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Marrow transplantation for severe aplastic anemia: methotrexate alone
compared with a combination of methotrexate and cyclosporine for prevention
of acute graft-versus-host disease
R Storb, HJ Deeg, V Farewell, K Doney, F Appelbaum, P Beatty, W Bensinger, CD Buckner, R Clift and J Hansen
Forty-six patients with severe aplastic anemia (median age, 23 years) were
treated with high-dose cyclophosphamide followed by infusion of marrow from
an HLA-identical family member. To evaluate postgrafting prophylaxis for
graft-v-host disease (GVHD), they were entered into a prospective
randomized trial comparing the effect of a combination of methotrexate and
cyclosporine (n = 22) to that of methotrexate alone (n = 24). Forty-four of
the forty-six patients had evidence of sustained marrow engraftment. Only
one patient in each of the two study groups showed graft rejection. A
significant reduction in the cumulative incidence of grades II to IV acute
GVHD was seen in patients given methotrexate/cyclosporine (18%) compared
with those given methotrexate alone (53%) (P = .012). In three patients
given methotrexate alone, grade III developed, and in six, grade IV acute
GVHD developed, compared with none given methotrexate/cyclosporine.
Eighteen of the 22 patients given methotrexate/cyclosporine and 15 of the
24 given methotrexate alone are alive between 5.5 and 44.5 months (median,
18 months), with actuarial survival rates at 2 years of 82% and 60%,
respectively (P = .062). The incidence of fatal infections was higher in
patients given methotrexate alone, whereas there are as yet no significant
differences in the incidence of chronic GVHD. We conclude that
methotrexate/cyclosporine treatment resulted in a significant decrease in
the incidence and severity of acute GVHD in patients who received
transplants for severe aplastic anemia and thus an improvement in survival.
Volume 68,
Issue 1,
pp. 119-125,
07/01/1986
Copyright © 1986 by The American Society of Hematology
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