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Cyclosporine or cyclosporine plus methylprednisolone for prophylaxis of
graft-versus-host disease: a prospective, randomized trial
HJ Deeg, D Lin, W Leisenring, M Boeckh, C Anasetti, FR Appelbaum, TR Chauncey, K Doney, M Flowers, P Martin, R Nash, G Schoch, KM Sullivan, RP Witherspoon and R Storb
Fred Hutchinson Cancer Research Center, Veterans Administration Medical
Center, University of Washington, Seattle 98104-2092, USA.
Patients with a lymphohematopoietic malignancy considered to be at high
risk for posttransplant relapse were enrolled in a study to compare the use
of cyclosporine (CSP) as a single agent with a combination of
methylprednisolone (MP) and CSP for graft-versus-host disease (GVHD)
prophylaxis after marrow transplantation from an HLA-identical sibling
donor. Sixty patients were randomized to receive CSP only and 62 were
randomized to receive CSP plus MP. Daily CSP was started on day -1 (5
mg/kg/d intravenously) and administered at gradually reduced doses until
day 180. MP was started on day 7 at 0.5 mg/kg/d, increased to 1.0 mg/kg/d
on day 15, started on a taper schedule on day 29, and discontinued on day
72. All 104 evaluable patients (surviving > or =28 days) had sustained
engraftment. The incidence rates of grades II-IV acute GVHD were 73% and
60% for patients receiving CSP and CSP plus MP, respectively (P = .01). No
difference was seen for grades III-IV GVHD. However, chronic GVHD occurred
somewhat more frequently in patients receiving CSP plus MP (44%) than in
patients receiving only CSP (21%; P = .02). The incidence of de novo
chronic GVHD was marginally higher in patients receiving CSP plus MP (P =
.08). No significant differences in the risk of infections were observed.
There was a suggestion that the risk of relapse was lower in patients
receiving CSP plus MP (P = .10) and, although the overall survival in the
two groups was not different (P = .44), there was a slight advantage in
favor of CSP plus MP-treated patients for relapse-free survival (P = .07).
These results suggest that prophylactic MP, when combined with CSP, has
only limited efficacy in acute GVHD prevention and may increase the
probability of chronic GVHD.
Volume 89,
Issue 10,
pp. 3880-3887,
05/15/1997
Copyright © 1997 by The American Society of Hematology
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