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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.

Publication ,  Journal Article
Sullivan, KM; Witherspoon, RP; Storb, R; Weiden, P; Flournoy, N; Dahlberg, S; Deeg, HJ; Sanders, JE; Doney, KC; Appelbaum, FR
Published in: Blood
August 1988

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.

Duke Scholars

Published In

Blood

ISSN

0006-4971

Publication Date

August 1988

Volume

72

Issue

2

Start / End Page

546 / 554

Location

United States

Related Subject Headings

  • Transplantation, Homologous
  • Thrombocytopenia
  • Prognosis
  • Prednisone
  • Middle Aged
  • Male
  • Infections
  • Infant
  • Immunology
  • Humans
 

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Sullivan, K. M., Witherspoon, R. P., Storb, R., Weiden, P., Flournoy, N., Dahlberg, S., … Appelbaum, F. R. (1988). 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. Blood, 72(2), 546–554.
Sullivan, K. M., R. P. Witherspoon, R. Storb, P. Weiden, N. Flournoy, S. Dahlberg, H. J. Deeg, J. E. Sanders, K. C. Doney, and F. R. Appelbaum. “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.Blood 72, no. 2 (August 1988): 546–54.
Sullivan KM, Witherspoon RP, Storb R, Weiden P, Flournoy N, Dahlberg S, Deeg HJ, Sanders JE, Doney KC, Appelbaum FR. 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. Blood. 1988 Aug;72(2):546–554.

Published In

Blood

ISSN

0006-4971

Publication Date

August 1988

Volume

72

Issue

2

Start / End Page

546 / 554

Location

United States

Related Subject Headings

  • Transplantation, Homologous
  • Thrombocytopenia
  • Prognosis
  • Prednisone
  • Middle Aged
  • Male
  • Infections
  • Infant
  • Immunology
  • Humans