title: Efficacy and safety of fludarabine and cyclophosphamide combined therapy in patients with refractory/recurrent B-cell chronic lymphocytic leukaemia (B-CLL)-Polish multicentre study.
abstract: The aim of this study was to investigate the efficacy of a combination of fludarabine (F) and cyclophosphamide (C) in the treatment of patients with refractory/recurrent B-cell chronic lymphocytic leukaemia (B-CLL). Between November 1999 and December 2001, 63 patients with B-CLL (median age 60 years) received a regimen that consisted of F 25 mg/m2 and C 250 mg/m2, days 1-3, intravenously, every 4 weeks, for a maximum of 6 courses, Response and toxicity were assessed according to current criteria (NCI-WG and WHO). Complete and partial remissions were achieved in 17.5% and 55.6% of patients, respectively; 19% of patients had stable disease and 7.9% of patients showed disease progression. The median follow-up was 16.5 (range 1.5-32) months. The median duration of progression-free survival (PFS) has not been reached among patients treated with FC regimen as second-line therapy. The median PFS was 13 (range 8-26) months in the 19 responding patients treated with FC regimen as third-line therapy. The most frequent side-effects were neutropenia (45%), thrombocytopenia (42%) and infections (57%). We conclude that the combination of fludarabine and cyclophosphamide demonstrated significant efficacy in pretreated, advanced B-CLL patients, with tolerable toxicity.
authors.affiliation: Department of Hematooncology, Medical University in Lublin, Poland. gogakahemat@o2.pl
authors.forename: M
authors.initials: M
authors.lastname: Kowal
authors.forename: A
authors.initials: A
authors.lastname: Dmoszyńska
authors.forename: K
authors.initials: K
authors.lastname: Lewandowski
authors.forename: A
authors.initials: A
authors.lastname: Hellmann
authors.forename: J
authors.initials: J
authors.lastname: Wegrzyn
authors.forename: A B
authors.initials: AB
authors.lastname: Skotnicki
authors.forename: D
authors.initials: D
authors.lastname: Wołowiec
authors.forename: K
authors.initials: K
authors.lastname: Kuliczkowski
authors.forename: J
authors.initials: J
authors.lastname: Piszcz
authors.forename: J
authors.initials: J
authors.lastname: Kłoczko
authors.forename: K
authors.initials: K
authors.lastname: Roznowski
authors.forename: M
authors.initials: M
authors.lastname: Komarnicki
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011044:Poland / Q000453:epidemiology; D012449:Safety; D015996:Survival Rate; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine