General AML

Clinical impact of post-remission therapy after MIDAM regimen in patients with acute myeloid leukemia

In a Letter to the Editor of the American Journal of Hematology, Salem Bahashwan and colleagues from Clermont Auvergne University, Clermont-Ferrand, France, reported data from their study which evaluated the efficacy and tolerance of gemtuzumab ozogamicin, intermediate-dose cytarabine, and mitoxantrone (MIDAM) as salvage therapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). The impact of post-remission therapy after MIDAM therapy was also evaluated.

Eighty-six patients (median age = 60 years; range: 17–75) with relapsed (n = 62) or refractory (n = 24) AML who were treated with MIDAM regimen between 2008 and 2013 at Clermont Auvergne University Hospital were included in this study. Patients received a MIDAM regimen consisting of gemtuzumab ozogamicin (9 mg/m2 on day 4), cytarabine (1 g/m2 every 12 hours on day 1–5), and mitoxantrone (12 mg/m2/d on day 1–3) as salvage therapy after one (n = 73) or more (n = 13) prior therapy lines. 

Key findings
  • Overall response rate: 63% (54/86)
  • Complete response (CR) rate: 36% (31/86)
  • CR with incomplete platelet count (CRp): 27% (23/86)
  • Eight (9.3%) patients had veno-occlusive disease (VOD) associated with MIDAM regimen
  • Grade 3–4 hyperbilirubinemia and febrile neutropenia occurred in 11 (12.8%) and all patients, respectively
  • Forty-six (53.5%) patients had persistent thrombocytopenia at day 45
  • 30-day mortality rate: 10% (9/86)

Of the 54 patients with CR or CRp, post-remission therapy consisted of chemo-based approaches (chemotherapy only, n = 10; chemotherapy plus autologous transplantation, n = 3) and allogeneic hematopoietic stem cell transplantation (allo-HSCT, n = 29). Seven patients who underwent allo-HSCT received consolidation therapy prior to allo-HSCT.

  • Median follow-up time: 6 years
  • 2-year relapse-free survival (RFS): 28%
    • Allo-HSCT as post-remission therapy led to a significantly better RFS compared to chemo-based and consolidation therapy: 51% vs 33% vs 9%, respectively, P = 0.001
  • 2-year overall survival (OS): 20%
    • Allo-HSCT as post-remission therapy led to a significantly better OS compared to chemo-based approaches: 43% vs 15%, respectively, P = 0.005
  • None of the patients who underwent allo-HSCT had VOD

This study represents the largest cohort of patients treated with MIDAM who have been analyzed. The findings of this study demonstrate that MIDAM regimen is a valid therapeutic option as salvage chemotherapy in patients with R/R AML and it is associated with an “acceptable toxicity profile.”

In addition, allo-HSCT was found to be the consolidation strategy of choice after MIDAM regimen and it is associated with no increased risk of VOD.

References
  1. Bahashwan S. et al. Outcome and impact of post-remission strategy after MIDAM regimen in patients with relapsing or refractory acute myeloid leukemia. Am J Hematol. 2018 Oct 29. DOI: 10.1002/ajh.25332. [Epub ahead of print].
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