Efficacy and toxicity of IFN-α2b combined with cytarabine in chronic myelogenous leukaemia

M. Lindauer, D. Domkin, H. Döhner, H. J. Kolb, A. Neubauer, D. Huhn, H. Kreiter, B. Koch, Ch Huber, W. Aulitzky, T. Fischer

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22 Scopus citations


Newly diagnosed chronic myelogenous leukaemia (CML) patients (n = 65) were treated with interferon (IFN)α2b (5 x 106 IU/d s.c.) combined with monthly courses of cytarabine (20 mg/d s.c. for 14 d). Median age of patients enrolled was 45 years. The endpoints of the study were clinical efficacy and toxicity. The survival rates at 3 years and 5 years were 77% and 56%, respectively. The rate of complete haematological response was 60%. Evaluation of cytogenetic response was available in 29/65 patients. A complete cytogenetic response was seen in 3/29 patients (10%). W.H.O. toxicity grade 3-4 occurred in only 22/523 evaluable treatment cycles. Since the study protocol required intermittent or definitive discontinuation of cytarabine in case of moderate leucopenia (white blood cells (WBC) <5 x 109/l), combined cytopenia (WBC < 5 x 109/l, platelets <100 x 109/l), and isolated moderate thrombocytopenia (<100 x 109/l), the drug had to be discontinued temporarily or definitively in 200 cycles and the dose of cytarabine had to be reduced in 35 cycles. Thus, only 25% of the planned dose of cytarabine could be administered. At this dosage it would appear that cytarabine had no effect on survival and did not improve remission rates. We conclude that a clinical benefit for the addition of cytarabine to the treatment of CML with IFN might only be achieved by the administration of a higher cumulative dose of cytarabine, suggesting that lower leucocyte counts of 2-4 x 109/l have to be tolerated.

Original languageEnglish
Pages (from-to)1013-1019
Number of pages7
JournalBritish Journal of Haematology
Issue number4
StatePublished - 1999
Externally publishedYes


  • CML treatment
  • Clinical responsiveness
  • Cytosine-arabinoside therapy
  • IFN-alpha therapy
  • Toxicity


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