Comparison of fixed dose reduced-intensity conditioning with fludarabine and busulfan to PK-guided busulfan AUC (FluBu4K) in hematopoietic stem cell transplant for AML/MDS

Abstract

A retrospective cohort study was conducted to assess differences in efficacy and tolerability between a busulfan AUC target of 16.4 mg × Hr/L per day (FluBu4K) and a conventional RIC regimen (FluBu2). Adult patients with a diagnosis of AML or MDS who received fludarabine + busulfan conditioning with or without antithymocyte globulin between 2015 and 2018 were included. The primary outcome was relapse free survival. Overall, 74 patients received conditioning with either FluBu4K or FluBu2. At 18 months, relapse-free survival was not significantly different, at 63.9% with FluBu4k compared to 57.5% with FluBu2 (p = 0.49). There was a statistically significant difference in the cumulative incidence of relapse at 18 months in favor of the FluBu4K regimen, at 12.0% vs 32.5% (p = 0.047). The results of this study indicate that for select patients, there may be benefit in choosing targeted FluBu4K over FluBu2. Adverse effects other than mucositis were not significantly different.

Keywords:

• Transplant toxicity;
• myeloid leukemias and dysplasias;
• pharmacotherapeutics;
• Clinical results;
• graft vs. host disease;
• infection complications

Acknowledgements

Study data were collected and managed using REDCap electronic data capture tools hosted at The Ohio State University. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing (1) an intuitive interface for validated data entry; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for importing data from external sources.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Table 1. Baseline characteristics.

Additional information

Funding

This work was supported by National Center for Advancing Translational Sciences under Grant UL1TR001070.