title: Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia.
abstract: Combination chemotherapy with fludarabine plus cyclophosphamide (FC) was compared with the standard regimen of fludarabine monotherapy in first-line treatment of younger patients with chronic lymphocytic leukemia (CLL). Between 1999 and 2003, a total of 375 patients younger than 66 years who predominantly had advanced CLL were randomly assigned to receive either fludarabine (25 mg/m(2) for 5 days intravenously, repeated every 28 days) or FC combination therapy (fludarabine 30 mg/m(2) plus cyclophosphamide 250 mg/m(2) for 3 days intravenously, repeated every 28 days). Both regimens were administered to a maximum of 6 courses. FC combination chemotherapy resulted in significantly higher complete remission rate (24%) and overall response rate (94%) compared with fludarabine alone (7% and 83%; P < .001 and P = .001). FC treatment also resulted in longer median progression-free survival (48 vs 20 months; P = .001) and longer treatment-free survival (37 vs 25 months; P < .001). Thus far, no difference in median overall survival has been observed. FC caused significantly more thrombocytopenia and leukocytopenia but did not increase the number of severe infections. In summary, first-line treatment with FC increases the response rates and the treatment-free interval in younger patients with advanced CLL.
authors.affiliation: Department of Internal Medicine I, University of Cologne, Kerpener Str 62, D-50924 Köln, Germany.
authors.forename: Barbara F
authors.initials: BF
authors.lastname: Eichhorst
authors.forename: Raymonde
authors.initials: R
authors.lastname: Busch
authors.forename: Georg
authors.initials: G
authors.lastname: Hopfinger
authors.forename: Rita
authors.initials: R
authors.lastname: Pasold
authors.forename: Manfred
authors.initials: M
authors.lastname: Hensel
authors.forename: Cordelia
authors.initials: C
authors.lastname: Steinbrecher
authors.forename: Siegfried
authors.initials: S
authors.lastname: Siehl
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jäger
authors.forename: Manuela
authors.initials: M
authors.lastname: Bergmann
authors.forename: Stephan
authors.initials: S
authors.lastname: Stilgenbauer
authors.forename: Carmen
authors.initials: C
authors.lastname: Schweighofer
authors.forename: Clemens M
authors.initials: CM
authors.lastname: Wendtner
authors.forename: Hartmut
authors.initials: H
authors.lastname: Döhner
authors.forename: Günter
authors.initials: G
authors.lastname: Brittinger
authors.forename: Bertold
authors.initials: B
authors.lastname: Emmerich
authors.forename: Michael
authors.initials: M
authors.lastname: Hallek
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007239:Infections / Q000209:etiology; D007262:Infusions, Intravenous; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D013921:Thrombocytopenia / Q000139:chemically induced; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine