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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.

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Author

  • Michele Baccarani
  • Gianantonio Rosti
  • Fausto Castagnetti
  • Ibrahim Haznedaroglu
  • Kimmo Porkka
  • Elisabetta Abruzzese
  • Giuliana Alimena
  • Hans Ehrencrona
  • Henrik Hjorth-Hansen
  • Veli Kairisto
  • Luciano Levato
  • Giovanni Martinelli
  • Arnon Nagler
  • Johan Lanng Nielsen
  • Ugur Ozbek
  • Francesca Palandri
  • Fausto Palmieri
  • Fabrizio Pane
  • Giovanna Rege-Cambrin
  • Domenico Russo
  • Giorgina Specchia
  • Nicoletta Testoni
  • Ole Weiss-Bjerrum
  • Giuseppe Saglio
  • Bengt Simonsson
Show all

Summary, in English

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.

Publishing year

2009

Language

English

Pages

4497-4504

Publication/Series

Blood

Volume

113

Issue

19

Document type

Journal article

Publisher

American Society of Hematology

Topic

  • Hematology

Keywords

  • 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

Status

Published

ISBN/ISSN/Other

  • ISSN: 1528-0020