Comparison of New Flu-Bu12-Tg Conditioning With the Standard Bu-Cy Myeloablative Regimen in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia

Abstract

Aims. This study compares the outcomes of patients with high-risk acute myeloid leukemia (AML) who underwent allogeneic stem cell transplantation (SCT) after conditioning combining busulfan (16 mg/kg orally) and cyclophosphamide (120 mg/kg intravenously) (BU-CY) with those allografted after administration of fludarabine (150 mg/m 2 intravenously), busulfan (12 mg/kg orally) and thymoglobulin (6 mg/kg intravenously) (FLU-BU12-TG).Material and methods. SCT after BU-CY and FLU-BU12-TG was performed in 21 and 10 AML patients. There were no significant differences between groups in number of patients treated in complete disease remission, gender, age, donors, CD34+, mononuclear cell (MNC) count in the graft and follow-up period. However, significantly more SCTs from unrelated (90% vs. 19%; p=0.00018) and HLA-mismatched donors (50% vs. 0%; p=0.0004) were performed in the FLU-BU12-TG group. The Cox proportional hazards model was used to assess the risk of post-transplant AML relapse and non-relapse mortality (NRM). The probability of post-transplant 2-year event-free survival (EFS) and overall survival (OS) were calculated using the Kaplan-Meier method.Results. No significant differences were found between the FLU-BU12-TG and BU-CY groups in risk of AML relapse (HR=1.036; 95% CI [0.102 -10.47]; p=0.9), post-transplant NRM (HR=0.25; 95% CI [0.031 -1.96]; p=0.18), 2-year EFS (89% vs. 43%; p=0.19) or OS (79% vs. 57%; p=0.23).Conclusion. These pilot results demonstrate the efficacy of the new FLU-BU12-TG conditioning regimen in patients allografted for high-risk AML. This conditioning might become an alternative approach in patients at high risk of severe post-transplant complications after the standard BU-CY myeloablative regimen.

Comparison of Reduced-Intensity and Myeloablative Conditioning Regimens for Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: A Meta-Analysis

“…Goker, 2013 [23] This study administered myeloablative doses of busulfan (total intravenous busulfan 12.8 mg/kg) in combination with fludarabine (Flu/Bu/ATG) to 60% of the patients in the RIC transplant group. Raida, 2011 [24] This study compared RTC regimen consisting of myeloablative doses of busulfan in combination with fludarabine and conventional MAC regimen. Lioure, 2012 [25] This study limited RIC regimens to patients aged above 50 years and MAC regimens to younger patients.…”

“…A further 252 articles were excluded because they included all patients with hematologic malignancies and did not perform separate analysis on patients with AML and ALL. Three studies [22][23][24] that compared reduced toxicity conditioning (RTC) regimen consisting of myeloablative doses of busulfan in combination with fludarabine and conventional MAC regimen were excluded from the meta-analysis. Two studies [25,26] were excluded as they limited RIC regimens to patients aged above 50 years and MAC regimens to younger patients.…”