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Hematopoietic cell transplantation in patients with intermediate and high-risk AML: results from the randomized Study Alliance Leukemia (SAL) AML 2003 trial
Authors | |
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Year of publication | 2015 |
Type | Article in Periodical |
Magazine / Source | Leukemia |
MU Faculty or unit | |
Citation | |
Doi | http://dx.doi.org/10.1038/leu.2014.335 |
Field | Oncology and hematology |
Keywords | ACUTE MYELOID-LEUKEMIA; 1ST COMPLETE REMISSION; POSTREMISSION THERAPY; HEMATOLOGIC MALIGNANCIES; DONOR TRANSPLANTATION; COMPARABLE SURVIVAL; INDUCTION THERAPY; UNRELATED DONORS; CLINICAL-TRIALS; INTENSITY |
Description | 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 intentto- 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. |