Effect and tolerability of combine therapy fludarabine plus cyclophosphamide in patients with B-chronic lymphocytic leukemia

Czech version

Authors: E. Tóthová; A. Kafková; T. Guman; M. Fričová; N. Štecová; E. Švorcová; M. Hlebašková
Authors‘ workplace: Klinika hematológie a onkohematológie Lekárskej fakulty UPJŠ a FNsP, Košice, Slovenská republika, prednosta prof. MUDr. Elena Tóthová, CSc.
Published in: Vnitř Lék 2005; 51(1): 31-35
Category: Original Contributions

Overview

Summary:
Introduction: Combined treatment of fludarabine (FLU) with cyclophosphamide (CY) may increase the complete remission (CR) rate, decreased minimal residual disease (MRD) and, possibly, prolong survival in B–chronic lymphocytic leukemia patients (B-CLL). The aim of study was to evaluate the activity and toxicity of FLU in combination with CY, the FLU-CY schedule, in patients with previously untreated B-CLL.

Material and methods:
From May 1999 to December 2003, 57 patients with advanced or progressive B-CLL, received treatment with FLU at a dose of 30 mg/m2 for three consecutive days and CY at a dose of 300 mg/m2 for three days. The cycles were repeated at four weeks intervals or longer if severe myelosuppression occurred. Guidelines for the evaluation of response and toxicity were those developed by the National Cancer Institute Sponsored Working Group. Minimal residual disease (MRD) was detected by immunophenotyping only in patients with CR standard criteria.

Results:
In the analyzed group an overall response (OR) rate of 86 % (95 % CI 80.6-94.7) was achieved, including complete response in 39 %. At the time of analysis 18/22 patients with CR are still in remission. Median duration of follow up in these is 19 (range 8-36) months. MRD was detected only in four patients with CR. Grade III/IV thrombocytopenia was seen in 3 (5.2 %) patients and grade III/IV neutropenia in 6 (10.5%). Severe infections were noted in 14 (24 %) patients. Two (3.5 %) patients died, one due to sepsis, one as a result of disease progression.

Conclusion:
The FLU-CY regimen is highly effective combination in previously untreated CLL patients with acceptable toxicity. The efficacy of the regimen seems to be higher than that observed earlier after treatment with FLU alone.

Key words:
chronic lymphocytic leukemia – fludarabine – cyclohosphamid – activity – toxicity

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