General AML

ASH 2017 | Azacitidine maintenance therapy in older AML patients 

The optimal post-remission therapy for the prevention of relapse in older Acute Myeloid Leukemia (AML) patients is not yet established.

The randomized phase III HOVON97 study (EudraCT 2008-001290-15) aimed to evaluate the efficacy and safety of azacitidine (AZA) as post-remission therapy in older patients (≥ 60 years) with AML or Myelodysplastic Syndrome (MDS) with Refractory Anemia with Excess Blasts (RAEB) in Complete Remission (CR)/ CR with incomplete blood count (CRi) after at least two cycles of intensive chemotherapy. The results of this study were presented by Geert Huls, MD, PhD, from the University Medical Center Groningen, Groningen, Netherlands, at the 59th American Society of Hematology (ASH) Annual Meeting, Atlanta, GA, on Sunday 10th December 2017.

Overall, 116 patients (median age = 69 years) were randomly assigned 1:1 to receive either AZA maintenance (50 mg/m2, Day 1–5, q 4 weeks, until relapse for a maximum of 12 weeks [AZA group, n = 56]) or observation (Control group, n = 60). The primary endpoint of the study was Disease Free Survival (DFS), with a goal to detect an increase in 12 months DFS from 40% in the Control group to 60% in the AZA group. The secondary endpoints of the study were Overall Survival (OS), probability of relapse, duration of hospitalization as well as transfusion requirements and adverse events.

Key findings:

  • Protocol completion was achieved in 38% (n= 23) and 63% (n = 35) in the Control and AZA group respectively
  • 1-year DFS in the AZA and control group; 63% vs 39%, P = 0.03
    • Azacitidine maintenance significantly improved DFS compared to control; HR = 0.61, P = 0.019
  • OS was not significantly different between the AZA and Control group; HR = 0.84 P = 0.46
  • 1-year OS in patients receiving allogenic hematopoietic cell transplant in the AZA (n = 3) and Control (n = 9) groups: 83% vs 64%, P = 0.07
  • Tolerability in the AZA and Control group respectively
    • Percentage of patients without platelet transfusions; 86% vs 93%
    • Percentage of patients without red blood cell transfusions; 86% vs 92%
    • Percentage of patients without nights in hospital; 86% vs 92%
    • Grade 3 serious AEs occurred in one patient in the AZA group

The speaker, Geert Huls, concluded by stating that AZA maintenance in older AML patients in CR/CRi after at least two cycles of intensive chemotherapy is “well tolerated” and significantly improved DFS in this group of patients. Additionally, AZA maintenance treatment also improved the OS of older AML patients who received allo-HCT. 

  1. Huls G. et al. Randomized Maintenance Therapy with Azacitidine (Vidaza) in Older Patients (≥ 60 years of age) with Acute Myeloid Leukemia (AML) and Refractory Anemia with Excess of Blasts (RAEB, RAEB-t). Results of the HOVON97 Phase III Randomized Multicentre Study (EudraCT 2008-001290-15). Oral Abstract #463: 59th ASH Annual Meeting and Exposition, Atlanta, GA.
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