Journal of Clinical Oncology, Vol 14, 2160-2166, Copyright © 1996 by American Society of Clinical Oncology
Oral cladribine as primary therapy for patients with B-cell chronic lymphocytic leukemia
G Juliusson, I Christiansen, MM Hansen, S Johnson, E Kimby, A Elmhorn- Rosenborg and J Liliemark
Department of Hematology, University Hospital, Linkoping, Sweden. Gunnar.Juliusson@Hem.US.LiO.Se
PURPOSE: Purine analogs have wide potential indications in the treatment of
hematologic malignancies, but intravenous administration has been required.
We previously established that the oral bioavailability of cladribine is
50%. Our aim was to evaluate the efficacy and toxicity of oral cladribine
to previously untreated patients with chronic lymphocytic leukemia (CLL).
PATIENTS AND METHODS: Sixty-three patients with symptomatic but previously
untreated CLL received cladribine solution 10 mg/m2/d orally for 5
consecutive days in monthly courses. RESULTS: Complete remission (CR) was
achieved in 24 patients (38%), and 23 patients (37%) had a partial response
(PR). Most patients, including those in whom there was no remission (NR)
achieved normal blood lymphocyte counts. Failure to meet response criteria
was mostly due to thrombocytopenia. The median response duration was not
reached at 2 years. The median survival time among 13 deceased patients was
322 days, whereas the median observation time of surviving patients is 760
days. The overall survival rate at 2 years is 82%. Response rate was
associated with clinical stage. Grade III to IV infectious toxicity
occurred in one third of patients. CONCLUSION: Orally administered
cladribine is an effective and feasible therapy for CLL, and produces
durable remissions in three quarters of the patients. However, significant
toxicity may occur and further studies are required to assess long-term
effects and quality-of-life aspects.
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