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Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial

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Author

  • Wolfgang U. Knauf
  • Toshko Lissitchkov
  • Ali Aldaoud
  • Anna M. Liberati
  • Javier Loscertales
  • Raoul Herbrecht
  • Gunnar Juliusson
  • Gerhard Postner
  • Liana Gercheva
  • Stefan Goranov
  • Martin Becker
  • Hans-Joerg Fricke
  • Francoise Huguet
  • Ilaria Del Giudice
  • Peter Klein
  • Karlheinz Merkle
  • Marco Montillo
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Summary, in English

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 54months 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 8.8months; P<0.0001; hazard ratio 2.83) and time to next treatment (31.7 vs 10.1months; P<0.0001) were improved for bendamustine over chlorambucil. OS was not different between groups for all patients or those =65years, >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.

Publishing year

2012

Language

English

Pages

67-77

Publication/Series

British Journal of Haematology

Volume

159

Issue

1

Document type

Journal article

Publisher

Wiley-Blackwell

Topic

  • Hematology

Keywords

  • bendamustine
  • chlorambucil
  • chronic lymphocytic leukaemia
  • complete
  • response
  • overall survival

Status

Published

ISBN/ISSN/Other

  • ISSN: 0007-1048