Reduced-intensity conditioning hematopoietic stem-cell transplantation (HSCT) is relatively well tolerated and may provide superior outcomes when compared with historical patients not treated with HSCT to maintain remission in selected older patients with acute myeloid leukemia (AML).1 These new study findings were published online ahead of print in the Journal of Clinical Oncology.
Although long-term survival rates for older patients with newly diagnosed AML are especially low, observational studies have suggested that allogeneic HSCT may improve overall survival by reducing the risk for relapse.
Therefore, researchers sought to prospectively evaluate the impact of HSCT in older patients with AML in first complete remission.
The study was led by Steven M. Devine, MD, professor of internal medicine and program director of the Blood and Bone Marrow Transplant Program at The Ohio State University Wexner Medical Center in Columbus, OH.
For the multicenter, phase 2 study, researchers enrolled 114 patients from 60 to 74 years with AML in first complete remission. Participants received reduced-intensity conditioning HSCT, of which 52% were from unrelated donors and were given antithymocyte globulin for graft-versus-host disease (GVHD) prophylaxis.
Results showed that 2-year disease-free survival and 2-year overall survival after transplantation were 42% (95% CI, 33 – 52) and 48% (95% CI, 39 – 58), respectively, for the entire cohort.
Among patients that received transplantations from unrelated donors, the disease-free survival rate 2 years after transplantation was 40% (95% CI, 29 – 55) and the overall survival rate was 50% (95% CI, 38 – 64).
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Researchers also found that nonrelapse mortality at 2 years was 15% (95% CI, 8 – 21). In total, 44% (95% CI, 35 – 53) of patients had experienced relapse within 2 years.
In regard to safety, grade 2 to 4 acute GVHD occurred in 9.6% (95% CI, 4 – 15) of patients, while chronic GVHD occurred in 28% (95% CI, 19 – 36) of patients.
“GVHD and NRM rates were lower than expected. Future transplantation studies in these patients should focus on further reducing the risk of relapse,” the authors concluded.
- Devine SM, Owzar K, Blum W, et al. Phase II study of allogeneic transplantation for older patients with acute myeloid leukemia in first complete remission using a reduced-intensity conditioning regimen: results from Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502 [published online ahead of print November 2, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.62.7273.