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

Abstract

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.

• Authors: 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
• Journal: Annals of hematology (Ann Hematol) Vol. 86 Issue 2 Pg. 117-25 (Feb 2007) ISSN: 1432-0584 [Electronic] Germany
• PMID: 17031690 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Interferon-alpha
• Cytarabine

Topics

• Adolescent
• Adult
• Aged
• Cytarabine (administration & dosage, therapeutic use)
• Cytogenetics
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Female
• Humans
• Interferon-alpha (adverse effects, therapeutic use)
• Leukemia, Myeloid, Chronic-Phase (drug therapy, genetics, pathology, surgery)
• Male
• Middle Aged
• Stem Cell Transplantation
• Survival Rate
• Transplantation, Homologous