Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.
Identifieur interne : 001020 ( PubMed/Curation ); précédent : 001019; suivant : 001021Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.
Auteurs : Andrew D. Zelenetz [États-Unis] ; Jacqueline C. Barrientos [États-Unis] ; Jennifer R. Brown [États-Unis] ; Bertrand Coiffier [France] ; Julio Delgado [Espagne] ; Mikl S Egyed [Hongrie] ; Paolo Ghia [Italie] ; Árpád Illés [Hongrie] ; Wojciech Jurczak [Pologne] ; Paula Marlton [Australie] ; Marco Montillo [Italie] ; Franck Morschhauser [France] ; Alexander S. Pristupa [Russie] ; Tadeusz Robak [Pologne] ; Jeff P. Sharman [États-Unis] ; David Simpson [Nouvelle-Zélande] ; Lukáš Smolej [République tchèque] ; Eugen Tausch [Allemagne] ; Adeboye H. Adewoye [États-Unis] ; Lyndah K. Dreiling [États-Unis] ; Yeonhee Kim [États-Unis] ; Stephan Stilgenbauer [Allemagne] ; Peter Hillmen [Royaume-Uni]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Chlorhydrate de bendamustine (administration et posologie), Femelle, Humains, Leucémie chronique lymphocytaire à cellules B (anatomopathologie), Leucémie chronique lymphocytaire à cellules B (traitement médicamenteux), Mâle, Méthode en double aveugle, Pronostic, Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Purines (administration et posologie), Quinazolinones (administration et posologie), Rituximab (administration et posologie), Récidive tumorale locale (anatomopathologie), Récidive tumorale locale (traitement médicamenteux), Résistance aux médicaments antinéoplasiques (), Stade de la tumeur, Sujet âgé, Taux de survie, Thérapie de rattrapage, Études de suivi.
- MESH :
- administration et posologie : Chlorhydrate de bendamustine, Purines, Quinazolinones, Rituximab.
- anatomopathologie : Leucémie chronique lymphocytaire à cellules B, Récidive tumorale locale.
- traitement médicamenteux : Leucémie chronique lymphocytaire à cellules B, Récidive tumorale locale.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Mâle, Méthode en double aveugle, Pronostic, Résistance aux médicaments antinéoplasiques, Stade de la tumeur, Sujet âgé, Taux de survie, Thérapie de rattrapage, Études de suivi.
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Bendamustine Hydrochloride (administration & dosage), Double-Blind Method, Drug Resistance, Neoplasm (drug effects), Female, Follow-Up Studies, Humans, Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy), Leukemia, Lymphocytic, Chronic, B-Cell (pathology), Male, Middle Aged, Neoplasm Recurrence, Local (drug therapy), Neoplasm Recurrence, Local (pathology), Neoplasm Staging, Prognosis, Purines (administration & dosage), Quinazolinones (administration & dosage), Rituximab (administration & dosage), Salvage Therapy, Survival Rate.
- MESH :
- chemical , administration & dosage : Bendamustine Hydrochloride, Purines, Quinazolinones, Rituximab.
- drug effects : Drug Resistance, Neoplasm.
- drug therapy : Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm Recurrence, Local.
- pathology : Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm Recurrence, Local.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Staging, Prognosis, Salvage Therapy, Survival Rate.
Abstract
Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population.
DOI: 10.1016/S1470-2045(16)30671-4
PubMed: 28139405
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Electronic address: zeleneta@mskcc.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Barrientos, Jacqueline C" sort="Barrientos, Jacqueline C" uniqKey="Barrientos J" first="Jacqueline C" last="Barrientos">Jacqueline C. Barrientos</name><affiliation wicri:level="1"><nlm:affiliation>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY</wicri:regionArea></affiliation></author><author><name sortKey="Brown, Jennifer R" sort="Brown, Jennifer R" uniqKey="Brown J" first="Jennifer R" last="Brown">Jennifer R. 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Pristupa</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.</nlm:affiliation><country xml:lang="fr">Russie</country><wicri:regionArea>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan</wicri:regionArea></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz</wicri:regionArea></affiliation></author><author><name sortKey="Sharman, Jeff P" sort="Sharman, Jeff P" uniqKey="Sharman J" first="Jeff P" last="Sharman">Jeff P. Sharman</name><affiliation wicri:level="1"><nlm:affiliation>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR</wicri:regionArea></affiliation></author><author><name sortKey="Simpson, David" sort="Simpson, David" uniqKey="Simpson D" first="David" last="Simpson">David Simpson</name><affiliation wicri:level="1"><nlm:affiliation>North Shore Hospital, Takapuna, Auckland, New Zealand.</nlm:affiliation><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>North Shore Hospital, Takapuna, Auckland</wicri:regionArea></affiliation></author><author><name sortKey="Smolej, Lukas" sort="Smolej, Lukas" uniqKey="Smolej L" first="Lukáš" last="Smolej">Lukáš Smolej</name><affiliation wicri:level="1"><nlm:affiliation>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové</wicri:regionArea></affiliation></author><author><name sortKey="Tausch, Eugen" sort="Tausch, Eugen" uniqKey="Tausch E" first="Eugen" last="Tausch">Eugen Tausch</name><affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Internal Medicine III, Ulm University, Ulm</wicri:regionArea></affiliation></author><author><name sortKey="Adewoye, Adeboye H" sort="Adewoye, Adeboye H" uniqKey="Adewoye A" first="Adeboye H" last="Adewoye">Adeboye H. Adewoye</name><affiliation wicri:level="1"><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Foster City, CA</wicri:regionArea></affiliation></author><author><name sortKey="Dreiling, Lyndah K" sort="Dreiling, Lyndah K" uniqKey="Dreiling L" first="Lyndah K" last="Dreiling">Lyndah K. Dreiling</name><affiliation wicri:level="1"><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Foster City, CA</wicri:regionArea></affiliation></author><author><name sortKey="Kim, Yeonhee" sort="Kim, Yeonhee" uniqKey="Kim Y" first="Yeonhee" last="Kim">Yeonhee Kim</name><affiliation wicri:level="1"><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Foster City, CA</wicri:regionArea></affiliation></author><author><name sortKey="Stilgenbauer, Stephan" sort="Stilgenbauer, Stephan" uniqKey="Stilgenbauer S" first="Stephan" last="Stilgenbauer">Stephan Stilgenbauer</name><affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Internal Medicine III, Ulm University, Ulm</wicri:regionArea></affiliation></author><author><name sortKey="Hillmen, Peter" sort="Hillmen, Peter" uniqKey="Hillmen P" first="Peter" last="Hillmen">Peter Hillmen</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology/Oncology, St James's University Hospital, Leeds, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology/Oncology, St James's University Hospital, Leeds</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28139405</idno><idno type="pmid">28139405</idno><idno type="doi">10.1016/S1470-2045(16)30671-4</idno><idno type="wicri:Area/PubMed/Corpus">001023</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001023</idno><idno type="wicri:Area/PubMed/Curation">001020</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001020</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.</title><author><name sortKey="Zelenetz, Andrew D" sort="Zelenetz, Andrew D" uniqKey="Zelenetz A" first="Andrew D" last="Zelenetz">Andrew D. Zelenetz</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: zeleneta@mskcc.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Barrientos, Jacqueline C" sort="Barrientos, Jacqueline C" uniqKey="Barrientos J" first="Jacqueline C" last="Barrientos">Jacqueline C. Barrientos</name><affiliation wicri:level="1"><nlm:affiliation>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY</wicri:regionArea></affiliation></author><author><name sortKey="Brown, Jennifer R" sort="Brown, Jennifer R" uniqKey="Brown J" first="Jennifer R" last="Brown">Jennifer R. Brown</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA</wicri:regionArea></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Haematology, Centre Hospitalier Lyon Sud, Pierre-Bénite</wicri:regionArea></affiliation></author><author><name sortKey="Delgado, Julio" sort="Delgado, Julio" uniqKey="Delgado J" first="Julio" last="Delgado">Julio Delgado</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Hospital Clínic, Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Haematology, Hospital Clínic, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Egyed, Mikl S" sort="Egyed, Mikl S" uniqKey="Egyed M" first="Mikl S" last="Egyed">Mikl S Egyed</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvar, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvar</wicri:regionArea></affiliation></author><author><name sortKey="Ghia, Paolo" sort="Ghia, Paolo" uniqKey="Ghia P" first="Paolo" last="Ghia">Paolo Ghia</name><affiliation wicri:level="1"><nlm:affiliation>Division of Experimental Oncology and Department of Onco-Haematology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Division of Experimental Oncology and Department of Onco-Haematology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan</wicri:regionArea></affiliation></author><author><name sortKey="Illes, Arpad" sort="Illes, Arpad" uniqKey="Illes A" first="Árpád" last="Illés">Árpád Illés</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, University of Debrecen, Debrecen, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Department of Haematology, University of Debrecen, Debrecen</wicri:regionArea></affiliation></author><author><name sortKey="Jurczak, Wojciech" sort="Jurczak, Wojciech" uniqKey="Jurczak W" first="Wojciech" last="Jurczak">Wojciech Jurczak</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Jagiellonian University, Krakow, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Haematology, Jagiellonian University, Krakow</wicri:regionArea></affiliation></author><author><name sortKey="Marlton, Paula" sort="Marlton, Paula" uniqKey="Marlton P" first="Paula" last="Marlton">Paula Marlton</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Princess Alexandra Hospital, University of Queensland, School of Medicine, Brisbane, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Haematology, Princess Alexandra Hospital, University of Queensland, School of Medicine, Brisbane</wicri:regionArea></affiliation></author><author><name sortKey="Montillo, Marco" sort="Montillo, Marco" uniqKey="Montillo M" first="Marco" last="Montillo">Marco Montillo</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan</wicri:regionArea></affiliation></author><author><name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name><affiliation wicri:level="1"><nlm:affiliation>CHRU Lille, Unité GRITA, Department of Haematology, Université de Lille, Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>CHRU Lille, Unité GRITA, Department of Haematology, Université de Lille, Lille</wicri:regionArea></affiliation></author><author><name sortKey="Pristupa, Alexander S" sort="Pristupa, Alexander S" uniqKey="Pristupa A" first="Alexander S" last="Pristupa">Alexander S. Pristupa</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.</nlm:affiliation><country xml:lang="fr">Russie</country><wicri:regionArea>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan</wicri:regionArea></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz</wicri:regionArea></affiliation></author><author><name sortKey="Sharman, Jeff P" sort="Sharman, Jeff P" uniqKey="Sharman J" first="Jeff P" last="Sharman">Jeff P. Sharman</name><affiliation wicri:level="1"><nlm:affiliation>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR</wicri:regionArea></affiliation></author><author><name sortKey="Simpson, David" sort="Simpson, David" uniqKey="Simpson D" first="David" last="Simpson">David Simpson</name><affiliation wicri:level="1"><nlm:affiliation>North Shore Hospital, Takapuna, Auckland, New Zealand.</nlm:affiliation><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>North Shore Hospital, Takapuna, Auckland</wicri:regionArea></affiliation></author><author><name sortKey="Smolej, Lukas" sort="Smolej, Lukas" uniqKey="Smolej L" first="Lukáš" last="Smolej">Lukáš Smolej</name><affiliation wicri:level="1"><nlm:affiliation>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové</wicri:regionArea></affiliation></author><author><name sortKey="Tausch, Eugen" sort="Tausch, Eugen" uniqKey="Tausch E" first="Eugen" last="Tausch">Eugen Tausch</name><affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Internal Medicine III, Ulm University, Ulm</wicri:regionArea></affiliation></author><author><name sortKey="Adewoye, Adeboye H" sort="Adewoye, Adeboye H" uniqKey="Adewoye A" first="Adeboye H" last="Adewoye">Adeboye H. Adewoye</name><affiliation wicri:level="1"><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Foster City, CA</wicri:regionArea></affiliation></author><author><name sortKey="Dreiling, Lyndah K" sort="Dreiling, Lyndah K" uniqKey="Dreiling L" first="Lyndah K" last="Dreiling">Lyndah K. Dreiling</name><affiliation wicri:level="1"><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Foster City, CA</wicri:regionArea></affiliation></author><author><name sortKey="Kim, Yeonhee" sort="Kim, Yeonhee" uniqKey="Kim Y" first="Yeonhee" last="Kim">Yeonhee Kim</name><affiliation wicri:level="1"><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Foster City, CA</wicri:regionArea></affiliation></author><author><name sortKey="Stilgenbauer, Stephan" sort="Stilgenbauer, Stephan" uniqKey="Stilgenbauer S" first="Stephan" last="Stilgenbauer">Stephan Stilgenbauer</name><affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Internal Medicine III, Ulm University, Ulm</wicri:regionArea></affiliation></author><author><name sortKey="Hillmen, Peter" sort="Hillmen, Peter" uniqKey="Hillmen P" first="Peter" last="Hillmen">Peter Hillmen</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology/Oncology, St James's University Hospital, Leeds, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology/Oncology, St James's University Hospital, Leeds</wicri:regionArea></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>Adult</term><term>Aged</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Bendamustine Hydrochloride (administration & dosage)</term><term>Double-Blind Method</term><term>Drug Resistance, Neoplasm (drug effects)</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)</term><term>Leukemia, Lymphocytic, Chronic, B-Cell (pathology)</term><term>Male</term><term>Middle Aged</term><term>Neoplasm Recurrence, Local (drug therapy)</term><term>Neoplasm Recurrence, Local (pathology)</term><term>Neoplasm Staging</term><term>Prognosis</term><term>Purines (administration & dosage)</term><term>Quinazolinones (administration & dosage)</term><term>Rituximab (administration & dosage)</term><term>Salvage Therapy</term><term>Survival Rate</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Chlorhydrate de bendamustine (administration et posologie)</term><term>Femelle</term><term>Humains</term><term>Leucémie chronique lymphocytaire à cellules B (anatomopathologie)</term><term>Leucémie chronique lymphocytaire à cellules B (traitement médicamenteux)</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Pronostic</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Purines (administration et posologie)</term><term>Quinazolinones (administration et posologie)</term><term>Rituximab (administration et posologie)</term><term>Récidive tumorale locale (anatomopathologie)</term><term>Récidive tumorale locale (traitement médicamenteux)</term><term>Résistance aux médicaments antinéoplasiques ()</term><term>Stade de la tumeur</term><term>Sujet âgé</term><term>Taux de survie</term><term>Thérapie de rattrapage</term><term>Études de suivi</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Bendamustine Hydrochloride</term><term>Purines</term><term>Quinazolinones</term><term>Rituximab</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Chlorhydrate de bendamustine</term><term>Purines</term><term>Quinazolinones</term><term>Rituximab</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Leucémie chronique lymphocytaire à cellules B</term><term>Récidive tumorale locale</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Drug Resistance, Neoplasm</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Lymphocytic, Chronic, B-Cell</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Leukemia, Lymphocytic, Chronic, B-Cell</term><term>Neoplasm Recurrence, Local</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>Leucémie chronique lymphocytaire à cellules B</term><term>Récidive tumorale locale</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>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Neoplasm Staging</term><term>Prognosis</term><term>Salvage Therapy</term><term>Survival Rate</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Pronostic</term><term>Résistance aux médicaments antinéoplasiques</term><term>Stade de la tumeur</term><term>Sujet âgé</term><term>Taux de survie</term><term>Thérapie de rattrapage</term><term>Études de suivi</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28139405</PMID><DateCreated><Year>2017</Year><Month>01</Month><Day>31</Day></DateCreated><DateCompleted><Year>2017</Year><Month>06</Month><Day>08</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>08</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>3</Issue><PubDate><Year>2017</Year><Month>Mar</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.</ArticleTitle><Pagination><MedlinePgn>297-311</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(16)30671-4</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(16)30671-4</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">For this international, multicentre, double-blind, placebo-controlled trial, adult patients (≥18 years) with relapsed or refractory chronic lymphocytic leukaemia requiring treatment who had measurable lymphadenopathy by CT or MRI and disease progression within 36 months since their last previous therapy were enrolled. Patients were randomly assigned (1:1) by a central interactive web response system to receive bendamustine plus rituximab for a maximum of six cycles (bendamustine: 70 mg/m(2) intravenously on days 1 and 2 for six 28-day cycles; rituximab: 375 mg/m(2) on day 1 of cycle 1, and 500 mg/m(2) on day 1 of cycles 2-6) in addition to either twice-daily oral idelalisib (150 mg) or placebo until disease progression or intolerable study drug-related toxicity. Randomisation was stratified by high-risk features (IGHV, del[17p], or TP53 mutation) and refractory versus relapsed disease. The primary endpoint was progression-free survival assessed by an independent review committee in the intention-to-treat population. This trial is ongoing and is registered with ClinicalTrials.gov, number NCT01569295.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between June 26, 2012, and Aug 21, 2014, 416 patients were enrolled and randomly assigned to the idelalisib (n=207) and placebo (n=209) groups. At a median follow-up of 14 months (IQR 7-18), median progression-free survival was 20·8 months (95% CI 16·6-26·4) in the idelalisib group and 11·1 months (8·9-11·1) in the placebo group (hazard ratio [HR] 0·33, 95% CI 0·25-0·44; p<0·0001). The most frequent grade 3 or worse adverse events in the idelalisib group were neutropenia (124 [60%] of 207 patients) and febrile neutropenia (48 [23%]), whereas in the placebo group they were neutropenia (99 [47%] of 209) and thrombocytopenia (27 [13%]). An increased risk of infection was reported in the idelalisib group compared with the placebo group (grade ≥3 infections and infestations: 80 [39%] of 207 vs 52 [25%] of 209). Serious adverse events, including febrile neutropenia, pneumonia, and pyrexia, were more common in the idelalisib group (140 [68%] of 207 patients) than in the placebo group (92 [44%] of 209). Treatment-emergent adverse events leading to death occurred in 23 (11%) patients in the idelalisib group and 15 (7%) in the placebo group, including six deaths from infections in the idelalisib group and three from infections in the placebo group.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Idelalisib in combination with bendamustine plus rituximab improved progression-free survival compared with bendamustine plus rituximab alone in patients with relapsed or refractory chronic lymphocytic leukaemia. However, careful attention needs to be paid to management of serious adverse events and infections associated with this regimen during treatment selection.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Gilead Sciences Inc.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Zelenetz</LastName><ForeName>Andrew D</ForeName><Initials>AD</Initials><AffiliationInfo><Affiliation>Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: zeleneta@mskcc.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barrientos</LastName><ForeName>Jacqueline C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Jennifer R</ForeName><Initials>JR</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coiffier</LastName><ForeName>Bertrand</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Haematology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Delgado</LastName><ForeName>Julio</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Haematology, Hospital Clínic, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Egyed</LastName><ForeName>Miklós</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvar, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ghia</LastName><ForeName>Paolo</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Division of Experimental Oncology and Department of Onco-Haematology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Illés</LastName><ForeName>Árpád</ForeName><Initials>Á</Initials><AffiliationInfo><Affiliation>Department of Haematology, University of Debrecen, Debrecen, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jurczak</LastName><ForeName>Wojciech</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Haematology, Jagiellonian University, Krakow, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marlton</LastName><ForeName>Paula</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Haematology, Princess Alexandra Hospital, University of Queensland, School of Medicine, Brisbane, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Montillo</LastName><ForeName>Marco</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morschhauser</LastName><ForeName>Franck</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>CHRU Lille, Unité GRITA, Department of Haematology, Université de Lille, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pristupa</LastName><ForeName>Alexander S</ForeName><Initials>AS</Initials><AffiliationInfo><Affiliation>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robak</LastName><ForeName>Tadeusz</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sharman</LastName><ForeName>Jeff P</ForeName><Initials>JP</Initials><AffiliationInfo><Affiliation>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Simpson</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>North Shore Hospital, Takapuna, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smolej</LastName><ForeName>Lukáš</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tausch</LastName><ForeName>Eugen</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Adewoye</LastName><ForeName>Adeboye H</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dreiling</LastName><ForeName>Lyndah K</ForeName><Initials>LK</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Yeonhee</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stilgenbauer</LastName><ForeName>Stephan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hillmen</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Haematology/Oncology, St James's University Hospital, Leeds, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>P30 CA008748</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</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>01</Month><Day>28</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="D011687">Purines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D052999">Quinazolinones</NameOfSubstance></Chemical><Chemical><RegistryNumber>4F4X42SYQ6</RegistryNumber><NameOfSubstance UI="D000069283">Rituximab</NameOfSubstance></Chemical><Chemical><RegistryNumber>981Y8SX18M</RegistryNumber><NameOfSubstance UI="D000069461">Bendamustine Hydrochloride</NameOfSubstance></Chemical><Chemical><RegistryNumber>YG57I8T5M0</RegistryNumber><NameOfSubstance UI="C552946">idelalisib</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Am J Hematol. 2015 May;90(5):446-60</RefSource><PMID Version="1">25908509</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2010 Oct 10;28(29):4473-9</RefSource><PMID Version="1">20697090</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Blood. 2008 Jun 15;111(12):5446-56</RefSource><PMID Version="1">18216293</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Leuk Res Rep. 2015 Sep 18;4(2):60-3</RefSource><PMID Version="1">26500849</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2007 Mar 1;25(7):799-804</RefSource><PMID 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MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000069461" MajorTopicYN="N">Bendamustine Hydrochloride</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019008" MajorTopicYN="N">Drug Resistance, Neoplasm</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015451" MajorTopicYN="N">Leukemia, Lymphocytic, Chronic, B-Cell</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009364" MajorTopicYN="N">Neoplasm Recurrence, Local</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009367" MajorTopicYN="N">Neoplasm Staging</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011379" MajorTopicYN="N">Prognosis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011687" MajorTopicYN="N">Purines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D052999" MajorTopicYN="N">Quinazolinones</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000069283" MajorTopicYN="N">Rituximab</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016879" MajorTopicYN="Y">Salvage Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>07</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>10</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>10</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="pmc-release"><Year>2018</Year><Month>03</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>2</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>6</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>2</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28139405</ArticleId><ArticleId IdType="pii">S1470-2045(16)30671-4</ArticleId><ArticleId IdType="doi">10.1016/S1470-2045(16)30671-4</ArticleId><ArticleId IdType="pmc">PMC5589180</ArticleId><ArticleId IdType="mid">NIHMS889304</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.
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