Long-term response to imatinib is not affected by the initial dose in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: final update from the Tyrosine Kinase Inhibitor Optimization and Selectivity (TOPS) study
Identifieur interne : 004071 ( Main/Exploration ); précédent : 004070; suivant : 004072Long-term response to imatinib is not affected by the initial dose in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: final update from the Tyrosine Kinase Inhibitor Optimization and Selectivity (TOPS) study
Auteurs : Michele Baccarani [Italie] ; Brian J. Druker [États-Unis] ; Susan Branford [Australie] ; Dong-Wook Kim [Corée du Sud] ; Fabrizio Pane [Italie] ; Lidia Mongay [États-Unis] ; Manisha Mone [États-Unis] ; Christine-Elke Ortmann [Suisse] ; Hagop M. Kantarjian [États-Unis] ; Jerald P. Radich [États-Unis] ; Timothy P. Hughes [Australie] ; Jorge E. Cortes [États-Unis] ; François Guilhot [France]Source :
- International journal of hematology [ 0925-5710 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Imatinib, Long terme, Dose, Homme, Leucémie myéloïde chronique, Essai clinique phase III, Chronique, Inhibiteur de la tyrosine kinase, Optimisation, Sélectivité, Gène hybride, Translocation chromosomique, Chromosome C9 anormal, Chromosome G22 anormal, Chromosome Ph1, Non-specific serine/threonine protein kinase, Gène onc cellulaire, Hématologie, Anticancéreux, Gène abl, Leucémie à chromosome Philadelphie positif, Gène bcr.
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Abnormal chromosome C9, Abnormal chromosome G22, Antineoplastic agent, C-Onc gene, Chromosome translocation, Chronic, Chronic myelogenous leukemia, Dose, Hematology, Human, Hybrid gene, Imatinib, Long term, Non-specific serine/threonine protein kinase, Optimization, Phase III trial, Philadelphia chromosome, Philadelphia positive leukemia, Selectivity, Tyrosine kinase inhibitor, bcr gene.
Abstract
The TOPS trial evaluated high- (800 mg/day; n = 319) versus standard-dose (400 mg/day; n = 157) imatinib in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Patients had a minimum follow-up of 42 months or discontinued early. Major molecular response (MMR) rates were similar between arms at (51.6 vs 50.2 % for 400 and 800 mg/day, respectively; P = 0.77) and by (75.8 vs 79.0 %; P = 0.4807) 42 months. There were no differences in event-free survival (EFS), progression-free survival (PFS), or overall survival (OS) between arms. The estimated rates of PFS on treatment and OS at 42 months were significantly higher in patients with MMR at 6, 12, and 18 months compared with those without MMR. Adverse events were more frequent with high-dose imatinib. Patients with ≤1 treatment interruption (vs >1) and those able to maintain imatinib ≥600 mg/day (vs <600 mg/day) in the first year of treatment had faster and higher response rates, but no improvement in EFS or PFS. Adherence to prescribed dose without interruption may be more important than initiation of therapy with higher doses of imatinib. Achievement of MMR correlated with long-term clinical outcomes.
Affiliations:
- Australie, Corée du Sud, France, Italie, Suisse, États-Unis
- Nouvelle-Aquitaine, Poitou-Charentes, Région capitale de Séoul
- Poitiers, Séoul
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Kantarjian</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>The University of Texas, MD Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author><author><name sortKey="Radich, Jerald P" sort="Radich, Jerald P" uniqKey="Radich J" first="Jerald P." last="Radich">Jerald P. Radich</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Fred Hutchinson Cancer Research Center</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Fred Hutchinson Cancer Research Center</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>Division of Haematology and Centre for Cancer Biology, SA Pathology, South Australian Health and Medical Research Institute, University of Adelaide</s1><s2>Adelaide</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide</wicri:noRegion></affiliation></author><author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>The University of Texas, MD Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author><author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Inserm CIC 1402, CHU de Poitiers</s1><s2>Poitiers</s2><s3>FRA</s3><sZ>13 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Poitou-Charentes</region><settlement type="city">Poitiers</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0188142</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0188142 INIST</idno><idno type="RBID">Pascal:14-0188142</idno><idno type="wicri:Area/PascalFrancis/Corpus">000320</idno><idno type="wicri:Area/PascalFrancis/Curation">005B42</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000208</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000208</idno><idno type="wicri:doubleKey">0925-5710:2014:Baccarani M:long:term:response</idno><idno type="wicri:Area/Main/Merge">004132</idno><idno type="wicri:Area/Main/Curation">004071</idno><idno type="wicri:Area/Main/Exploration">004071</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Long-term response to imatinib is not affected by the initial dose in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: final update from the Tyrosine Kinase Inhibitor Optimization and Selectivity (TOPS) study</title><author><name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Hematology and Oncology "L. e A. Seràgnoli," S.Orsola-Malpighi University Hospital, University of Bologna, Via Massarenti 9</s1><s2>40138 Bologna</s2><s3>ITA</s3><sZ>1 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>40138 Bologna</wicri:noRegion></affiliation></author><author><name sortKey="Druker, Brian J" sort="Druker, Brian J" uniqKey="Druker B" first="Brian J." last="Druker">Brian J. Druker</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Knight Cancer Institute, Oregon Health & Science University</s1><s2>Portland, OR</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Portland, OR</wicri:noRegion></affiliation></author><author><name sortKey="Branford, Susan" sort="Branford, Susan" uniqKey="Branford S" first="Susan" last="Branford">Susan Branford</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Centre for Cancer Biology, SA Pathology, University of Adelaide</s1><s2>Adelaide</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide</wicri:noRegion></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="04"><s1>Seoul St. Mary's Hospital, The Catholic University of Korea</s1><s2>Seoul</s2><s3>KOR</s3><sZ>4 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="Pane, Fabrizio" sort="Pane, Fabrizio" uniqKey="Pane F" first="Fabrizio" last="Pane">Fabrizio Pane</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>University of Naples Federico II</s1><s2>Naples</s2><s3>ITA</s3><sZ>5 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>University of Naples Federico II</wicri:noRegion></affiliation></author><author><name sortKey="Mongay, Lidia" sort="Mongay, Lidia" uniqKey="Mongay L" first="Lidia" last="Mongay">Lidia Mongay</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Novartis Pharmaceuticals Corporation</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Mone, Manisha" sort="Mone, Manisha" uniqKey="Mone M" first="Manisha" last="Mone">Manisha Mone</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Novartis Pharmaceuticals Corporation</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Ortmann, Christine Elke" sort="Ortmann, Christine Elke" uniqKey="Ortmann C" first="Christine-Elke" last="Ortmann">Christine-Elke Ortmann</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>8 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></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="1"><inist:fA14 i1="08"><s1>The University of Texas, MD Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author><author><name sortKey="Radich, Jerald P" sort="Radich, Jerald P" uniqKey="Radich J" first="Jerald P." last="Radich">Jerald P. Radich</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Fred Hutchinson Cancer Research Center</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Fred Hutchinson Cancer Research Center</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>Division of Haematology and Centre for Cancer Biology, SA Pathology, South Australian Health and Medical Research Institute, University of Adelaide</s1><s2>Adelaide</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Adelaide</wicri:noRegion></affiliation></author><author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>The University of Texas, MD Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author><author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Inserm CIC 1402, CHU de Poitiers</s1><s2>Poitiers</s2><s3>FRA</s3><sZ>13 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Poitou-Charentes</region><settlement type="city">Poitiers</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">International journal of hematology</title><title level="j" type="abbreviated">Int. j. hematol.</title><idno type="ISSN">0925-5710</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">International journal of hematology</title><title level="j" type="abbreviated">Int. j. hematol.</title><idno type="ISSN">0925-5710</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abnormal chromosome C9</term><term>Abnormal chromosome G22</term><term>Antineoplastic agent</term><term>C-Onc gene</term><term>Chromosome translocation</term><term>Chronic</term><term>Chronic myelogenous leukemia</term><term>Dose</term><term>Hematology</term><term>Human</term><term>Hybrid gene</term><term>Imatinib</term><term>Long term</term><term>Non-specific serine/threonine protein kinase</term><term>Optimization</term><term>Phase III trial</term><term>Philadelphia chromosome</term><term>Philadelphia positive leukemia</term><term>Selectivity</term><term>Tyrosine kinase inhibitor</term><term>bcr gene</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Imatinib</term><term>Long terme</term><term>Dose</term><term>Homme</term><term>Leucémie myéloïde chronique</term><term>Essai clinique phase III</term><term>Chronique</term><term>Inhibiteur de la tyrosine kinase</term><term>Optimisation</term><term>Sélectivité</term><term>Gène hybride</term><term>Translocation chromosomique</term><term>Chromosome C9 anormal</term><term>Chromosome G22 anormal</term><term>Chromosome Ph1</term><term>Non-specific serine/threonine protein kinase</term><term>Gène onc cellulaire</term><term>Hématologie</term><term>Anticancéreux</term><term>Gène abl</term><term>Leucémie à chromosome Philadelphie positif</term><term>Gène bcr</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The TOPS trial evaluated high- (800 mg/day; n = 319) versus standard-dose (400 mg/day; n = 157) imatinib in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Patients had a minimum follow-up of 42 months or discontinued early. Major molecular response (MMR) rates were similar between arms at (51.6 vs 50.2 % for 400 and 800 mg/day, respectively; P = 0.77) and by (75.8 vs 79.0 %; P = 0.4807) 42 months. There were no differences in event-free survival (EFS), progression-free survival (PFS), or overall survival (OS) between arms. The estimated rates of PFS on treatment and OS at 42 months were significantly higher in patients with MMR at 6, 12, and 18 months compared with those without MMR. Adverse events were more frequent with high-dose imatinib. Patients with ≤1 treatment interruption (vs >1) and those able to maintain imatinib ≥600 mg/day (vs <600 mg/day) in the first year of treatment had faster and higher response rates, but no improvement in EFS or PFS. Adherence to prescribed dose without interruption may be more important than initiation of therapy with higher doses of imatinib. Achievement of MMR correlated with long-term clinical outcomes.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Corée du Sud</li><li>France</li><li>Italie</li><li>Suisse</li><li>États-Unis</li></country><region><li>Nouvelle-Aquitaine</li><li>Poitou-Charentes</li><li>Région capitale de Séoul</li></region><settlement><li>Poitiers</li><li>Séoul</li></settlement></list><tree><country name="Italie"><noRegion><name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name></noRegion><name sortKey="Pane, Fabrizio" sort="Pane, Fabrizio" uniqKey="Pane F" first="Fabrizio" last="Pane">Fabrizio Pane</name></country><country name="États-Unis"><noRegion><name sortKey="Druker, Brian J" sort="Druker, Brian J" uniqKey="Druker B" first="Brian J." last="Druker">Brian J. Druker</name></noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name><name sortKey="Mone, Manisha" sort="Mone, Manisha" uniqKey="Mone M" first="Manisha" last="Mone">Manisha Mone</name><name sortKey="Mongay, Lidia" sort="Mongay, Lidia" uniqKey="Mongay L" first="Lidia" last="Mongay">Lidia Mongay</name><name sortKey="Radich, Jerald P" sort="Radich, Jerald P" uniqKey="Radich J" first="Jerald P." last="Radich">Jerald P. Radich</name></country><country name="Australie"><noRegion><name sortKey="Branford, Susan" sort="Branford, Susan" uniqKey="Branford S" first="Susan" last="Branford">Susan Branford</name></noRegion><name sortKey="Hughes, Timothy P" sort="Hughes, Timothy P" uniqKey="Hughes T" first="Timothy P." last="Hughes">Timothy P. Hughes</name></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="Suisse"><noRegion><name sortKey="Ortmann, Christine Elke" sort="Ortmann, Christine Elke" uniqKey="Ortmann C" first="Christine-Elke" last="Ortmann">Christine-Elke Ortmann</name></noRegion></country><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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