title: Cladribine prolongs progression-free survival and time to second treatment compared to fludarabine and high-dose chlorambucil in chronic lymphocytic leukemia.
abstract: We conducted a randomized phase III trial to compare the efficacy and safety of two purine analogs, cladribine and fludarabine, with high-dose chlorambucil, in patients with previously untreated chronic lymphocytic leukemia (CLL). Between 1997 and 2004, 223 patients with CLL were randomly assigned to cladribine, fludarabine or chlorambucil, for six cycles of therapy with frequent health-related quality of life assessments. There was no statistical difference for the primary endpoint of overall response with cladribine (70%), fludarabine (67%) and chlorambucil (59%), or complete remission (12%, 7% and 8%), respectively. However, the median progression-free survival (25, 10, 9 months) and median time to second treatment (40, 22, 21 months) were superior with cladribine. There was no significant difference in overall survival (96, 82 and 91 months), nor in toxicity or HRQoL assessments. Monotherapy with cladribine gives superior PFS and longer response duration than fludarabine and chlorambucil as first-line treatment of CLL.
authors: Department of Haematology, Royal North Shore Hospital , Sydney , Australia.
authors: Stephen P
authors: SP
authors: Mulligan
authors: Karin
authors: K
authors: Karlsson
authors: Mats
authors: M
authors: Strömberg
authors: Viggo
authors: V
authors: Jønsson
authors: Devinder
authors: D
authors: Gill
authors: Jens
authors: J
authors: Hammerström
authors: Mark
authors: M
authors: Hertzberg
authors: Roger
authors: R
authors: McLennan
authors: Bertil
authors: B
authors: Uggla
authors: John
authors: J
authors: Norman
authors: Jonas
authors: J
authors: Wallvik
authors: Gunnel
authors: G
authors: Sundström
authors: Hemming
authors: H
authors: Johansson
authors: Yvonne
authors: Y
authors: Brandberg
authors: Jan
authors: J
authors: Liliemark
authors: Gunnar
authors: G
authors: Juliusson
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002699:Chlorambucil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017338:Cladribine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D019233:Retreatment; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D002699:Chlorambucil; D017338:Cladribine; D014740:Vidarabine; C024352:fludarabine
keywords: CLL; Lymphoid leukemia; chemotherapeutic approaches; pharmacotherapeutics