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Blood, 26 March 2009, Vol. 113, No. 13, pp. 2888-2894.
Prepublished online as a Blood First Edition Paper on November 10, 2008; DOI 10.1182/blood-2008-07-168401.


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CLINICAL TRIALS AND OBSERVATIONS

Initial therapy of acute graft-versus-host disease with low-dose prednisone does not compromise patient outcomes

Marco Mielcarek1,2, Barry E. Storer1,3,4, Michael Boeckh1,2, Paul A. Carpenter1,2, George B. McDonald1,2, H. Joachim Deeg1,2, Richard A. Nash1,2, Mary E. D. Flowers1,2, Kristine Doney1,2, Stephanie Lee1,2, Kieren A. Marr1,2, Terry Furlong1, Rainer Storb1,2, Frederick R. Appelbaum1,2, and Paul J. Martin1,2

1 Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; 2 Department of Medicine, University of Washington School of Medicine, Seattle; 3 Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA; and 4 Department of Biostatistics, University of Washington School of Medicine, Seattle

We hypothesized that initial treatment of acute graft-versus-host disease (GVHD) with low-dose glucocorticoids (prednisone-equivalent dose of 1 mg/kg per day) instead of standard-dose glucocorticoids (prednisone-equivalent dose of 2 mg/kg per day) does not compromise major transplantation outcomes. We retrospectively analyzed outcomes among 733 patients who received transplants between 2000 and 2005 according to initial treatment with low-dose (n = 347) versus standard-dose (n = 386) systemic glucocorticoids. The mean cumulative prednisone-equivalent doses at day 100 after starting treatment were 44 and 87 mg/kg for patients given low-dose and standard-dose glucocorticoids, respectively. Adjusted outcomes between the groups given low-dose versus standard-dose glucocorticoids were not statistically significantly different: overall mortality (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.9-1.4), relapse (HR, 1.22; 95% CI, 0.9-1.7), nonrelapse mortality (HR, 1.06; 95% CI, 0.8-1.5). The small number of patients with grades III/IV acute GVHD at onset precluded definitive conclusions for this subgroup. In multivariate analysis, the risks of invasive fungal infections (HR, 0.59; 95% CI, 0.3-1.0) and the duration of hospitalization (odds ratio, 0.62; 95% CI, 0.4-0.9) were reduced in the low-dose prednisone group. We conclude that initial treatment with low-dose glucocorticoids for patients with grades I-II GVHD did not compromise disease control or mortality and was associated with decreased toxicity.


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