Fludarabine plus cyclophosphamide is an efficient treatment for advanced chronic lymphocytic leukaemia, (CLL): results of a phase II study of the German CLL Study Group

The efficacy and toxicity of a combination of fludarabine and cyclophospham ide (FC) was evaluated in patients with B-cell chronic lymphocytic leukaemi a (CLL). Between April 1997 and July 1998, 36 patients with. CLL (median ag e 59 years) received a regimen that consisted of fludarabine 30 mg/m(2) in a 30-min IV infusion, d 1-3, and cyclophosphamide 250 mg/m(2) in a 30-min I V infusion on d 1-3. Cycles were repeated every 28 d. Twenty-one patients h ad received between one and three different treatment regimens prior to the study, while 15 patients had received no prior therapy. The median Eastern Cooperative Oncology Group performance score was 1. One patient was at Bin et stage A, 18 were stage B and 17 patients were, stage C. Objective respon ses, assessed according to the revised guidelines of the National Cancer In stitute-sponsored Working Group, were recorded in 29 out of 32 assessable p atients (90.6%). Twenty-four partial remissions and five complete remission s were observed. Two patients showed no change and one patient showed disea se progression. At February 2000, three of the responders had relapsed. Sev ere neutropenia, anaemia and thrombocytopenia (Common Toxicity Criteria gra de 3 and 4) were observed in 25, six and six patients (69.4%, 16.7% and 16. 7%) respectively. Other side-effects were uncommon. No treatment-related de aths and no grade 3 or 4 infections occurred. We conclude that the combinat ion of fludarabine and cyclophosphamide showed significant activity in pati ents with CLL. Myelosuppression was the major side-effect. These results wa rrant further study on the FC combination in randomized trials.