Allogeneic Hematopoietic Cell Transplantation in Intermediate Risk Acute Myeloid Leukemia negative for FLT3 -ITD, NPM1- or biallelic CEBPA Mutations

Abstract

Background: The value of allogeneic hematopoietic cell transplantation (alloHCT) as post-remission treatment is not well defined for patients with intermediate-risk acute myeloid leukemia (AML) without FLT3-ITD, biallelic CEBPA-, or NPM1 mutations (here referred to as NPM1^mut-neg/CEBPA^dm-neg/FLT3-ITD^neg AML) in first complete remission (CR1).Patients and methods: We addressed this question using data from two prospective randomized controlled trials on intensive induction- and risk-stratified post-remission therapy The NPM1^mut-neg/CEBPA^dm-neg/FLT3-ITD^neg AML subgroup comprised 497 patients, aged 18-60 years.Results: In donor versus no-donor analyses, patients with a matched related donor had a longer relapse-free survival (RFS) (HR 0.5; 95%-CI, 0.3 - 0.9, p = .02) and a trend towards better overall survival (OS) (HR 0.6, 95%-CI, 0.3 - 1.1, p = .08) compared to patients who received post-remission chemotherapy. Notably, only 58% of patients in the donor group were transplanted in CR1. We therefore complemented the donor versus no-donor analysis with multivariable Cox regression analyses, where alloHCT was tested as a time-dependent covariate: OS (HR 0.58, 95%-CI, 0.37 - 0.9, p = .02) and RFS (HR 0.51; 95%-CI, 0.34 - 0.76; p = .001) for patients who received alloHCT compared to chemotherapy in CR1 were significantly longer.Conclusion: Outside clinical trials, alloHCT should be the preferred post-remission treatment for patients with intermediate risk NPM1^mut-neg/CEBPA^dm-neg/FLT3-ITD^neg AML in CR1.Cinicaltrials.gov identifier: NCT00180115, NCT00180102

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