Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial.
Identifieur interne : 000924 ( Main/Exploration ); précédent : 000923; suivant : 000925Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial.
Auteurs : Paolo A. Ascierto [Italie] ; Michele Del Vecchio [Italie] ; Caroline Robert [France] ; Andrzej Mackiewicz [Pologne] ; Vanna Chiarion-Sileni [Italie] ; Ana Arance [Espagne] ; Céleste Lebbé [France] ; Lars Bastholt [Danemark] ; Omid Hamid [États-Unis] ; Piotr Rutkowski [Pologne] ; Catriona Mcneil [Australie] ; Claus Garbe [Allemagne] ; Carmen Loquai [Allemagne] ; Brigitte Dreno [France] ; Luc Thomas [France] ; Jean-Jacques Grob [France] ; Gabriella Liszkay [Hongrie] ; Marta Nyakas [Norvège] ; Ralf Gutzmer [Allemagne] ; Joanna Pikiel [Pologne] ; Florent Grange [France] ; Christoph Hoeller [Autriche] ; Virginia Ferraresi [Italie] ; Michael Smylie [Canada] ; Dirk Schadendorf [Allemagne] ; Laurent Mortier [France] ; Inge Marie Svane [Danemark] ; Delphine Hennicken [États-Unis] ; Anila Qureshi [États-Unis] ; Michele Maio [Italie]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Alanine transaminase (sang), Analyse de l'intention de traiter, Anticorps monoclonaux (administration et posologie), Anticorps monoclonaux (effets indésirables), Antinéoplasiques (administration et posologie), Antinéoplasiques (effets indésirables), Colite (), Diarrhée (), Femelle, Humains, Hypophysite (), Mâle, Mélanome (secondaire), Mélanome (traitement médicamenteux), Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Taux de survie, Études de suivi.
- MESH :
- administration et posologie : Anticorps monoclonaux, Antinéoplasiques.
- effets indésirables : Anticorps monoclonaux, Antinéoplasiques.
- sang : Alanine transaminase.
- secondaire : Mélanome.
- traitement médicamenteux : Mélanome.
- Adulte d'âge moyen, Analyse de l'intention de traiter, Colite, Diarrhée, Femelle, Humains, Hypophysite, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Taux de survie, Études de suivi.
English descriptors
- KwdEn :
- Aged, Alanine Transaminase (blood), Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal (adverse effects), Antineoplastic Agents (administration & dosage), Antineoplastic Agents (adverse effects), Colitis (chemically induced), Diarrhea (chemically induced), Double-Blind Method, Female, Follow-Up Studies, Humans, Hypophysitis (chemically induced), Intention to Treat Analysis, Male, Melanoma (drug therapy), Melanoma (secondary), Middle Aged, Survival Rate, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Antineoplastic Agents.
- chemical , adverse effects : Antibodies, Monoclonal, Antineoplastic Agents.
- chemical , blood : Alanine Transaminase.
- chemically induced : Colitis, Diarrhea, Hypophysitis.
- drug therapy : Melanoma.
- secondary : Melanoma.
- Aged, Double-Blind Method, Female, Follow-Up Studies, Humans, Intention to Treat Analysis, Male, Middle Aged, Survival Rate, Treatment Outcome.
Abstract
A phase 2 trial suggested increased overall survival and increased incidence of treatment-related grade 3-4 adverse events with ipilimumab 10 mg/kg compared with ipilimumab 3 mg/kg in patients with advanced melanoma. We report a phase 3 trial comparing the benefit-risk profile of ipilimumab 10 mg/kg versus 3 mg/kg.
DOI: 10.1016/S1470-2045(17)30231-0
PubMed: 28359784
Affiliations:
- Allemagne, Australie, Autriche, Canada, Danemark, Espagne, France, Hongrie, Italie, Norvège, Pologne, États-Unis
- Bade-Wurtemberg, Basse-Saxe, Californie, Catalogne, Champagne-Ardenne, District de Tübingen, Grand Est, Hauts-de-France, Hongrie centrale, Latium, Lombardie, New Jersey, Nord-Pas-de-Calais, Pays de la Loire, Provence-Alpes-Côte d'Azur, Rhénanie-Palatinat, Vienne (Autriche), Île-de-France, Østlandet
- Barcelone, Budapest, Hanovre, Lille, Marseille, Mayence, Milan, Nantes, Oslo, Paris, Reims, Rome, Tübingen, Vienne (Autriche)
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 000D14
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- to stream PubMed, to step Checkpoint: 000D11
- to stream Ncbi, to step Merge: 004549
- to stream Ncbi, to step Curation: 004549
- to stream Ncbi, to step Checkpoint: 004549
- to stream Main, to step Merge: 000919
- to stream Main, to step Curation: 000924
Le document en format XML
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<author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name>
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<author><name sortKey="Svane, Inge Marie" sort="Svane, Inge Marie" uniqKey="Svane I" first="Inge Marie" last="Svane">Inge Marie Svane</name>
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<author><name sortKey="Hennicken, Delphine" sort="Hennicken, Delphine" uniqKey="Hennicken D" first="Delphine" last="Hennicken">Delphine Hennicken</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Princeton, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
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<author><name sortKey="Qureshi, Anila" sort="Qureshi, Anila" uniqKey="Qureshi A" first="Anila" last="Qureshi">Anila Qureshi</name>
<affiliation wicri:level="2"><nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Princeton, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
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<author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name>
<affiliation wicri:level="1"><nlm:affiliation>University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>University Hospital of Siena, Istituto Toscano Tumori, Siena</wicri:regionArea>
<wicri:noRegion>Siena</wicri:noRegion>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial.</title>
<author><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name>
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<country xml:lang="fr">Italie</country>
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<author><name sortKey="Del Vecchio, Michele" sort="Del Vecchio, Michele" uniqKey="Del Vecchio M" first="Michele" last="Del Vecchio">Michele Del Vecchio</name>
<affiliation wicri:level="3"><nlm:affiliation>Medical Oncology, National Cancer Institute, Milan, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Medical Oncology, National Cancer Institute, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
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<author><name sortKey="Bastholt, Lars" sort="Bastholt, Lars" uniqKey="Bastholt L" first="Lars" last="Bastholt">Lars Bastholt</name>
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<country xml:lang="fr">Danemark</country>
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<author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
<affiliation wicri:level="2"><nlm:affiliation>The Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The Angeles Clinic and Research Institute, Los Angeles, CA</wicri:regionArea>
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<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, Warsaw, Poland.</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Maria Sklodowska-Curie Memorial Cancer Center, Warsaw</wicri:regionArea>
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<author><name sortKey="Mcneil, Catriona" sort="Mcneil, Catriona" uniqKey="Mcneil C" first="Catriona" last="Mcneil">Catriona Mcneil</name>
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<country xml:lang="fr">Australie</country>
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<author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
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<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Eberhard Karls University, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
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<author><name sortKey="Loquai, Carmen" sort="Loquai, Carmen" uniqKey="Loquai C" first="Carmen" last="Loquai">Carmen Loquai</name>
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<wicri:regionArea>University Medical Center, Mainz</wicri:regionArea>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Oncodermatology, INSERM Research Unit 892, Nantes University Hospital, Nantes</wicri:regionArea>
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<author><name sortKey="Thomas, Luc" sort="Thomas, Luc" uniqKey="Thomas L" first="Luc" last="Thomas">Luc Thomas</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Dermatology, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Dermatology, Centre Hospitalier Lyon-Sud, Pierre-Bénite</wicri:regionArea>
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<author><name sortKey="Liszkay, Gabriella" sort="Liszkay, Gabriella" uniqKey="Liszkay G" first="Gabriella" last="Liszkay">Gabriella Liszkay</name>
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<author><name sortKey="Nyakas, Marta" sort="Nyakas, Marta" uniqKey="Nyakas M" first="Marta" last="Nyakas">Marta Nyakas</name>
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<wicri:regionArea>Oslo University Hospital, Oslo</wicri:regionArea>
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<author><name sortKey="Gutzmer, Ralf" sort="Gutzmer, Ralf" uniqKey="Gutzmer R" first="Ralf" last="Gutzmer">Ralf Gutzmer</name>
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<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Medizinische Hochschule Hannover, Hannover</wicri:regionArea>
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<settlement type="city">Hanovre</settlement>
</placeName>
</affiliation>
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<author><name sortKey="Pikiel, Joanna" sort="Pikiel, Joanna" uniqKey="Pikiel J" first="Joanna" last="Pikiel">Joanna Pikiel</name>
<affiliation wicri:level="1"><nlm:affiliation>Wojewodzkie Centrum Oncologii, Gdańsk, Poland.</nlm:affiliation>
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<wicri:regionArea>Wojewodzkie Centrum Oncologii, Gdańsk</wicri:regionArea>
<wicri:noRegion>Gdańsk</wicri:noRegion>
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</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>Department of Dermatology, Reims University Hospital, Reims, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Dermatology, Reims University Hospital, Reims</wicri:regionArea>
<placeName><region type="region">Grand Est</region>
<region type="old region">Champagne-Ardenne</region>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
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<author><name sortKey="Hoeller, Christoph" sort="Hoeller, Christoph" uniqKey="Hoeller C" first="Christoph" last="Hoeller">Christoph Hoeller</name>
<affiliation wicri:level="3"><nlm:affiliation>Medical University of Vienna, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Medical University of Vienna, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ferraresi, Virginia" sort="Ferraresi, Virginia" uniqKey="Ferraresi V" first="Virginia" last="Ferraresi">Virginia Ferraresi</name>
<affiliation wicri:level="3"><nlm:affiliation>Istituti Fisioterapici Ospitalieri, Rome, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Istituti Fisioterapici Ospitalieri, Rome</wicri:regionArea>
<placeName><settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Smylie, Michael" sort="Smylie, Michael" uniqKey="Smylie M" first="Michael" last="Smylie">Michael Smylie</name>
<affiliation wicri:level="1"><nlm:affiliation>Cross Cancer Institute, Edmonton, AB, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
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</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>University Hospital Essen, Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
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<author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name>
<affiliation wicri:level="3"><nlm:affiliation>Hôspital Claude Huriez, Lille, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hôspital Claude Huriez, Lille</wicri:regionArea>
<placeName><region type="region">Hauts-de-France</region>
<region type="old region">Nord-Pas-de-Calais</region>
<settlement type="city">Lille</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Svane, Inge Marie" sort="Svane, Inge Marie" uniqKey="Svane I" first="Inge Marie" last="Svane">Inge Marie Svane</name>
<affiliation wicri:level="1"><nlm:affiliation>Herlev Hospital, University of Copenhagen, Herlev, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Herlev Hospital, University of Copenhagen, Herlev</wicri:regionArea>
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</author>
<author><name sortKey="Hennicken, Delphine" sort="Hennicken, Delphine" uniqKey="Hennicken D" first="Delphine" last="Hennicken">Delphine Hennicken</name>
<affiliation wicri:level="2"><nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Princeton, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Qureshi, Anila" sort="Qureshi, Anila" uniqKey="Qureshi A" first="Anila" last="Qureshi">Anila Qureshi</name>
<affiliation wicri:level="2"><nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bristol-Myers Squibb, Princeton, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name>
<affiliation wicri:level="1"><nlm:affiliation>University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>University Hospital of Siena, Istituto Toscano Tumori, Siena</wicri:regionArea>
<wicri:noRegion>Siena</wicri:noRegion>
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<series><title level="j">The Lancet. Oncology</title>
<idno type="eISSN">1474-5488</idno>
<imprint><date when="2017" type="published">2017</date>
</imprint>
</series>
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<term>Alanine Transaminase (blood)</term>
<term>Antibodies, Monoclonal (administration & dosage)</term>
<term>Antibodies, Monoclonal (adverse effects)</term>
<term>Antineoplastic Agents (administration & dosage)</term>
<term>Antineoplastic Agents (adverse effects)</term>
<term>Colitis (chemically induced)</term>
<term>Diarrhea (chemically induced)</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Hypophysitis (chemically induced)</term>
<term>Intention to Treat Analysis</term>
<term>Male</term>
<term>Melanoma (drug therapy)</term>
<term>Melanoma (secondary)</term>
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<term>Survival Rate</term>
<term>Treatment Outcome</term>
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<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Alanine transaminase (sang)</term>
<term>Analyse de l'intention de traiter</term>
<term>Anticorps monoclonaux (administration et posologie)</term>
<term>Anticorps monoclonaux (effets indésirables)</term>
<term>Antinéoplasiques (administration et posologie)</term>
<term>Antinéoplasiques (effets indésirables)</term>
<term>Colite ()</term>
<term>Diarrhée ()</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hypophysite ()</term>
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<term>Mélanome (secondaire)</term>
<term>Mélanome (traitement médicamenteux)</term>
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<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Taux de survie</term>
<term>Études de suivi</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Antineoplastic Agents</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Antineoplastic Agents</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Alanine Transaminase</term>
</keywords>
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<term>Antinéoplasiques</term>
</keywords>
<keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Colitis</term>
<term>Diarrhea</term>
<term>Hypophysitis</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Melanoma</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux</term>
<term>Antinéoplasiques</term>
</keywords>
<keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Alanine transaminase</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="traitement médicamenteux" xml:lang="fr"><term>Mélanome</term>
</keywords>
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<term>Mâle</term>
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<front><div type="abstract" xml:lang="en">A phase 2 trial suggested increased overall survival and increased incidence of treatment-related grade 3-4 adverse events with ipilimumab 10 mg/kg compared with ipilimumab 3 mg/kg in patients with advanced melanoma. We report a phase 3 trial comparing the benefit-risk profile of ipilimumab 10 mg/kg versus 3 mg/kg.</div>
</front>
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<country name="Australie"><noRegion><name sortKey="Mcneil, Catriona" sort="Mcneil, Catriona" uniqKey="Mcneil C" first="Catriona" last="Mcneil">Catriona Mcneil</name>
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<country name="Norvège"><region name="Østlandet"><name sortKey="Nyakas, Marta" sort="Nyakas, Marta" uniqKey="Nyakas M" first="Marta" last="Nyakas">Marta Nyakas</name>
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<country name="Canada"><noRegion><name sortKey="Smylie, Michael" sort="Smylie, Michael" uniqKey="Smylie M" first="Michael" last="Smylie">Michael Smylie</name>
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