Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials.
Identifieur interne : 001479 ( PubMed/Curation ); précédent : 001478; suivant : 001480Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials.
Auteurs : Georgina V. Long [Australie] ; Jean-Jacques Grob [France] ; Paul Nathan [Royaume-Uni] ; Antoni Ribas [États-Unis] ; Caroline Robert [France] ; Dirk Schadendorf [Allemagne] ; Stephen R. Lane [États-Unis] ; Carmen Mak [États-Unis] ; Philippe Legenne [Suisse] ; Keith T. Flaherty [États-Unis] ; Michael A. Davies [États-Unis]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2016.
Descripteurs français
- KwdFr :
- Essais contrôlés randomisés comme sujet, Femelle, Humains, Imidazoles (administration et posologie), Mutation, Mâle, Mélanome (génétique), Mélanome (mortalité), Mélanome (traitement médicamenteux), Oximes (administration et posologie), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Protéines proto-oncogènes B-raf (génétique), Pyridones (administration et posologie), Pyrimidinones (administration et posologie), Études rétrospectives, Évolution de la maladie.
- MESH :
- administration et posologie : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- génétique : Mélanome, Protéines proto-oncogènes B-raf.
- mortalité : Mélanome.
- traitement médicamenteux : Mélanome.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Essais contrôlés randomisés comme sujet, Femelle, Humains, Mutation, Mâle, Études rétrospectives, Évolution de la maladie.
English descriptors
- KwdEn :
- Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Disease Progression, Female, Humans, Imidazoles (administration & dosage), Male, Melanoma (drug therapy), Melanoma (genetics), Melanoma (mortality), Mutation, Oximes (administration & dosage), Proto-Oncogene Proteins B-raf (genetics), Pyridones (administration & dosage), Pyrimidinones (administration & dosage), Randomized Controlled Trials as Topic, Retrospective Studies.
- MESH :
- chemical , administration & dosage : Imidazoles, Oximes, Pyridones, Pyrimidinones.
- drug therapy : Melanoma.
- genetics : Melanoma, Proto-Oncogene Proteins B-raf.
- mortality : Melanoma.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Disease Progression, Female, Humans, Male, Mutation, Randomized Controlled Trials as Topic, Retrospective Studies.
Abstract
Dabrafenib plus trametinib treatment provides significant benefits over BRAF-inhibitor monotherapy in patients with BRAF(V600E)-mutant or BRAF(V600K)-mutant advanced melanoma; however, in many patients the disease progresses, leading to death. With many treatment options available, understanding clinical factors that predict long-term response and survival for treatments is important for optimisation of patient management. We aimed to identify clinical factors associated with long-term response and survival using pooled data from randomised trials of dabrafenib plus trametinib in patients with metastatic BRAF-mutant melanoma.
DOI: 10.1016/S1470-2045(16)30578-2
PubMed: 27864013
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Long</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, Australia. Electronic address: georgina.long@sydney.edu.au.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney</wicri:regionArea></affiliation></author><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="1"><nlm:affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille Université, Marseille CEDEX 05, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille Université, Marseille CEDEX 05</wicri:regionArea></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></affiliation></author><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Hematology/Oncology, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, Hematology/Oncology, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA</wicri:regionArea></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline 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="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; German Cancer Consortium, Heidelberg, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg</wicri:regionArea></affiliation></author><author><name sortKey="Lane, Stephen R" sort="Lane, Stephen R" uniqKey="Lane S" first="Stephen R" last="Lane">Stephen R. Lane</name><affiliation wicri:level="1"><nlm:affiliation>Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Mak, Carmen" sort="Mak, Carmen" uniqKey="Mak C" first="Carmen" last="Mak">Carmen Mak</name><affiliation wicri:level="1"><nlm:affiliation>Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea></affiliation></author><author><name sortKey="Legenne, Philippe" sort="Legenne, Philippe" uniqKey="Legenne P" first="Philippe" last="Legenne">Philippe Legenne</name><affiliation wicri:level="1"><nlm:affiliation>Global Oncology, Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Global Oncology, Novartis Pharma AG, Basel</wicri:regionArea></affiliation></author><author><name sortKey="Flaherty, Keith T" sort="Flaherty, Keith T" uniqKey="Flaherty K" first="Keith T" last="Flaherty">Keith T. Flaherty</name><affiliation wicri:level="1"><nlm:affiliation>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Davies, Michael A" sort="Davies, Michael A" uniqKey="Davies M" first="Michael A" last="Davies">Michael A. Davies</name><affiliation wicri:level="1"><nlm:affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MDAnderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Melanoma Medical Oncology and Systems Biology, The University of Texas MDAnderson Cancer Center, Houston, TX</wicri:regionArea></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Disease Progression</term><term>Female</term><term>Humans</term><term>Imidazoles (administration & dosage)</term><term>Male</term><term>Melanoma (drug therapy)</term><term>Melanoma (genetics)</term><term>Melanoma (mortality)</term><term>Mutation</term><term>Oximes (administration & dosage)</term><term>Proto-Oncogene Proteins B-raf (genetics)</term><term>Pyridones (administration & dosage)</term><term>Pyrimidinones (administration & dosage)</term><term>Randomized Controlled Trials as Topic</term><term>Retrospective Studies</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Humains</term><term>Imidazoles (administration et posologie)</term><term>Mutation</term><term>Mâle</term><term>Mélanome (génétique)</term><term>Mélanome (mortalité)</term><term>Mélanome (traitement médicamenteux)</term><term>Oximes (administration et posologie)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Protéines proto-oncogènes B-raf (génétique)</term><term>Pyridones (administration et posologie)</term><term>Pyrimidinones (administration et posologie)</term><term>Études rétrospectives</term><term>Évolution de la maladie</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Imidazoles</term><term>Oximes</term><term>Pyridones</term><term>Pyrimidinones</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Imidazoles</term><term>Oximes</term><term>Pyridones</term><term>Pyrimidinones</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Melanoma</term><term>Proto-Oncogene Proteins B-raf</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Mélanome</term><term>Protéines proto-oncogènes B-raf</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Mélanome</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Mélanome</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disease Progression</term><term>Female</term><term>Humans</term><term>Male</term><term>Mutation</term><term>Randomized Controlled Trials as Topic</term><term>Retrospective Studies</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Humains</term><term>Mutation</term><term>Mâle</term><term>Études rétrospectives</term><term>Évolution de la maladie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Dabrafenib plus trametinib treatment provides significant benefits over BRAF-inhibitor monotherapy in patients with BRAF(V600E)-mutant or BRAF(V600K)-mutant advanced melanoma; however, in many patients the disease progresses, leading to death. With many treatment options available, understanding clinical factors that predict long-term response and survival for treatments is important for optimisation of patient management. We aimed to identify clinical factors associated with long-term response and survival using pooled data from randomised trials of dabrafenib plus trametinib in patients with metastatic BRAF-mutant melanoma.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27864013</PMID><DateCreated><Year>2016</Year><Month>11</Month><Day>19</Day></DateCreated><DateCompleted><Year>2017</Year><Month>05</Month><Day>29</Day></DateCompleted><DateRevised><Year>2017</Year><Month>05</Month><Day>29</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>17</Volume><Issue>12</Issue><PubDate><Year>2016</Year><Month>Dec</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials.</ArticleTitle><Pagination><MedlinePgn>1743-1754</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(16)30578-2</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(16)30578-2</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Dabrafenib plus trametinib treatment provides significant benefits over BRAF-inhibitor monotherapy in patients with BRAF(V600E)-mutant or BRAF(V600K)-mutant advanced melanoma; however, in many patients the disease progresses, leading to death. With many treatment options available, understanding clinical factors that predict long-term response and survival for treatments is important for optimisation of patient management. We aimed to identify clinical factors associated with long-term response and survival using pooled data from randomised trials of dabrafenib plus trametinib in patients with metastatic BRAF-mutant melanoma.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We did a retrospective individual data analysis based on all published randomised trials that included treatment-naive patients with BRAF(V600E)-mutant or BRAF(V600K)-mutant metastatic melanoma who received the approved dose of dabrafenib 150 mg twice daily plus trametinib 2 mg once daily. Data were pooled from patients in the BRF113220 (part C; March 26, 2010, to Jan 15, 2015), COMBI-d (May 4, 2012, to Jan 12, 2015), and COMBI-v (June 4, 2012, to March 13, 2015) randomised trials. Patients with untreated brain metastases were not permitted to enrol in these trials. Baseline factors, identified a priori based on known melanoma clinical or prognostic characteristics, were analysed for association with progression-free survival and overall survival using univariate and multivariate analyses and assessed for hierarchical effect on outcomes using regression tree analyses. We also analysed factors identified after baseline, on treatment, and at progression, for associations with survival after progression. The trials included in this analysis are registered with ClinicalTrials.gov: BRF113220, number NCT01072175; COMBI-d, number NCT01584648; COMBI-v, number NCT01597908.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">617 patients were included in this analysis with a median follow-up of 20·0 months (range 0-48·0, IQR 10·1-24·8); 396 patients had progression events (ie, disease progression or death) and 290 patients had died. Median progression-free survival (11·1 months [95% CI 9·7-12·9]), median overall survival (25·6 months [23·1-34·3]), 1-year progression-free survival (48% [44-52]) and overall survival (74% [71-78]), and 2-year progression-free survival (30% [26-34]) and overall survival (53% [49-57]) were consistent with those in the individual trials. Patients with normal lactate dehydrogenase (LDH) concentration and fewer than three organ sites containing metastases (n=237) had the longest 1-year progression-free survival (68% [95% CI 62-74]) and overall survival (90% [87-94]) and 2-year progression-free survival (46% [40-54]) and overall survival (75% [70-81]), whereas patients with LDH concentration at least two times the upper limit of normal (n=70) had the shortest 1-year progression-free survival (8% [3-19]) and overall survival (40% [29-55]) and 2-year progression-free survival (2% [0-13]) and overall survival (7% [3-19]). Of patients with disease progression (n=379), survival after progression was longest in those with progression in baseline or new non-CNS lesions (n=205; median 10·0 months [95% CI 7·9-12·0]) and shortest in those with new CNS lesions or concurrent progression in baseline and new lesions (n=171; median 4·0 months [3·5-4·9]).</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Several patient and clinical characteristics at and after baseline are associated with outcomes with dabrafenib plus trametinib, and durable benefit is possible with targeted treatment in defined patient subsets.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Novartis.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Long</LastName><ForeName>Georgina V</ForeName><Initials>GV</Initials><AffiliationInfo><Affiliation>Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, Australia. Electronic address: georgina.long@sydney.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grob</LastName><ForeName>Jean-Jacques</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Service de Dermatologie, Centre Hospitalo-Universitaire Timone, Aix Marseille Université, Marseille CEDEX 05, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nathan</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Mount Vernon Cancer Centre, Northwood, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ribas</LastName><ForeName>Antoni</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Medicine, Hematology/Oncology, UCLA Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robert</LastName><ForeName>Caroline</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>Schadendorf</LastName><ForeName>Dirk</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Dermatology, University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lane</LastName><ForeName>Stephen R</ForeName><Initials>SR</Initials><AffiliationInfo><Affiliation>Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mak</LastName><ForeName>Carmen</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Legenne</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Global Oncology, Novartis Pharma AG, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Flaherty</LastName><ForeName>Keith T</ForeName><Initials>KT</Initials><AffiliationInfo><Affiliation>Developmental Therapeutics and Melanoma Programs, Massachusetts General Hospital Cancer Center, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Davies</LastName><ForeName>Michael A</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Melanoma Medical Oncology and Systems Biology, The University of Texas MDAnderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList 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Studies</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>05</Month><Day>31</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>09</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>10</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>11</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>5</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>11</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27864013</ArticleId><ArticleId IdType="pii">S1470-2045(16)30578-2</ArticleId><ArticleId 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