AustralieFrV1, Main, Exploration, bibRecord, 003523

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 : 003523 ( Main/Exploration ); précédent : 003522; suivant : 003524

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 [Australie] ; Andreas Hochhaus [Allemagne] ; Hagop M. Kantarjian [États-Unis] ; Francisco Cervantes [Espagne] ; François Guilhot [France] ; Dietger Niederwieser [Allemagne] ; Philipp D. Le Coutre [Allemagne] ; Gianantonio Rosti [Italie] ; Gert Ossenkoppele [Pays-Bas] ; Clarisse Lobo [Brésil] ; Hirohiko Shibayama [Japon] ; Xiaolin Fan [États-Unis] ; Hans D. Menssen [Suisse] ; Charisse Kemp [États-Unis] ; Richard A. Larson [États-Unis] ; Giuseppe Saglio [Italie]

Source :

Haematologica [ 0390-6078 ] ; 2014.

RBID : PMC:4077082

Descripteurs français

KwdFr :
- Antinéoplasiques (administration et posologie), Antinéoplasiques (effets indésirables), Benzamides (administration et posologie), Benzamides (effets indésirables), Humains, Inhibiteurs de protéines kinases (administration et posologie), Inhibiteurs de protéines kinases (effets indésirables), Leucémie myéloïde en phase chronique (traitement médicamenteux), Mésylate d'imatinib, Pipérazines (administration et posologie), Pipérazines (effets indésirables), Pyrimidines (administration et posologie), Pyrimidines (effets indésirables), Résultat thérapeutique, Substitution de médicament, Échec thérapeutique, Études de suivi.
MESH :
- administration et posologie : Antinéoplasiques, Benzamides, Inhibiteurs de protéines kinases, Pipérazines, Pyrimidines.
- effets indésirables : Antinéoplasiques, Benzamides, Inhibiteurs de protéines kinases, Pipérazines, Pyrimidines.
- traitement médicamenteux : Leucémie myéloïde en phase chronique.
- Humains, Mésylate d'imatinib, Résultat thérapeutique, Substitution de médicament, Échec thérapeutique, Études de suivi.

English descriptors

KwdEn :
- Antineoplastic Agents (administration & dosage), Antineoplastic Agents (adverse effects), Benzamides (administration & dosage), Benzamides (adverse effects), Drug Substitution, Follow-Up Studies, Humans, Imatinib Mesylate, Leukemia, Myeloid, Chronic-Phase (drug therapy), Piperazines (administration & dosage), Piperazines (adverse effects), Protein Kinase Inhibitors (administration & dosage), Protein Kinase Inhibitors (adverse effects), Pyrimidines (administration & dosage), Pyrimidines (adverse effects), Treatment Failure, Treatment Outcome.
MESH :
- chemical , administration & dosage : Antineoplastic Agents, Benzamides, Piperazines, Protein Kinase Inhibitors, Pyrimidines.
- chemical , adverse effects : Antineoplastic Agents, Benzamides, Piperazines, Protein Kinase Inhibitors, Pyrimidines.
- drug therapy : Leukemia, Myeloid, Chronic-Phase.
- Drug Substitution, Follow-Up Studies, Humans, Imatinib Mesylate, Treatment Failure, Treatment Outcome.

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

Affiliations:

Allemagne, Australie, Brésil, Espagne, France, Italie, Japon, Pays-Bas, Suisse, États-Unis
Hollande-Septentrionale, Illinois, New Jersey, Texas, État de Rio de Janeiro
Amsterdam, Rio de Janeiro

Le document en format XML

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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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<author><name sortKey="Larson, Richard A" sort="Larson, Richard A" uniqKey="Larson R" first="Richard A." last="Larson">Richard A. Larson</name>
<affiliation wicri:level="2"><nlm:aff id="af15-0991204">The University of Chicago, IL, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The University of Chicago, IL</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
<affiliation wicri:level="1"><nlm:aff id="af16-0991204">University of Turin, Orbassano, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>University of Turin, Orbassano</wicri:regionArea>
<wicri:noRegion>Orbassano</wicri:noRegion>
</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>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Agents (administration & dosage)</term>
<term>Antineoplastic Agents (adverse effects)</term>
<term>Benzamides (administration & dosage)</term>
<term>Benzamides (adverse effects)</term>
<term>Drug Substitution</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Imatinib Mesylate</term>
<term>Leukemia, Myeloid, Chronic-Phase (drug therapy)</term>
<term>Piperazines (administration & dosage)</term>
<term>Piperazines (adverse effects)</term>
<term>Protein Kinase Inhibitors (administration & dosage)</term>
<term>Protein Kinase Inhibitors (adverse effects)</term>
<term>Pyrimidines (administration & dosage)</term>
<term>Pyrimidines (adverse effects)</term>
<term>Treatment Failure</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Antinéoplasiques (administration et posologie)</term>
<term>Antinéoplasiques (effets indésirables)</term>
<term>Benzamides (administration et posologie)</term>
<term>Benzamides (effets indésirables)</term>
<term>Humains</term>
<term>Inhibiteurs de protéines kinases (administration et posologie)</term>
<term>Inhibiteurs de protéines kinases (effets indésirables)</term>
<term>Leucémie myéloïde en phase chronique (traitement médicamenteux)</term>
<term>Mésylate d'imatinib</term>
<term>Pipérazines (administration et posologie)</term>
<term>Pipérazines (effets indésirables)</term>
<term>Pyrimidines (administration et posologie)</term>
<term>Pyrimidines (effets indésirables)</term>
<term>Résultat thérapeutique</term>
<term>Substitution de médicament</term>
<term>Échec thérapeutique</term>
<term>Études de suivi</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Agents</term>
<term>Benzamides</term>
<term>Piperazines</term>
<term>Protein Kinase Inhibitors</term>
<term>Pyrimidines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Agents</term>
<term>Benzamides</term>
<term>Piperazines</term>
<term>Protein Kinase Inhibitors</term>
<term>Pyrimidines</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Benzamides</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Pipérazines</term>
<term>Pyrimidines</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myeloid, Chronic-Phase</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Benzamides</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Pipérazines</term>
<term>Pyrimidines</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Leucémie myéloïde en phase chronique</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Drug Substitution</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Imatinib Mesylate</term>
<term>Treatment Failure</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Humains</term>
<term>Mésylate d'imatinib</term>
<term>Résultat thérapeutique</term>
<term>Substitution de médicament</term>
<term>Échec thérapeutique</term>
<term>Études de suivi</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<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>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Brésil</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Japon</li>
<li>Pays-Bas</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Hollande-Septentrionale</li>
<li>Illinois</li>
<li>New Jersey</li>
<li>Texas</li>
<li>État de Rio de Janeiro</li>
</region>
<settlement><li>Amsterdam</li>
<li>Rio de Janeiro</li>
</settlement>
</list>
<tree><country name="Australie"><noRegion><name sortKey="Hughes, Timothy P" sort="Hughes, Timothy P" uniqKey="Hughes T" first="Timothy P." last="Hughes">Timothy P. Hughes</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="Allemagne"><noRegion><name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name>
</noRegion>
<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>
<name sortKey="Niederwieser, Dietger" sort="Niederwieser, Dietger" uniqKey="Niederwieser D" first="Dietger" last="Niederwieser">Dietger Niederwieser</name>
</country>
<country name="États-Unis"><region name="Texas"><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
</region>
<name sortKey="Fan, Xiaolin" sort="Fan, Xiaolin" uniqKey="Fan X" first="Xiaolin" last="Fan">Xiaolin Fan</name>
<name sortKey="Kemp, Charisse" sort="Kemp, Charisse" uniqKey="Kemp C" first="Charisse" last="Kemp">Charisse Kemp</name>
<name sortKey="Larson, Richard A" sort="Larson, Richard A" uniqKey="Larson R" first="Richard A." last="Larson">Richard A. Larson</name>
</country>
<country name="Espagne"><noRegion><name sortKey="Cervantes, Francisco" sort="Cervantes, Francisco" uniqKey="Cervantes F" first="Francisco" last="Cervantes">Francisco Cervantes</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name>
</noRegion>
</country>
<country name="Italie"><noRegion><name sortKey="Rosti, Gianantonio" sort="Rosti, Gianantonio" uniqKey="Rosti G" first="Gianantonio" last="Rosti">Gianantonio Rosti</name>
</noRegion>
<name sortKey="Saglio, Giuseppe" sort="Saglio, Giuseppe" uniqKey="Saglio G" first="Giuseppe" last="Saglio">Giuseppe Saglio</name>
</country>
<country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Ossenkoppele, Gert" sort="Ossenkoppele, Gert" uniqKey="Ossenkoppele G" first="Gert" last="Ossenkoppele">Gert Ossenkoppele</name>
</region>
</country>
<country name="Brésil"><region name="État de Rio de Janeiro"><name sortKey="Lobo, Clarisse" sort="Lobo, Clarisse" uniqKey="Lobo C" first="Clarisse" last="Lobo">Clarisse Lobo</name>
</region>
</country>
<country name="Japon"><noRegion><name sortKey="Shibayama, Hirohiko" sort="Shibayama, Hirohiko" uniqKey="Shibayama H" first="Hirohiko" last="Shibayama">Hirohiko Shibayama</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Menssen, Hans D" sort="Menssen, Hans D" uniqKey="Menssen H" first="Hans D." last="Menssen">Hans D. Menssen</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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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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