Tacrolimus plus sirolimus with or without ATG as GVHD prophylaxis in HLA-mismatched unrelated donor allogeneic stem cell transplantation

Bone Marrow Transplant. 2017 Mar;52(3):438-444. doi: 10.1038/bmt.2016.269. Epub 2016 Nov 7.

Abstract

HLA-matched related or unrelated donors are not universally available. Consequently, patients can be offered hematopoietic stem cell transplantation (HSCT) from alternative donors, including mismatched unrelated donors (MMURD), known to cause a higher incidence of acute GVHD (aGVHD) and chronic GVHD. In vivo T-cell-depletion strategies, such as antithymocyte globulin (ATG) therapy, significantly decrease the risk of GVHD. We performed a multicenter, retrospective study comparing tacrolimus (TAC) and sirolimus (SIR) with or without ATG in 104 patients (TAC-SIR=45, TAC-SIR-ATG=59) who underwent MMURD HSCT. Use of ATG was associated with a lower incidence, albeit not statistically significant, of grades 2-4 aGVHD (46% vs 64%, P=0.09), no difference in grades 3-4 aGVHD (10% vs 15%, P=0.43), a trend for a lower incidence of moderate/severe chronic GVHD (16% vs 37%, P=0.09) and more frequent Epstein-Barr virus reactivation (54% vs 18%, P=0.0002). There were no statistically significant differences in 3-year overall survival (OS) (TAC-SIR-ATG=40% (95% confidence interval (CI)=24-56%) vs TAC-SIR=54% (95% CI=37-70%), P=0.43) or 3-year cumulative incidence of relapse/progression (TAC-SIR-ATG=40% (95% CI=28-58%) vs TAC-SIR=22% (95% CI=13-39%), P=0.92). An intermediate Center for International Blood & Marrow Transplant Research disease risk resulted in a significantly lower non-relapse mortality and better OS at 3 years. Our study suggests that addition of ATG to TAC-SIR in MMURD HSCT does not affect OS when compared with TAC-SIR alone.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Allografts
  • Chronic Disease
  • Disease-Free Survival
  • Female
  • Graft vs Host Disease / mortality*
  • Graft vs Host Disease / prevention & control*
  • HLA Antigens
  • Humans
  • Lymphocyte Depletion
  • Male
  • Middle Aged
  • Retrospective Studies
  • Sirolimus / administration & dosage*
  • Stem Cell Transplantation*
  • Survival Rate
  • T-Lymphocytes
  • Tacrolimus / administration & dosage*
  • Unrelated Donors*

Substances

  • HLA Antigens
  • Sirolimus
  • Tacrolimus