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.
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.
Yagasaki
Hiroshi
H
Department of Pediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Kojima
Seiji
S
Yabe
Hiromasa
H
Kato
Koji
K
Kigasawa
Hisato
H
Sakamaki
Hisashi
H
Tsuchida
Masahiro
M
Kato
Shunichi
S
Kawase
Takakaza
T
Muramatsu
Hideki
H
Morishima
Yasuo
Y
Kodera
Yoshihisa
Y
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
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus; D008727:Methotrexate