Myeloablative haploidentical transplantation is superior to chemotherapy for patients with intermediate-risk acute myelogenous leukemia in first complete remission

Purpose: Although myeloablative human leukocyte antigen (HLA) haploidentical hematopoietic stem cell transplantation (haplo-HSCT) following pretransplant ATG and granulocyte colony-stimulating factor (G-CSF) stimulated grafts (ATG+G-CSF) has been confirmed as an alternative to HSCT from HLA-matched sibling donors(MSDs), the effect of haplo-HSCT on postremission treatment of patients with AML with intermediate risk (int-risk AML) who achieved first complete remission (CR1) has not been defined. Experimental Design: In this prospective trial, among 443 consecutive patients aged 16-60 years with newly diagnosed de novo AML with int-risk cytogenetics, 147 patients with molecular int-risk AML who achieved CR1 within two courses of induction and remained in CR1 at 4 months postremission either received chemotherapy (n=69) or underwent haplo-HSCT (n=78). Results: The 3-year leukemia-free survival (LFS) and overall survival (OS) were significantly higher in the haplo-HSCT group than in the chemotherapy group (74.3% vs 47.3%, P=0.0004 and 80.8% vs 53.5%, P=0.0001, respectively). In the multivariate analysis with propensity score adjustment, postremission treatment (haplo-HSCT vs chemotherapy) was an independent risk factor affecting the LFS (HR 0.360, 95% CI 0.163-0.793, P=0.011), OS (HR 0.361, 95% CI 0.156-0.832, P=0.017) and cumulative incidence of relapse (CIR; HR 0.161, 95% CI 0.057-0.459, P=0.001) either in entire cohort or stratified by minimal residual disease after the second consolidation. Conclusions: Myeloablative haplo-HSCT with ATG+G-CSF is superior to chemotherapy as a postremission treatment in patients with int-risk AML during CR1. Haplo-HSCT might be a first-line postremission therapy for int-risk AML in the absence of MSDs.

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