Prospective Cohort Study Comparing Intravenous Busulfan to Total Body Irradiation in Hematopoietic Cell Transplantation

Overview

Journal Blood

Publisher Elsevier

Specialty Hematology

Date 2013 Oct 2

PMID 24081656

Citations 57

Authors

Christopher Bredeson

Jennifer LeRademacher

Kazunobu Kato

John F Dipersio

Edward Agura

Steven M Devine

Frederick R Appelbaum

Marcie R Tomblyn

Ginna G Laport

Xiaochun Zhu

Philip L McCarthy

Vincent T Ho

Kenneth R Cooke

Elizabeth Armstrong

Angela Smith

J Douglas Rizzo

Jeanne M Burkart

Marcelo C Pasquini

Affiliations

Soon will be listed here.

Abstract

We conducted a prospective cohort study testing the noninferiority of survival of ablative intravenous busulfan (IV-BU) vs ablative total body irradiation (TBI)-based regimens in myeloid malignancies. A total of 1483 patients undergoing transplantation for myeloid malignancies (IV-BU, N = 1025; TBI, N = 458) were enrolled. Cohorts were similar with respect to age, gender, race, performance score, disease, and disease stage at transplantation. Most patients had acute myeloid leukemia (68% IV-BU, 78% TBI). Grafts were primarily peripheral blood (77%) from HLA-matched siblings (40%) or well-matched unrelated donors (48%). Two-year probabilities of survival (95% confidence interval [CI]), were 56% (95% CI, 53%-60%) and 48% (95% CI, 43%-54%, P = .019) for IV-BU (relative risk, 0.82; 95% CI, 0.68-0.98, P = .03) and TBI, respectively. Corresponding incidences of transplant-related mortality (TRM) were 18% (95% CI, 16%-21%) and 19% (95% CI, 15%-23%, P = .75) and disease progression were 34% (95% CI, 31%-37%) and 39% (95% CI, 34%-44%, P = .08). The incidence of hepatic veno-occlusive disease (VOD) was 5% for IV-BU and 1% with TBI (P < .001). There were no differences in progression-free survival and graft-versus-host disease. Compared with TBI, IV-BU resulted in superior survival with no increased risk for relapse or TRM. These results support the use of myeloablative IV-BU vs TBI-based conditioning regimens for treatment of myeloid malignancies.

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