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

Knauf, Wolfgang U.; Lissitchkov, Toshko; Aldaoud, Ali; Liberati, Anna M.; Loscertales, Javier; Herbrecht, Raoul; Juliusson, Gunnar LU ; Postner, Gerhard; Gercheva, Liana and Goranov, Stefan, et al. (2012) In British Journal of Haematology 159(1). p.67-77
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 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... (More)
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. (Less)
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published
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keywords
bendamustine, chlorambucil, chronic lymphocytic leukaemia, complete, response, overall survival
in
British Journal of Haematology
volume
159
issue
1
pages
67 - 77
publisher
Federation of European Neuroscience Societies and Blackwell Publishing Ltd
external identifiers
  • wos:000308871500009
  • scopus:84866314013
ISSN
0007-1048
DOI
10.1111/bjh.12000
language
English
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yes
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a5a99b51-cd94-461c-803e-d8b442bb90f4 (old id 3189801)
date added to LUP
2012-12-03 07:09:45
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2017-10-22 03:18:58
@article{a5a99b51-cd94-461c-803e-d8b442bb90f4,
  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 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&lt;0.0001; hazard ratio 2.83) and time to next treatment (31.7 vs 10.1months; P&lt;0.0001) were improved for bendamustine over chlorambucil. OS was not different between groups for all patients or those =65years, &gt;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.},
  author       = {Knauf, Wolfgang U. and Lissitchkov, Toshko and Aldaoud, Ali and Liberati, Anna M. and Loscertales, Javier and Herbrecht, Raoul and Juliusson, Gunnar and Postner, Gerhard and Gercheva, Liana and Goranov, Stefan and Becker, Martin and Fricke, Hans-Joerg and Huguet, Francoise and Del Giudice, Ilaria and Klein, Peter and Merkle, Karlheinz and Montillo, Marco},
  issn         = {0007-1048},
  keyword      = {bendamustine,chlorambucil,chronic lymphocytic leukaemia,complete,response,overall survival},
  language     = {eng},
  number       = {1},
  pages        = {67--77},
  publisher    = {Federation of European Neuroscience Societies and Blackwell Publishing Ltd},
  series       = {British Journal of Haematology},
  title        = {Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial},
  url          = {http://dx.doi.org/10.1111/bjh.12000},
  volume       = {159},
  year         = {2012},
}