Hematopoietic cell transplantation in patients with intermediate and high-risk AML: results from the randomized Study Alliance Leukemia (SAL) AML 2003 trial

Schetelig J, Schaich M, Schaefer-Eckart K, Haenel M, Aulitzky WE, Einsele H, Schmitz N, Rösler W, Stelljes M, Baldus CD, Ho AD, Neubauer A, Serve H, Mayer J, Berdel WE, Mohr B, Oelschlaegel U, Parmentier S, Roellig C, Kramer M, Platzbecker U, Illmer T, Thiede C, Bornhaeuser M, Ehninger G (2015)

Publication Type: Journal article

Publication year: 2015

Journal

Leukemia Springer Nature

Book Volume: 29

Pages Range: 1060-8

Journal Issue: 5

DOI: 10.1038/leu.2014.335

Abstract

The optimal timing of allogeneic hematopoietic stem cell transplantation (HCT) in acute myeloid leukemia (AML) is controversial. We report on 1179 patients with a median age of 48 years who were randomized upfront. In the control arm, sibling HCT was scheduled in the first complete remission for intermediate-risk or high-risk AML and matched unrelated HCT in complex karyotype AML. In the experimental arm, matched unrelated HCT in first remission was offered also to patients with an FLT3-ITD (FMS-like tyrosine kinase 3-internal tandem duplication) allelic ratio >0.8, poor day +15 marrow blast clearance and adverse karyotypes. Further, allogeneic HCT was recommended in high-risk AML to be performed in aplasia after induction chemotherapy. In the intent-to-treat (ITT) analysis, superiority of the experimental transplant strategy could not be shown with respect to overall survival (OS) or event-free survival. As-treated analyses suggest a profound effect of allogeneic HCT on OS (HR 0.73; P=0.002) and event-free survival (HR 0.67; P<0.001). In high-risk patients, OS was significantly improved after allogeneic HCT in aplasia (HR 0.64; P=0.046) and after HCT in remission (HR 0.74; P=0.03). Although superiority of one study arm could not be demonstrated in the ITT analysis, secondary analyses suggest that early allogeneic HCT is a promising strategy for patients with high-risk AML.

Authors with CRIS profile

Wolf Rösler Department of Medicine 5 – Haematology and Oncology

Involved external institutions

Asklepios Kliniken DE Germany (DE) Universitätsklinikum Gießen und Marburg (UKGM) DE Germany (DE) Technische Universität Dresden DE Germany (DE) Universitätsklinikum Münster DE Germany (DE) Masaryk University CZ Czech Republic (CZ) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) Ruprecht-Karls-Universität Heidelberg DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE) Universitätsklinikum Würzburg DE Germany (DE) Robert-Bosch-Krankenhaus DE Germany (DE) Klinikum Chemnitz DE Germany (DE) Klinikum Nürnberg DE Germany (DE)

How to cite

APA:

Schetelig, J., Schaich, M., Schaefer-Eckart, K., Haenel, M., Aulitzky, W.E., Einsele, H.,... Ehninger, G. (2015). Hematopoietic cell transplantation in patients with intermediate and high-risk AML: results from the randomized Study Alliance Leukemia (SAL) AML 2003 trial. Leukemia, 29(5), 1060-8. https://dx.doi.org/10.1038/leu.2014.335

MLA:

Schetelig, J., et al. "Hematopoietic cell transplantation in patients with intermediate and high-risk AML: results from the randomized Study Alliance Leukemia (SAL) AML 2003 trial." Leukemia 29.5 (2015): 1060-8.

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