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Clinical Trial
. 2013 Dec 5;122(24):3871-8.
doi: 10.1182/blood-2013-08-519009. Epub 2013 Sep 30.

Prospective cohort study comparing intravenous busulfan to total body irradiation in hematopoietic cell transplantation

Christopher Bredeson  1 , 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
Clinical Trial

Prospective cohort study comparing intravenous busulfan to total body irradiation in hematopoietic cell transplantation

Christopher Bredeson et al. Blood. .

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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Figures

Figure 1
Figure 1
Outcomes of allogeneic HCT with IV-BU or TBI conditioning regimens. (A) Survival by conditioning regimens. (B) Progression free survival by conditioning regimens. (C) Cumulative incidence of TRM by conditioning regimens. (D) Cumulative incidence of disease relapse by conditioning regimens.
Figure 2
Figure 2
Survival after allogeneic HCT with IV-BU or TBI conditioning stratified on diagnosis and disease status. (A) Survival by diagnosis and conditioning regimens. (B) Survival by disease status and conditioning regimens
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References

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