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Alternating-day cyclosporine and prednisone for treatment of high-risk
chronic graft-v-host disease
KM Sullivan, RP Witherspoon, R Storb, HJ Deeg, S Dahlberg, JE Sanders, FR Appelbaum, KC Doney, P Weiden and C Anasetti
Fred Hutchinson Cancer Research Center, Department of Medicine, Seattle, WA
98104.
Therapy of chronic graft-v-host disease (GVHD) has been unsatisfactory in
patients with platelet counts less than 100,000/microL. Survival at 5 years
after marrow transplant is only 26% in such patients treated with
trimethoprim-sulfamethoxazole (TMP-SMX) and every other day with
prednisone. Since October 1982, 61 patients with high-risk extensive
chronic GVHD were treated with a new alternating-day regimen of prednisone
(1 mg/kg every other day) and oral cyclosporine (6 mg/kg every 12 hours
every other day) with one double-strength TMP-SMX tablet twice daily. Forty
patients (group I) received primary treatment of thrombocytopenic chronic
GVHD (median platelet count 35 [range 7 to 87] x 10(3)/microL). Twenty-one
patients (group II) received salvage treatment after failing initial
prednisone +/- azathioprine. Twenty-one patients in group I and 15 in group
II survive with a minimum of 2 years and a median of 3.7 years follow-up.
At 4 years after transplant, actuarial survival is 51% (group I) and 67%
(group II). Causes of death included interstitial pneumonia (six), relapse
(five), GVHD without infection (five), infection (four), organ failure
(three), and hemorrhage (two). Mortality increased with the progressive
type onset of chronic GVHD and treatment failure. Toxicity included
hypertension (13), nephrotoxicity (nine), nausea (seven), aseptic necrosis
(five), neurologic abnormalities (four), and diabetes (three). Median
cyclosporine levels at four and 36 hours were 296 and 64 ng/mL,
respectively. Four patients required permanent discontinuation of
cyclosporine, but none required renal dialysis. Karnofsky performance
scores for 25 survivors are 90% to 100%, scores for six survivors are 70%
to 89%, and scores for five survivors are less than 70%. Alternating-day
cyclosporine and prednisone has acceptable toxicity and appears to improve
survival in patients with high-risk chronic GVHD.
Volume 72,
Issue 2,
pp. 555-561,
08/01/1988
Copyright © 1988 by The American Society of Hematology
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