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Prednisone and azathioprine compared with prednisone and placebo for
treatment of chronic graft-v-host disease: prognostic influence of
prolonged thrombocytopenia after allogeneic marrow transplantation
KM Sullivan, RP Witherspoon, R Storb, P Weiden, N Flournoy, S Dahlberg, HJ Deeg, JE Sanders, KC Doney and FR Appelbaum
Fred Hutchinson Cancer Research Center, Department of Medicine Seattle, WA
98104.
We conducted a randomized, double-blind comparison of prednisone and
placebo (group I) v prednisone and azathioprine (1.5 mg/kg/day) (group II)
as early treatment of extensive chronic graft-v-host disease (GVHD).
Patients with platelet counts less than 100,000/microL were placed into
therapy with prednisone alone (group III). All three groups received
identical doses of prednisone (1 mg/kg every other day) and one
double-strength trimethoprim-sulfamethoxazole (TMP-SMX) tablet twice daily.
Between January 1980 and December 1983, 179 previously untreated patients
were enrolled and 164 were evaluable. Patients randomized to group I (n =
63) and group II (n = 63) were well matched for prognostic factors; those
placed into group III (n = 38) had more frequent acute GVHD and progressive
onset of chronic GVHD. Median duration of therapy was 2 years.
Complications included diabetes (5%), aseptic necrosis (5%) and infection.
For groups I, II, and III, the respective incidence of infection was
disseminated varicella, 11%, 24%, 34%; bacteremia, 6%, 11%, 34%; and
interstitial pneumonia, 5%, 14%, 18%. Recurrent malignancy was the most
frequent cause of death and did not differ significantly across the groups.
Nonrelapse mortality, however, did differ: 21% in group I, 40% in group II,
and 58% in group III (I v II, P = .003; I v III, P = .001). Forty patients
in group I, 30 in group II, and 10 in group III survive with a minimum
follow-up of 3.8 years. Karnofsky performance scores for 68 survivors are
90% to 100%, scores for seven survivors are 70% to 89% and scores for five
survivors are less than 70%. Actuarial survival at 5 years after transplant
is 61% in group I, 47% in group II, and 26% in group III (I v II, P = .03;
I v III, P = .0001). Treatment with prednisone alone results in fewer
infections and better survival than prednisone and azathioprine in
standard-risk chronic GVHD. Treatment with prednisone alone is less
effective in high-risk patients with thrombocytopenia, and other strategies
are required.
Volume 72,
Issue 2,
pp. 546-554,
08/01/1988
Copyright © 1988 by The American Society of Hematology
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