High-vs low-dose cytarabine combined with interferon alfa in patients with first chronic phase chronic myeloid leukemia. A prospective randomized phase III study

被引:0
作者
W. Deenik
B. van der Holt
G. E. G. Verhoef
A. V. M. B. Schattenberg
L. F. Verdonck
S. M. G. J. Daenen
P. Zachée
P. H. M. Westveer
W. M. Smit
S. Wittebol
H. C. Schouten
B. Löwenberg
G. J. Ossenkoppele
J. J. Cornelissen
机构
[1] Erasmus University Medical Center/Daniel den Hoed,Department of Hematology
[2] University Hospital Gasthuisberg,undefined
[3] University Medical Center Nijmegen,undefined
[4] University Medical Center Utrecht,undefined
[5] University Medical Center Groningen,undefined
[6] University Hospital Antwerp,undefined
[7] Medical Spectrum Twente,undefined
[8] Meander Medical Center,undefined
[9] University Hospital Maastricht,undefined
[10] Free University Medical Center,undefined
[11] HOVON Data Center,undefined
来源
Annals of Hematology | 2007年 / 86卷
关键词
Chronic myeloid leukemia; Cytarabine; Interferon alfa; Allogeneic stem cell transplantation; Cytogenetic response;
D O I
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摘要
A prospective randomized phase III study was performed to evaluate whether intensified cytarabine would induce a higher response rate and longer event-free interval as compared to low-dose cytarabine in chronic myeloid leukemia (CML). One hundred and eighteen patients with CML in early chronic phase entered the study. Twenty-eight out of 32 patients assigned to group A received two cycles of a combination of intensified cytarabine and idarubicin followed by interferon alfa (IFN-α) maintenance, 28 patients in group B received standard treatment by a combination of low-dose cytarabine and IFN-α. Forty-nine patients with a human leukocyte antigen-identical sibling donor proceeded to allogeneic stem cell transplantation (allo-SCT) and nine patients were excluded from the analysis. Hematological response was observed in 97% of the patients in group A vs 86% of the patients in group B during the first year of treatment. In group A, 16 patients (50%) achieved a major cytogenetic response, which compared to seven patients (25%) with a major cytogenetic response in group B. With a median follow-up of 58 months (range 34–76), event-free survival was not significantly different between arms A and B. The estimated 5-year survival rate was 56% in the intensified arm and 77% in the low-dose arm (P = 0.05). Recipients of allo-SCT showed a 5-year estimated survival rate of 55%. Although intensified cytarabine induced a higher initial percentage of major and complete cytogenetic responses, responses were not sustained by IFN-α maintenance therapy.
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页码:117 / 125
页数:8
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