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

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

Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Combined Modality Therapy, Europe, Female, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Survival Rate, Transplantation, Autologous, Treatment Outcome, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
0006-4971
1516-21
Michallet, Mauricette
3454f183-4456-461e-a735-da1109e3240b
Dreger, Peter
4974057a-734a-4cc4-b27b-7142a3ed1e3c
Sutton, Laurent
72c11926-3f87-4572-bf90-13cce6bfd212
Brand, Ronald
7949e68c-e9b7-462e-9e42-0920d4be65a9
Richards, Sue
c6716b3c-db48-40e3-a714-219bb8aa91c5
van Os, Marleen
a58ef45d-7894-43dc-bc56-dc2aeec4ffb4
Sobh, Mohamad
12b4b9ec-9166-44e1-a7bf-a988dd87d0c1
Choquet, Sylvain
9945ae05-a794-44cc-a430-a427d4071a71
Corront, Bernadette
d545bcfe-8ff5-4dd8-923f-88e380b28c83
Dearden, Claire
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Gratwohl, Alois
8e05a04a-10ac-436f-906a-81cc024be11a
Herr, Wolfgang
659e8a16-2ca3-4d82-95db-891519bc78f6
Catovsky, Daniel
0c2a5c78-d841-456e-88c7-581850d4e80a
Hallek, Michael
a89a1dba-2fe4-4361-898e-3189e113417d
de Witte, Theo
0c2b1cc7-b871-4ce6-9ab6-0658061d8402
Niederwieser, Dietger
1d5f45bf-6493-4635-ba0d-258e90c61cc6
Leporrier, Michel
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Milligan, Donald
8b40f81d-a5ba-467f-a944-c127256174d3
Orchard, Kim
794654ab-d6cc-488a-ac11-c9217433c7a2
EBMT Chronic Leukemia Working Party
Michallet, Mauricette
3454f183-4456-461e-a735-da1109e3240b
Dreger, Peter
4974057a-734a-4cc4-b27b-7142a3ed1e3c
Sutton, Laurent
72c11926-3f87-4572-bf90-13cce6bfd212
Brand, Ronald
7949e68c-e9b7-462e-9e42-0920d4be65a9
Richards, Sue
c6716b3c-db48-40e3-a714-219bb8aa91c5
van Os, Marleen
a58ef45d-7894-43dc-bc56-dc2aeec4ffb4
Sobh, Mohamad
12b4b9ec-9166-44e1-a7bf-a988dd87d0c1
Choquet, Sylvain
9945ae05-a794-44cc-a430-a427d4071a71
Corront, Bernadette
d545bcfe-8ff5-4dd8-923f-88e380b28c83
Dearden, Claire
820743d1-e8d6-4f70-8f75-31415d5f210f
Gratwohl, Alois
8e05a04a-10ac-436f-906a-81cc024be11a
Herr, Wolfgang
659e8a16-2ca3-4d82-95db-891519bc78f6
Catovsky, Daniel
0c2a5c78-d841-456e-88c7-581850d4e80a
Hallek, Michael
a89a1dba-2fe4-4361-898e-3189e113417d
de Witte, Theo
0c2b1cc7-b871-4ce6-9ab6-0658061d8402
Niederwieser, Dietger
1d5f45bf-6493-4635-ba0d-258e90c61cc6
Leporrier, Michel
e4f1f34c-8788-44f8-8c75-502757a8dd29
Milligan, Donald
8b40f81d-a5ba-467f-a944-c127256174d3
Orchard, Kim
794654ab-d6cc-488a-ac11-c9217433c7a2

Michallet, Mauricette, Dreger, Peter, Sutton, Laurent, Brand, Ronald, Richards, Sue, van Os, Marleen, Sobh, Mohamad, Choquet, Sylvain, Corront, Bernadette, Dearden, Claire, Gratwohl, Alois, Herr, Wolfgang, Catovsky, Daniel, Hallek, Michael, de Witte, Theo, Niederwieser, Dietger, Leporrier, Michel, Milligan, Donald and Orchard, Kim , EBMT Chronic Leukemia Working Party (2011) Autologous hematopoietic stem cell transplantation in chronic lymphocytic leukemia: results of European intergroup randomized trial comparing autografting versus observation. Blood, 117 (5), 1516-21. (doi:10.1182/blood-2010-09-308775).

Record type: Article

Abstract

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.

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More information

Published date: 3 February 2011
Keywords: Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Combined Modality Therapy, Europe, Female, Hematopoietic Stem Cell Transplantation, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Middle Aged, Survival Rate, Transplantation, Autologous, Treatment Outcome, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial

Identifiers

Local EPrints ID: 413219
URI: http://eprints.soton.ac.uk/id/eprint/413219
ISSN: 0006-4971
PURE UUID: d5119c0b-eb09-4b33-bf06-a07fe797ecef
ORCID for Kim Orchard: ORCID iD orcid.org/0000-0003-2276-3925

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Date deposited: 17 Aug 2017 16:30
Last modified: 16 Mar 2024 03:26

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Contributors

Author: Mauricette Michallet
Author: Peter Dreger
Author: Laurent Sutton
Author: Ronald Brand
Author: Sue Richards
Author: Marleen van Os
Author: Mohamad Sobh
Author: Sylvain Choquet
Author: Bernadette Corront
Author: Claire Dearden
Author: Alois Gratwohl
Author: Wolfgang Herr
Author: Daniel Catovsky
Author: Michael Hallek
Author: Theo de Witte
Author: Dietger Niederwieser
Author: Michel Leporrier
Author: Donald Milligan
Author: Kim Orchard ORCID iD
Corporate Author: EBMT Chronic Leukemia Working Party

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