AustralieFrV1, Pmc, Corpus, bibRecord, 001858

Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily

Identifieur interne : 001858 ( Pmc/Corpus ); précédent : 001857; suivant : 001859

Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily

Auteurs : Timothy P. Hughes ; Andreas Hochhaus ; Hagop M. Kantarjian ; Francisco Cervantes ; François Guilhot ; Dietger Niederwieser ; Philipp D. Le Coutre ; Gianantonio Rosti ; Gert Ossenkoppele ; Clarisse Lobo ; Hirohiko Shibayama ; Xiaolin Fan ; Hans D. Menssen ; Charisse Kemp ; Richard A. Larson ; Giuseppe Saglio

Source :

Haematologica [ 0390-6078 ] ; 2014.

RBID : PMC:4077082

Abstract

In a randomized, phase III trial of nilotinib versus imatinib in patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase, more patients had suboptimal response or treatment failure on front-line imatinib than on nilotinib. Patients with suboptimal response/treatment failure on imatinib 400 mg once or twice daily or nilotinib 300 mg twice daily could enter an extension study to receive nilotinib 400 mg twice daily. After a 19-month median follow up, the safety profile of nilotinib 400 mg twice daily in patients switching from imatinib (n=35) was consistent with previous reports, and few new adverse events occurred in patients escalating from nilotinib 300 mg twice daily (n=19). Of patients previously treated with imatinib or nilotinib 300 mg twice daily, respectively, 15 of 26 (58%) and 2 of 6 (33%) without complete cytogenetic response at extension study entry, and 11 of 34 (32%) and 7 of 18 (39%) without major molecular response at extension study entry, achieved these responses at any time on nilotinib 400 mg twice daily. Estimated 18-month rates of freedom from progression and overall survival after entering the extension study were lower for patients switched from imatinib (85% and 87%, respectively) versus nilotinib 300 mg twice daily (95% and 94%, respectively). Nilotinib dose escalation was generally well tolerated and improved responses in about one-third of patients with suboptimal response/treatment failure. Switch to nilotinib improved responses in some patients with suboptimal response/treatment failure on imatinib, but many did not achieve complete cytogenetic response (clinicaltrials.gov identifiers:00718263, 00471497 - extension).

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077082

DOI: 10.3324/haematol.2013.091272
PubMed: 24532039
PubMed Central: 4077082

Links to Exploration step

PMC:4077082

Le document en format XML

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<author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name>
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<author><name sortKey="Niederwieser, Dietger" sort="Niederwieser, Dietger" uniqKey="Niederwieser D" first="Dietger" last="Niederwieser">Dietger Niederwieser</name>
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<author><name sortKey="Ossenkoppele, Gert" sort="Ossenkoppele, Gert" uniqKey="Ossenkoppele G" first="Gert" last="Ossenkoppele">Gert Ossenkoppele</name>
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<author><name sortKey="Shibayama, Hirohiko" sort="Shibayama, Hirohiko" uniqKey="Shibayama H" first="Hirohiko" last="Shibayama">Hirohiko Shibayama</name>
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<author><name sortKey="Fan, Xiaolin" sort="Fan, Xiaolin" uniqKey="Fan X" first="Xiaolin" last="Fan">Xiaolin Fan</name>
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<author><name sortKey="Menssen, Hans D" sort="Menssen, Hans D" uniqKey="Menssen H" first="Hans D." last="Menssen">Hans D. Menssen</name>
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</affiliation>
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<author><name sortKey="Kemp, Charisse" sort="Kemp, Charisse" uniqKey="Kemp C" first="Charisse" last="Kemp">Charisse Kemp</name>
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</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><nlm:aff id="af15-0991204">The University of Chicago, IL, USA</nlm:aff>
</affiliation>
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<author><name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily</title>
<author><name sortKey="Hughes, Timothy P" sort="Hughes, Timothy P" uniqKey="Hughes T" first="Timothy P." last="Hughes">Timothy P. Hughes</name>
<affiliation><nlm:aff id="af1-0991204">South Australian Health and Medical Research Institute, University of Adelaide, Australia</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af2-0991204">Division of Haematology and Centre for Cancer Biology, SA Pathology, Adelaide, Australia</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name>
<affiliation><nlm:aff id="af3-0991204">Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Germany</nlm:aff>
</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><nlm:aff id="af4-0991204">The University of Texas MD Anderson Cancer Center, Houston, TX, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Cervantes, Francisco" sort="Cervantes, Francisco" uniqKey="Cervantes F" first="Francisco" last="Cervantes">Francisco Cervantes</name>
<affiliation><nlm:aff id="af5-0991204">IDIBAPS, University of Barcelona, Spain</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name>
<affiliation><nlm:aff id="af6-0991204">Inserm CIC 0802, CHU de Poitiers, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Niederwieser, Dietger" sort="Niederwieser, Dietger" uniqKey="Niederwieser D" first="Dietger" last="Niederwieser">Dietger Niederwieser</name>
<affiliation><nlm:aff id="af7-0991204">Division of Hematology and Oncology, University of Leipzig, Germany</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Le Coutre, Philipp D" sort="Le Coutre, Philipp D" uniqKey="Le Coutre P" first="Philipp D." last="Le Coutre">Philipp D. Le Coutre</name>
<affiliation><nlm:aff id="af8-0991204">Charité - Universitätsmedizin Berlin, Germany</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Rosti, Gianantonio" sort="Rosti, Gianantonio" uniqKey="Rosti G" first="Gianantonio" last="Rosti">Gianantonio Rosti</name>
<affiliation><nlm:aff id="af9-0991204">University of Bologna, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Ossenkoppele, Gert" sort="Ossenkoppele, Gert" uniqKey="Ossenkoppele G" first="Gert" last="Ossenkoppele">Gert Ossenkoppele</name>
<affiliation><nlm:aff id="af10-0991204">VU University Medical Center, Amsterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Lobo, Clarisse" sort="Lobo, Clarisse" uniqKey="Lobo C" first="Clarisse" last="Lobo">Clarisse Lobo</name>
<affiliation><nlm:aff id="af11-0991204">HEMORIO, Rio de Janeiro, Brazil</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Shibayama, Hirohiko" sort="Shibayama, Hirohiko" uniqKey="Shibayama H" first="Hirohiko" last="Shibayama">Hirohiko Shibayama</name>
<affiliation><nlm:aff id="af12-0991204">Osaka University Graduate School of Medicine, Osaka, Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fan, Xiaolin" sort="Fan, Xiaolin" uniqKey="Fan X" first="Xiaolin" last="Fan">Xiaolin Fan</name>
<affiliation><nlm:aff id="af13-0991204">Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Menssen, Hans D" sort="Menssen, Hans D" uniqKey="Menssen H" first="Hans D." last="Menssen">Hans D. Menssen</name>
<affiliation><nlm:aff id="af14-0991204">Novartis Pharma AG, Basel, Switzerland</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kemp, Charisse" sort="Kemp, Charisse" uniqKey="Kemp C" first="Charisse" last="Kemp">Charisse Kemp</name>
<affiliation><nlm:aff id="af13-0991204">Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA</nlm:aff>
</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><nlm:aff id="af15-0991204">The University of Chicago, IL, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
<affiliation><nlm:aff id="af16-0991204">University of Turin, Orbassano, Italy</nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">Haematologica</title>
<idno type="ISSN">0390-6078</idno>
<idno type="eISSN">1592-8721</idno>
<imprint><date when="2014">2014</date>
</imprint>
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<front><div type="abstract" xml:lang="en"><p>In a randomized, phase III trial of nilotinib <italic>versus</italic>
 imatinib in patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase, more patients had suboptimal response or treatment failure on front-line imatinib than on nilotinib. Patients with suboptimal response/treatment failure on imatinib 400 mg once or twice daily or nilotinib 300 mg twice daily could enter an extension study to receive nilotinib 400 mg twice daily. After a 19-month median follow up, the safety profile of nilotinib 400 mg twice daily in patients switching from imatinib (n=35) was consistent with previous reports, and few new adverse events occurred in patients escalating from nilotinib 300 mg twice daily (n=19). Of patients previously treated with imatinib or nilotinib 300 mg twice daily, respectively, 15 of 26 (58%) and 2 of 6 (33%) without complete cytogenetic response at extension study entry, and 11 of 34 (32%) and 7 of 18 (39%) without major molecular response at extension study entry, achieved these responses at any time on nilotinib 400 mg twice daily. Estimated 18-month rates of freedom from progression and overall survival after entering the extension study were lower for patients switched from imatinib (85% and 87%, respectively) <italic>versus</italic>
 nilotinib 300 mg twice daily (95% and 94%, respectively). Nilotinib dose escalation was generally well tolerated and improved responses in about one-third of patients with suboptimal response/treatment failure. Switch to nilotinib improved responses in some patients with suboptimal response/treatment failure on imatinib, but many did not achieve complete cytogenetic response (<italic><ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link>
 identifiers:00718263, 00471497 - extension</italic>
).</p>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
  <front><journal-meta><journal-id journal-id-type="nlm-ta">Haematologica</journal-id>
<journal-id journal-id-type="iso-abbrev">Haematologica</journal-id>
<journal-id journal-id-type="hwp">haematol</journal-id>
<journal-id journal-id-type="publisher-id">Haematologica</journal-id>
<journal-title-group><journal-title>Haematologica</journal-title>
</journal-title-group>
<issn pub-type="ppub">0390-6078</issn>
<issn pub-type="epub">1592-8721</issn>
<publisher><publisher-name>Ferrata Storti Foundation</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">24532039</article-id>
<article-id pub-id-type="pmc">4077082</article-id>
<article-id pub-id-type="doi">10.3324/haematol.2013.091272</article-id>
<article-id pub-id-type="publisher-id">0991204</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Articles</subject>
<subj-group subj-group-type="heading"><subject>Chronic Myeloid Leukemia</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group><article-title>Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Hughes</surname>
<given-names>Timothy P.</given-names>
</name>
<xref ref-type="aff" rid="af1-0991204">1</xref>
<xref ref-type="aff" rid="af2-0991204">2</xref>
<xref ref-type="corresp" rid="c1-0991204"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hochhaus</surname>
<given-names>Andreas</given-names>
</name>
<xref ref-type="aff" rid="af3-0991204">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kantarjian</surname>
<given-names>Hagop M.</given-names>
</name>
<xref ref-type="aff" rid="af4-0991204">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Cervantes</surname>
<given-names>Francisco</given-names>
</name>
<xref ref-type="aff" rid="af5-0991204">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Guilhot</surname>
<given-names>François</given-names>
</name>
<xref ref-type="aff" rid="af6-0991204">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Niederwieser</surname>
<given-names>Dietger</given-names>
</name>
<xref ref-type="aff" rid="af7-0991204">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>le Coutre</surname>
<given-names>Philipp D.</given-names>
</name>
<xref ref-type="aff" rid="af8-0991204">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Rosti</surname>
<given-names>Gianantonio</given-names>
</name>
<xref ref-type="aff" rid="af9-0991204">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Ossenkoppele</surname>
<given-names>Gert</given-names>
</name>
<xref ref-type="aff" rid="af10-0991204">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lobo</surname>
<given-names>Clarisse</given-names>
</name>
<xref ref-type="aff" rid="af11-0991204">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Shibayama</surname>
<given-names>Hirohiko</given-names>
</name>
<xref ref-type="aff" rid="af12-0991204">12</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fan</surname>
<given-names>Xiaolin</given-names>
</name>
<xref ref-type="aff" rid="af13-0991204">13</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Menssen</surname>
<given-names>Hans D.</given-names>
</name>
<xref ref-type="aff" rid="af14-0991204">14</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kemp</surname>
<given-names>Charisse</given-names>
</name>
<xref ref-type="aff" rid="af13-0991204">13</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Larson</surname>
<given-names>Richard A.</given-names>
</name>
<xref ref-type="aff" rid="af15-0991204">15</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Saglio</surname>
<given-names>Giuseppe</given-names>
</name>
<xref ref-type="aff" rid="af16-0991204">16</xref>
</contrib>
</contrib-group>
<aff id="af1-0991204"><label>1</label>
South Australian Health and Medical Research Institute, University of Adelaide, Australia</aff>
<aff id="af2-0991204"><label>2</label>
Division of Haematology and Centre for Cancer Biology, SA Pathology, Adelaide, Australia</aff>
<aff id="af3-0991204"><label>3</label>
Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Germany</aff>
<aff id="af4-0991204"><label>4</label>
The University of Texas MD Anderson Cancer Center, Houston, TX, USA</aff>
<aff id="af5-0991204"><label>5</label>
IDIBAPS, University of Barcelona, Spain</aff>
<aff id="af6-0991204"><label>6</label>
Inserm CIC 0802, CHU de Poitiers, France</aff>
<aff id="af7-0991204"><label>7</label>
Division of Hematology and Oncology, University of Leipzig, Germany</aff>
<aff id="af8-0991204"><label>8</label>
Charité - Universitätsmedizin Berlin, Germany</aff>
<aff id="af9-0991204"><label>9</label>
University of Bologna, Italy</aff>
<aff id="af10-0991204"><label>10</label>
VU University Medical Center, Amsterdam, The Netherlands</aff>
<aff id="af11-0991204"><label>11</label>
HEMORIO, Rio de Janeiro, Brazil</aff>
<aff id="af12-0991204"><label>12</label>
Osaka University Graduate School of Medicine, Osaka, Japan</aff>
<aff id="af13-0991204"><label>13</label>
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA</aff>
<aff id="af14-0991204"><label>14</label>
Novartis Pharma AG, Basel, Switzerland</aff>
<aff id="af15-0991204"><label>15</label>
The University of Chicago, IL, USA</aff>
<aff id="af16-0991204"><label>16</label>
University of Turin, Orbassano, Italy</aff>
<author-notes><corresp id="c1-0991204">Correspondence: <email>timothy.hughes@health.sa.gov.au</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>7</month>
<year>2014</year>
</pub-date>
<volume>99</volume>
<issue>7</issue>
<fpage>1204</fpage>
<lpage>1211</lpage>
<history><date date-type="received"><day>04</day>
<month>6</month>
<year>2013</year>
</date>
<date date-type="accepted"><day>05</day>
<month>2</month>
<year>2014</year>
</date>
</history>
<permissions><copyright-statement>Copyright© Ferrata Storti Foundation</copyright-statement>
<copyright-year>2014</copyright-year>
</permissions>
<self-uri content-type="pdf" xlink:type="simple" xlink:href="991204.pdf"></self-uri>
<abstract><p>In a randomized, phase III trial of nilotinib <italic>versus</italic>
 imatinib in patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase, more patients had suboptimal response or treatment failure on front-line imatinib than on nilotinib. Patients with suboptimal response/treatment failure on imatinib 400 mg once or twice daily or nilotinib 300 mg twice daily could enter an extension study to receive nilotinib 400 mg twice daily. After a 19-month median follow up, the safety profile of nilotinib 400 mg twice daily in patients switching from imatinib (n=35) was consistent with previous reports, and few new adverse events occurred in patients escalating from nilotinib 300 mg twice daily (n=19). Of patients previously treated with imatinib or nilotinib 300 mg twice daily, respectively, 15 of 26 (58%) and 2 of 6 (33%) without complete cytogenetic response at extension study entry, and 11 of 34 (32%) and 7 of 18 (39%) without major molecular response at extension study entry, achieved these responses at any time on nilotinib 400 mg twice daily. Estimated 18-month rates of freedom from progression and overall survival after entering the extension study were lower for patients switched from imatinib (85% and 87%, respectively) <italic>versus</italic>
 nilotinib 300 mg twice daily (95% and 94%, respectively). Nilotinib dose escalation was generally well tolerated and improved responses in about one-third of patients with suboptimal response/treatment failure. Switch to nilotinib improved responses in some patients with suboptimal response/treatment failure on imatinib, but many did not achieve complete cytogenetic response (<italic><ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link>
 identifiers:00718263, 00471497 - extension</italic>
).</p>
</abstract>
</article-meta>
</front>
</pmc>
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   |clé=     PMC:4077082
   |texte=   Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily
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	Serveur d'exploration sur les relations entre la France et l'Australie
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Serveur d'exploration sur les relations entre la France et l'Australie

Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily

Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily

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