Dasatinib or High-Dose Imatinib for Chronic-Phase Chronic Myeloid Leukemia Resistant to Imatinib at a Dose of 400 to 600 Milligrams Daily: Two-Year Follow-Up of a Randomized Phase 2 Study (START-R)
Identifieur interne : 008B88 ( Main/Merge ); précédent : 008B87; suivant : 008B89Dasatinib or High-Dose Imatinib for Chronic-Phase Chronic Myeloid Leukemia Resistant to Imatinib at a Dose of 400 to 600 Milligrams Daily: Two-Year Follow-Up of a Randomized Phase 2 Study (START-R)
Auteurs : Hagop Kantarjian [États-Unis] ; Ricardo Pasquini [Brésil] ; Vincent Levy [France] ; Saengsuree Jootar [Thaïlande] ; Jerzy Holowiecki [Pologne] ; Nelson Hamerschlak [Brésil] ; Timothy Hughes [Australie] ; Eric Bleickardt [États-Unis] ; David Dejardin [États-Unis] ; Jorge Cortes [États-Unis] ; Neil P. Shah [États-Unis]Source :
- Cancer [ 0008-543X ] ; 2009.
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Abstract
BACKGROUND: In patients with chronic-phase chronic myeloid leukemia (CP-CML), imatinib resistance is of increasing importance. Imatinib dose escalation was the main treatment option before dasatinib, which has 325-fold more potent inhibition than imatinib against unmutated Bcr-Abl in vitro. Data with a minimum of 2 years of follow-up were available for the current study of dasatinib and high-dose imatinib in CP-CML resistant to imatinib at daily doses from 400 mg to 600 mg. METHODS: A phase 2, open-label study was initiated of 150 patients with imatinib-resistant CP-CML who were randomized (2:1) to receive either dasatinib 70 mg twice daily (n = 101) or high-dose imatinib 800 mg (400 mg twice daily; n = 49). RESULTS: At a minimum follow-up of 2 years, dasatinib demonstrated higher rates of complete hematologic response (93% vs 82%; P = .034), major cytogenetic response (MCyR) (53% vs 33%; P=.017), and complete cytogenetic response (44% vs 18%; P =.0025). At 18 months, the MCyR was maintained in 90% of patients on the dasatinib arm and in 74% of patients on the high-dose imatinib arm. Major molecular response rates also were more frequent with dasatinib than with high-dose imatinib (29% vs 12%; P = .028). The estimated progression-free survival also favored dasatinib (unstratified log-rank test; P =.0012). CONCLUSIONS: After 2 years of follow-up, dasatinib demonstrated durable responses and improved response and progression-free survival rates relative to high-dose imatinib.
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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 Resistant to Imatinib at a Dose of 400 to 600 Milligrams Daily: Two-Year Follow-Up of a Randomized Phase 2 Study (START-R)</title><author><name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Leukemia, The University of Texas M. D. Anderson Cancer Center</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</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="02"><s1>Hospital De Clinicas De Curitiba</s1><s2>Parana</s2><s3>BRA</s3><sZ>2 aut.</sZ></inist:fA14><country>Brésil</country><wicri:noRegion>Hospital De Clinicas De Curitiba</wicri:noRegion></affiliation></author><author><name sortKey="Levy, Vincent" sort="Levy, Vincent" uniqKey="Levy V" first="Vincent" last="Levy">Vincent Levy</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Clinical Investigation Center, AP-HP, INSERM U9504, Hôpital Saint-Louis</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 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="Jootar, Saengsuree" sort="Jootar, Saengsuree" uniqKey="Jootar S" first="Saengsuree" last="Jootar">Saengsuree Jootar</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Ramathibodi Hospital, Mahidol University</s1><s2>Bangkok</s2><s3>THA</s3><sZ>4 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Bangkok</wicri:noRegion></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="05"><s1>University Hospital-SPSKM</s1><s2>Katowice</s2><s3>POL</s3><sZ>5 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>University Hospital-SPSKM</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="06"><s1>Hospital Israelita Albert Einstein</s1><s2>Sao Paulo</s2><s3>BRA</s3><sZ>6 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="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Division of Hematology, Institute of Medical and Veterinary Science</s1><s2>Adelaide, South Australia</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide, South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Bleickardt, Eric" sort="Bleickardt, Eric" uniqKey="Bleickardt E" first="Eric" last="Bleickardt">Eric Bleickardt</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Bristol-Myers Squibb</s1><s2>Wallingford, Connecticut</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Dejardin, David" sort="Dejardin, David" uniqKey="Dejardin D" first="David" last="Dejardin">David Dejardin</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Bristol-Myers Squibb</s1><s2>Wallingford, Connecticut</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Leukemia, The University of Texas M. D. Anderson Cancer Center</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Shah, Neil P" sort="Shah, Neil P" uniqKey="Shah N" first="Neil P." last="Shah">Neil P. Shah</name><affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Division of Hematology and Oncology, University of California at San Francisco School of Medicine</s1><s2>San Francisco, California</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">09-0402349</idno><date when="2009">2009</date><idno type="stanalyst">PASCAL 09-0402349 INIST</idno><idno type="RBID">Pascal:09-0402349</idno><idno type="wicri:Area/PascalFrancis/Corpus">002B58</idno><idno type="wicri:Area/PascalFrancis/Curation">003465</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">002C19</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">002C19</idno><idno type="wicri:doubleKey">0008-543X:2009:Kantarjian H:dasatinib:or:high</idno><idno type="wicri:Area/Main/Merge">008B88</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Dasatinib or High-Dose Imatinib for Chronic-Phase Chronic Myeloid Leukemia Resistant to Imatinib at a Dose of 400 to 600 Milligrams Daily: Two-Year Follow-Up of a Randomized Phase 2 Study (START-R)</title><author><name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Leukemia, The University of Texas M. D. Anderson Cancer Center</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</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="02"><s1>Hospital De Clinicas De Curitiba</s1><s2>Parana</s2><s3>BRA</s3><sZ>2 aut.</sZ></inist:fA14><country>Brésil</country><wicri:noRegion>Hospital De Clinicas De Curitiba</wicri:noRegion></affiliation></author><author><name sortKey="Levy, Vincent" sort="Levy, Vincent" uniqKey="Levy V" first="Vincent" last="Levy">Vincent Levy</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Clinical Investigation Center, AP-HP, INSERM U9504, Hôpital Saint-Louis</s1><s2>Paris</s2><s3>FRA</s3><sZ>3 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="Jootar, Saengsuree" sort="Jootar, Saengsuree" uniqKey="Jootar S" first="Saengsuree" last="Jootar">Saengsuree Jootar</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Ramathibodi Hospital, Mahidol University</s1><s2>Bangkok</s2><s3>THA</s3><sZ>4 aut.</sZ></inist:fA14><country>Thaïlande</country><wicri:noRegion>Bangkok</wicri:noRegion></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="05"><s1>University Hospital-SPSKM</s1><s2>Katowice</s2><s3>POL</s3><sZ>5 aut.</sZ></inist:fA14><country>Pologne</country><wicri:noRegion>University Hospital-SPSKM</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="06"><s1>Hospital Israelita Albert Einstein</s1><s2>Sao Paulo</s2><s3>BRA</s3><sZ>6 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="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Division of Hematology, Institute of Medical and Veterinary Science</s1><s2>Adelaide, South Australia</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide, South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Bleickardt, Eric" sort="Bleickardt, Eric" uniqKey="Bleickardt E" first="Eric" last="Bleickardt">Eric Bleickardt</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Bristol-Myers Squibb</s1><s2>Wallingford, Connecticut</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Dejardin, David" sort="Dejardin, David" uniqKey="Dejardin D" first="David" last="Dejardin">David Dejardin</name><affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Bristol-Myers Squibb</s1><s2>Wallingford, Connecticut</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Leukemia, The University of Texas M. D. Anderson Cancer Center</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Shah, Neil P" sort="Shah, Neil P" uniqKey="Shah N" first="Neil P." last="Shah">Neil P. Shah</name><affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Division of Hematology and Oncology, University of California at San Francisco School of Medicine</s1><s2>San Francisco, California</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Cancer</title><title level="j" type="abbreviated">Cancer</title><idno type="ISSN">0008-543X</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Cancer</title><title level="j" type="abbreviated">Cancer</title><idno type="ISSN">0008-543X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Cancerology</term><term>Chronic myelogenous leukemia</term><term>Dasatinib</term><term>Enzyme inhibitor</term><term>Follow up study</term><term>High dose</term><term>Imatinib</term><term>Phase II trial</term><term>Protein-tyrosine kinase</term><term>Randomization</term><term>Treatment resistance</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Dasatinib</term><term>Anticancéreux</term><term>Dose forte</term><term>Imatinib</term><term>Protein-tyrosine kinase</term><term>Inhibiteur enzyme</term><term>Essai clinique phase II</term><term>Leucémie myéloïde chronique</term><term>Résistance traitement</term><term>Etude longitudinale</term><term>Randomisation</term><term>Cancérologie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: In patients with chronic-phase chronic myeloid leukemia (CP-CML), imatinib resistance is of increasing importance. Imatinib dose escalation was the main treatment option before dasatinib, which has 325-fold more potent inhibition than imatinib against unmutated Bcr-Abl in vitro. Data with a minimum of 2 years of follow-up were available for the current study of dasatinib and high-dose imatinib in CP-CML resistant to imatinib at daily doses from 400 mg to 600 mg. METHODS: A phase 2, open-label study was initiated of 150 patients with imatinib-resistant CP-CML who were randomized (2:1) to receive either dasatinib 70 mg twice daily (n = 101) or high-dose imatinib 800 mg (400 mg twice daily; n = 49). RESULTS: At a minimum follow-up of 2 years, dasatinib demonstrated higher rates of complete hematologic response (93% vs 82%; P = .034), major cytogenetic response (MCyR) (53% vs 33%; P=.017), and complete cytogenetic response (44% vs 18%; P =.0025). At 18 months, the MCyR was maintained in 90% of patients on the dasatinib arm and in 74% of patients on the high-dose imatinib arm. Major molecular response rates also were more frequent with dasatinib than with high-dose imatinib (29% vs 12%; P = .028). The estimated progression-free survival also favored dasatinib (unstratified log-rank test; P =.0012). CONCLUSIONS: After 2 years of follow-up, dasatinib demonstrated durable responses and improved response and progression-free survival rates relative to high-dose imatinib.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Brésil</li><li>France</li><li>Pologne</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>Californie</li><li>Connecticut</li><li>Texas</li><li>État de São Paulo</li><li>Île-de-France</li></region><settlement><li>Paris</li><li>São Paulo</li></settlement></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name></region><name sortKey="Bleickardt, Eric" sort="Bleickardt, Eric" uniqKey="Bleickardt E" first="Eric" last="Bleickardt">Eric Bleickardt</name><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name><name sortKey="Dejardin, David" sort="Dejardin, David" uniqKey="Dejardin D" first="David" last="Dejardin">David Dejardin</name><name sortKey="Shah, Neil P" sort="Shah, Neil P" uniqKey="Shah N" first="Neil P." last="Shah">Neil P. 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="Levy, Vincent" sort="Levy, Vincent" uniqKey="Levy V" first="Vincent" last="Levy">Vincent Levy</name></region></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="Pologne"><noRegion><name sortKey="Holowiecki, Jerzy" sort="Holowiecki, Jerzy" uniqKey="Holowiecki J" first="Jerzy" last="Holowiecki">Jerzy Holowiecki</name></noRegion></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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