title: Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial.
abstract: The efficacy of bendamustine versus chlorambucil in a phase III trial of previously untreated patients with Binet stage B/C chronic lymphocytic leukaemia (CLL) was re-evaluated after a median observation time of 54 months in May 2010. Overall survival (OS) was analysed for the first time. At follow-up, investigator-assessed complete response (CR) rate (21·0% vs 10·8%), median progression-free survival (21·2 vs 8·8 months; P < 0·0001; hazard ratio 2·83) and time to next treatment (31·7 vs 10·1 months; P < 0·0001) were improved for bendamustine over chlorambucil. OS was not different between groups for all patients or those ≤65 years, >65 years, responders and non-responders. However, patients with objective response or a CR experienced a significantly longer OS than non-responders or those without a CR. Significantly more patients on chlorambucil progressed to second/further lines of treatment compared with those on bendamustine (78·3% vs 63·6%; P = 0·004). The benefits of bendamustine over chlorambucil were achieved without reducing quality of life. In conclusion, bendamustine is significantly more effective than chlorambucil in previously untreated CLL patients, with the achievement of a CR or objective response appearing to prolong OS. Bendamustine should be considered as a preferred first-line option over chlorambucil for CLL patients ineligible for fludarabine, cyclophosphamide and rituximab.
authors.affiliation: Onkologische Gemeinschaftspraxis, Frankfurt, Germany. Wolfgang.Knauf@telemed.de
authors.forename: Wolfgang U
authors.initials: WU
authors.lastname: Knauf
authors.forename: Toshko
authors.initials: T
authors.lastname: Lissitchkov
authors.forename: Ali
authors.initials: A
authors.lastname: Aldaoud
authors.forename: Anna M
authors.initials: AM
authors.lastname: Liberati
authors.forename: Javier
authors.initials: J
authors.lastname: Loscertales
authors.forename: Raoul
authors.initials: R
authors.lastname: Herbrecht
authors.forename: Gunnar
authors.initials: G
authors.lastname: Juliusson
authors.forename: Gerhard
authors.initials: G
authors.lastname: Postner
authors.forename: Liana
authors.initials: L
authors.lastname: Gercheva
authors.forename: Stefan
authors.initials: S
authors.lastname: Goranov
authors.forename: Martin
authors.initials: M
authors.lastname: Becker
authors.forename: Hans-Joerg
authors.initials: HJ
authors.lastname: Fricke
authors.forename: Francoise
authors.initials: F
authors.lastname: Huguet
authors.forename: Ilaria
authors.initials: I
authors.lastname: Del Giudice
authors.forename: Peter
authors.initials: P
authors.lastname: Klein
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Merkle
authors.forename: Marco
authors.initials: M
authors.lastname: Montillo
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D002699:Chlorambucil / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018906:Antineoplastic Agents, Alkylating; D009588:Nitrogen Mustard Compounds; D002699:Chlorambucil; D000069461:Bendamustine Hydrochloride