AustralieFrV1, Main, Exploration, bibRecord, 007686

Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

Identifieur interne : 007686 ( Main/Exploration ); précédent : 007685; suivant : 007687

Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

Auteurs : Giuseppe Saglio [Italie] ; Dong-Wook Kim [Corée du Sud] ; Surapol Issaragrisil [Thaïlande] ; Philipp Le Coutre [Allemagne] ; Gabriel Etienne [France] ; Clarisse Lobo [Brésil] ; Ricardo Pasquini [Brésil] ; Richard E. Clark [Royaume-Uni] ; Andreas Hochhaus [Allemagne] ; Timothy P. Hughes [Australie] ; Neil Gallagher [Suisse] ; Albert Hoenekopp [Suisse] ; MEI DONG [États-Unis] ; Ariful Haque [États-Unis] ; Richard A. Larson [États-Unis] ; Hagop M. Kantarjian [États-Unis]

Source :

The New England journal of medicine [ 0028-4793 ] ; 2010.

RBID : Pascal:10-0317554

Descripteurs français

Pascal (Inist)
- Nilotinib, Etude comparative, Inhibiteur enzyme, Imatinib, Stade précoce, Médecine, Leucémie myéloïde chronique, Anticancéreux.
Wicri :
- topic : Médecine.

English descriptors

KwdEn :
- Antineoplastic agent, Chronic myelogenous leukemia, Comparative study, Early stage, Enzyme inhibitor, Imatinib, Medicine, Nilotinib.

Abstract

BACKGROUND Nilotinib has been shown to be a more potent inhibitor of BCR-ABL than imatinib. We evaluated the efficacy and safety of nilotinib, as compared with imatinib, in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase. METHODS In this phase 3, randomized, open-label, multicenter study, we assigned 846 patients with chronic-phase Philadelphia chromosome-positive CML in a 1:1:1 ratio to receive nilotinib (at a dose of either 300 mg or 400 mg twice daily) or imatinib (at a dose of 400 mg once daily). The primary end point was the rate of major molecular response at 12 months. RESULTS At 12 months, the rates of major molecular response for nilotinib (44% for the 300-mg dose and 43% for the 400-mg dose) were nearly twice that for imatinib (22%) (P<0.001 for both comparisons). The rates of complete cytogenetic response by 12 months were significantly higher for nilotinib (80% for the 300-mg dose and 78% for the 400-mg dose) than for imatinib (65%) (P<0.001 for both comparisons). Patients receiving either the 300-mg dose or the 400-mg dose of nilotinib twice daily had a significant improvement in the time to progression to the accelerated phase or blast crisis, as compared with those receiving imatinib (P=0.01 and P=0.004, respectively). No patient with progression to the accelerated phase or blast crisis had a major molecular response. Gastrointestinal and fluid-retention events were more frequent among patients receiving imatinib, whereas dermatologic events and headache were more frequent in those receiving nilotinib. Discontinuations due to aminotransferase and bilirubin elevations were low in all three study groups. CONCLUSIONS Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome-positive CML.

Affiliations:

Allemagne, Australie, Brésil, Corée du Sud, France, Italie, Royaume-Uni, Suisse, Thaïlande, États-Unis
Aquitaine, Berlin, Illinois, Nouvelle-Aquitaine, Piémont, Région capitale de Séoul, Texas, État de Rio de Janeiro
Berlin, Bordeaux, Chicago, Houston, Rio de Janeiro, Séoul, Turin

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 002579
to stream PascalFrancis, to step Curation: 003A07
to stream PascalFrancis, to step Checkpoint: 002206
to stream Main, to step Merge: 007C74
to stream Main, to step Curation: 007686

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia</title>
<author><name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>University of Turin, San Luigi Gonzaga Hospital, Orbassano</s1>
<s2>Turin</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName><settlement type="city">Turin</settlement>
<region type="région" nuts="2">Piémont</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kim, Dong Wook" sort="Kim, Dong Wook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Seoul St. Mary's Hospital, Catholic University of Korea</s1>
<s2>Seoul</s2>
<s3>KOR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Corée du Sud</country>
<placeName><settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Issaragrisil, Surapol" sort="Issaragrisil, Surapol" uniqKey="Issaragrisil S" first="Surapol" last="Issaragrisil">Surapol Issaragrisil</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Siriraj Hospital, Mahidol University</s1>
<s2>Bangkok</s2>
<s3>THA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Thaïlande</country>
<wicri:noRegion>Bangkok</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Le Coutre, Philipp" sort="Le Coutre, Philipp" uniqKey="Le Coutre P" first="Philipp" last="Le Coutre">Philipp Le Coutre</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Charité, Campus Virchow, Universitätsmedizin Berlin</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Etienne, Gabriel" sort="Etienne, Gabriel" uniqKey="Etienne G" first="Gabriel" last="Etienne">Gabriel Etienne</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Institut Bergonié</s1>
<s2>Bordeaux</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lobo, Clarisse" sort="Lobo, Clarisse" uniqKey="Lobo C" first="Clarisse" last="Lobo">Clarisse Lobo</name>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti</s1>
<s2>Rio de Janeiro</s2>
<s3>BRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Brésil</country>
<placeName><settlement type="city">Rio de Janeiro</settlement>
<region type="state">État de Rio de Janeiro</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pasquini, Ricardo" sort="Pasquini, Ricardo" uniqKey="Pasquini R" first="Ricardo" last="Pasquini">Ricardo Pasquini</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Universidade Federal do Paraná</s1>
<s2>Curitiba, Paraná</s2>
<s3>BRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Brésil</country>
<wicri:noRegion>Universidade Federal do Paraná</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Clark, Richard E" sort="Clark, Richard E" uniqKey="Clark R" first="Richard E." last="Clark">Richard E. Clark</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Royal Liverpool University Hospital</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Royal Liverpool University Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Universitätsklinikum Jena</s1>
<s2>Jena</s2>
<s3>DEU</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Jena</wicri:noRegion>
<wicri:noRegion>Universitätsklinikum Jena</wicri:noRegion>
<wicri:noRegion>Universitätsklinikum Jena</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hughes, Timothy P" sort="Hughes, Timothy P" uniqKey="Hughes T" first="Timothy P." last="Hughes">Timothy P. Hughes</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Royal Adelaide Hospital</s1>
<s2>Adelaide, SA</s2>
<s3>AUS</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Royal Adelaide Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gallagher, Neil" sort="Gallagher, Neil" uniqKey="Gallagher N" first="Neil" last="Gallagher">Neil Gallagher</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Novartis Pharma</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hoenekopp, Albert" sort="Hoenekopp, Albert" uniqKey="Hoenekopp A" first="Albert" last="Hoenekopp">Albert Hoenekopp</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Novartis Pharma</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mei Dong" sort="Mei Dong" uniqKey="Mei Dong" last="Mei Dong">MEI DONG</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, NJ</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Haque, Ariful" sort="Haque, Ariful" uniqKey="Haque A" first="Ariful" last="Haque">Ariful Haque</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, NJ</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Larson, Richard A" sort="Larson, Richard A" uniqKey="Larson R" first="Richard A." last="Larson">Richard A. Larson</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>University of Chicago</s1>
<s2>Chicago</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Chicago</settlement>
<region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
<affiliation wicri:level="3"><inist:fA14 i1="14"><s1>University of Texas M.D. Anderson Cancer Center</s1>
<s2>Houston</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">10-0317554</idno>
<date when="2010">2010</date>
<idno type="stanalyst">PASCAL 10-0317554 INIST</idno>
<idno type="RBID">Pascal:10-0317554</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">002579</idno>
<idno type="wicri:Area/PascalFrancis/Curation">003A07</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">002206</idno>
<idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">002206</idno>
<idno type="wicri:doubleKey">0028-4793:2010:Saglio G:nilotinib:versus:imatinib</idno>
<idno type="wicri:Area/Main/Merge">007C74</idno>
<idno type="wicri:Area/Main/Curation">007686</idno>
<idno type="wicri:Area/Main/Exploration">007686</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia</title>
<author><name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>University of Turin, San Luigi Gonzaga Hospital, Orbassano</s1>
<s2>Turin</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName><settlement type="city">Turin</settlement>
<region type="région" nuts="2">Piémont</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kim, Dong Wook" sort="Kim, Dong Wook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Seoul St. Mary's Hospital, Catholic University of Korea</s1>
<s2>Seoul</s2>
<s3>KOR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Corée du Sud</country>
<placeName><settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Issaragrisil, Surapol" sort="Issaragrisil, Surapol" uniqKey="Issaragrisil S" first="Surapol" last="Issaragrisil">Surapol Issaragrisil</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Siriraj Hospital, Mahidol University</s1>
<s2>Bangkok</s2>
<s3>THA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Thaïlande</country>
<wicri:noRegion>Bangkok</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Le Coutre, Philipp" sort="Le Coutre, Philipp" uniqKey="Le Coutre P" first="Philipp" last="Le Coutre">Philipp Le Coutre</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Charité, Campus Virchow, Universitätsmedizin Berlin</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Etienne, Gabriel" sort="Etienne, Gabriel" uniqKey="Etienne G" first="Gabriel" last="Etienne">Gabriel Etienne</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Institut Bergonié</s1>
<s2>Bordeaux</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lobo, Clarisse" sort="Lobo, Clarisse" uniqKey="Lobo C" first="Clarisse" last="Lobo">Clarisse Lobo</name>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti</s1>
<s2>Rio de Janeiro</s2>
<s3>BRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Brésil</country>
<placeName><settlement type="city">Rio de Janeiro</settlement>
<region type="state">État de Rio de Janeiro</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pasquini, Ricardo" sort="Pasquini, Ricardo" uniqKey="Pasquini R" first="Ricardo" last="Pasquini">Ricardo Pasquini</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Universidade Federal do Paraná</s1>
<s2>Curitiba, Paraná</s2>
<s3>BRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Brésil</country>
<wicri:noRegion>Universidade Federal do Paraná</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Clark, Richard E" sort="Clark, Richard E" uniqKey="Clark R" first="Richard E." last="Clark">Richard E. Clark</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Royal Liverpool University Hospital</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Royal Liverpool University Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Universitätsklinikum Jena</s1>
<s2>Jena</s2>
<s3>DEU</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Jena</wicri:noRegion>
<wicri:noRegion>Universitätsklinikum Jena</wicri:noRegion>
<wicri:noRegion>Universitätsklinikum Jena</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hughes, Timothy P" sort="Hughes, Timothy P" uniqKey="Hughes T" first="Timothy P." last="Hughes">Timothy P. Hughes</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Royal Adelaide Hospital</s1>
<s2>Adelaide, SA</s2>
<s3>AUS</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Royal Adelaide Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gallagher, Neil" sort="Gallagher, Neil" uniqKey="Gallagher N" first="Neil" last="Gallagher">Neil Gallagher</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Novartis Pharma</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hoenekopp, Albert" sort="Hoenekopp, Albert" uniqKey="Hoenekopp A" first="Albert" last="Hoenekopp">Albert Hoenekopp</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Novartis Pharma</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mei Dong" sort="Mei Dong" uniqKey="Mei Dong" last="Mei Dong">MEI DONG</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, NJ</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Haque, Ariful" sort="Haque, Ariful" uniqKey="Haque A" first="Ariful" last="Haque">Ariful Haque</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, NJ</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Larson, Richard A" sort="Larson, Richard A" uniqKey="Larson R" first="Richard A." last="Larson">Richard A. Larson</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>University of Chicago</s1>
<s2>Chicago</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Chicago</settlement>
<region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
<affiliation wicri:level="3"><inist:fA14 i1="14"><s1>University of Texas M.D. Anderson Cancer Center</s1>
<s2>Houston</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
</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="2010">2010</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 myelogenous leukemia</term>
<term>Comparative study</term>
<term>Early stage</term>
<term>Enzyme inhibitor</term>
<term>Imatinib</term>
<term>Medicine</term>
<term>Nilotinib</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Nilotinib</term>
<term>Etude comparative</term>
<term>Inhibiteur enzyme</term>
<term>Imatinib</term>
<term>Stade précoce</term>
<term>Médecine</term>
<term>Leucémie myéloïde chronique</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 Nilotinib has been shown to be a more potent inhibitor of BCR-ABL than imatinib. We evaluated the efficacy and safety of nilotinib, as compared with imatinib, in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase. METHODS In this phase 3, randomized, open-label, multicenter study, we assigned 846 patients with chronic-phase Philadelphia chromosome-positive CML in a 1:1:1 ratio to receive nilotinib (at a dose of either 300 mg or 400 mg twice daily) or imatinib (at a dose of 400 mg once daily). The primary end point was the rate of major molecular response at 12 months. RESULTS At 12 months, the rates of major molecular response for nilotinib (44% for the 300-mg dose and 43% for the 400-mg dose) were nearly twice that for imatinib (22%) (P<0.001 for both comparisons). The rates of complete cytogenetic response by 12 months were significantly higher for nilotinib (80% for the 300-mg dose and 78% for the 400-mg dose) than for imatinib (65%) (P<0.001 for both comparisons). Patients receiving either the 300-mg dose or the 400-mg dose of nilotinib twice daily had a significant improvement in the time to progression to the accelerated phase or blast crisis, as compared with those receiving imatinib (P=0.01 and P=0.004, respectively). No patient with progression to the accelerated phase or blast crisis had a major molecular response. Gastrointestinal and fluid-retention events were more frequent among patients receiving imatinib, whereas dermatologic events and headache were more frequent in those receiving nilotinib. Discontinuations due to aminotransferase and bilirubin elevations were low in all three study groups. CONCLUSIONS Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome-positive CML.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Brésil</li>
<li>Corée du Sud</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>Thaïlande</li>
<li>États-Unis</li>
</country>
<region><li>Aquitaine</li>
<li>Berlin</li>
<li>Illinois</li>
<li>Nouvelle-Aquitaine</li>
<li>Piémont</li>
<li>Région capitale de Séoul</li>
<li>Texas</li>
<li>État de Rio de Janeiro</li>
</region>
<settlement><li>Berlin</li>
<li>Bordeaux</li>
<li>Chicago</li>
<li>Houston</li>
<li>Rio de Janeiro</li>
<li>Séoul</li>
<li>Turin</li>
</settlement>
</list>
<tree><country name="Italie"><region name="Piémont"><name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
</region>
</country>
<country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Kim, Dong Wook" sort="Kim, Dong Wook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name>
</region>
</country>
<country name="Thaïlande"><noRegion><name sortKey="Issaragrisil, Surapol" sort="Issaragrisil, Surapol" uniqKey="Issaragrisil S" first="Surapol" last="Issaragrisil">Surapol Issaragrisil</name>
</noRegion>
</country>
<country name="Allemagne"><region name="Berlin"><name sortKey="Le Coutre, Philipp" sort="Le Coutre, Philipp" uniqKey="Le Coutre P" first="Philipp" last="Le Coutre">Philipp Le Coutre</name>
</region>
<name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name>
</country>
<country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Etienne, Gabriel" sort="Etienne, Gabriel" uniqKey="Etienne G" first="Gabriel" last="Etienne">Gabriel Etienne</name>
</region>
</country>
<country name="Brésil"><region name="État de Rio de Janeiro"><name sortKey="Lobo, Clarisse" sort="Lobo, Clarisse" uniqKey="Lobo C" first="Clarisse" last="Lobo">Clarisse Lobo</name>
</region>
<name sortKey="Pasquini, Ricardo" sort="Pasquini, Ricardo" uniqKey="Pasquini R" first="Ricardo" last="Pasquini">Ricardo Pasquini</name>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Clark, Richard E" sort="Clark, Richard E" uniqKey="Clark R" first="Richard E." last="Clark">Richard E. Clark</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Hughes, Timothy P" sort="Hughes, Timothy P" uniqKey="Hughes T" first="Timothy P." last="Hughes">Timothy P. Hughes</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Gallagher, Neil" sort="Gallagher, Neil" uniqKey="Gallagher N" first="Neil" last="Gallagher">Neil Gallagher</name>
</noRegion>
<name sortKey="Hoenekopp, Albert" sort="Hoenekopp, Albert" uniqKey="Hoenekopp A" first="Albert" last="Hoenekopp">Albert Hoenekopp</name>
</country>
<country name="États-Unis"><noRegion><name sortKey="Mei Dong" sort="Mei Dong" uniqKey="Mei Dong" last="Mei Dong">MEI DONG</name>
</noRegion>
<name sortKey="Haque, Ariful" sort="Haque, Ariful" uniqKey="Haque A" first="Ariful" last="Haque">Ariful Haque</name>
<name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
<name sortKey="Larson, Richard A" sort="Larson, Richard A" uniqKey="Larson R" first="Richard A." last="Larson">Richard A. Larson</name>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 007686 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 007686 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     Pascal:10-0317554
   |texte=   Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia
}}

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024

	Serveur d'exploration sur les relations entre la France et l'Australie
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur les relations entre la France et l'Australie

Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri