Primary AlloHCT During First Complete Remission and Overall Survival Rates Among Patients With AML

Results from a Randomized Phase 3 Trial

After a patient’s first complete response (CR), primary allogeneic hematopoietic cell transplant (alloHCT) was not correlated with superior overall survival (OS) rates among patients with acute myeloid leukemia (AML) and an available donor compared with consolidation therapy, according to findings from a phase 3 trial recently published in JAMA Oncology. 

Martin Bornhäuser, MD, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany, and coauthors stated that the objective of their study was “to explore the optimal therapy for patients with intermediate-risk AML after first complete remission.” To do this, Dr Bornhäuser and colleagues aimed to assess endpoints including OS, disease-free survival, cumulative incidence of relapse, treatment-related mortality, and quality of life. 

143 patients with intermediate-risk AML who had reached first CR or CR with incomplete blood cell count recovery after conventional induction therapy and had a matched sibling or unrelated donor available were enrolled in this study. Patients were randomized 1:1 to either receive alloHCT or high-dose cytarabine for consolidation and salvage HCT only in case of relapse. 

Results indicated that at 2 years, the probability of survival was 74% after primary allogeneic HCT and 84% after consolidation chemotherapy. Disease-free survival was 69% after alloHCT compared with 40% after consolidation chemotherapy. After patients’ first CR, alloHCT was associated with a cumulative incidence of relapse at 2 years of 20%, versus 58% for consolidation chemotherapy. Non-relapse mortality at 2 years after primary allogeneic HCT was 9% versus 2% after consolidation chemotherapy. There were no comparable differences in safety between the groups. 

In conclusion, although alloHCT increased disease-free survival, it was not correlated with superior OS rates among patients 60 years of age or younger with intermediate-risk AML and an available donor,  compared with consolidation therapy.

As endpoints were met, Dr Bornhäuser et al concluded, “In intermediate-risk AML in first complete remission, allo-HCT may be delayed to first relapse, and patients may be counseled accordingly.” 

Source: 

Bornhäuser M, Schliemann C, Schetelig J, et al. Allogeneic hematopoietic cell transplantation vs standard consolidation chemotherapy in patients with intermediate-risk acute myeloid leukemia:
A randomized clinical trial. JAMA Oncology. Published online February 9, 2022. doi:https://doi.org/10.1001/jamaoncol.2022.7605