Purpose: To evaluate the clinical efficacy and safety of high-dose methylprednisolone (HDMP) in patients with fludarabine-refractory chronic lymphocytic leukaemia (CLL).
Methods: Twelve patients who were refractory to fludarabine-based treatment were treated with 2-6 cycles of HDMP (1g/m(2) for 5days).
Results: Ten patients (83.3%) responded to treatment and three (25.0%) achieved a complete remission (CR). Two (16.7%) of which had no evidence of minimal residual disease (MRD) after treatment. Patients with leukaemia cells that have high expression of ZAP-70 or CD38, unmutated immunoglobulin heavy chain variable region (IGHV), mutated p53 or adverse cytogenetic features achieved response to treatment at rates that appeared similar to those achieved by patients who did not have such disease characteristics. With a median follow-up of 13 (4-30) months, the median overall survival (OS) and the progression-free survival (PFS) have not been achieved. Treatment with HDMP was well tolerated, notably in the patients having poor myeloid reserve and pretreated cytopaenias.
Conclusions: HDMP is an effective non-myelotoxic regimen for the treatment of patients with fludarabine-refractory CLL.
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