AustralieFrV1, Main, Exploration, bibRecord, 007638

Phase III, Randomized, Open-Label Study of Daily Imatinib Mesylate 400 mg Versus 800 mg in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase Using Molecular End Points: Tyrosine Kinase Inhibitor Optimization and Selectivity Study

Identifieur interne : 007638 ( Main/Exploration ); précédent : 007637; suivant : 007639

Phase III, Randomized, Open-Label Study of Daily Imatinib Mesylate 400 mg Versus 800 mg in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase Using Molecular End Points: Tyrosine Kinase Inhibitor Optimization and Selectivity Study

Auteurs : Jorge E. Cortes [États-Unis, Italie, France, Australie, Corée du Sud, Brésil, Argentine, Israël, Slovaquie, Suisse] ; Michele Baccarani ; François Guilhot ; Brian J. Druker ; Susan Branford ; Dong-Wook Kim ; Fabrizio Pane ; Ricardo Pasquini ; Stuart L. Goldberg ; Matt Kalaycio ; Beatriz Moiraghi ; Jacob M. Rowe ; Elena Tothova ; Carmino De Souza ; Marc Rudoltz ; Richard Yu ; Tillmann Krahnke ; Hagop M. Kantarjian ; Jerald P. Radich ; Timothy P. Hughes

Source :

Journal of clinical oncology [ 0732-183X ] ; 2010.

RBID : Pascal:10-0079414

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Traitement, Randomisation, Imatinib, Etude comparative, Homme, Stade précoce, Leucémie myéloïde chronique, Protein-tyrosine kinase, Optimisation, Sélectivité, Cancérologie, Anticancéreux, STI 571.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Antineoplastic agent, Cancerology, Chronic myelogenous leukemia, Comparative study, Early stage, Human, Imatinib, Optimization, Phase III trial, Protein-tyrosine kinase, Randomization, Selectivity, Treatment.

Abstract

Purpose To evaluate the safety and efficacy of initial treatment with imatinib mesylate 800 mg/d (400 mg twice daily) versus 400 mg/d in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Patients and Methods A total of 476 patients were randomly assigned 2:1 to imatinib 800 mg (n = 319) or 400 mg (n = 157) daily. The primary end point was the major molecular response (MMR) rate at 12 months. Results At 12 months, differences in MMR and complete cytogenetic response (CCyR) rates were not statistically significant (MMR, 46% v 40%; P = .2035; CCyR, 70% v 66%; P = .3470). However, MMR occurred faster among patients randomly assigned to imatinib 800 mg/d, who had higher rates of MMR at 3 and 6 months compared with those in the imatinib 400-mg/d arm (P = .0035 by log-rank test). CCyR also occurred faster in the 800-mg/d arm (CCyR at 6 months, 57% v 45%; P = .0146). The most common adverse events were edema, gastrointestinal problems, and rash, and all were more common in patients in the 800-mg/d arm. Grades 3 to 4 hematologic toxicity also occurred more frequently in patients receiving imatinib 800 mg/d. Conclusion MMR rates at 1 year were similar with imatinib 800 mg/d and 400 mg/d, but MMR and CCyR occurred earlier in patients treated with 800 mg/d. Continued follow-up is needed to determine the clinical significance of earlier responses on high-dose imatinib.

Affiliations:

Argentine, Australie, Brésil, Corée du Sud, France, Israël, Italie, Slovaquie, Suisse, États-Unis
Nouvelle-Aquitaine, Poitou-Charentes, Région capitale de Séoul
Poitiers, Séoul

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

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Le document en format XML

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<term>Early stage</term>
<term>Human</term>
<term>Imatinib</term>
<term>Optimization</term>
<term>Phase III trial</term>
<term>Protein-tyrosine kinase</term>
<term>Randomization</term>
<term>Selectivity</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Traitement</term>
<term>Randomisation</term>
<term>Imatinib</term>
<term>Etude comparative</term>
<term>Homme</term>
<term>Stade précoce</term>
<term>Leucémie myéloïde chronique</term>
<term>Protein-tyrosine kinase</term>
<term>Optimisation</term>
<term>Sélectivité</term>
<term>Cancérologie</term>
<term>Anticancéreux</term>
<term>STI 571</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose To evaluate the safety and efficacy of initial treatment with imatinib mesylate 800 mg/d (400 mg twice daily) versus 400 mg/d in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Patients and Methods A total of 476 patients were randomly assigned 2:1 to imatinib 800 mg (n = 319) or 400 mg (n = 157) daily. The primary end point was the major molecular response (MMR) rate at 12 months. Results At 12 months, differences in MMR and complete cytogenetic response (CCyR) rates were not statistically significant (MMR, 46% v 40%; P = .2035; CCyR, 70% v 66%; P = .3470). However, MMR occurred faster among patients randomly assigned to imatinib 800 mg/d, who had higher rates of MMR at 3 and 6 months compared with those in the imatinib 400-mg/d arm (P = .0035 by log-rank test). CCyR also occurred faster in the 800-mg/d arm (CCyR at 6 months, 57% v 45%; P = .0146). The most common adverse events were edema, gastrointestinal problems, and rash, and all were more common in patients in the 800-mg/d arm. Grades 3 to 4 hematologic toxicity also occurred more frequently in patients receiving imatinib 800 mg/d. Conclusion MMR rates at 1 year were similar with imatinib 800 mg/d and 400 mg/d, but MMR and CCyR occurred earlier in patients treated with 800 mg/d. Continued follow-up is needed to determine the clinical significance of earlier responses on high-dose imatinib.</div>
</front>
</TEI>
<affiliations><list><country><li>Argentine</li>
<li>Australie</li>
<li>Brésil</li>
<li>Corée du Sud</li>
<li>France</li>
<li>Israël</li>
<li>Italie</li>
<li>Slovaquie</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><noCountry><name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name>
<name sortKey="Branford, Susan" sort="Branford, Susan" uniqKey="Branford S" first="Susan" last="Branford">Susan Branford</name>
<name sortKey="De Souza, Carmino" sort="De Souza, Carmino" uniqKey="De Souza C" first="Carmino" last="De Souza">Carmino De Souza</name>
<name sortKey="Druker, Brian J" sort="Druker, Brian J" uniqKey="Druker B" first="Brian J." last="Druker">Brian J. Druker</name>
<name sortKey="Goldberg, Stuart L" sort="Goldberg, Stuart L" uniqKey="Goldberg S" first="Stuart L." last="Goldberg">Stuart L. Goldberg</name>
<name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name>
<name sortKey="Hughes, Timothy P" sort="Hughes, Timothy P" uniqKey="Hughes T" first="Timothy P." last="Hughes">Timothy P. Hughes</name>
<name sortKey="Kalaycio, Matt" sort="Kalaycio, Matt" uniqKey="Kalaycio M" first="Matt" last="Kalaycio">Matt Kalaycio</name>
<name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name>
<name sortKey="Kim, Dong Wook" sort="Kim, Dong Wook" uniqKey="Kim D" first="Dong-Wook" last="Kim">Dong-Wook Kim</name>
<name sortKey="Krahnke, Tillmann" sort="Krahnke, Tillmann" uniqKey="Krahnke T" first="Tillmann" last="Krahnke">Tillmann Krahnke</name>
<name sortKey="Moiraghi, Beatriz" sort="Moiraghi, Beatriz" uniqKey="Moiraghi B" first="Beatriz" last="Moiraghi">Beatriz Moiraghi</name>
<name sortKey="Pane, Fabrizio" sort="Pane, Fabrizio" uniqKey="Pane F" first="Fabrizio" last="Pane">Fabrizio Pane</name>
<name sortKey="Pasquini, Ricardo" sort="Pasquini, Ricardo" uniqKey="Pasquini R" first="Ricardo" last="Pasquini">Ricardo Pasquini</name>
<name sortKey="Radich, Jerald P" sort="Radich, Jerald P" uniqKey="Radich J" first="Jerald P." last="Radich">Jerald P. Radich</name>
<name sortKey="Rowe, Jacob M" sort="Rowe, Jacob M" uniqKey="Rowe J" first="Jacob M." last="Rowe">Jacob M. Rowe</name>
<name sortKey="Rudoltz, Marc" sort="Rudoltz, Marc" uniqKey="Rudoltz M" first="Marc" last="Rudoltz">Marc Rudoltz</name>
<name sortKey="Tothova, Elena" sort="Tothova, Elena" uniqKey="Tothova E" first="Elena" last="Tothova">Elena Tothova</name>
<name sortKey="Yu, Richard" sort="Yu, Richard" uniqKey="Yu R" first="Richard" last="Yu">Richard Yu</name>
</noCountry>
<country name="États-Unis"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</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="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
<name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
<name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</country>
<country name="Italie"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</noRegion>
<name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</country>
<country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</noRegion>
</country>
<country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</region>
</country>
<country name="Brésil"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</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="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</country>
<country name="Argentine"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</noRegion>
</country>
<country name="Israël"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</noRegion>
</country>
<country name="Slovaquie"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Phase III, Randomized, Open-Label Study of Daily Imatinib Mesylate 400 mg Versus 800 mg in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase Using Molecular End Points: Tyrosine Kinase Inhibitor Optimization and Selectivity Study

Phase III, Randomized, Open-Label Study of Daily Imatinib Mesylate 400 mg Versus 800 mg in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase Using Molecular End Points: Tyrosine Kinase Inhibitor Optimization and Selectivity Study

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