dehydrogenase). The dabrafenib plus trametinib safety profile was consistent with previous clinical trial observations, and no new safety signals were detected with long-term use.</AbstractText><AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">These data demonstrate that durable (≥3 years) survival is achievable with dabrafenib plus trametinib in patients with BRAF V600-mutant metastatic melanoma and support long-term first-line use of the combination in this setting.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Long</LastName><ForeName>G V</ForeName><Initials>GV</Initials><AffiliationInfo><Affiliation>Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, North Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Flaherty</LastName><ForeName>K T</ForeName><Initials>KT</Initials><AffiliationInfo><Affiliation>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stroyakovskiy</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Moscow City Oncology Hospital #62, Moscow, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gogas</LastName><ForeName>H</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>First Department of Medicine, "Laiko" General Hospital, National and Kapodistrian University of Athens, Athens, Greece.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Levchenko</LastName><ForeName>E</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Petrov Research Institute of Oncology, Saint Petersburg, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Braud</LastName><ForeName>F</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Dipartimento di Medicina Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Larkin</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Royal Marsden NHS Foundation Trust, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garbe</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Dermatology, University of Tübingen, Tübingen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jouary</LastName><ForeName>T</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Service D'oncologie Médicale, Hopital Francois Mitterrand, Pau, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hauschild</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chiarion-Sileni</LastName><ForeName>V</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Melanoma and Oesophageal Oncology Unit, Veneto Oncology Institute-IRCCS, Padova, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lebbe</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>APHP Dermatology and CIC Departments, INSERM U976, University Paris Diderot, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mandalà</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, Bergamo, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Millward</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Sir Charles Gairdner Hospital, Perth, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Arance</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bondarenko</LastName><ForeName>I</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Dnipropetrovsk State Medical Academy, Clinical Hospital #4, Dnipropetrovsk, Ukraine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Haanen</LastName><ForeName>J B A G</ForeName><Initials>JBAG</Initials><AffiliationInfo><Affiliation>Netherlands Cancer Institute, Amsterdam, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hansson</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Oncology-Pathology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Utikal</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><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.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferraresi</LastName><ForeName>V</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology A, Regina Elena National Cancer Institute, Rome, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mohr</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Dermatologisches Zentrum Buxtehude, Elbe Kliniken Buxtehude, Buxtehude, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Probachai</LastName><ForeName>V</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Dnipropetrovsk Clinical Oncology Center of Dnipropetrovsk State Council, Dnipropetrovsk, Ukraine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schadendorf</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Dermatology, University Hospital Essen, Essen, Germany.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>German Cancer Consortium, Heidelberg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nathan</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Mount Vernon Cancer Centre, Northwood, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robert</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gustave Roussy, Département de Médecine Oncologique, Service de Dermatologie et Université Paris-Sud, Faculté de Médecine, Villejuif, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ribas</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hematology/Oncology, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Davies</LastName><ForeName>M A</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MD Anderson Cancer Center, Houston, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lane</LastName><ForeName>S R</ForeName><Initials>SR</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Legos</LastName><ForeName>J J</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mookerjee</LastName><ForeName>B</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grob</LastName><ForeName>J-J</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix-Marseille Université, Marseille, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Ann Oncol</MedlineTA><NlmUniqueID>9007735</NlmUniqueID><ISSNLinking>0923-7534</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">BRAF</Keyword><Keyword MajorTopicYN="N">dabrafenib</Keyword><Keyword MajorTopicYN="N">durable outcomes</Keyword><Keyword MajorTopicYN="N">melanoma</Keyword><Keyword MajorTopicYN="N">metastatic</Keyword><Keyword MajorTopicYN="N">trametinib</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>02</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>5</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>5</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>5</Month><Day>6</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28475671</ArticleId><ArticleId IdType="pii">3798688</ArticleId><ArticleId 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