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Title
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High-vs low-dose cytarabine combined with interferon alfa in patients with first chronic phase chronic myeloid leukemia : a prospective randomized phase III study
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Author
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Abstract
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| 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-alpha) maintenance, 28 patients in group B received standard treatment by a combination of low-dose cytarabine and IFN-alpha. 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-alpha maintenance therapy. |
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Language
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English
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Source (journal)
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Annals of hematology. - Berlin
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Publication
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Berlin
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2007
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ISSN
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0939-5555
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DOI
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10.1007/S00277-006-0186-1
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Volume/pages
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86
:2
(2007)
, p. 117-125
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ISI
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000243816000006
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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