Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial.
Identifieur interne : 004B55 ( Ncbi/Merge ); précédent : 004B54; suivant : 004B56Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial.
Auteurs : Michele Maio [Italie] ; Arnaud Scherpereel [France] ; Luana Calabr [Italie] ; Joachim Aerts [Pays-Bas] ; Susana Cedres Perez [Espagne] ; Alessandra Bearz [Italie] ; Kristiaan Nackaerts [Belgique] ; Dean A. Fennell [Royaume-Uni] ; Dariusz Kowalski [Pologne] ; Anne S. Tsao [États-Unis] ; Paul Taylor [Royaume-Uni] ; Federica Grosso [Italie] ; Scott J. Antonia [États-Unis] ; Anna K. Nowak [Australie] ; Maria Taboada [Royaume-Uni] ; Martina Puglisi [Royaume-Uni] ; Paul K. Stockman [Royaume-Uni] ; Hedy L. Kindler [États-Unis]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Anticorps monoclonaux (usage thérapeutique), Antinéoplasiques (usage thérapeutique), Critères d'évaluation de la réponse dans les tumeurs solides, Femelle, Humains, Mâle, Mésothéliome (anatomopathologie), Mésothéliome (mortalité), Mésothéliome (traitement médicamenteux), Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Survie sans rechute, Taux de survie, Tumeurs du poumon (anatomopathologie), Tumeurs du poumon (mortalité), Tumeurs du poumon (traitement médicamenteux).
- MESH :
- anatomopathologie : Mésothéliome, Tumeurs du poumon.
- mortalité : Mésothéliome, Tumeurs du poumon.
- traitement médicamenteux : Mésothéliome, Tumeurs du poumon.
- usage thérapeutique : Anticorps monoclonaux, Antinéoplasiques.
- Adulte d'âge moyen, Critères d'évaluation de la réponse dans les tumeurs solides, Femelle, Humains, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Survie sans rechute, Taux de survie.
English descriptors
- KwdEn :
- Aged, Antibodies, Monoclonal (therapeutic use), Antineoplastic Agents (therapeutic use), Disease-Free Survival, Double-Blind Method, Female, Humans, Lung Neoplasms (drug therapy), Lung Neoplasms (mortality), Lung Neoplasms (pathology), Male, Mesothelioma (drug therapy), Mesothelioma (mortality), Mesothelioma (pathology), Middle Aged, Response Evaluation Criteria in Solid Tumors, Survival Rate, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Antibodies, Monoclonal, Antineoplastic Agents.
- drug therapy : Lung Neoplasms, Mesothelioma.
- mortality : Lung Neoplasms, Mesothelioma.
- pathology : Lung Neoplasms, Mesothelioma.
- Aged, Disease-Free Survival, Double-Blind Method, Female, Humans, Male, Middle Aged, Response Evaluation Criteria in Solid Tumors, Survival Rate, Treatment Outcome.
Abstract
New therapeutic strategies for malignant mesothelioma are urgently needed. In the DETERMINE study, we investigated the effects of the cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab in patients with previously treated advanced malignant mesothelioma.
DOI: 10.1016/S1470-2045(17)30446-1
PubMed: 28729154
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pubmed:28729154Le document en format XML
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Fennell</name><affiliation wicri:level="1"><nlm:affiliation>University Hospitals of Leicester, Leicester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University Hospitals of Leicester, Leicester</wicri:regionArea><wicri:noRegion>Leicester</wicri:noRegion></affiliation></author><author><name sortKey="Kowalski, Dariusz" sort="Kowalski, Dariusz" uniqKey="Kowalski D" first="Dariusz" last="Kowalski">Dariusz Kowalski</name><affiliation wicri:level="1"><nlm:affiliation>Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Maria Sklodowska-Curie Institute of Oncology, Warsaw</wicri:regionArea><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Tsao, Anne S" sort="Tsao, Anne S" uniqKey="Tsao A" first="Anne S" last="Tsao">Anne S. Tsao</name><affiliation wicri:level="2"><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Taylor, Paul" sort="Taylor, Paul" uniqKey="Taylor P" first="Paul" last="Taylor">Paul Taylor</name><affiliation wicri:level="3"><nlm:affiliation>University Hospital of South Manchester, Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University Hospital of South Manchester, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Grosso, Federica" sort="Grosso, Federica" uniqKey="Grosso F" first="Federica" last="Grosso">Federica Grosso</name><affiliation wicri:level="1"><nlm:affiliation>Mesothelioma Unit-Medical Oncology Department, SS Antonio e Biagio General Hospital, Alessandria, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Mesothelioma Unit-Medical Oncology Department, SS Antonio e Biagio General Hospital, Alessandria</wicri:regionArea><wicri:noRegion>Alessandria</wicri:noRegion></affiliation></author><author><name sortKey="Antonia, Scott J" sort="Antonia, Scott J" uniqKey="Antonia S" first="Scott J" last="Antonia">Scott J. Antonia</name><affiliation wicri:level="2"><nlm:affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>H Lee Moffitt Cancer Center, Tampa, FL</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Nowak, Anna K" sort="Nowak, Anna K" uniqKey="Nowak A" first="Anna K" last="Nowak">Anna K. 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Stockman</name><affiliation wicri:level="1"><nlm:affiliation>AstraZeneca, Alderley Park, Macclesfield, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>AstraZeneca, Alderley Park, Macclesfield</wicri:regionArea><wicri:noRegion>Macclesfield</wicri:noRegion></affiliation></author><author><name sortKey="Kindler, Hedy L" sort="Kindler, Hedy L" uniqKey="Kindler H" first="Hedy L" last="Kindler">Hedy L. Kindler</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, University of Chicago, Chicago, IL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Chicago, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28729154</idno><idno type="pmid">28729154</idno><idno type="doi">10.1016/S1470-2045(17)30446-1</idno><idno type="wicri:Area/PubMed/Corpus">000534</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000534</idno><idno type="wicri:Area/PubMed/Curation">000532</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000532</idno><idno type="wicri:Area/PubMed/Checkpoint">000532</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000532</idno><idno type="wicri:Area/Ncbi/Merge">004B55</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial.</title><author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name><affiliation wicri:level="1"><nlm:affiliation>Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy. Electronic address: mmaiocro@gmail.com.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena</wicri:regionArea><wicri:noRegion>Siena</wicri:noRegion></affiliation></author><author><name sortKey="Scherpereel, Arnaud" sort="Scherpereel, Arnaud" uniqKey="Scherpereel A" first="Arnaud" last="Scherpereel">Arnaud Scherpereel</name><affiliation wicri:level="3"><nlm:affiliation>Pulmonary and Thoracic Oncology, University of Lille, CHU de Lille, Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pulmonary and Thoracic Oncology, University of Lille, CHU de Lille, 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="Calabr, Luana" sort="Calabr, Luana" uniqKey="Calabr L" first="Luana" last="Calabr">Luana Calabr</name><affiliation wicri:level="1"><nlm:affiliation>Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena</wicri:regionArea><wicri:noRegion>Siena</wicri:noRegion></affiliation></author><author><name sortKey="Aerts, Joachim" sort="Aerts, Joachim" uniqKey="Aerts J" first="Joachim" last="Aerts">Joachim Aerts</name><affiliation wicri:level="3"><nlm:affiliation>Erasmus Medical Center, Rotterdam, Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Erasmus Medical Center, Rotterdam</wicri:regionArea><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Perez, Susana Cedres" sort="Perez, Susana Cedres" uniqKey="Perez S" first="Susana Cedres" last="Perez">Susana Cedres Perez</name><affiliation wicri:level="3"><nlm:affiliation>Vall d'Hebron Institute of Oncology, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Vall d'Hebron Institute of Oncology, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Bearz, Alessandra" sort="Bearz, Alessandra" uniqKey="Bearz A" first="Alessandra" last="Bearz">Alessandra Bearz</name><affiliation wicri:level="1"><nlm:affiliation>Centro di Riferimento Oncologico di Aviano, Pordenone, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Centro di Riferimento Oncologico di Aviano, Pordenone</wicri:regionArea><wicri:noRegion>Pordenone</wicri:noRegion></affiliation></author><author><name sortKey="Nackaerts, Kristiaan" sort="Nackaerts, Kristiaan" uniqKey="Nackaerts K" first="Kristiaan" last="Nackaerts">Kristiaan Nackaerts</name><affiliation wicri:level="1"><nlm:affiliation>KU Leuven-University of Leuven, University Hospitals, Leuven, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>KU Leuven-University of Leuven, University Hospitals, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Fennell, Dean A" sort="Fennell, Dean A" uniqKey="Fennell D" first="Dean A" last="Fennell">Dean A. Fennell</name><affiliation wicri:level="1"><nlm:affiliation>University Hospitals of Leicester, Leicester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University Hospitals of Leicester, Leicester</wicri:regionArea><wicri:noRegion>Leicester</wicri:noRegion></affiliation></author><author><name sortKey="Kowalski, Dariusz" sort="Kowalski, Dariusz" uniqKey="Kowalski D" first="Dariusz" last="Kowalski">Dariusz Kowalski</name><affiliation wicri:level="1"><nlm:affiliation>Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Maria Sklodowska-Curie Institute of Oncology, Warsaw</wicri:regionArea><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Tsao, Anne S" sort="Tsao, Anne S" uniqKey="Tsao A" first="Anne S" last="Tsao">Anne S. Tsao</name><affiliation wicri:level="2"><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Taylor, Paul" sort="Taylor, Paul" uniqKey="Taylor P" first="Paul" last="Taylor">Paul Taylor</name><affiliation wicri:level="3"><nlm:affiliation>University Hospital of South Manchester, Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University Hospital of South Manchester, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Grosso, Federica" sort="Grosso, Federica" uniqKey="Grosso F" first="Federica" last="Grosso">Federica Grosso</name><affiliation wicri:level="1"><nlm:affiliation>Mesothelioma Unit-Medical Oncology Department, SS Antonio e Biagio General Hospital, Alessandria, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Mesothelioma Unit-Medical Oncology Department, SS Antonio e Biagio General Hospital, Alessandria</wicri:regionArea><wicri:noRegion>Alessandria</wicri:noRegion></affiliation></author><author><name sortKey="Antonia, Scott J" sort="Antonia, Scott J" uniqKey="Antonia S" first="Scott J" last="Antonia">Scott J. Antonia</name><affiliation wicri:level="2"><nlm:affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>H Lee Moffitt Cancer Center, Tampa, FL</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Nowak, Anna K" sort="Nowak, Anna K" uniqKey="Nowak A" first="Anna K" last="Nowak">Anna K. Nowak</name><affiliation wicri:level="1"><nlm:affiliation>School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA</wicri:regionArea><wicri:noRegion>WA</wicri:noRegion></affiliation></author><author><name sortKey="Taboada, Maria" sort="Taboada, Maria" uniqKey="Taboada M" first="Maria" last="Taboada">Maria Taboada</name><affiliation wicri:level="1"><nlm:affiliation>AstraZeneca, Alderley Park, Macclesfield, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>AstraZeneca, Alderley Park, Macclesfield</wicri:regionArea><wicri:noRegion>Macclesfield</wicri:noRegion></affiliation></author><author><name sortKey="Puglisi, Martina" sort="Puglisi, Martina" uniqKey="Puglisi M" first="Martina" last="Puglisi">Martina Puglisi</name><affiliation wicri:level="1"><nlm:affiliation>AstraZeneca, Cambridge, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>AstraZeneca, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Stockman, Paul K" sort="Stockman, Paul K" uniqKey="Stockman P" first="Paul K" last="Stockman">Paul K. Stockman</name><affiliation wicri:level="1"><nlm:affiliation>AstraZeneca, Alderley Park, Macclesfield, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>AstraZeneca, Alderley Park, Macclesfield</wicri:regionArea><wicri:noRegion>Macclesfield</wicri:noRegion></affiliation></author><author><name sortKey="Kindler, Hedy L" sort="Kindler, Hedy L" uniqKey="Kindler H" first="Hedy L" last="Kindler">Hedy L. Kindler</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, University of Chicago, Chicago, IL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Chicago, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Antibodies, Monoclonal (therapeutic use)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Disease-Free Survival</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Lung Neoplasms (drug therapy)</term><term>Lung Neoplasms (mortality)</term><term>Lung Neoplasms (pathology)</term><term>Male</term><term>Mesothelioma (drug therapy)</term><term>Mesothelioma (mortality)</term><term>Mesothelioma (pathology)</term><term>Middle Aged</term><term>Response Evaluation Criteria in Solid Tumors</term><term>Survival Rate</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Anticorps monoclonaux (usage thérapeutique)</term><term>Antinéoplasiques (usage thérapeutique)</term><term>Critères d'évaluation de la réponse dans les tumeurs solides</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Mésothéliome (anatomopathologie)</term><term>Mésothéliome (mortalité)</term><term>Mésothéliome (traitement médicamenteux)</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Survie sans rechute</term><term>Taux de survie</term><term>Tumeurs du poumon (anatomopathologie)</term><term>Tumeurs du poumon (mortalité)</term><term>Tumeurs du poumon (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Mésothéliome</term><term>Tumeurs du poumon</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Lung Neoplasms</term><term>Mesothelioma</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Lung Neoplasms</term><term>Mesothelioma</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Mésothéliome</term><term>Tumeurs du poumon</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Lung Neoplasms</term><term>Mesothelioma</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Mésothéliome</term><term>Tumeurs du poumon</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Antinéoplasiques</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Disease-Free Survival</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Response Evaluation Criteria in Solid Tumors</term><term>Survival Rate</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Critères d'évaluation de la réponse dans les tumeurs solides</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Survie sans rechute</term><term>Taux de survie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">New therapeutic strategies for malignant mesothelioma are urgently needed. In the DETERMINE study, we investigated the effects of the cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab in patients with previously treated advanced malignant mesothelioma.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28729154</PMID><DateCreated><Year>2017</Year><Month>07</Month><Day>21</Day></DateCreated><DateCompleted><Year>2017</Year><Month>09</Month><Day>25</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>25</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>9</Issue><PubDate><Year>2017</Year><Month>Sep</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial.</ArticleTitle><Pagination><MedlinePgn>1261-1273</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(17)30446-1</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(17)30446-1</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">New therapeutic strategies for malignant mesothelioma are urgently needed. In the DETERMINE study, we investigated the effects of the cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody tremelimumab in patients with previously treated advanced malignant mesothelioma.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">DETERMINE was a double-blind, placebo-controlled, phase 2b trial done at 105 study centres across 19 countries in patients with unresectable pleural or peritoneal malignant mesothelioma who had progressed after one or two previous systemic treatments for advanced disease. Eligible patients were aged 18 years or older with Eastern Cooperative Oncology Group performance status of 0 or 1 and measurable disease as defined in the modified Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 for pleural mesothelioma or RECIST version 1.1 for peritoneal mesothelioma. Patients were randomly assigned (2:1) in blocks of three, stratified by European Organisation for Research and Treatment of Cancer status (low risk vs high risk), line of therapy (second line vs third line), and anatomic site (pleural vs peritoneal), by use of an interactive voice or web system, to receive intravenous tremelimumab (10 mg/kg) or placebo every 4 weeks for 7 doses and every 12 weeks thereafter until a treatment discontinuation criterion was met. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study drug. The trial is ongoing but no longer recruiting participants, and is registered with ClinicalTrials.gov, number NCT01843374.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between May 17, 2013, and Dec 4, 2014, 571 patients were randomly assigned to receive tremelimumab (n=382) or placebo (n=189), of whom 569 patients received treatment (two patients in the tremelimumab group were excluded from the safety population because they did not receive treatment). At the data cutoff date (Jan 24, 2016), 307 (80%) of 382 patients had died in the tremelimumab group and 154 (81%) of 189 patients had died in the placebo group. Median overall survival in the intention-to-treat population did not differ between the treatment groups: 7·7 months (95% CI 6·8-8·9) in the tremelimumab group and 7·3 months (5·9-8·7) in the placebo group (hazard ratio 0·92 [95% CI 0·76-1·12], p=0·41). Treatment-emergent adverse events of grade 3 or worse occurred in 246 (65%) of 380 patients in the tremelimumab group and 91 (48%) of 189 patients in the placebo group; the most common were dyspnoea (34 [9%] patients in the tremelimumab group vs 27 [14%] patients in the placebo group), diarrhoea (58 [15%] vs one [<1%]), and colitis (26 [7%] vs none). The most common serious adverse events were diarrhoea (69 [18%] patients in the tremelimumab group vs one [<1%] patient in the placebo group), dyspnoea (29 [8%] vs 24 [13%]), and colitis (24 [6%] vs none). Treatment-emergent events leading to death occurred in 36 (9%) of 380 patients in the tremelimumab group and 12 (6%) of 189 in the placebo group; those leading to the death of more than one patient were mesothelioma (three [1%] patients in the tremelimumab group vs two [1%] in the placebo group), dyspnoea (three [1%] vs two [1%]); respiratory failure (one [<1%] vs three [2%]), myocardial infarction (three [1%] vs none), lung infection (three [1%] patients vs none), cardiac failure (one [<1%] vs one [<1%]), and colitis (two [<1%] vs none). Treatment-related adverse events leading to death occurred in five (1%) patients in the tremelimumab group and none in the placebo group. The causes of death were lung infection in one patient, intestinal perforation and small intestinal obstruction in one patient; colitis in two patients, and neuritis and skin ulcer in one patient.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Tremelimumab did not significantly prolong overall survival compared with placebo in patients with previously treated malignant mesothelioma. The safety profile of tremelimumab was consistent with the known safety profile of CTLA-4 inhibitors. Investigations into whether immunotherapy combination regimens can provide greater efficacy than monotherapies in malignant mesothelioma are ongoing.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">AstraZeneca.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Maio</LastName><ForeName>Michele</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy. Electronic address: mmaiocro@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scherpereel</LastName><ForeName>Arnaud</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Pulmonary and Thoracic Oncology, University of Lille, CHU de Lille, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Calabrò</LastName><ForeName>Luana</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aerts</LastName><ForeName>Joachim</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Erasmus Medical Center, Rotterdam, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Perez</LastName><ForeName>Susana Cedres</ForeName><Initials>SC</Initials><AffiliationInfo><Affiliation>Vall d'Hebron Institute of Oncology, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bearz</LastName><ForeName>Alessandra</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Centro di Riferimento Oncologico di Aviano, Pordenone, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nackaerts</LastName><ForeName>Kristiaan</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>KU Leuven-University of Leuven, University Hospitals, Leuven, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fennell</LastName><ForeName>Dean A</ForeName><Initials>DA</Initials><AffiliationInfo><Affiliation>University Hospitals of Leicester, Leicester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kowalski</LastName><ForeName>Dariusz</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tsao</LastName><ForeName>Anne S</ForeName><Initials>AS</Initials><AffiliationInfo><Affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Taylor</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>University Hospital of South Manchester, Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grosso</LastName><ForeName>Federica</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Mesothelioma Unit-Medical Oncology Department, SS Antonio e Biagio General Hospital, Alessandria, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Antonia</LastName><ForeName>Scott J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nowak</LastName><ForeName>Anna K</ForeName><Initials>AK</Initials><AffiliationInfo><Affiliation>School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Taboada</LastName><ForeName>Maria</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>AstraZeneca, Alderley Park, Macclesfield, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Puglisi</LastName><ForeName>Martina</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>AstraZeneca, Cambridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stockman</LastName><ForeName>Paul K</ForeName><Initials>PK</Initials><AffiliationInfo><Affiliation>AstraZeneca, Alderley Park, Macclesfield, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kindler</LastName><ForeName>Hedy L</ForeName><Initials>HL</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of Chicago, Chicago, IL, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>07</Month><Day>17</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Oncol</MedlineTA><NlmUniqueID>100957246</NlmUniqueID><ISSNLinking>1470-2045</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>QEN1X95CIX</RegistryNumber><NameOfSubstance UI="C520704">tremelimumab</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Disease" UI="C562839">Mesothelioma, Malignant</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008175" MajorTopicYN="N">Lung Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008654" MajorTopicYN="N">Mesothelioma</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D066066" MajorTopicYN="N">Response Evaluation Criteria in Solid Tumors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>02</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>05</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>05</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>7</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>9</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>7</Month><Day>22</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28729154</ArticleId><ArticleId IdType="pii">S1470-2045(17)30446-1</ArticleId><ArticleId IdType="doi">10.1016/S1470-2045(17)30446-1</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Espagne</li><li>France</li><li>Italie</li><li>Pays-Bas</li><li>Pologne</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Catalogne</li><li>Floride</li><li>Grand Manchester</li><li>Hauts-de-France</li><li>Hollande-Méridionale</li><li>Illinois</li><li>Nord-Pas-de-Calais</li><li>Texas</li></region><settlement><li>Barcelone</li><li>Lille</li><li>Manchester</li><li>Rotterdam</li></settlement></list><tree><country name="Italie"><noRegion><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name></noRegion><name sortKey="Bearz, Alessandra" sort="Bearz, Alessandra" uniqKey="Bearz A" first="Alessandra" last="Bearz">Alessandra Bearz</name><name sortKey="Calabr, Luana" sort="Calabr, Luana" uniqKey="Calabr L" first="Luana" last="Calabr">Luana Calabr</name><name sortKey="Grosso, Federica" sort="Grosso, Federica" uniqKey="Grosso F" first="Federica" last="Grosso">Federica Grosso</name></country><country name="France"><region name="Hauts-de-France"><name sortKey="Scherpereel, Arnaud" sort="Scherpereel, Arnaud" uniqKey="Scherpereel A" first="Arnaud" last="Scherpereel">Arnaud Scherpereel</name></region></country><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Aerts, Joachim" sort="Aerts, Joachim" uniqKey="Aerts J" first="Joachim" last="Aerts">Joachim Aerts</name></region></country><country name="Espagne"><region name="Catalogne"><name sortKey="Perez, Susana Cedres" sort="Perez, Susana Cedres" uniqKey="Perez S" first="Susana Cedres" last="Perez">Susana Cedres Perez</name></region></country><country name="Belgique"><noRegion><name sortKey="Nackaerts, Kristiaan" sort="Nackaerts, Kristiaan" uniqKey="Nackaerts K" first="Kristiaan" last="Nackaerts">Kristiaan Nackaerts</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Fennell, Dean A" sort="Fennell, Dean A" uniqKey="Fennell D" first="Dean A" last="Fennell">Dean A. Fennell</name></noRegion><name sortKey="Puglisi, Martina" sort="Puglisi, Martina" uniqKey="Puglisi M" first="Martina" last="Puglisi">Martina Puglisi</name><name sortKey="Stockman, Paul K" sort="Stockman, Paul K" uniqKey="Stockman P" first="Paul K" last="Stockman">Paul K. Stockman</name><name sortKey="Taboada, Maria" sort="Taboada, Maria" uniqKey="Taboada M" first="Maria" last="Taboada">Maria Taboada</name><name sortKey="Taylor, Paul" sort="Taylor, Paul" uniqKey="Taylor P" first="Paul" last="Taylor">Paul Taylor</name></country><country name="Pologne"><noRegion><name sortKey="Kowalski, Dariusz" sort="Kowalski, Dariusz" uniqKey="Kowalski D" first="Dariusz" last="Kowalski">Dariusz Kowalski</name></noRegion></country><country name="États-Unis"><region name="Texas"><name sortKey="Tsao, Anne S" sort="Tsao, Anne S" uniqKey="Tsao A" first="Anne S" last="Tsao">Anne S. Tsao</name></region><name sortKey="Antonia, Scott J" sort="Antonia, Scott J" uniqKey="Antonia S" first="Scott J" last="Antonia">Scott J. Antonia</name><name sortKey="Kindler, Hedy L" sort="Kindler, Hedy L" uniqKey="Kindler H" first="Hedy L" last="Kindler">Hedy L. Kindler</name></country><country name="Australie"><noRegion><name sortKey="Nowak, Anna K" sort="Nowak, Anna K" uniqKey="Nowak A" first="Anna K" last="Nowak">Anna K. Nowak</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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