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Autologous peripheral blood stem cell transplantation for acute myeloid leukemia


Vellenga, E; van Putten, W; Ossenkoppele, G J; Verdonck, L F; Theobald, L F; Cornelisson, J J; Huijgens, P C; Maertens, J; Gratwohl, A; Schaafsma, R; Schanz, U; Graux, C; Schouten, H C; Ferrant, A; Bargetzi, M; Fey, M F; Löwenberg, B (2011). Autologous peripheral blood stem cell transplantation for acute myeloid leukemia. Blood, 118(23):6037-6042.

Abstract

We report the results of a prospective, randomized phase 3 trial evaluating the use of autologous peripheral blood stem cell transplantation (ASCT) vs. intensive consolidation chemotherapy in newly diagnosed AML patients in complete remission (CR1). Patients with AML between 16-60 yrs of age in CR1 after two cycles of intensive chemotherapy and not eligible for allogeneic SCT were randomized between intensive chemotherapy with etoposide and mitoxantrone or ASCT following high-dose cyclophosphamide and busulfan. Of patients randomized (chemotherapy n=259; ASCT n=258), more than 90% received their assigned treatment arm. The two groups were comparable as regards prognostic factors. The ASCT group showed a markedly reduced relapse rate (58% vs. 70%, p=0.02) and better relapse free survival (RFS) at five years (38% vs. 29%, p= 0.065, HR 0.82 (0.66-1.1) with non-relapse mortality of 4% vs. 1% in the chemotherapy arm (p=0.02). Overall survival (OS) was similar (44% vs. 41% at 5 years, p=0.86) due to more opportunities for salvage with second-line chemotherapy and stem cell transplantation in patients relapsing on the chemotherapy arm. This large study shows a relapse advantage for ASCT as post remission therapy but similar survival since more relapsing patients on the chemotherapy arm were salvaged with a late transplantation for relapse. This trial is registered at http://www.trialregister.nl as NTR230 and NTR291.

Abstract

We report the results of a prospective, randomized phase 3 trial evaluating the use of autologous peripheral blood stem cell transplantation (ASCT) vs. intensive consolidation chemotherapy in newly diagnosed AML patients in complete remission (CR1). Patients with AML between 16-60 yrs of age in CR1 after two cycles of intensive chemotherapy and not eligible for allogeneic SCT were randomized between intensive chemotherapy with etoposide and mitoxantrone or ASCT following high-dose cyclophosphamide and busulfan. Of patients randomized (chemotherapy n=259; ASCT n=258), more than 90% received their assigned treatment arm. The two groups were comparable as regards prognostic factors. The ASCT group showed a markedly reduced relapse rate (58% vs. 70%, p=0.02) and better relapse free survival (RFS) at five years (38% vs. 29%, p= 0.065, HR 0.82 (0.66-1.1) with non-relapse mortality of 4% vs. 1% in the chemotherapy arm (p=0.02). Overall survival (OS) was similar (44% vs. 41% at 5 years, p=0.86) due to more opportunities for salvage with second-line chemotherapy and stem cell transplantation in patients relapsing on the chemotherapy arm. This large study shows a relapse advantage for ASCT as post remission therapy but similar survival since more relapsing patients on the chemotherapy arm were salvaged with a late transplantation for relapse. This trial is registered at http://www.trialregister.nl as NTR230 and NTR291.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Hematology
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:27 September 2011
Deposited On:01 Dec 2011 08:42
Last Modified:05 Apr 2016 15:07
Publisher:American Society of Hematology
ISSN:0006-4971
Additional Information:This research was originally published in Blood. 2011 Dec 1;118(23):6037-6042. Copyright by the American Society of Hematology
Publisher DOI:https://doi.org/10.1182/blood-2011-07-370247
PubMed ID:21951683

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