Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
Identifieur interne : 005B58 ( PascalFrancis/Curation ); précédent : 005B57; suivant : 005B59Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
Auteurs : J. C. Byrd [États-Unis] ; J. R. Brown [États-Unis] ; S. O'Brien [États-Unis] ; J. C. Barrientos [États-Unis] ; N. E. Kay [États-Unis] ; N. M. Reddy [États-Unis] ; S. Coutre [États-Unis] ; C. S. Tam [Australie] ; S. P. Mulligan [Australie] ; U. Jaeger [Autriche] ; S. Devereux [Royaume-Uni] ; P. M. Barr [États-Unis] ; R. R. Furman [États-Unis] ; T. J. Kipps [États-Unis] ; F. Cymbalista [États-Unis] ; C. Pocock [Royaume-Uni] ; P. Thornton [Irlande (pays)] ; F. Caligaris-Cappio [Italie] ; T. Robak ; J. Delgado ; S. J. Schuster ; M. Montillo ; A. Schuh [Royaume-Uni] ; S. De Vos [États-Unis] ; D. Gill [Australie] ; A. Bloor [Royaume-Uni] ; C. Dearden [Royaume-Uni] ; C. Moreno ; J. J. Jones [États-Unis] ; A. D. Chu [États-Unis] ; M. Fardis [États-Unis] ; J. Mcgreivy [États-Unis] ; F. Clow [France] ; D. F. James [États-Unis] ; P. Hillmen [Royaume-Uni]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Médecine.
English descriptors
- KwdEn :
Abstract
BACKGROUND In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome. METHODS In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points. RESULTS At a median follow-up of 9.4 months, ibrutinib significantly improved progression-free survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P<0.001). Ibrutinib also significantly improved overall survival (hazard ratio for death, 0.43; P=0.005). At 12 months, the overall survival rate was 90% in the ibrutinib group and 81% in the ofatumumab group. The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group (42.6% vs. 4.1%, P<0.001). An additional 20% of ibrutinib-treated patients had a partial response with lymphocytosis. Similar effects were observed regardless of whether patients had a chromosome 17p13.1 deletion or resistance to purine analogues. The most frequent nonhematologic adverse events were diarrhea, fatigue, pyrexia, and nausea in the ibrutinib group and fatigue, infusion-related reactions, and cough in the ofatumumab group. CONCLUSIONS Ibrutinib, as compared with ofatumumab, significantly improved progression-free survival, overall survival, and response rate among patients with previously treated CLL or SLL.
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Reddy</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Vanderbilt-Ingram Cancer Center</s1><s2>Nashville, California</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Coutre, S" sort="Coutre, S" uniqKey="Coutre S" first="S." last="Coutre">S. Coutre</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Stanford University School of Medicine and Stanford Cancer Institute</s1><s2>Stanford, California</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Tam, C S" sort="Tam, C S" uniqKey="Tam C" first="C. S." last="Tam">C. S. Tam</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Peter MacCallum Cancer Centre and St. Vincent's Hospital</s1><s2>Melbourne, VIC</s2><s3>AUS</s3><sZ>8 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Mulligan, S P" sort="Mulligan, S P" uniqKey="Mulligan S" first="S. P." last="Mulligan">S. P. Mulligan</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Royal North Shore Hospital</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Jaeger, U" sort="Jaeger, U" uniqKey="Jaeger U" first="U." last="Jaeger">U. Jaeger</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Medical University of Vienna</s1><s2>Vienna</s2><s3>AUT</s3><sZ>10 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Devereux, S" sort="Devereux, S" uniqKey="Devereux S" first="S." last="Devereux">S. Devereux</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Kings College Hospital, National Health Service (NHS) Foundation Trust Denmark Hill</s1><s2>London</s2><s3>GBR</s3><sZ>11 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="Barr, P M" sort="Barr, P M" uniqKey="Barr P" first="P. M." last="Barr">P. M. Barr</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>University of Rochester Cancer Center</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Furman, R R" sort="Furman, R R" uniqKey="Furman R" first="R. R." last="Furman">R. R. 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Thornton</name><affiliation wicri:level="1"><inist:fA14 i1="24"><s1>Beaumont Hospital</s1><s2>Dublin</s2><s3>IRL</s3><sZ>17 aut.</sZ></inist:fA14><country>Irlande (pays)</country></affiliation></author><author><name sortKey="Caligaris Cappio, F" sort="Caligaris Cappio, F" uniqKey="Caligaris Cappio F" first="F." last="Caligaris-Cappio">F. Caligaris-Cappio</name><affiliation wicri:level="1"><inist:fA14 i1="25"><s1>Universita Vita-Salute San Raffaele</s1><s2>Milan</s2><s3>ITA</s3><sZ>18 aut.</sZ></inist:fA14><country>Italie</country></affiliation></author><author><name sortKey="Robak, T" sort="Robak, T" uniqKey="Robak T" first="T." last="Robak">T. Robak</name></author><author><name sortKey="Delgado, J" sort="Delgado, J" uniqKey="Delgado J" first="J." last="Delgado">J. Delgado</name></author><author><name sortKey="Schuster, S J" sort="Schuster, S J" uniqKey="Schuster S" first="S. J." last="Schuster">S. J. 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Gill</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Princess Alexandra Hospital</s1><s2>Brisbane, QLD</s2><s3>AUS</s3><sZ>25 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Bloor, A" sort="Bloor, A" uniqKey="Bloor A" first="A." last="Bloor">A. Bloor</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Christie NHS Foundation Trust Hematology and Transplant Unit</s1><s2>Manchester</s2><s3>GBR</s3><sZ>26 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="Dearden, C" sort="Dearden, C" uniqKey="Dearden C" first="C." last="Dearden">C. Dearden</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Royal Marsden Hospital and the Institute of Cancer Research</s1><s2>Sutton</s2><s3>GBR</s3><sZ>27 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="Moreno, C" sort="Moreno, C" uniqKey="Moreno C" first="C." last="Moreno">C. Moreno</name></author><author><name sortKey="Jones, J J" sort="Jones, J J" uniqKey="Jones J" first="J. J." last="Jones">J. J. Jones</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Ohio State University Comprehensive Cancer Center</s1><s2>Columbus, New York</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>29 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Chu, A D" sort="Chu, A D" uniqKey="Chu A" first="A. D." last="Chu">A. D. Chu</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Fardis, M" sort="Fardis, M" uniqKey="Fardis M" first="M." last="Fardis">M. Fardis</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Mcgreivy, J" sort="Mcgreivy, J" uniqKey="Mcgreivy J" first="J." last="Mcgreivy">J. Mcgreivy</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Clow, F" sort="Clow, F" uniqKey="Clow F" first="F." last="Clow">F. Clow</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Hôpital Avicenne</s1><s2>Paris</s2><s3>FRA</s3><sZ>33 aut.</sZ></inist:fA14><country>France</country></affiliation></author><author><name sortKey="James, D F" sort="James, D F" uniqKey="James D" first="D. F." last="James">D. F. James</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Hillmen, P" sort="Hillmen, P" uniqKey="Hillmen P" first="P." last="Hillmen">P. Hillmen</name><affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Leeds Teaching Hospitals, St. James Institute of Oncology</s1><s2>Leeds</s2><s3>GBR</s3><sZ>35 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0198874</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0198874 INIST</idno><idno type="RBID">Pascal:14-0198874</idno><idno type="wicri:Area/PascalFrancis/Corpus">000304</idno><idno type="wicri:Area/PascalFrancis/Curation">005B58</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia</title><author><name sortKey="Byrd, J C" sort="Byrd, J C" uniqKey="Byrd J" first="J. C." last="Byrd">J. C. Byrd</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Ohio State University Comprehensive Cancer Center</s1><s2>Columbus, New York</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>29 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Brown, J R" sort="Brown, J R" uniqKey="Brown J" first="J. R." last="Brown">J. R. Brown</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Dana-Farber Cancer Institute</s1><s2>Boston, New York</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="O Brien, S" sort="O Brien, S" uniqKey="O Brien S" first="S." last="O'Brien">S. O'Brien</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>M.D. Anderson Cancer Center</s1><s2>Houston, New York</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Barrientos, J C" sort="Barrientos, J C" uniqKey="Barrientos J" first="J. C." last="Barrientos">J. C. Barrientos</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Hofstra North Shore-LIJ School of Medicine</s1><s2>Hempstead, New York</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Kay, N E" sort="Kay, N E" uniqKey="Kay N" first="N. E." last="Kay">N. E. Kay</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Mayo Clinic, Rochester</s1><s2>MN, California</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Reddy, N M" sort="Reddy, N M" uniqKey="Reddy N" first="N. M." last="Reddy">N. M. Reddy</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Vanderbilt-Ingram Cancer Center</s1><s2>Nashville, California</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Coutre, S" sort="Coutre, S" uniqKey="Coutre S" first="S." last="Coutre">S. Coutre</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Stanford University School of Medicine and Stanford Cancer Institute</s1><s2>Stanford, California</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Tam, C S" sort="Tam, C S" uniqKey="Tam C" first="C. S." last="Tam">C. S. Tam</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Peter MacCallum Cancer Centre and St. Vincent's Hospital</s1><s2>Melbourne, VIC</s2><s3>AUS</s3><sZ>8 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Mulligan, S P" sort="Mulligan, S P" uniqKey="Mulligan S" first="S. P." last="Mulligan">S. P. Mulligan</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Royal North Shore Hospital</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Jaeger, U" sort="Jaeger, U" uniqKey="Jaeger U" first="U." last="Jaeger">U. Jaeger</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Medical University of Vienna</s1><s2>Vienna</s2><s3>AUT</s3><sZ>10 aut.</sZ></inist:fA14><country>Autriche</country></affiliation></author><author><name sortKey="Devereux, S" sort="Devereux, S" uniqKey="Devereux S" first="S." last="Devereux">S. Devereux</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Kings College Hospital, National Health Service (NHS) Foundation Trust Denmark Hill</s1><s2>London</s2><s3>GBR</s3><sZ>11 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="Barr, P M" sort="Barr, P M" uniqKey="Barr P" first="P. M." last="Barr">P. M. Barr</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>University of Rochester Cancer Center</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Furman, R R" sort="Furman, R R" uniqKey="Furman R" first="R. R." last="Furman">R. R. Furman</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>New York-Presbyterian Hospital and Weill Cornell Medical College</s1><s2>New York, New York</s2><s3>USA</s3><sZ>13 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Kipps, T J" sort="Kipps, T J" uniqKey="Kipps T" first="T. J." last="Kipps">T. J. Kipps</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Moores UCSD Cancer Center</s1><s2>San Diego, California</s2><s3>USA</s3><sZ>14 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Cymbalista, F" sort="Cymbalista, F" uniqKey="Cymbalista F" first="F." last="Cymbalista">F. Cymbalista</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Pocock, C" sort="Pocock, C" uniqKey="Pocock C" first="C." last="Pocock">C. Pocock</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>East Kent Hospitals</s1><s2>Canterbury</s2><s3>GBR</s3><sZ>16 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="Thornton, P" sort="Thornton, P" uniqKey="Thornton P" first="P." last="Thornton">P. Thornton</name><affiliation wicri:level="1"><inist:fA14 i1="24"><s1>Beaumont Hospital</s1><s2>Dublin</s2><s3>IRL</s3><sZ>17 aut.</sZ></inist:fA14><country>Irlande (pays)</country></affiliation></author><author><name sortKey="Caligaris Cappio, F" sort="Caligaris Cappio, F" uniqKey="Caligaris Cappio F" first="F." last="Caligaris-Cappio">F. Caligaris-Cappio</name><affiliation wicri:level="1"><inist:fA14 i1="25"><s1>Universita Vita-Salute San Raffaele</s1><s2>Milan</s2><s3>ITA</s3><sZ>18 aut.</sZ></inist:fA14><country>Italie</country></affiliation></author><author><name sortKey="Robak, T" sort="Robak, T" uniqKey="Robak T" first="T." last="Robak">T. Robak</name></author><author><name sortKey="Delgado, J" sort="Delgado, J" uniqKey="Delgado J" first="J." last="Delgado">J. Delgado</name></author><author><name sortKey="Schuster, S J" sort="Schuster, S J" uniqKey="Schuster S" first="S. J." last="Schuster">S. J. Schuster</name></author><author><name sortKey="Montillo, M" sort="Montillo, M" uniqKey="Montillo M" first="M." last="Montillo">M. Montillo</name></author><author><name sortKey="Schuh, A" sort="Schuh, A" uniqKey="Schuh A" first="A." last="Schuh">A. Schuh</name><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Oxford Biomedical Research Centre</s1><s2>Oxford</s2><s3>GBR</s3><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="De Vos, S" sort="De Vos, S" uniqKey="De Vos S" first="S." last="De Vos">S. De Vos</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>David Geffen School of Medicine at UCLA</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>24 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Gill, D" sort="Gill, D" uniqKey="Gill D" first="D." last="Gill">D. Gill</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Princess Alexandra Hospital</s1><s2>Brisbane, QLD</s2><s3>AUS</s3><sZ>25 aut.</sZ></inist:fA14><country>Australie</country></affiliation></author><author><name sortKey="Bloor, A" sort="Bloor, A" uniqKey="Bloor A" first="A." last="Bloor">A. Bloor</name><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Christie NHS Foundation Trust Hematology and Transplant Unit</s1><s2>Manchester</s2><s3>GBR</s3><sZ>26 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="Dearden, C" sort="Dearden, C" uniqKey="Dearden C" first="C." last="Dearden">C. Dearden</name><affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Royal Marsden Hospital and the Institute of Cancer Research</s1><s2>Sutton</s2><s3>GBR</s3><sZ>27 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author><author><name sortKey="Moreno, C" sort="Moreno, C" uniqKey="Moreno C" first="C." last="Moreno">C. Moreno</name></author><author><name sortKey="Jones, J J" sort="Jones, J J" uniqKey="Jones J" first="J. J." last="Jones">J. J. Jones</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Ohio State University Comprehensive Cancer Center</s1><s2>Columbus, New York</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>29 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Chu, A D" sort="Chu, A D" uniqKey="Chu A" first="A. D." last="Chu">A. D. Chu</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Fardis, M" sort="Fardis, M" uniqKey="Fardis M" first="M." last="Fardis">M. Fardis</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Mcgreivy, J" sort="Mcgreivy, J" uniqKey="Mcgreivy J" first="J." last="Mcgreivy">J. Mcgreivy</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Clow, F" sort="Clow, F" uniqKey="Clow F" first="F." last="Clow">F. Clow</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Hôpital Avicenne</s1><s2>Paris</s2><s3>FRA</s3><sZ>33 aut.</sZ></inist:fA14><country>France</country></affiliation></author><author><name sortKey="James, D F" sort="James, D F" uniqKey="James D" first="D. F." last="James">D. F. James</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></inist:fA14><country>États-Unis</country></affiliation></author><author><name sortKey="Hillmen, P" sort="Hillmen, P" uniqKey="Hillmen P" first="P." last="Hillmen">P. Hillmen</name><affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Leeds Teaching Hospitals, St. James Institute of Oncology</s1><s2>Leeds</s2><s3>GBR</s3><sZ>35 aut.</sZ></inist:fA14><country>Royaume-Uni</country></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Chronic</term><term>Comparative study</term><term>Leukemia</term><term>Medicine</term><term>Ofatumumab</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Leucémie</term><term>Ofatumumab</term><term>Etude comparative</term><term>Traitement</term><term>Chronique</term><term>Médecine</term><term>Anticancéreux</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome. METHODS In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points. RESULTS At a median follow-up of 9.4 months, ibrutinib significantly improved progression-free survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P<0.001). Ibrutinib also significantly improved overall survival (hazard ratio for death, 0.43; P=0.005). At 12 months, the overall survival rate was 90% in the ibrutinib group and 81% in the ofatumumab group. The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group (42.6% vs. 4.1%, P<0.001). An additional 20% of ibrutinib-treated patients had a partial response with lymphocytosis. Similar effects were observed regardless of whether patients had a chromosome 17p13.1 deletion or resistance to purine analogues. The most frequent nonhematologic adverse events were diarrhea, fatigue, pyrexia, and nausea in the ibrutinib group and fatigue, infusion-related reactions, and cough in the ofatumumab group. CONCLUSIONS Ibrutinib, as compared with ofatumumab, significantly improved progression-free survival, overall survival, and response rate among patients with previously treated CLL or SLL.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0028-4793</s0></fA01><fA02 i1="01"><s0>NEJMAG</s0></fA02><fA03 i2="1"><s0>N. Engl. j. med.</s0></fA03><fA05><s2>371</s2></fA05><fA06><s2>3</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia</s1></fA08><fA11 i1="01" i2="1"><s1>BYRD (J. C.)</s1></fA11><fA11 i1="02" i2="1"><s1>BROWN (J. R.)</s1></fA11><fA11 i1="03" i2="1"><s1>O'BRIEN (S.)</s1></fA11><fA11 i1="04" i2="1"><s1>BARRIENTOS (J. C.)</s1></fA11><fA11 i1="05" i2="1"><s1>KAY (N. E.)</s1></fA11><fA11 i1="06" i2="1"><s1>REDDY (N. M.)</s1></fA11><fA11 i1="07" i2="1"><s1>COUTRE (S.)</s1></fA11><fA11 i1="08" i2="1"><s1>TAM (C. S.)</s1></fA11><fA11 i1="09" i2="1"><s1>MULLIGAN (S. P.)</s1></fA11><fA11 i1="10" i2="1"><s1>JAEGER (U.)</s1></fA11><fA11 i1="11" i2="1"><s1>DEVEREUX (S.)</s1></fA11><fA11 i1="12" i2="1"><s1>BARR (P. M.)</s1></fA11><fA11 i1="13" i2="1"><s1>FURMAN (R. R.)</s1></fA11><fA11 i1="14" i2="1"><s1>KIPPS (T. J.)</s1></fA11><fA11 i1="15" i2="1"><s1>CYMBALISTA (F.)</s1></fA11><fA11 i1="16" i2="1"><s1>POCOCK (C.)</s1></fA11><fA11 i1="17" i2="1"><s1>THORNTON (P.)</s1></fA11><fA11 i1="18" i2="1"><s1>CALIGARIS-CAPPIO (F.)</s1></fA11><fA11 i1="19" i2="1"><s1>ROBAK (T.)</s1></fA11><fA11 i1="20" i2="1"><s1>DELGADO (J.)</s1></fA11><fA11 i1="21" i2="1"><s1>SCHUSTER (S. J.)</s1></fA11><fA11 i1="22" i2="1"><s1>MONTILLO (M.)</s1></fA11><fA11 i1="23" i2="1"><s1>SCHUH (A.)</s1></fA11><fA11 i1="24" i2="1"><s1>DE VOS (S.)</s1></fA11><fA11 i1="25" i2="1"><s1>GILL (D.)</s1></fA11><fA11 i1="26" i2="1"><s1>BLOOR (A.)</s1></fA11><fA11 i1="27" i2="1"><s1>DEARDEN (C.)</s1></fA11><fA11 i1="28" i2="1"><s1>MORENO (C.)</s1></fA11><fA11 i1="29" i2="1"><s1>JONES (J. J.)</s1></fA11><fA11 i1="30" i2="1"><s1>CHU (A. D.)</s1></fA11><fA11 i1="31" i2="1"><s1>FARDIS (M.)</s1></fA11><fA11 i1="32" i2="1"><s1>MCGREIVY (J.)</s1></fA11><fA11 i1="33" i2="1"><s1>CLOW (F.)</s1></fA11><fA11 i1="34" i2="1"><s1>JAMES (D. F.)</s1></fA11><fA11 i1="35" i2="1"><s1>HILLMEN (P.)</s1></fA11><fA14 i1="01"><s1>Ohio State University Comprehensive Cancer Center</s1><s2>Columbus, New York</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>29 aut.</sZ></fA14><fA14 i1="02"><s1>Dana-Farber Cancer Institute</s1><s2>Boston, New York</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>M.D. Anderson Cancer Center</s1><s2>Houston, New York</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Hofstra North Shore-LIJ School of Medicine</s1><s2>Hempstead, New York</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>University of Rochester Cancer Center</s1><s2>Rochester, New York</s2><s3>USA</s3><sZ>12 aut.</sZ></fA14><fA14 i1="06"><s1>New York-Presbyterian Hospital and Weill Cornell Medical College</s1><s2>New York, New York</s2><s3>USA</s3><sZ>13 aut.</sZ></fA14><fA14 i1="07"><s1>Mayo Clinic, Rochester</s1><s2>MN, California</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="08"><s1>Vanderbilt-Ingram Cancer Center</s1><s2>Nashville, California</s2><s3>USA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="09"><s1>Stanford University School of Medicine and Stanford Cancer Institute</s1><s2>Stanford, California</s2><s3>USA</s3><sZ>7 aut.</sZ></fA14><fA14 i1="10"><s1>Moores UCSD Cancer Center</s1><s2>San Diego, California</s2><s3>USA</s3><sZ>14 aut.</sZ></fA14><fA14 i1="11"><s1>David Geffen School of Medicine at UCLA</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>24 aut.</sZ></fA14><fA14 i1="12"><s1>Pharmacyclics</s1><s2>Sunnyvale, California</s2><s3>USA</s3><sZ>15 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ><sZ>32 aut.</sZ><sZ>34 aut.</sZ></fA14><fA14 i1="13"><s1>Peter MacCallum Cancer Centre and St. Vincent's Hospital</s1><s2>Melbourne, VIC</s2><s3>AUS</s3><sZ>8 aut.</sZ></fA14><fA14 i1="14"><s1>Royal North Shore Hospital</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>9 aut.</sZ></fA14><fA14 i1="15"><s1>Princess Alexandra Hospital</s1><s2>Brisbane, QLD</s2><s3>AUS</s3><sZ>25 aut.</sZ></fA14><fA14 i1="16"><s1>Medical University of Vienna</s1><s2>Vienna</s2><s3>AUT</s3><sZ>10 aut.</sZ></fA14><fA14 i1="17"><s1>Kings College Hospital, National Health Service (NHS) Foundation Trust Denmark Hill</s1><s2>London</s2><s3>GBR</s3><sZ>11 aut.</sZ></fA14><fA14 i1="18"><s1>East Kent Hospitals</s1><s2>Canterbury</s2><s3>GBR</s3><sZ>16 aut.</sZ></fA14><fA14 i1="19"><s1>Oxford Biomedical Research Centre</s1><s2>Oxford</s2><s3>GBR</s3><sZ>23 aut.</sZ></fA14><fA14 i1="20"><s1>Christie NHS Foundation Trust Hematology and Transplant Unit</s1><s2>Manchester</s2><s3>GBR</s3><sZ>26 aut.</sZ></fA14><fA14 i1="21"><s1>Royal Marsden Hospital and the Institute of Cancer Research</s1><s2>Sutton</s2><s3>GBR</s3><sZ>27 aut.</sZ></fA14><fA14 i1="22"><s1>Leeds Teaching Hospitals, St. James Institute of Oncology</s1><s2>Leeds</s2><s3>GBR</s3><sZ>35 aut.</sZ></fA14><fA14 i1="23"><s1>Hôpital Avicenne</s1><s2>Paris</s2><s3>FRA</s3><sZ>33 aut.</sZ></fA14><fA14 i1="24"><s1>Beaumont Hospital</s1><s2>Dublin</s2><s3>IRL</s3><sZ>17 aut.</sZ></fA14><fA14 i1="25"><s1>Universita Vita-Salute San Raffaele</s1><s2>Milan</s2><s3>ITA</s3><sZ>18 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>RESONATE Investigators</s1><s3>INC</s3></fA17><fA20><s1>213-223</s1></fA20><fA21><s1>2014</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>6013</s2><s5>354000504822650050</s5></fA43><fA44><s0>0000</s0><s1>© 2014 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>28 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>14-0198874</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>The New England journal of medicine</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>BACKGROUND In patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL), a short duration of response to therapy or adverse cytogenetic abnormalities are associated with a poor outcome. We evaluated the efficacy of ibrutinib, a covalent inhibitor of Bruton's tyrosine kinase, in patients at risk for a poor outcome. METHODS In this multicenter, open-label, phase 3 study, we randomly assigned 391 patients with relapsed or refractory CLL or SLL to receive daily ibrutinib or the anti-CD20 antibody ofatumumab. The primary end point was the duration of progression-free survival, with the duration of overall survival and the overall response rate as secondary end points. RESULTS At a median follow-up of 9.4 months, ibrutinib significantly improved progression-free survival; the median duration was not reached in the ibrutinib group (with a rate of progression-free survival of 88% at 6 months), as compared with a median of 8.1 months in the ofatumumab group (hazard ratio for progression or death in the ibrutinib group, 0.22; P<0.001). Ibrutinib also significantly improved overall survival (hazard ratio for death, 0.43; P=0.005). At 12 months, the overall survival rate was 90% in the ibrutinib group and 81% in the ofatumumab group. The overall response rate was significantly higher in the ibrutinib group than in the ofatumumab group (42.6% vs. 4.1%, P<0.001). An additional 20% of ibrutinib-treated patients had a partial response with lymphocytosis. Similar effects were observed regardless of whether patients had a chromosome 17p13.1 deletion or resistance to purine analogues. The most frequent nonhematologic adverse events were diarrhea, fatigue, pyrexia, and nausea in the ibrutinib group and fatigue, infusion-related reactions, and cough in the ofatumumab group. CONCLUSIONS Ibrutinib, as compared with ofatumumab, significantly improved progression-free survival, overall survival, and response rate among patients with previously treated CLL or SLL.</s0></fC01><fC02 i1="01" i2="X"><s0>002B01</s0></fC02><fC02 i1="02" i2="X"><s0>002B19B</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Leucémie</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Leukemia</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Leucemia</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Ofatumumab</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Ofatumumab</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Ofatumumab</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Etude comparative</s0><s5>07</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Comparative study</s0><s5>07</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>07</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Traitement</s0><s5>08</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Treatment</s0><s5>08</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Tratamiento</s0><s5>08</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Chronique</s0><s5>09</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Chronic</s0><s5>09</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Crónico</s0><s5>09</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Médecine</s0><s5>13</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Medicine</s0><s5>13</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Medicina</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Anticancéreux</s0><s5>30</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Antineoplastic agent</s0><s5>30</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Anticanceroso</s0><s5>30</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Anticorps monoclonal</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Monoclonal antibody</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Anticuerpo monoclonal</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Hémopathie maligne</s0><s2>NM</s2><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Malignant hemopathy</s0><s2>NM</s2><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Hemopatía maligna</s0><s2>NM</s2><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Antigène CD20</s0><s4>INC</s4><s5>86</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Anti-CD20</s0><s4>INC</s4><s5>87</s5></fC07><fN21><s1>244</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist></record>Pour manipuler ce document sous Unix (Dilib)
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