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

Biol Blood Marrow Transplant. 2008 Aug;14(8):920-6. doi: 10.1016/j.bbmt.2008.05.024.

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.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Busulfan / therapeutic use
  • Female
  • Graft Survival
  • Graft vs Host Disease / drug therapy
  • Graft vs Host Disease / prevention & control*
  • Hematologic Neoplasms / complications
  • Hematologic Neoplasms / mortality
  • Hematologic Neoplasms / therapy
  • Histocompatibility Testing
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Methotrexate / administration & dosage
  • Middle Aged
  • Peripheral Blood Stem Cell Transplantation / adverse effects
  • Peripheral Blood Stem Cell Transplantation / methods*
  • Peripheral Blood Stem Cell Transplantation / mortality
  • Premedication
  • Sirolimus / administration & dosage
  • Tacrolimus / administration & dosage
  • Tissue Donors
  • Transplantation Conditioning / methods*
  • Transplantation, Homologous
  • Vidarabine / analogs & derivatives
  • Vidarabine / therapeutic use

Substances

  • Immunosuppressive Agents
  • Vidarabine
  • Busulfan
  • fludarabine
  • Sirolimus
  • Tacrolimus
  • Methotrexate