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.
Subject(s)
Antineoplastic Agents, Alkylating/therapeutic use , Chlorambucil/therapeutic use , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Nitrogen Mustard Compounds/therapeutic use , Antineoplastic Agents, Alkylating/adverse effects , Bendamustine Hydrochloride , Chlorambucil/adverse effects , Disease-Free Survival , Female , Humans , Male , Middle Aged , Nitrogen Mustard Compounds/adverse effectsABSTRACT
PURPOSE: This randomized, open-label, parallel-group, multicenter study was designed to compare the efficacy and safety of bendamustine and chlorambucil in previously untreated patients with advanced (Binet stage B or C) chronic lymphocytic leukemia (CLL). PATIENTS AND METHODS: Patients (Subject(s)
Chlorambucil/therapeutic use
, Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy
, Nitrogen Mustard Compounds/therapeutic use
, Adult
, Aged
, Antineoplastic Agents/adverse effects
, Antineoplastic Agents/therapeutic use
, Bendamustine Hydrochloride
, Chlorambucil/adverse effects
, Disease-Free Survival
, Female
, Fever/chemically induced
, Follow-Up Studies
, Humans
, Male
, Middle Aged
, Nausea/chemically induced
, Neutropenia/chemically induced
, Nitrogen Mustard Compounds/adverse effects
, Thrombocytopenia/chemically induced
, Time Factors
, Treatment Outcome