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Cyclosporine as prophylaxis for graft-versus-host disease: a randomized
study in patients undergoing marrow transplantation for acute
nonlymphoblastic leukemia
HJ Deeg, R Storb, ED Thomas, N Flournoy, MS Kennedy, M Banaji, FR Appelbaum, WI Bensinger, CD Buckner and RA Clift
Seventy-five patients, 13 to 49 years of age, with acute nonlymphoblastic
leukemia in first remission were treated with cyclophosphamide,
fractionated total body irradiation, and marrow transplantation from an
HLA-identical sibling and randomized to receive either cyclosporine (CSP)
(n = 36) or methotrexate (MTX) (n = 39) as prophylaxis for graft-v-host
disease (GVHD). All patients engrafted, and 22 who were given CSP and 21
who were given MTX, are alive at 20 to 47 (median, 35) months (P = .5).
Engraftment as assessed by granulocyte recovery (P less than .0005) and
platelet transfusion requirement (P = .01) was faster in patients on CSP.
Twelve patients (33%) on CSP and 22 (56%) on MTX developed acute GVHD of
grades II through IV (P = .07) and 15 of 30 on CSP and 14 of 32 on MTX that
were at risk developed chronic GVHD. The most frequent causes of death were
interstitial pneumonitis and marrow relapse of leukemia, which occurred
with similar frequency in both groups. Beneficial effects observed in
patients on CSP included less severe mucositis and shorter duration of
hospitalization; adverse effects included renal function impairment and
hypertension. These data confirm that CSP is a useful immunosuppressant in
patients undergoing marrow transplantation but fail to show a significant
improvement in survival as compared with the standard regimen of MTX.
Volume 65,
Issue 6,
pp. 1325-1334,
06/01/1985
Copyright © 1985 by The American Society of Hematology
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