Autologous stem cell transplantation versus consolidation chemotherapy as post-remission treatment in newly diagnosed favorable and intermediate risk patients with AML: A comparative analysis of HOVON-SAKK-Nordic trials

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Abstract High‐dose chemotherapy (CT), followed by autologous hematopoietic cell transplantation (auto‐HCT) or consolidation CT, are postremission strategies for European LeukemiaNet 2022 (ELN2022) favorable‐ or intermediate‐risk patients with acute myeloid leukemia (AML) in complete remission (CR) without measurable residual disease (MRD). We conducted a retrospective, nonrandomized analysis to compare the efficacy and safety of auto‐HCT versus CT in newly diagnosed AML patients aged 18–65 years treated within two recent HOVON–SAKK–Nordic trials. From a total of 1005 patients with ELN2022 favorable‐ or intermediate‐risk AML, 224 received busulfan/cyclophosphamide (Bu/Cy), followed by auto‐HCT, and 199 received mitoxantrone/etoposide‐based CT. The 5‐year relapse‐free survival (RFS) and overall survival (OS) were comparable between auto‐HCT and CT (RFS: 60% vs. 56%, P = 0.70; OS: 72% vs. 71%, P = 0.76). In multivariable analysis, auto‐HCT was not associated with a significant difference in RFS (HR 0.80, 95% CI 0.56–1.13, P = 0.20) or OS (HR 0.91, 95% CI 0.60–1.37, P = 0.64). Median time to platelet and neutrophil recovery was shorter with auto‐HCT than CT (platelet: 42 vs. 57 days, neutrophil: 13 vs. 39 days). Subgroup analysis revealed that patients achieving CR after the second induction cycle or with baseline white blood cell counts >20 × 10 9 /L had longer RFS with auto‐HCT compared to CT (HR 0.17, P = 0.003 and HR 0.48, P = 0.02), which was not observed for OS. Focusing on ELN2022 favorable‐risk patients (excluding NPM1 mut MRD‐positive) and MRD‐negative intermediate‐risk patients, RFS and OS were not different between consolidation strategies. Collectively, auto‐HCT yielded similar RFS and OS to mitoxantrone/etoposide‐based CT in favorable‐ and intermediate‐risk AML, particularly in MRD‐negative patients, with faster hematologic recovery.