ELN2017 risk stratification improves outcome prediction when applied to the prospective GIMEMA AML1310 protocol

The 2017 version of the ELN recommendations, by integrating cytogenetics and mutational status of specific genes, sort out patients with Acute Myeloid Leukemia into 3 prognostically distinct risk categories: favorable (ELN2017-FR), intermediate (ELN2017-IR) and adverse (ELN2017-AR). We performed a post-hoc analysis of the GIMEMA AML1310 trial to investigate the applicability of the ELN2017 risk stratification to our study population. In this trial, after induction and consolidation, patients in complete remission were to receive autologous stem cell transplant (AuSCT) if categorized as favorable-risk or allogeneic stem cell transplant (ASCT) if adverse-risk. Intermediate-risk pts were to receive AuSCT or ASCT based on the post-consolidation levels of Measurable Residual Disease as measured by flow-cytometry. Risk categorization was originally conducted according to NCCN2009 recommendations. Among 500 patients, 445 (89%) were re-classified according to the ELN2017 criteria: ELN2017-FR (186/455; 41.8%), ELN2017-IR (179/445 40.2%) and ELN2017-AR (80/455; 18%); in 55 patients (11%) ELN2017 was not applicable (ELN2017-NC). Two-year overall survival (OS) was 68.8%, 51.3%, 45.8% and 42.8% for ELN2017-FR, ELN2017-IR, ELN2017-NC, and ELN2017-AR group, respectively (p<0.001). When comparing the two different transplant strategies in each ELN2017 risk category, a significant benefit of AuSCT over ASCT was observed among ELN2017-FR patients (2-years OS of 83.3% vs. 66.7%; p=0.0421). The two transplant procedures performed almost equally in the ELN2017-IR group (2-years OS of 73.9% vs. 70.8%; p=0.5552). This post-hoc analysis of the GIMEMA AML1310 trial, confirms that the ELN2017 classification is able to accurately discriminate patients with different outcomes and who may benefit from different transplant strategies.