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Risk stratification; Acute myeloid leukemia Estratificació del risc; Leucèmia mieloide aguda Estratificación de riesgo; Leucemia mieloide aguda The 2017 European LeukemiaNet (ELN 2017) guidelines for the diagnosis and management of acute myeloid leukemia (AML) have become fundamental guidelines to assess the prognosis and postremission therapy of patients. However, they have been retrospectively validated in few studies with patients included in different treatment protocols. We analyzed 861 patients included in the Cooperativo Para el Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias-12 risk-adapted protocol, which indicates cytarabine-based consolidation for patients allocated to the ELN 2017 favorable-risk group, whereas it recommends allogeneic stem cell transplantation (alloSCT) as a postremission strategy for the ELN 2017 intermediate- and adverse-risk groups. We retrospectively classified patients according to the ELN 2017, with 327 (48%), 109 (16%), and 245 (36%) patients allocated to the favorable-, intermediate-, and adverse-risk group, respectively. The 2- and 5-year overall survival (OS) rates were 77% and 70% for favorable-risk patients, 52% and 46% for intermediate-risk patients, and 33% and 23% for adverse-risk patients, respectively. Furthermore, we identified a subgroup of patients within the adverse group (inv(3)/t(3;3), complex karyotype, and/or TP53 mutation/17p abnormality) with a particularly poor outcome, with a 2-year OS of 15%. Our study validates the ELN 2017 risk stratification in a large cohort of patients treated with an ELN-2017 risk-adapted protocol based on alloSCT after remission for nonfavorable ELN subgroups and identifies a genetic subset with a very poor outcome that warrants investigation of novel strategies. This study was supported (in part) by Fondo de Investigaciones Sanitarias/Instituto de Salud Carlos III (ISCIII) grants PI16/01027, PI19/1476, and PI20/01621; Health Research and Innovation Strategic Plan (PERIS) grant SLT002/16/00433 and research group support SGR 1395 and SGR 1655 from Generalitat de Catalunya; resident award “Emili Letang” 2019 (Hospital Clínic de Barcelona); and “Beca de Investigación FEHH 2019” (Fundación Española de Hematologia y Hemoterapia).

On behalf of the PETHEMA Group, Spanish Society of Hematology., [Background]: Pediatric‐based or ‐inspired trials have improved the prognosis of adolescents and young adults (AYA) with Philadelphia chromosome‐negative (Ph‐neg) acute lymphoblastic leukemia (ALL)., [Methods]: This study reports the results of treatment of the ALLRE08 trial, a full pediatric trial for AYA aged 15‐30 years with standard‐risk (SR) ALL., [Results]: From 2008 to 2018, 89 patients (38 adolescents [15‐18 years] and 51 young adults [YA, 19‐30 years], median age: 20 [15‐29] years) were enrolled in the ALLRE08 trial. The complete response (CR) was 95%. Twenty‐two patients were transferred to a high‐risk (HR) protocol because of poor marrow response on day 14 (n = 20) or high‐level of end‐induction minimal residual response (MRD ≥ 0.25%, n = 2). Cumulative incidence of relapse (CIR) at 5 years was 35% (95%CI: 23%‐47%), with significant differences between adolescents and YA: 13% (4%‐28%) vs 52% (34%‐67%), P = .012. No treatment‐related mortality was observed in 66/66 patients following the ALLRE08 trial vs 3/23 patients moved to a HR trial. The estimated 5‐year overall survival (OS) was 74% (95%CI: 63%‐85%), with significantly higher rates for adolescents vs YA: 87% (95%CI: 74%‐100%) vs 63% (46%‐80%), P = .021. Although CIR or OS were lower in patients who were transferred to a HR trial, the differences were not statistically significant (CIR: 34% [21%‐47%] vs 37% [14%‐61%]; OS: 78% [66%‐90%] vs 61% [31%;91%])., [Conclusion]: A full pediatric trial is feasible and effective for AYA with Ph‐neg, SR‐ALL, with better results for adolescents than for YA. Outcome of patients with poor early response rescued with a HR trial was not significantly inferior., We thanks to the following institutions from Spain their support for this paper: ICO‐Hospital Germans Trias i Pujol. Josep Carreras Research Institute. Universitat Autònoma de Barcelona. Hospital Universitari i Politècnic La Fe, Valencia. Hospital Clínico Valencia. Hospital Central de Asturias, Oviedo. Hospital Universitario Virgen del Rocío, Sevilla. Hospital General Universitario de Alicante. Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona. Hospital General Universitario de Castellón. ICO‐Hospital Josep Trueta, Girona. Hospital Dr Peset, Valencia. ICO‐Hospital Duran i Reynals, L'Hospitalet de Llobregat. Hospital Son Espases, Palma de Mallorca. Hospital Clínico Universitario, Cancer Research Center (IBMCC‐CSIC/USAL), Cytometry Service, Salamanca. Hospital San Pedro de Alcántara, Cáceres. Hospital Morales Meseguer, Murcia. Hospital Mútua de Terrassa, Terrassa. Hospital Doce de Octubre, Madrid. Hospital Ramón y Cajal, Madrid. Hospital de Sant Pau, Barcelona. Hospital Arnau de Vilanova, Lleida. Hospital Lucus Augusti, Lugo. ICO‐Hospital Joan XXIII, Tarragona.