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Salvage chemotherapy to induce remission prior to allo-HSCT vs immediate transplant in patients with R/R AML
Allogeneic hematopoietic stem cell transplant (allo-HSCT) is currently the only treatment that offers long-term disease-free survival in patients with relapsed/refractory acute myeloid leukemia. However, the impact of therapeutic interventions to induce complete remission prior to allo-HSCT has never been fully evaluated in randomized trials.
Recently, Stelljes et al.1 published results from the phase III ASAP trial (NCT02461537) in Lancet Hematology, comparing disease control strategies and immediate allo-HSCT vs standard salvage chemotherapy to induce remission prior to allo-HSCT. We summarize the key results below.
Study design1
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In this open-label, multicenter, randomized controlled trial, patients in the remission induction group received high-dose cytarabine (3 g/m2 twice daily on Days 1–3) and mitoxantrone (10 mg/m2 on Days 3–5); patients in the disease control group proceeded to allo-HSCT as soon as possible.
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The primary endpoint was the rate of treatment success, defined as complete remission on Day 56 post allo-HSCT.
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The key secondary endpoint was overall survival from randomization.
Key findings1
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A total of 281 patients were enrolled:
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141 in the remission induction group; and
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140 in the disease control group.
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The median follow up was 37 months.
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In the per-protocol population (n = 272), treatment success was achieved by more patients in the disease control group than in the remission induction group (84% vs 81%; p = 0.047).
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Survival outcomes were comparable in the intent-to-treat population for patients treated with remission induction or disease control (Figure 1).
Figure 1. Survival outcomes for patients with relapsed/refractory AML treated with salvage chemotherapy before allo-HSCT or disease control and immediate allo-HSCT (intention-to-treat population)*
AML, acute myeloid leukemia; allo-HSCT, allogeneic hematopoietic stem cell transplant; CIR, cumulative incidence of relapse; CR, complete remission; LFS leukemia-free survival; NRM, non-relapse mortality; OS, overall survival.
*Adapted from Stelljes, et al.1
†Estimated difference in treatment success was 3.4%.
Non-inferiority could not be shown at the 2.5% significance level.
Safety
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Non-hematological Grade ≥3 adverse events were more frequent in the remission induction group vs the disease control group (61% vs 21%; p < 0.0001).
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The most common event across both groups was infection (55% vs 16%; p < 0.0001).
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The cumulative incidence of Grade 2–4 acute graft-versus-host disease at Day 120 post HSCT was comparable between the induction remission and disease control groups in the per-protocol population (21% vs 22%, p = 0.74).
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Within 28 days, 6 patients died in the remission induction group and 8 patients from the disease control group (p = 0.65).
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Key learnings |
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- Stelljes M, Middeke J, Bug G, et al. Remission induction versus immediate allogeneic hematopoietic stem cell transplantation for patients with relapsed or poor responsive acute myeloid leukemia (ASAP): a randomized, open-label, phase 3, non-inferiority trial. Lancet Hematol. 2024. Online ahead of print. DOI: 10.1016/S2352-3026(24)00065-6
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