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GIMEMA AML1310 trial: 6-year update on risk-adapted, MRD-directed therapy for younger patients with AML
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The multicenter, prospective, risk-adapted, MRD-oriented, phase II GIMEMA AML1310 trial (NCT01452646) assessed whether delivering post-remission therapy with risk-determined intensity, based on upfront genetic risk and post-consolidation MRD status, could improve outcomes in 500 patients aged 18–60 years with previously untreated AML.1 Post-consolidation therapy was chosen based on NCCN 2009 risk stratification and MRD status, with patients in the favorable-risk, intermediate-risk and MRD-negative, and intermediate-risk with no leukemia-associated immunophenotype groups receiving auto-HSCT, and patients in the poor-risk, and intermediate-risk and MRD-positive groups receiving allo-HSCT. 1 Following primary results from this trial, updated results, with a follow-up of 6 years, were published in Blood Advances by Venditti, et al.1 |
| Key learnings |
| Overall, 6-year OS and DFS rates were 42.7% and 41.9%, respectively. In the favorable-risk, poor-risk, intermediate-risk, and intermediate-risk with no LAIP groups, 6-year OS rates were 58.5%, 34.1%, 41.4%, and 32.5%, and 6-year DFS rates were 50.1%, 34.8%, 45%, and 29.1%, respectively, demonstrating the benefit of auto-HSCT in lower-risk patients, and the long-term survival benefit of allo-HSCT in higher-risk patients. |
| In the intermediate-risk group, where transplantation was allocated based on MRD status, 6-year OS rates were similar between patients who were MRD positive vs MRD negative (57.8% vs 57%), as were 6-year DFS rates (52.7% vs 46.6%), highlighting the utility of MRD-directed therapy in these patients. |
| A post hoc analysis demonstrated a 65.4% concordance with the ELN 2017 risk stratification, mainly in the favorable- and intermediate-risk categories, with post-consolidation MRD assessment remaining an important factor for intermediate-risk. |
| These updated 6-year results confirm the long-term benefit of a risk-adapted, MRD-directed post-remission treatment strategy in younger patients with previously untreated AML. |
Abbreviations: allo-HSCT, allogeneic hematopoietic stem cell transplantation; AML, acute myeloid leukemia; auto-HSCT, autologous hematopoietic stem cell transplantation; DFS, disease-free survival; ELN, European LeukemiaNet; GIMEMA, Gruppo Italiano Malattie EMatologiche dell'Adulto; LAIP, leukemia-associated immunophenotype; MRD, measurable residual disease; NCCN, National Comprehensive Cancer Network; OS, overall survival.
References
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