Reduced-intensity conditioning allogeneic hematopoietic cell transplantation using oral fludarabine as part of the conditioning regimen.

BACKGROUND: In 2003, oral fludarabine was introduced for the treatment of patients with hematologic malignancies as an alternative to its intravenous (i.v.) formulation. In an attempt to simplify the management of patients undergoing reduced intensity allogeneic hematopoietic transplantation, we have incorporated oral fludarabine in the conditioning regimen.

METHODS: We present a non-randomized retrospective analysis of 37 patients conditioned with oral fludarabine compared with 144 patients conditioned with the i.v. formulation. In addition to fludarabine, the conditioning regimens also included melphalan or busulfan depending on the underlying disease. Donors were HLA-matched siblings in 75% of cases and unrelated donors in the remaining 25%.

RESULTS: Eight patients (22%) receiving oral fludarabine were switched to the i.v. route because of gastrointestinal toxicity (three patients), patient preference (two patients) and physician preference (three patients). There were no statistical differences in terms of hospital admission (P=0.16), time to neutrophil engraftment (P=0.35), time to platelet engraftment (P=0.38), acute graft versus host disease rate (P=0.71) and non-relapse mortality at days +30 (P=1.0) and +100 (P=0.43).

DISCUSSION: This preliminary analysis confirms that oral fludarabine can replace its i.v. formulation as part of reduced-intensity conditioning regimens with no deleterious effect on any of the early transplantation outcomes. In addition, oral fludarabine can be more convenient for patients and caregivers, facilitating its implementation.