Patients with acute graft-versus-host disease (GvHD) grade I were randomized to an observation arm (n=85) or to a treatment arm (n=86) consisting of 6-methylprednisolone 1 mg/kg/day, after stratification for age and donor type. The primary end point was development of grade II-IV GvHD. The cumulative incidence of grade II-IV GvHD was 50% in the observation arm and 33% in the treatment arm (P=0.005). However, grade III-IV GvHD was comparable (13% vs. 10%, respectively; P=0.6), and this was true for sibling and alternative donor transplants. Moderate/severe chronic GvHD was also comparable (17% vs. 9%). In multivariate analysis, an early interval between transplant and randomization (<day +20) was the only negative predictor of grade III-IV GvHD. Patients in the observation arm had less infectious bacterial episodes (12 vs. 25; P=0.04), less severe infectious fungal episodes (0 vs. 3; P=0.04), and less severe adverse events (3 vs. 11; P=0.07). At five years, non-relapse mortality was 20% versus 26% (P=0.2), relapse-related mortality 25% versus 21%, and actuarial survival was 51% versus 41% (P=0.3) in the observation and treatment arms, respectively. In multivariate analysis, advanced disease phase, older age and an early onset of GvHD were significant negative predictors of survival, independent of the randomization arm. In conclusion, steroid treatment of acute grade I GvHD prevents progression to grade II but not to grade III-IV GvHD, and there is no effect on non-relapse mortality and survival. Patients treated with steroids are at a higher risk of developing infections and have more adverse events. (Trial registered as EUDTRACT 2008-000413-29).
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