Tacrolimus/Methotrexate versus cyclosporine/methotrexate as graft-versus-host disease prophylaxis in patients with severe aplastic anemia who received bone marrow transplantation from unrelated donors: results of matched pair analysis

Biol Blood Marrow Transplant. 2009 Dec;15(12):1603-8. doi: 10.1016/j.bbmt.2009.08.012. Epub 2009 Oct 4.

Abstract

Tacrolimus (FK) and cyclosporine (CsA) have been shown to be effective in the prophylaxis of graft-versus-host disease (GVHD). However, no comparative studies have yet been conducted to examine the efficacy of FK/methotrexate (MTX) and CsA/MTX in patients with severe aplastic anemia (SAA) given unrelated donor bone marrow transplantation (U-BMT). We used matched-pair analysis to compare FK/MTX with CsA/MTX in patients with SAA who received U-BMT through the Japan Marrow Donor Program. Forty-seven pairs could be matched exactly for recipient age and conditioning regimens. Forty-five patients achieved engraftment in the FK group and 42 patients in the CsA group. The probability of grade II-IV acute GVHD (aGVHD) was 28.9% in the FK group and 32.6% in the CsA group (P=.558). The probability of chronic GVHD (cGVHD) was 13.3% in the FK group and 36.0% in the CsA group (P=.104). The 5-year survival rate was 82.8% in the FK group and 49.5% in the CsA group (P=.012). The study shows the superiority of FK/MTX over CsA/MTX in overall survival because of the lower incidence of transplantation-related deaths. A prospective randomized study comparing FK/MTX and CsA/MTX is warranted.

MeSH terms

  • Anemia, Aplastic / surgery*
  • Bone Marrow Transplantation / immunology
  • Bone Marrow Transplantation / methods*
  • Cyclosporine / therapeutic use*
  • Female
  • Graft vs Host Disease / blood
  • Graft vs Host Disease / drug therapy
  • Graft vs Host Disease / immunology
  • Graft vs Host Disease / prevention & control*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Matched-Pair Analysis
  • Methotrexate / therapeutic use*
  • Survival Rate
  • Tacrolimus / therapeutic use*
  • Tissue Donors

Substances

  • Immunosuppressive Agents
  • Cyclosporine
  • Tacrolimus
  • Methotrexate