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.
Författare
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.
Publiceringsår
2009
Språk
Engelska
Sidor
4497-4504
Publikation/Tidskrift/Serie
Blood
Volym
113
Issue
19
Länkar
Dokumenttyp
Artikel i tidskrift
Förlag
American Society of Hematology
Ämne
- Hematology
Nyckelord
- 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/Övrigt
- ISSN: 1528-0020