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Blood, 1 October 2000, Vol. 96, No. 7, pp. 2391-2398
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
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
Tapani Ruutu,
Liisa Volin,
Terttu Parkkali,
Eeva Juvonen, and
Erkki Elonen
From the Department of Medicine, Helsinki University
Central Hospital, Helsinki, Finland.
The role of corticosteroids in the prophylaxis of graft-versus-host
disease (GVHD) is not well established. We have conducted a
prospective, randomized, open-label, single-center study about the
effect of adding methylprednisolone (MP) to the widely used prophylactic regimen consisting of cyclosporine A and methotrexate. A
total of 108 consecutive patients treated with allogeneic bone marrow
transplantation from an HLA-identical sibling donor for malignant blood
disease were entered into the study; 53 patients were randomized
to receive and 55 were randomized not to receive prophylactic MP. The
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 shorter 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
treatment in the group of patients not given prophylactic MP. There
were no significant differences between the study groups in relapse
rate or survival. In conclusion, the addition of MP to the combination
of cyclosporine and methotrexate markedly reduced the incidence
of acute GVHD without causing untoward effects. The timing of
corticosteroid administration is probably important for the efficacy.
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