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Clinical Trial
. 2008 Aug;14(8):920-6.
doi: 10.1016/j.bbmt.2008.05.024.

Sirolimus, tacrolimus, and low-dose methotrexate as graft-versus-host disease prophylaxis in related and unrelated donor reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation

Edwin P Alyea  1 , Shuli Li, Haesook T Kim, Corey Cutler, Vincent Ho, Robert J Soiffer, Joseph H Antin
Affiliations
Clinical Trial

Sirolimus, tacrolimus, and low-dose methotrexate as graft-versus-host disease prophylaxis in related and unrelated donor reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation

Edwin P Alyea et al. Biol Blood Marrow Transplant. 2008 Aug.

Abstract

We assessed the combination of sirolimus, tacrolimus, and low-dose methotrexate as acute graft-versus-host disease (aGVHD) prophylaxis after reduced-intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation from matched related (MRD, n = 46) and unrelated (URD, n = 45) donors. All patients received fludarabine and intravenous busulfan conditioning followed by transplantation of mobilized PBSC. The median time to neutrophil engraftment was 13 days. The cumulative incidence of grade II-IV and III-IV aGVHD were 16% and 7%, respectively. There was no difference in the incidence of aGVHD between MRD and URD cohorts. Two-year cumulative incidence of extensive chronic GVHD (cGVHD) was 40%. Relapse-free survival (RFS) at 2 years was 34%: 21% in MRD and 45% in URD. Overall survival (OS) at 2 years was 59%: 47% in MRD and 67% in URD. High levels (>90%) of donor derived hematopoiesis were achieved in 59% of patients early after transplantation. The addition of sirolimus to tacrolimus and low-dose methotrexate as GVHD prophylaxis following RIC with fludarabine and low-dose intravenous busulfan is associated with rapid engraftment, low rates of aGVHD, and achievement of high levels of donor chimerism.

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Conflict of interest statement

The Authors have no financial conflicts to report.

Figures

Figure 1
Figure 1
Cumulative incidence of grade 2–4 acute graft versus host disease after transplantation. MRD: Matched Related Donor, URD: Unrelated Donor
Figure 2
Figure 2
Cumulative incidence of relapse with treatment related mortality as a competing risk. MRD: Matched Related Donor; URD: Unrelated Donor; TRM: treatment related mortality
Figure 3
Figure 3
Figure 3a-Overall Survival Figure 3b-Progression Free Survival
Figure 3
Figure 3
Figure 3a-Overall Survival Figure 3b-Progression Free Survival
See this image and copyright information in PMC

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