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Autologous hematopoietic stem cell transplantation in chronic lymphocytic leukemia: results of European intergroup randomized trial comparing autografting versus observation

We present results of a phase 3 randomized trial of autografting in chronic lymphocytic leukemia versus observation for responding patients after first- or second-line treatment. The primary objective was to demonstrate that autografting improves the 5-year event-free survival (EFS) from 30% to 50%....

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Main Authors: Michallet, Mauricette (Author) , Dreger, Peter (Author) , Sutton, Laurent (Author) , Brand, Ronald (Author) , Richards, Sue (Author) , van Os, Marleen (Author) , Sobh, Mohamad (Author) , Choquet, Sylvain (Author) , Corront, Bernadette (Author) , Dearden, Claire (Author) , Gratwohl, Alois (Author) , Herr, Wolfgang (Author) , Catovsky, Daniel (Author) , Hallek, Michael (Author) , de Witte, Theo (Author) , Niederwieser, Dietger (Author) , Leporrier, Michel (Author) , Milligan, Donald (Author)
Format: Article (Journal)
Language:English
Published: 2011
In: Blood
Year: 2011, Volume: 117, Issue: 5, Pages: 1516-1521
ISSN:1528-0020
DOI:10.1182/blood-2010-09-308775
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1182/blood-2010-09-308775
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Author Notes:Mauricette Michallet, Peter Dreger, Laurent Sutton, Ronald Brand, Sue Richards, Marleen van Os, Mohamad Sobh, Sylvain Choquet, Bernadette Corront, Claire Dearden, Alois Gratwohl, Wolfgang Herr, Daniel Catovsky, Michael Hallek, Theo de Witte, Dietger Niederwieser, Michel Leporrier, and Donald Milligan, on behalf of the EBMT Chronic Leukemia Working Party
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Summary:We present results of a phase 3 randomized trial of autografting in chronic lymphocytic leukemia versus observation for responding patients after first- or second-line treatment. The primary objective was to demonstrate that autografting improves the 5-year event-free survival (EFS) from 30% to 50%. There were 223 enrolled patients, 72% men and 28% women, 83% after first and 17% after second-line treatment. Binet stages were progressive A 13%, B 67%, C 20%; at randomization, 59% were in complete remission, and 41% in less than complete remission. Patients were randomized between autografting (n = 112) and observation (n = 111). Median EFS was 24.4 months (range, 16.7-32 months) in the observation group and 51.2 months (39.8-62.5 months) in the autografting group; the 5-year EFS was 24% and 42%, respectively (P < .001). Accordingly, the 5-year relapse incidence was 76% versus 54% (P < .001). Median time to relapse requiring therapy or death was 40 months (25-56 months) in the observation arm and 65 months (59-71 months) after autografting (P = .002). Cox modeling confirmed that autografting significantly improved EFS (hazard ratio 0.44, 95% confidence interval 0.30-0.65; P < .001). At 5 years, the probability of OS was 85.5% and 84.3% for autografting and observation, respectively (P = .77). In chronic lymphocytic leukemia, consolidating autografting reduces the risk of progression by more than 50% but has no effect on overall survival.
Item Description:Prepublished online as Blood First Edition paper, November 24, 2010
Gesehen am 19.08.2022
Physical Description:Online Resource
ISSN:1528-0020
DOI:10.1182/blood-2010-09-308775

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