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Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study.

Baccarani, Michele; Rosti, Gianantonio; Castagnetti, Fausto; Haznedaroglu, Ibrahim; Porkka, Kimmo; Abruzzese, Elisabetta; Alimena, Giuliana; Ehrencrona, Hans LU ; Hjorth-Hansen, Henrik and Kairisto, Veli, et al. (2009) In Blood 113(19). p.4497-4504
Abstract
Imatinib mesylate (IM), 400 mg daily, is the standard treatment of Philadelphia-positive (Ph(+)) chronic myeloid leukemia (CML). Preclinical data and results of single-arm studies raised the suggestion that better results could be achieved with a higher dose. To investigate whether the systematic use of a higher dose of IM could lead to better results, 216 patients with Ph(+) CML at high risk (HR) according to the Sokal index were randomly assigned to receive IM 800 mg or 400 mg daily, as front-line therapy, for at least 1 year. The CCgR rate at 1 year was 64% and 58% for the high-dose arm and for the standard-dose arm, respectively (P = .435). No differences were detectable in the CgR at 3 and 6 months, in the molecular response rate at... (More)
Imatinib mesylate (IM), 400 mg daily, is the standard treatment of Philadelphia-positive (Ph(+)) chronic myeloid leukemia (CML). Preclinical data and results of single-arm studies raised the suggestion that better results could be achieved with a higher dose. To investigate whether the systematic use of a higher dose of IM could lead to better results, 216 patients with Ph(+) CML at high risk (HR) according to the Sokal index were randomly assigned to receive IM 800 mg or 400 mg daily, as front-line therapy, for at least 1 year. The CCgR rate at 1 year was 64% and 58% for the high-dose arm and for the standard-dose arm, respectively (P = .435). No differences were detectable in the CgR at 3 and 6 months, in the molecular response rate at any time, as well as in the rate of other events. Twenty-four (94%) of 25 patients who could tolerate the full 800-mg dose achieved a CCgR, and only 4 (23%) of 17 patients who could tolerate less than 350 mg achieved a CCgR. This study does not support the extensive use of high-dose IM (800 mg daily) front-line in all CML HR patients. This trial was registered at www.clinicaltrials.gov as #NCT00514488. (Less)
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Middle Aged, Male, BCR-ABL Positive, Chronic, Myelogenous, Leukemia, Humans, bcr-abl, Fusion Proteins, Female, Europe, Drug, Dose-Response Relationship, Cytogenetic Analysis, 80 and over, Aged, Adolescent, Adult, Piperazines, Prognosis, Protein Kinase Inhibitors, Protein-Tyrosine Kinases, Pyrimidines, Risk Factors, Survival Rate, Treatment Outcome, Young Adult
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Blood
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113
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19
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4497 - 4504
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American Society of Hematology
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  • scopus:66549108340
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1528-0020
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English
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09ee5dff-c5d1-4763-9492-319c64effa59 (old id 4021771)
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http://dx.doi.org/10.1182/blood-2008-12-191254
http://www.ncbi.nlm.nih.gov/pubmed/19264678
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2013-10-21 10:55:22
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2017-12-03 03:47:18
@article{09ee5dff-c5d1-4763-9492-319c64effa59,
  abstract     = {Imatinib mesylate (IM), 400 mg daily, is the standard treatment of Philadelphia-positive (Ph(+)) chronic myeloid leukemia (CML). Preclinical data and results of single-arm studies raised the suggestion that better results could be achieved with a higher dose. To investigate whether the systematic use of a higher dose of IM could lead to better results, 216 patients with Ph(+) CML at high risk (HR) according to the Sokal index were randomly assigned to receive IM 800 mg or 400 mg daily, as front-line therapy, for at least 1 year. The CCgR rate at 1 year was 64% and 58% for the high-dose arm and for the standard-dose arm, respectively (P = .435). No differences were detectable in the CgR at 3 and 6 months, in the molecular response rate at any time, as well as in the rate of other events. Twenty-four (94%) of 25 patients who could tolerate the full 800-mg dose achieved a CCgR, and only 4 (23%) of 17 patients who could tolerate less than 350 mg achieved a CCgR. This study does not support the extensive use of high-dose IM (800 mg daily) front-line in all CML HR patients. This trial was registered at www.clinicaltrials.gov as #NCT00514488.},
  author       = {Baccarani, Michele and Rosti, Gianantonio and Castagnetti, Fausto and Haznedaroglu, Ibrahim and Porkka, Kimmo and Abruzzese, Elisabetta and Alimena, Giuliana and Ehrencrona, Hans and Hjorth-Hansen, Henrik and Kairisto, Veli and Levato, Luciano and Martinelli, Giovanni and Nagler, Arnon and Lanng Nielsen, Johan and Ozbek, Ugur and Palandri, Francesca and Palmieri, Fausto and Pane, Fabrizio and Rege-Cambrin, Giovanna and Russo, Domenico and Specchia, Giorgina and Testoni, Nicoletta and Weiss-Bjerrum, Ole and Saglio, Giuseppe and Simonsson, Bengt},
  issn         = {1528-0020},
  keyword      = {Middle Aged,Male,BCR-ABL Positive,Chronic,Myelogenous,Leukemia,Humans,bcr-abl,Fusion Proteins,Female,Europe,Drug,Dose-Response Relationship,Cytogenetic Analysis,80 and over,Aged,Adolescent,Adult,Piperazines,Prognosis,Protein Kinase Inhibitors,Protein-Tyrosine Kinases,Pyrimidines,Risk Factors,Survival Rate,Treatment Outcome,Young Adult},
  language     = {eng},
  number       = {19},
  pages        = {4497--4504},
  publisher    = {American Society of Hematology},
  series       = {Blood},
  title        = {Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study.},
  volume       = {113},
  year         = {2009},
}