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

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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; Postner, Gerhard; Gercheva, Liana; Goranov, Stefan; Becker, Martin; Fricke, Hans-Joerg; Huguet, Francoise; Del Giudice, Ilaria; Klein, Peter; Merkle, Karlheinz; Montillo, Marco.

I: British Journal of Haematology, Vol. 159, Nr. 1, 2012, s. 67-77.

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

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Knauf, WU, Lissitchkov, T, Aldaoud, A, Liberati, AM, Loscertales, J, Herbrecht, R, Juliusson, G, Postner, G, Gercheva, L, Goranov, S, Becker, M, Fricke, H-J, Huguet, F, Del Giudice, I, Klein, P, Merkle, K & Montillo, M 2012, 'Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial', British Journal of Haematology, vol. 159, nr. 1, s. 67-77. https://doi.org/10.1111/bjh.12000

APA

CBE

Knauf WU, Lissitchkov T, Aldaoud A, Liberati AM, Loscertales J, Herbrecht R, Juliusson G, Postner G, Gercheva L, Goranov S, Becker M, Fricke H-J, Huguet F, Del Giudice I, Klein P, Merkle K, Montillo M. 2012. Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial. British Journal of Haematology. 159(1):67-77. https://doi.org/10.1111/bjh.12000

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Author

Knauf, Wolfgang U. ; Lissitchkov, Toshko ; Aldaoud, Ali ; Liberati, Anna M. ; Loscertales, Javier ; Herbrecht, Raoul ; Juliusson, Gunnar ; Postner, Gerhard ; Gercheva, Liana ; Goranov, Stefan ; Becker, Martin ; Fricke, Hans-Joerg ; Huguet, Francoise ; Del Giudice, Ilaria ; Klein, Peter ; Merkle, Karlheinz ; Montillo, Marco. / Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial. I: British Journal of Haematology. 2012 ; Vol. 159, Nr. 1. s. 67-77.

RIS

TY - JOUR

T1 - Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial

AU - Knauf, Wolfgang U.

AU - Lissitchkov, Toshko

AU - Aldaoud, Ali

AU - Liberati, Anna M.

AU - Loscertales, Javier

AU - Herbrecht, Raoul

AU - Juliusson, Gunnar

AU - Postner, Gerhard

AU - Gercheva, Liana

AU - Goranov, Stefan

AU - Becker, Martin

AU - Fricke, Hans-Joerg

AU - Huguet, Francoise

AU - Del Giudice, Ilaria

AU - Klein, Peter

AU - Merkle, Karlheinz

AU - Montillo, Marco

PY - 2012

Y1 - 2012

N2 - 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.

AB - 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.

KW - bendamustine

KW - chlorambucil

KW - chronic lymphocytic leukaemia

KW - complete

KW - response

KW - overall survival

U2 - 10.1111/bjh.12000

DO - 10.1111/bjh.12000

M3 - Article

VL - 159

SP - 67

EP - 77

JO - British Journal of Haematology

T2 - British Journal of Haematology

JF - British Journal of Haematology

SN - 0007-1048

IS - 1

ER -