title: Low-dose oral fludarabine plus cyclophosphamide in elderly patients with untreated and relapsed or refractory chronic lymphocytic Leukaemia.
abstract: Fludarabine plus cyclophosphamide (FC) at conventional doses is an effective treatment for chronic lymphocytic leukaemia (CLL). However, FC at standard doses may give hematological and non-hematological toxicity, predominantly in the elderly. Intravenous or oral low-dose FC regimens remain highly effective in elderly patients with Low-Grade Lymphomas other than CLL and are well tolerated. We tested efficacy and toxicity of oral FC at reduced doses in 26 elderly patients (median 71 years) with previously untreated (UT-CLL, n = 14) or relapsed/refractory CLL (R-CLL, n = 12), unfit for conventional treatments. Twentyfour-of-26 (92%) patients (14/14, 100% UT-CLL; 10/12, 83.5% R-CLL) obtained a response, with 12/26 (46%) complete responses (9/14, 64.2% in UT-CLL; 3/12, 25% in R-CLL). Non-hematological toxicity was mild and myelosuppression was documented in 8/26 (31%) patients (4/14, 28% UT-CLL; 4/12, 33% R-CLL). With a median follow-up of 24 months, median event-free survival was 48 months with no differences between UT-CLL and R-CLL and all responders were alive. Low-dose oral FC treatment showed good efficacy in both untreated and refractory/relapsed CLL. The treatment is useful in elderly patients who cannot benefit of more aggressive schedules and is easy to administer on an outpatient basis.
authors.affiliation: Ematologia e Trapianti, Università di Siena, AOUS, Italy. forconif@unisi.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Forconi
authors.forename: Alberto
authors.initials: A
authors.lastname: Fabbri
authors.forename: Mariapia
authors.initials: M
authors.lastname: Lenoci
authors.forename: Elisa
authors.initials: E
authors.lastname: Sozzi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gozzetti
authors.forename: Maristella
authors.initials: M
authors.lastname: Tassi
authors.forename: Donatella
authors.initials: D
authors.lastname: Raspadori
authors.forename: Francesco
authors.initials: F
authors.lastname: Lauria
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007108:Immune Tolerance; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D012008:Recurrence; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine