title: 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.
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.
authors.affiliation: Department of Pediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yagasaki
authors.forename: Seiji
authors.initials: S
authors.lastname: Kojima
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Yabe
authors.forename: Koji
authors.initials: K
authors.lastname: Kato
authors.forename: Hisato
authors.initials: H
authors.lastname: Kigasawa
authors.forename: Hisashi
authors.initials: H
authors.lastname: Sakamaki
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuchida
authors.forename: Shunichi
authors.initials: S
authors.lastname: Kato
authors.forename: Takakaza
authors.initials: T
authors.lastname: Kawase
authors.forename: Hideki
authors.initials: H
authors.lastname: Muramatsu
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Morishima
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Kodera
mesh_terms: D000741:Anemia, Aplastic / Q000601:surgery*; D016026:Bone Marrow Transplantation / Q000276:immunology / Q000379:methods*; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D006086:Graft vs Host Disease / Q000097:blood / Q000188:drug therapy / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D016555:Matched-Pair Analysis; D008727:Methotrexate / Q000627:therapeutic use*; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*; D014019:Tissue Donors
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus; D008727:Methotrexate