AustralieFrV1, Main, Exploration, bibRecord, 007B76

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 : 007B76 ( Main/Exploration ); précédent : 007B75; suivant : 007B77

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 ; 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 ] ; 2009.

RBID : PMC:4979244

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.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4979244

DOI: 10.1200/JCO.2009.25.3724
PubMed: 20008622
PubMed Central: 4979244

Affiliations:

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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</title>
<author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
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<author><name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
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<author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
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<author><name sortKey="Druker, Brian J" sort="Druker, Brian J" uniqKey="Druker B" first="Brian J." last="Druker">Brian J. Druker</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
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<author><name sortKey="Branford, Susan" sort="Branford, Susan" uniqKey="Branford S" first="Susan" last="Branford">Susan Branford</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
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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>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
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<author><name sortKey="Pane, Fabrizio" sort="Pane, Fabrizio" uniqKey="Pane F" first="Fabrizio" last="Pane">Fabrizio Pane</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
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<author><name sortKey="Pasquini, Ricardo" sort="Pasquini, Ricardo" uniqKey="Pasquini R" first="Ricardo" last="Pasquini">Ricardo Pasquini</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
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<author><name sortKey="Goldberg, Stuart L" sort="Goldberg, Stuart L" uniqKey="Goldberg S" first="Stuart L." last="Goldberg">Stuart L. Goldberg</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Kalaycio, Matt" sort="Kalaycio, Matt" uniqKey="Kalaycio M" first="Matt" last="Kalaycio">Matt Kalaycio</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Moiraghi, Beatriz" sort="Moiraghi, Beatriz" uniqKey="Moiraghi B" first="Beatriz" last="Moiraghi">Beatriz Moiraghi</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Rowe, Jacob M" sort="Rowe, Jacob M" uniqKey="Rowe J" first="Jacob M." last="Rowe">Jacob M. Rowe</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Tothova, Elena" sort="Tothova, Elena" uniqKey="Tothova E" first="Elena" last="Tothova">Elena Tothova</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="De Souza, Carmino" sort="De Souza, Carmino" uniqKey="De Souza C" first="Carmino" last="De Souza">Carmino De Souza</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Rudoltz, Marc" sort="Rudoltz, Marc" uniqKey="Rudoltz M" first="Marc" last="Rudoltz">Marc Rudoltz</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Yu, Richard" sort="Yu, Richard" uniqKey="Yu R" first="Richard" last="Yu">Richard Yu</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Krahnke, Tillmann" sort="Krahnke, Tillmann" uniqKey="Krahnke T" first="Tillmann" last="Krahnke">Tillmann Krahnke</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
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<idno type="wicri:Area/Main/Exploration">007B76</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">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</title>
<author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Branford, Susan" sort="Branford, Susan" uniqKey="Branford S" first="Susan" last="Branford">Susan Branford</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Pane, Fabrizio" sort="Pane, Fabrizio" uniqKey="Pane F" first="Fabrizio" last="Pane">Fabrizio Pane</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Pasquini, Ricardo" sort="Pasquini, Ricardo" uniqKey="Pasquini R" first="Ricardo" last="Pasquini">Ricardo Pasquini</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Goldberg, Stuart L" sort="Goldberg, Stuart L" uniqKey="Goldberg S" first="Stuart L." last="Goldberg">Stuart L. Goldberg</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Kalaycio, Matt" sort="Kalaycio, Matt" uniqKey="Kalaycio M" first="Matt" last="Kalaycio">Matt Kalaycio</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Moiraghi, Beatriz" sort="Moiraghi, Beatriz" uniqKey="Moiraghi B" first="Beatriz" last="Moiraghi">Beatriz Moiraghi</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Rowe, Jacob M" sort="Rowe, Jacob M" uniqKey="Rowe J" first="Jacob M." last="Rowe">Jacob M. Rowe</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Tothova, Elena" sort="Tothova, Elena" uniqKey="Tothova E" first="Elena" last="Tothova">Elena Tothova</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="De Souza, Carmino" sort="De Souza, Carmino" uniqKey="De Souza C" first="Carmino" last="De Souza">Carmino De Souza</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Rudoltz, Marc" sort="Rudoltz, Marc" uniqKey="Rudoltz M" first="Marc" last="Rudoltz">Marc Rudoltz</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Yu, Richard" sort="Yu, Richard" uniqKey="Yu R" first="Richard" last="Yu">Richard Yu</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Krahnke, Tillmann" sort="Krahnke, Tillmann" uniqKey="Krahnke T" first="Tillmann" last="Krahnke">Tillmann Krahnke</name>
<affiliation><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</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><nlm:aff id="aff1">From the University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Bologna, Instituto de Emotologia L. e A. Seràgnoli, Bologna; University of Naples, Naples, Italy; Clinical Investigation Centre 802 INSERM, CHU de Poitiers, Poitiers, France; Oregon Health Sciences University Knight Cancer Institute, Portland, OR; SA Pathology, Royal Adelaide Hospital, Adelaide, Australia; Seoul St Mary's Hospital, Catholic University of Korea, Seoul, Korea; Hospital De Clinicas De Curitiba, Parana; Hospital de Clinicas da UNICAMP, Campinas, Brazil; The Cancer Center, Hackensack University Medical Center, Hackensack; Novartis Pharmaceuticals, East Hanover, NJ; Cleveland Clinic Foundation, Cleveland, OH; Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina; Rambam Medical Center, Haifa, Israel; Hospital University of PJS, Kosice, Slovakia; Novartis Pharma AG, Basel, Switzerland; and Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:aff>
<wicri:noCountry code="subfield">WA.</wicri:noCountry>
</affiliation>
</author>
</analytic>
<series><title level="j">Journal of Clinical Oncology</title>
<idno type="ISSN">0732-183X</idno>
<idno type="eISSN">1527-7755</idno>
<imprint><date when="2009">2009</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Purpose</title>
<p>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.</p>
</sec>
<sec><title>Patients and Methods</title>
<p>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.</p>
</sec>
<sec><title>Results</title>
<p>At 12 months, differences in MMR and complete cytogenetic response (CCyR) rates were not statistically significant (MMR, 46% <italic>v</italic>
 40%; <italic>P</italic>
 = .2035; CCyR, 70% <italic>v</italic>
 66%; <italic>P</italic>
 = .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 (<italic>P</italic>
 = .0035 by log-rank test). CCyR also occurred faster in the 800-mg/d arm (CCyR at 6 months, 57% <italic>v</italic>
 45%; <italic>P</italic>
 = .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.</p>
</sec>
<sec><title>Conclusion</title>
<p>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.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list></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="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E." last="Cortes">Jorge E. Cortes</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>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 007B76 | SxmlIndent | more

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{{Explor lien
   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     PMC:4979244
   |texte=   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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       | NlmPubMed2Wicri -a AustralieFrV1

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024

Serveur d'exploration sur les relations entre la France et l'Australie

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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Abstract

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	Serveur d'exploration sur les relations entre la France et l'Australie
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