We report the results of a controlled study in which BMT patients with moderate/severe acute graft-versus-host disease (GVHD) who responded to primary treatment with corticosteroids were prospectively randomized to short versus long taper of their steroid doses. Thirty patients with moderate/severe acute GVHD who responded by 14 days were eligible for random assignment of their steroid tapering schedule. Patients in the short taper group received a total PRED dose of 2275 mg/m2 over 86 days, whereas those in the long taper group received 6300 mg/m2 over 147 days. Patients in the long taper group achieved resolution of acute GVHD after a median of 30 days of therapy (range 6-30), whereas those receiving the short taper resolved after a median of 42 days (12-74) (P=0.01). After 8 weeks of therapy, only 2 of 13 evaluable long taper and 3 of 13 short taper patients still had active GVHD. The median PRED dose required to achieve complete resolution of acute GVHD was not different between the two groups: 1300 mg/m2 for the long taper patients and 1800 mg/m2 for the short taper patients. Importantly, the incidence of chronic GVHD and survival at 6 months was similar in the 2 groups. The incidence of steroid-related complications was similar, as well. This study suggests that the rapid administration of high-dose PRED to a cumulative dose of 2000 mg/m2 might lead to complete and prompt resolution of acute GVHD in the majority of patients and that rapid PRED taper might provide a mechanism for minimizing steroid-related morbidity. Further investigation and formal studies of the dose-response relationships and kinetics of steroid administration may lead to improvement in the management of acute GVHD.
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Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Univ Washington, Dept Med, Seattle, WA USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Martin, Paul J.
Storer, Barry E.
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Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Univ Washington, Dept Biostat, Seattle, WA 98195 USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Storer, Barry E.
Carpenter, Paul A.
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Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Univ Washington, Dept Pediat, Seattle, WA 98195 USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Carpenter, Paul A.
Couriel, Daniel R.
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Univ Michigan, Dept Med, Ann Arbor, MI 48109 USA
Univ Michigan, Dept Pediat, Ann Arbor, MI 48109 USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Couriel, Daniel R.
Flowers, Mary E. D.
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Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Univ Washington, Dept Med, Seattle, WA USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Flowers, Mary E. D.
Gupta, Vikas
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Princess Margaret Hosp, Dept Med, Toronto, ON M4X 1K9, CanadaFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Gupta, Vikas
Hsu, Jack W.
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Univ Florida, Dept Med, Gainesville, FL USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Hsu, Jack W.
Jagasia, Madan
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Vanderbilt Univ, Dept Med, Nashville, TN USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Jagasia, Madan
Kitko, Carrie L.
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Univ Michigan, Dept Med, Ann Arbor, MI 48109 USA
Univ Michigan, Dept Pediat, Ann Arbor, MI 48109 USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Kitko, Carrie L.
Maziarz, Richard T.
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Oregon Hlth & Sci Univ, Dept Med, Portland, OR 97201 USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Maziarz, Richard T.
Rowley, Scott D.
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Hackensack Univ Med Ctr, Div Stem Cell Transplantat, Hackensack, NJ USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Rowley, Scott D.
Shaughnessy, Paul J.
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Univ Texas Hlth Sci Ctr San Antonio, Texas Transplant Inst, Dept Med, San Antonio, TX 78229 USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Shaughnessy, Paul J.
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van Besien, Koen
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Weisdorf, Daniel
Lee, Stephanie J.
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Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
Univ Washington, Dept Med, Seattle, WA USAFred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA