Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib : a randomized phase 2 trial. Commentary
Identifieur interne : 009650 ( Main/Exploration ); précédent : 009649; suivant : 009651Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib : a randomized phase 2 trial. Commentary
Auteurs : Charles A. Schiffer [États-Unis] ; Hagop Kantarjian [États-Unis] ; Ricardo Pasquini [Brésil] ; Nelson Hamerschlak [Brésil] ; Philippe Rousselot [France] ; Jerzy Holowiecki [Pologne] ; Saengsuree Jootar [Thaïlande] ; Tadeusz Robak [Pologne] ; Nina Khoroshko [Russie] ; Tamas Masszi [Hongrie] ; Aleksander Skotnicki [Pologne] ; Andrzej Hellmann [Pologne] ; Andrey Zaritsky [Russie] ; Anatoly Golenkov [Russie] ; Jerald Radich [États-Unis] ; Timothy Hughes [Australie] ; Athena Countouriotis [États-Unis] ; Neil Shah [États-Unis]Source :
- Blood [ 0006-4971 ] ; 2007.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Therapeutic options for chronic myelogenous leukemia (CML) resistant to 400 to 600 mg imatinib are limited. Escalating imatinib doses may overcome resistance. Dasatinib, a significantly more potent inhibitor of BCR-ABL, is safe and effective in this population. Patients with imatinib-resistant chronic-phase (CP) CML were randomized 2:1 to 140 mg dasatinib (n = 101) or 800 mg imatinib (n = 49). With a median follow up of 15 months, complete hematologic responses were observed in 93% and 82% of patients receiving dasatinib and high-dose imatinib (P = .034), respectively. Dasatinib resulted in higher major cytogenetic response rates (52%) than high-dose imatinib (33%) (P = .023); this included complete cytogenetic response in 40% and 16% (P = .004). Major molecular responses were also more frequent with dasatinib (16% versus 4%; P = 0.038). Treatment failure (hazard ratio [HR], 0.16; P <.001) and progression-free survival (HR, 0.14; P <.001) both favored dasatinib. Superficial edema (42% versus 15%) and fluid retention (45% versus 30%) were more prevalent with imatinib; pleural effusion was more common with dasatinib (17% versus 0%). Grade 3 to 4 nonhematologic toxicity was minimal. Cytopenias were more frequent and severe with dasatinib. Dasatinib represents a safe and effective therapy for CP-CML resistant to conventional imatinib doses with improved cytogenetic and molecular response rates and progression-free survival relative to high-dose imatinib.
Affiliations:
- Australie, Brésil, France, Hongrie, Pologne, Russie, Thaïlande, États-Unis
- District fédéral central, Hongrie centrale, État de São Paulo, Île-de-France
- Budapest, Moscou, Paris, São Paulo
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib : a randomized phase 2 trial. Commentary</title><author><name sortKey="Schiffer, Charles A" sort="Schiffer, Charles A" uniqKey="Schiffer C" first="Charles A." last="Schiffer">Charles A. Schiffer</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>KARMANOS CANCER INSTITUTE</s1><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>KARMANOS CANCER INSTITUTE</wicri:noRegion></affiliation></author><author><name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>M. D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>M. D. Anderson Cancer Center</wicri:noRegion></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="03"><s1>Hospital De Clinicas De Curitiba</s1><s2>Curitiba, Parana</s2><s3>BRA</s3><sZ>3 aut.</sZ></inist:fA14><country>Brésil</country><wicri:noRegion>Hospital De Clinicas De Curitiba</wicri:noRegion></affiliation></author><author><name sortKey="Hamerschlak, Nelson" sort="Hamerschlak, Nelson" uniqKey="Hamerschlak N" first="Nelson" last="Hamerschlak">Nelson Hamerschlak</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hospital Israelita Albert Einstein</s1><s2>Sao Paulo</s2><s3>BRA</s3><sZ>4 aut.</sZ></inist:fA14><country>Brésil</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Rousselot, Philippe" sort="Rousselot, Philippe" uniqKey="Rousselot P" first="Philippe" last="Rousselot">Philippe Rousselot</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Hospital Saint Louis</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Holowiecki, Jerzy" sort="Holowiecki, Jerzy" uniqKey="Holowiecki J" first="Jerzy" last="Holowiecki">Jerzy Holowiecki</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Katedra I Klinika Hematologii I Transplantacji Szpiku</s1><s2>Katowice</s2><s3>POL</s3><sZ>6 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Katedra I Klinika Hematologii I Transplantacji Szpiku</wicri:noRegion></affiliation></author><author><name sortKey="Jootar, Saengsuree" sort="Jootar, Saengsuree" uniqKey="Jootar S" first="Saengsuree" last="Jootar">Saengsuree Jootar</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Ramathibodi Hospital</s1><s2>Bangkok</s2><s3>THA</s3><sZ>7 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Ramathibodi Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Szpital Specjalistyczny Im. Kopernika Klinika Hematologii</s1><s2>Lodz</s2><s3>POL</s3><sZ>8 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Szpital Specjalistyczny Im. Kopernika Klinika Hematologii</wicri:noRegion></affiliation></author><author><name sortKey="Khoroshko, Nina" sort="Khoroshko, Nina" uniqKey="Khoroshko N" first="Nina" last="Khoroshko">Nina Khoroshko</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>National Research Hematology Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>National Medical Center</s1><s2>Budapest</s2><s3>HUN</s3><sZ>10 aut.</sZ></inist:fA14><country>Hongrie</country><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></affiliation></author><author><name sortKey="Skotnicki, Aleksander" sort="Skotnicki, Aleksander" uniqKey="Skotnicki A" first="Aleksander" last="Skotnicki">Aleksander Skotnicki</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Collegium Medicum Uniwesytetu Jagiellonskiego</s1><s2>Krakow</s2><s3>POL</s3><sZ>11 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Collegium Medicum Uniwesytetu Jagiellonskiego</wicri:noRegion></affiliation></author><author><name sortKey="Hellmann, Andrzej" sort="Hellmann, Andrzej" uniqKey="Hellmann A" first="Andrzej" last="Hellmann">Andrzej Hellmann</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Klinika Hematologii, Akademia Medyczna</s1><s2>Gdansk</s2><s3>POL</s3><sZ>12 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Gdansk</wicri:noRegion></affiliation></author><author><name sortKey="Zaritsky, Andrey" sort="Zaritsky, Andrey" uniqKey="Zaritsky A" first="Andrey" last="Zaritsky">Andrey Zaritsky</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>St Petersburg State Medical University</s1><s2>St Petersburg</s2><s3>RUS</s3><sZ>13 aut.</sZ></inist:fA14><country>Russie</country><wicri:noRegion>St Petersburg State Medical University</wicri:noRegion></affiliation></author><author><name sortKey="Golenkov, Anatoly" sort="Golenkov, Anatoly" uniqKey="Golenkov A" first="Anatoly" last="Golenkov">Anatoly Golenkov</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Moscow Region Research Clinical Institute</s1><s2>Moscow</s2><s3>RUS</s3><sZ>14 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Radich, Jerald" sort="Radich, Jerald" uniqKey="Radich J" first="Jerald" last="Radich">Jerald Radich</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Clinical Research Division, Fred Hutchinson Cancer Research Center</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Seattle, WA</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Division of Hematology, Institute of Medical and Veterinary Science</s1><s2>Adelaide</s2><s3>AUS</s3><sZ>16 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide</wicri:noRegion></affiliation></author><author><name sortKey="Countouriotis, Athena" sort="Countouriotis, Athena" uniqKey="Countouriotis A" first="Athena" last="Countouriotis">Athena Countouriotis</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Bristol-Myers Squibb</s1><s2>Wallingford, CT</s2><s3>USA</s3><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb</wicri:noRegion></affiliation></author><author><name sortKey="Shah, Neil" sort="Shah, Neil" uniqKey="Shah N" first="Neil" last="Shah">Neil Shah</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Division of Hematology and Oncology, University College of San Francisco School of Medicine</s1><s2>San Francisco, CA</s2><s3>USA</s3><sZ>18 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>San Francisco, CA</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">07-0397572</idno><date when="2007">2007</date><idno type="stanalyst">PASCAL 07-0397572 INIST</idno><idno type="RBID">Pascal:07-0397572</idno><idno type="wicri:Area/PascalFrancis/Corpus">003A17</idno><idno type="wicri:Area/PascalFrancis/Curation">002671</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">003977</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">003977</idno><idno type="wicri:doubleKey">0006-4971:2007:Schiffer C:dasatinib:or:high</idno><idno type="wicri:Area/Main/Merge">00A089</idno><idno type="wicri:Area/Main/Curation">009650</idno><idno type="wicri:Area/Main/Exploration">009650</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib : a randomized phase 2 trial. Commentary</title><author><name sortKey="Schiffer, Charles A" sort="Schiffer, Charles A" uniqKey="Schiffer C" first="Charles A." last="Schiffer">Charles A. Schiffer</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>KARMANOS CANCER INSTITUTE</s1><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>KARMANOS CANCER INSTITUTE</wicri:noRegion></affiliation></author><author><name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>M. D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>M. D. Anderson Cancer Center</wicri:noRegion></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="03"><s1>Hospital De Clinicas De Curitiba</s1><s2>Curitiba, Parana</s2><s3>BRA</s3><sZ>3 aut.</sZ></inist:fA14><country>Brésil</country><wicri:noRegion>Hospital De Clinicas De Curitiba</wicri:noRegion></affiliation></author><author><name sortKey="Hamerschlak, Nelson" sort="Hamerschlak, Nelson" uniqKey="Hamerschlak N" first="Nelson" last="Hamerschlak">Nelson Hamerschlak</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hospital Israelita Albert Einstein</s1><s2>Sao Paulo</s2><s3>BRA</s3><sZ>4 aut.</sZ></inist:fA14><country>Brésil</country><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Rousselot, Philippe" sort="Rousselot, Philippe" uniqKey="Rousselot P" first="Philippe" last="Rousselot">Philippe Rousselot</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Hospital Saint Louis</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Holowiecki, Jerzy" sort="Holowiecki, Jerzy" uniqKey="Holowiecki J" first="Jerzy" last="Holowiecki">Jerzy Holowiecki</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Katedra I Klinika Hematologii I Transplantacji Szpiku</s1><s2>Katowice</s2><s3>POL</s3><sZ>6 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Katedra I Klinika Hematologii I Transplantacji Szpiku</wicri:noRegion></affiliation></author><author><name sortKey="Jootar, Saengsuree" sort="Jootar, Saengsuree" uniqKey="Jootar S" first="Saengsuree" last="Jootar">Saengsuree Jootar</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Ramathibodi Hospital</s1><s2>Bangkok</s2><s3>THA</s3><sZ>7 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Ramathibodi Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Szpital Specjalistyczny Im. Kopernika Klinika Hematologii</s1><s2>Lodz</s2><s3>POL</s3><sZ>8 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Szpital Specjalistyczny Im. Kopernika Klinika Hematologii</wicri:noRegion></affiliation></author><author><name sortKey="Khoroshko, Nina" sort="Khoroshko, Nina" uniqKey="Khoroshko N" first="Nina" last="Khoroshko">Nina Khoroshko</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>National Research Hematology Center</s1><s2>Moscow</s2><s3>RUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>National Medical Center</s1><s2>Budapest</s2><s3>HUN</s3><sZ>10 aut.</sZ></inist:fA14><country>Hongrie</country><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></affiliation></author><author><name sortKey="Skotnicki, Aleksander" sort="Skotnicki, Aleksander" uniqKey="Skotnicki A" first="Aleksander" last="Skotnicki">Aleksander Skotnicki</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Collegium Medicum Uniwesytetu Jagiellonskiego</s1><s2>Krakow</s2><s3>POL</s3><sZ>11 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Collegium Medicum Uniwesytetu Jagiellonskiego</wicri:noRegion></affiliation></author><author><name sortKey="Hellmann, Andrzej" sort="Hellmann, Andrzej" uniqKey="Hellmann A" first="Andrzej" last="Hellmann">Andrzej Hellmann</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Klinika Hematologii, Akademia Medyczna</s1><s2>Gdansk</s2><s3>POL</s3><sZ>12 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>Gdansk</wicri:noRegion></affiliation></author><author><name sortKey="Zaritsky, Andrey" sort="Zaritsky, Andrey" uniqKey="Zaritsky A" first="Andrey" last="Zaritsky">Andrey Zaritsky</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>St Petersburg State Medical University</s1><s2>St Petersburg</s2><s3>RUS</s3><sZ>13 aut.</sZ></inist:fA14><country>Russie</country><wicri:noRegion>St Petersburg State Medical University</wicri:noRegion></affiliation></author><author><name sortKey="Golenkov, Anatoly" sort="Golenkov, Anatoly" uniqKey="Golenkov A" first="Anatoly" last="Golenkov">Anatoly Golenkov</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Moscow Region Research Clinical Institute</s1><s2>Moscow</s2><s3>RUS</s3><sZ>14 aut.</sZ></inist:fA14><country>Russie</country><placeName><settlement type="city">Moscou</settlement><region>District fédéral central</region></placeName></affiliation></author><author><name sortKey="Radich, Jerald" sort="Radich, Jerald" uniqKey="Radich J" first="Jerald" last="Radich">Jerald Radich</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Clinical Research Division, Fred Hutchinson Cancer Research Center</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Seattle, WA</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Division of Hematology, Institute of Medical and Veterinary Science</s1><s2>Adelaide</s2><s3>AUS</s3><sZ>16 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide</wicri:noRegion></affiliation></author><author><name sortKey="Countouriotis, Athena" sort="Countouriotis, Athena" uniqKey="Countouriotis A" first="Athena" last="Countouriotis">Athena Countouriotis</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Bristol-Myers Squibb</s1><s2>Wallingford, CT</s2><s3>USA</s3><sZ>17 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Bristol-Myers Squibb</wicri:noRegion></affiliation></author><author><name sortKey="Shah, Neil" sort="Shah, Neil" uniqKey="Shah N" first="Neil" last="Shah">Neil Shah</name><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Division of Hematology and Oncology, University College of San Francisco School of Medicine</s1><s2>San Francisco, CA</s2><s3>USA</s3><sZ>18 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>San Francisco, CA</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Blood</title><title level="j" type="abbreviated">Blood</title><idno type="ISSN">0006-4971</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Blood</title><title level="j" type="abbreviated">Blood</title><idno type="ISSN">0006-4971</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Chronic myelocytic leukemia</term><term>Clinical trial</term><term>Enzyme inhibitor</term><term>First line treatment</term><term>Hematology</term><term>High dose</term><term>Imatinib</term><term>Phase II trial</term><term>Protein-tyrosine kinase</term><term>Randomization</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Imatinib</term><term>Anticancéreux</term><term>Dose forte</term><term>Protein-tyrosine kinase</term><term>Inhibiteur enzyme</term><term>Essai clinique phase II</term><term>Essai clinique</term><term>Randomisation</term><term>Hématologie</term><term>Dasatinib</term><term>Leucémie myéloïde chronique</term><term>Traitement première intention</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Therapeutic options for chronic myelogenous leukemia (CML) resistant to 400 to 600 mg imatinib are limited. Escalating imatinib doses may overcome resistance. Dasatinib, a significantly more potent inhibitor of BCR-ABL, is safe and effective in this population. Patients with imatinib-resistant chronic-phase (CP) CML were randomized 2:1 to 140 mg dasatinib (n = 101) or 800 mg imatinib (n = 49). With a median follow up of 15 months, complete hematologic responses were observed in 93% and 82% of patients receiving dasatinib and high-dose imatinib (P = .034), respectively. Dasatinib resulted in higher major cytogenetic response rates (52%) than high-dose imatinib (33%) (P = .023); this included complete cytogenetic response in 40% and 16% (P = .004). Major molecular responses were also more frequent with dasatinib (16% versus 4%; P = 0.038). Treatment failure (hazard ratio [HR], 0.16; P <.001) and progression-free survival (HR, 0.14; P <.001) both favored dasatinib. Superficial edema (42% versus 15%) and fluid retention (45% versus 30%) were more prevalent with imatinib; pleural effusion was more common with dasatinib (17% versus 0%). Grade 3 to 4 nonhematologic toxicity was minimal. Cytopenias were more frequent and severe with dasatinib. Dasatinib represents a safe and effective therapy for CP-CML resistant to conventional imatinib doses with improved cytogenetic and molecular response rates and progression-free survival relative to high-dose imatinib.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Brésil</li><li>France</li><li>Hongrie</li><li>Pologne</li><li>Russie</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>District fédéral central</li><li>Hongrie centrale</li><li>État de São Paulo</li><li>Île-de-France</li></region><settlement><li>Budapest</li><li>Moscou</li><li>Paris</li><li>São Paulo</li></settlement></list><tree><country name="États-Unis"><noRegion><name sortKey="Schiffer, Charles A" sort="Schiffer, Charles A" uniqKey="Schiffer C" first="Charles A." last="Schiffer">Charles A. Schiffer</name></noRegion><name sortKey="Countouriotis, Athena" sort="Countouriotis, Athena" uniqKey="Countouriotis A" first="Athena" last="Countouriotis">Athena Countouriotis</name><name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name><name sortKey="Radich, Jerald" sort="Radich, Jerald" uniqKey="Radich J" first="Jerald" last="Radich">Jerald Radich</name><name sortKey="Shah, Neil" sort="Shah, Neil" uniqKey="Shah N" first="Neil" last="Shah">Neil Shah</name></country><country name="Brésil"><noRegion><name sortKey="Pasquini, Ricardo" sort="Pasquini, Ricardo" uniqKey="Pasquini R" first="Ricardo" last="Pasquini">Ricardo Pasquini</name></noRegion><name sortKey="Hamerschlak, Nelson" sort="Hamerschlak, Nelson" uniqKey="Hamerschlak N" first="Nelson" last="Hamerschlak">Nelson Hamerschlak</name></country><country name="France"><region name="Île-de-France"><name sortKey="Rousselot, Philippe" sort="Rousselot, Philippe" uniqKey="Rousselot P" first="Philippe" last="Rousselot">Philippe Rousselot</name></region></country><country name="Pologne"><noRegion><name sortKey="Holowiecki, Jerzy" sort="Holowiecki, Jerzy" uniqKey="Holowiecki J" first="Jerzy" last="Holowiecki">Jerzy Holowiecki</name></noRegion><name sortKey="Hellmann, Andrzej" sort="Hellmann, Andrzej" uniqKey="Hellmann A" first="Andrzej" last="Hellmann">Andrzej Hellmann</name><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><name sortKey="Skotnicki, Aleksander" sort="Skotnicki, Aleksander" uniqKey="Skotnicki A" first="Aleksander" last="Skotnicki">Aleksander Skotnicki</name></country><country name="Thaïlande"><noRegion><name sortKey="Jootar, Saengsuree" sort="Jootar, Saengsuree" uniqKey="Jootar S" first="Saengsuree" last="Jootar">Saengsuree Jootar</name></noRegion></country><country name="Russie"><region name="District fédéral central"><name sortKey="Khoroshko, Nina" sort="Khoroshko, Nina" uniqKey="Khoroshko N" first="Nina" last="Khoroshko">Nina Khoroshko</name></region><name sortKey="Golenkov, Anatoly" sort="Golenkov, Anatoly" uniqKey="Golenkov A" first="Anatoly" last="Golenkov">Anatoly Golenkov</name><name sortKey="Zaritsky, Andrey" sort="Zaritsky, Andrey" uniqKey="Zaritsky A" first="Andrey" last="Zaritsky">Andrey Zaritsky</name></country><country name="Hongrie"><region name="Hongrie centrale"><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name></region></country><country name="Australie"><noRegion><name sortKey="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib : a randomized phase 2 trial. Commentary
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