AustralieFrV1, Main, Exploration, bibRecord, 008B66

Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia

Identifieur interne : 008B66 ( Main/Exploration ); précédent : 008B65; suivant : 008B67

Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia

Auteurs : Philipp Le Coutre [Allemagne] ; Oliver G. Ottmann [Allemagne] ; Francis Giles [États-Unis] ; Dong-Wook Kim [Corée du Sud] ; Jorge Cortes [États-Unis] ; Norbert Gattermann [Allemagne] ; Jane F. Apperley [Royaume-Uni] ; Richard A. Larson [États-Unis] ; Elisabetta Abruzzese [Italie] ; Stephen G. O'Brien [Royaume-Uni] ; Kazimierz Kuliczkowski [Pologne] ; Andreas Hochhaus [Allemagne] ; Francois-Xavier Mahon [France] ; Giuseppe Saglio [Italie] ; Marco Gobbi [Italie] ; Yok-Lam Kwong [Hong Kong] ; Michele Baccarani [Italie] ; Timothy Hughes [Australie] ; Giovanni Martinelli [Italie] ; Jerald P. Radich [États-Unis] ; MING ZHENG [États-Unis] ; YAPING SHOU [États-Unis] ; Hagop Kantarjian [États-Unis]

Source :

Blood [ 0006-4971 ] ; 2008.

RBID : Pascal:08-0213938

Descripteurs français

Pascal (Inist)
- Nilotinib, Gène hybride, Translocation chromosomique, Imatinib, Chromosome C9 anormal, Chromosome G22 anormal, Chromosome Ph1, Non-specific serine/threonine protein kinase, Gène onc cellulaire, Inhibiteur de la tyrosine kinase, Homme, Protein-tyrosine kinase, Inhibiteur enzyme, Résistance, Leucémie myéloïde chronique, Hématologie, Anticancéreux, Gène bcr, Gène abl.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Abnormal chromosome C9, Abnormal chromosome G22, Antineoplastic agent, C-Onc gene, Chromosome translocation, Chronic myelogenous leukemia, Enzyme inhibitor, Hematology, Human, Hybrid gene, Imatinib, Nilotinib, Non-specific serine/threonine protein kinase, Philadelphia chromosome, Protein-tyrosine kinase, Resistance, Tyrosine kinase inhibitor.

Abstract

Patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia (CML-AP) have very limited therapeutic options. Nilotinib is a highly selective BCR-ABL tyrosine kinase inhibitor. This phase 2 trial was designed to characterize the efficacy and safety of nilotinib (400 mg twice daily) in this patient population with hematologic response (HR) as primary efficacy endpoint A total of 119 patients were enrolled and had a median duration of treatment of 202 days (range, 2-611 days). An HR was observed in 56 patients (47%; 95% confidence interval [Cl], 38%-56%). Major cytogenetic response (MCyR) was observed in 35 patients (29%; 95% Cl, 21%-39%). The median duration of HR has not been reached. Overall survival rate among the 119 patients after 12 months of follow-up was 79% (95% Cl, 70%-87%). Nonhematologic adverse events were mostly mild to moderate. Severe peripheral edema and pleural effusions were not observed. The most common grade 3 or higher hematologic adverse events were thrombocytopenia (35%) and neutropenia (21%). Grade 3 or higher bilirubin and lipase elevations occurred in 9% and 18% of patients, respectively, resulting in treatment discontinuation in one patient. In conclusion, nilotinib is an effective and well-tolerated treatment in imatinib-resistant and -intolerant CML-AP. This trial is registered at www.clinicaltrials. gov as NCT00384228.

Affiliations:

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

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Le document en format XML

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<author><name sortKey="Ming Zheng" sort="Ming Zheng" uniqKey="Ming Zheng" last="Ming Zheng">MING ZHENG</name>
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<author><name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia</title>
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<author><name sortKey="Kim, Dong Wook" sort="Kim, Dong Wook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name>
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<author><name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name>
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<author><name sortKey="Gattermann, Norbert" sort="Gattermann, Norbert" uniqKey="Gattermann N" first="Norbert" last="Gattermann">Norbert Gattermann</name>
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<author><name sortKey="Apperley, Jane F" sort="Apperley, Jane F" uniqKey="Apperley J" first="Jane F." last="Apperley">Jane F. Apperley</name>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Hammersmith Hospital</s1>
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<author><name sortKey="Larson, Richard A" sort="Larson, Richard A" uniqKey="Larson R" first="Richard A." last="Larson">Richard A. Larson</name>
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<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of Chicago Cancer Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Abruzzese, Elisabetta" sort="Abruzzese, Elisabetta" uniqKey="Abruzzese E" first="Elisabetta" last="Abruzzese">Elisabetta Abruzzese</name>
<affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Ospedale San Eugenio, Tor Vergata University</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>9 aut.</sZ>
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<country>Italie</country>
<placeName><settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="O Brien, Stephen G" sort="O Brien, Stephen G" uniqKey="O Brien S" first="Stephen G." last="O'Brien">Stephen G. O'Brien</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Royal Victoria Infirmary</s1>
<s2>Newcastle upon Tyne</s2>
<s3>GBR</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Royal Victoria Infirmary</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kuliczkowski, Kazimierz" sort="Kuliczkowski, Kazimierz" uniqKey="Kuliczkowski K" first="Kazimierz" last="Kuliczkowski">Kazimierz Kuliczkowski</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Klinika Hematologii</s1>
<s2>Wroclaw</s2>
<s3>POL</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Pologne</country>
<wicri:noRegion>Klinika Hematologii</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="3"><inist:fA14 i1="11"><s1>Medizinische Fakultat Mannheim, Universität Heidelberg</s1>
<s2>Mannheim</s2>
<s3>DEU</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Mannheim</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mahon, Francois Xavier" sort="Mahon, Francois Xavier" uniqKey="Mahon F" first="Francois-Xavier" last="Mahon">Francois-Xavier Mahon</name>
<affiliation wicri:level="3"><inist:fA14 i1="12"><s1>Hôpital Pellegrin</s1>
<s2>Bordeaux</s2>
<s3>FRA</s3>
<sZ>13 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="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Ospedale San Luigi Gonzaga</s1>
<s2>Torino</s2>
<s3>ITA</s3>
<sZ>14 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="Gobbi, Marco" sort="Gobbi, Marco" uniqKey="Gobbi M" first="Marco" last="Gobbi">Marco Gobbi</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Ospedale San Martino</s1>
<s2>Genoa</s2>
<s3>ITA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Ospedale San Martino</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kwong, Yok Lam" sort="Kwong, Yok Lam" uniqKey="Kwong Y" first="Yok-Lam" last="Kwong">Yok-Lam Kwong</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Queen Mary Hospital</s1>
<s3>HKG</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Hong Kong</country>
<wicri:noRegion>Queen Mary Hospital</wicri:noRegion>
</affiliation>
</author>
<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="16"><s1>Policlinico San Orsola Malpighi</s1>
<s2>Bologna</s2>
<s3>ITA</s3>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Policlinico San Orsola Malpighi</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="17"><s1>Royal Adelaide Hospital</s1>
<s2>Adelaide</s2>
<s3>AUS</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Royal Adelaide Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Martinelli, Giovanni" sort="Martinelli, Giovanni" uniqKey="Martinelli G" first="Giovanni" last="Martinelli">Giovanni Martinelli</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Policlinico San Orsola Malpighi</s1>
<s2>Bologna</s2>
<s3>ITA</s3>
<sZ>17 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Policlinico San Orsola Malpighi</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="18"><s1>Fred Hutchinson Cancer Research Center</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Fred Hutchinson Cancer Research Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ming Zheng" sort="Ming Zheng" uniqKey="Ming Zheng" last="Ming Zheng">MING ZHENG</name>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, NJ</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Yaping Shou" sort="Yaping Shou" uniqKey="Yaping Shou" last="Yaping Shou">YAPING SHOU</name>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, NJ</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</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="03"><s1>M. D. Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>M. D. Anderson Cancer Center</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="2008">2008</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>Abnormal chromosome C9</term>
<term>Abnormal chromosome G22</term>
<term>Antineoplastic agent</term>
<term>C-Onc gene</term>
<term>Chromosome translocation</term>
<term>Chronic myelogenous leukemia</term>
<term>Enzyme inhibitor</term>
<term>Hematology</term>
<term>Human</term>
<term>Hybrid gene</term>
<term>Imatinib</term>
<term>Nilotinib</term>
<term>Non-specific serine/threonine protein kinase</term>
<term>Philadelphia chromosome</term>
<term>Protein-tyrosine kinase</term>
<term>Resistance</term>
<term>Tyrosine kinase inhibitor</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Nilotinib</term>
<term>Gène hybride</term>
<term>Translocation chromosomique</term>
<term>Imatinib</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>Inhibiteur de la tyrosine kinase</term>
<term>Homme</term>
<term>Protein-tyrosine kinase</term>
<term>Inhibiteur enzyme</term>
<term>Résistance</term>
<term>Leucémie myéloïde chronique</term>
<term>Hématologie</term>
<term>Anticancéreux</term>
<term>Gène bcr</term>
<term>Gène abl</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia (CML-AP) have very limited therapeutic options. Nilotinib is a highly selective BCR-ABL tyrosine kinase inhibitor. This phase 2 trial was designed to characterize the efficacy and safety of nilotinib (400 mg twice daily) in this patient population with hematologic response (HR) as primary efficacy endpoint A total of 119 patients were enrolled and had a median duration of treatment of 202 days (range, 2-611 days). An HR was observed in 56 patients (47%; 95% confidence interval [Cl], 38%-56%). Major cytogenetic response (MCyR) was observed in 35 patients (29%; 95% Cl, 21%-39%). The median duration of HR has not been reached. Overall survival rate among the 119 patients after 12 months of follow-up was 79% (95% Cl, 70%-87%). Nonhematologic adverse events were mostly mild to moderate. Severe peripheral edema and pleural effusions were not observed. The most common grade 3 or higher hematologic adverse events were thrombocytopenia (35%) and neutropenia (21%). Grade 3 or higher bilirubin and lipase elevations occurred in 9% and 18% of patients, respectively, resulting in treatment discontinuation in one patient. In conclusion, nilotinib is an effective and well-tolerated treatment in imatinib-resistant and -intolerant CML-AP. This trial is registered at www.clinicaltrials. gov as NCT00384228.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Corée du Sud</li>
<li>France</li>
<li>Hong Kong</li>
<li>Italie</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Aquitaine</li>
<li>Bade-Wurtemberg</li>
<li>Berlin</li>
<li>District de Darmstadt</li>
<li>District de Düsseldorf</li>
<li>District de Karlsruhe</li>
<li>Grand Londres</li>
<li>Hesse (Land)</li>
<li>Latium</li>
<li>Nouvelle-Aquitaine</li>
<li>Piémont</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Région capitale de Séoul</li>
</region>
<settlement><li>Berlin</li>
<li>Bordeaux</li>
<li>Düsseldorf</li>
<li>Francfort-sur-le-Main</li>
<li>Londres</li>
<li>Mannheim</li>
<li>Rome</li>
<li>Séoul</li>
<li>Turin</li>
</settlement>
</list>
<tree><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="Gattermann, Norbert" sort="Gattermann, Norbert" uniqKey="Gattermann N" first="Norbert" last="Gattermann">Norbert Gattermann</name>
<name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name>
<name sortKey="Ottmann, Oliver G" sort="Ottmann, Oliver G" uniqKey="Ottmann O" first="Oliver G." last="Ottmann">Oliver G. Ottmann</name>
</country>
<country name="États-Unis"><noRegion><name sortKey="Giles, Francis" sort="Giles, Francis" uniqKey="Giles F" first="Francis" last="Giles">Francis Giles</name>
</noRegion>
<name sortKey="Cortes, Jorge" sort="Cortes, Jorge" uniqKey="Cortes J" first="Jorge" last="Cortes">Jorge Cortes</name>
<name sortKey="Kantarjian, Hagop" sort="Kantarjian, Hagop" uniqKey="Kantarjian H" first="Hagop" last="Kantarjian">Hagop Kantarjian</name>
<name sortKey="Larson, Richard A" sort="Larson, Richard A" uniqKey="Larson R" first="Richard A." last="Larson">Richard A. Larson</name>
<name sortKey="Ming Zheng" sort="Ming Zheng" uniqKey="Ming Zheng" last="Ming Zheng">MING ZHENG</name>
<name sortKey="Radich, Jerald P" sort="Radich, Jerald P" uniqKey="Radich J" first="Jerald P." last="Radich">Jerald P. Radich</name>
<name sortKey="Yaping Shou" sort="Yaping Shou" uniqKey="Yaping Shou" last="Yaping Shou">YAPING SHOU</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="Royaume-Uni"><region name="Angleterre"><name sortKey="Apperley, Jane F" sort="Apperley, Jane F" uniqKey="Apperley J" first="Jane F." last="Apperley">Jane F. Apperley</name>
</region>
<name sortKey="O Brien, Stephen G" sort="O Brien, Stephen G" uniqKey="O Brien S" first="Stephen G." last="O'Brien">Stephen G. O'Brien</name>
</country>
<country name="Italie"><region name="Latium"><name sortKey="Abruzzese, Elisabetta" sort="Abruzzese, Elisabetta" uniqKey="Abruzzese E" first="Elisabetta" last="Abruzzese">Elisabetta Abruzzese</name>
</region>
<name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name>
<name sortKey="Gobbi, Marco" sort="Gobbi, Marco" uniqKey="Gobbi M" first="Marco" last="Gobbi">Marco Gobbi</name>
<name sortKey="Martinelli, Giovanni" sort="Martinelli, Giovanni" uniqKey="Martinelli G" first="Giovanni" last="Martinelli">Giovanni Martinelli</name>
<name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Kuliczkowski, Kazimierz" sort="Kuliczkowski, Kazimierz" uniqKey="Kuliczkowski K" first="Kazimierz" last="Kuliczkowski">Kazimierz Kuliczkowski</name>
</noRegion>
</country>
<country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Mahon, Francois Xavier" sort="Mahon, Francois Xavier" uniqKey="Mahon F" first="Francois-Xavier" last="Mahon">Francois-Xavier Mahon</name>
</region>
</country>
<country name="Hong Kong"><noRegion><name sortKey="Kwong, Yok Lam" sort="Kwong, Yok Lam" uniqKey="Kwong Y" first="Yok-Lam" last="Kwong">Yok-Lam Kwong</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>

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	Serveur d'exploration sur les relations entre la France et l'Australie
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Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia

Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia

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