Cyclosporine, methotrexate, and methylprednisolone compared with cyclosporine and methotrexate for the prevention of graft-versus-host disease in bone marrow transplantation from HLA-identical sibling donor: a prospective randomized study

The role of corticosteroids in the prophylaxis of graft-versus-host disease (GVHD) is not well established. We have conducted a prospective, randomize d, open-label, single-center study about the effect of adding methylprednis olone (MP) to the widely used prophylactic regimen consisting of cyclospori ne A and methotrexate. A total of 108 consecutive patients treated with all ogeneic bone marrow transplantation from an HLA-identical sibling donor for malignant blood disease were entered into the study; 53 patients were rand omized to receive and 55 were randomized not to receive prophylactic MP. Th e dose of MP was 0.5 mg/kg on days 14 to 20, 1 mg/kg on days 21 to 34, 0.5 mg/kg on days 35 to 48, and thereafter the dose was slowly tapered and the administration discontinued on day 110, In the group given prophylactic MP, the incidence of acute GVHD was lower (19% vs 56%, P = .0001), there was a trend toward a lower incidence of chronic GVHD among low-risk patients (P = .06), and during the first 4 months the time spent at hospital was shorte r and there were fewer infections. The total amount of MP given was similar in the study groups because of a higher incidence of acute GVHD and its tr eatment in the group of patients not given prophylactic MP. Them were no si gnificant differences between the study groups in relapse rate or survival, In conclusion, the addition of MP to the combination of cyclosporine and m ethotrexate markedly reduced the incidence of acute GVHD without causing un toward effects. The timing of corticosteroid administration is probably imp ortant for the efficacy. (Blood, 2000;96:2391-2398) (C) 2000 by The America n Society of Hematology.