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Blood, 1 July 2002, Vol. 100, No. 1, pp. 48-51
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Therapy for chronic graft-versus-host disease: a randomized trial
comparing cyclosporine plus prednisone versus prednisone alone
Sibel Koc,
Wendy Leisenring,
Mary E. D. Flowers,
Claudio Anasetti,
H. Joachim Deeg,
Richard A. Nash,
Jean E. Sanders,
Robert P. Witherspoon,
Rainer Storb,
Frederick R. Appelbaum, and
Paul J. Martin
From the Division of Clinical Research, Fred Hutchinson
Cancer Research Center, and the Department of Medicine, University of
Washington, Seattle, WA.
Results of previous studies have suggested that
transplantation-related mortality among patients with chronic
graft-versus-host disease (GVHD) may be reduced by combined treatment
with cyclosporine (CSP) and prednisone rather than by prednisone alone.
In a randomized trial, we assessed the efficacy of cyclosporine plus
prednisone versus prednisone alone as initial therapy for chronic GHVD
among patients whose platelet counts were higher than 100 000/µL.
Prednisone was administered initially at a dose of 1.0 mg/kg per day
orally, followed by a prolonged taper, and cyclosporine was
administered at 6 mg/kg orally twice daily every other day. The
cumulative incidence of transplantation-related mortality at 5 years
from enrollment was 17% (95% CI, 0.11-0.23) in the CSP plus
prednisone arm and 13% (95% CI, 0.08-0.19) in the prednisone arm. The
hazards of transplantation-related mortality, overall mortality,
recurrent malignancy, secondary therapy, and discontinuation of all
immunosuppressive therapy were not significantly different between the
2 arms, but survival without recurrent malignancy was lower in the
2-drug arm (P = .03). Avascular necrosis developed in 18 (13%) of the 142 patients in the CSP plus prednisone arm and in 32 (22%) of the 145 patients in the prednisone arm
(P = .04). Treatment with CSP plus prednisone may reduce
the risk for steroid-related toxicity, but results of the current study
do not substantiate the hypothesis that the administration of CSP
reduces transplantation-related mortality among patients with chronic GVHD.
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