In a retrospective study, we compared 15 patients who received cyclosporine
(CsA), methotrexate (MTX) and prednisone (PDN) and 15 patients who receive
d CsA-MTX for GVHD prophylaxis after allogeneic BMT (HLA-identical sibling
(n = 22), related one HLA mismatch (n = 1), unrelated matched donors (n = 6
), unrelated one HLA mismatch (n = 1)). The primary objectives of this stud
y were to compare the incidence of GVHD and post-transplantation complicati
ons. Secondary objectives were to compare relapse rate, transplant-related
mortality and overall survival. The incidence of acute GVHD grade III-IV wa
s similar between the two groups (P = 0.66), as was the incidence of chroni
c GVHD (P = 0.67). Incidence of arterial hypertension was significantly hig
her in patients who received prophylactic PDN, (P = 0.03) and more insulin
treatment was required in this group (P = 0.003). We observed no difference
s in the incidence of infections or upper digestive tract bleeding. Musculo
skeletal complications appeared earlier in the group which received PDN. Wi
th a median follow-up of 4.4 years, patients in the CsA-MTX group had bette
r overall survival, 46.7% vs 13.3% (P = 0.026). Relapse was a more frequent
cause of death in the CsA-MTX group, whereas procedure-related mortality w
as more frequent in the CsA-MTX-PDN group (P = 0.013). These results sugges
t that prophylactic prednisone when combined with cyclosporine and methotre
xate adds no benefit in acute or chronic GVHD prevention and may increase t
he morbidity of allogeneic transplantation. Corticosteroids may be reserved
for GVHD treatment.