Cyclosporine plus methylprednisolone versus cyclophosphamide plus methylprednisolone as prophylaxis for graft‐versus‐host disease: A randomized double‐blind study in patients undergoing allogeneic marrow transplantation

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Abstract
Eighty‐two patients, 12–39 years old, with acute and chronic leukemia, non‐Hodgkin's lymphoma, aplastic anemia and adrenal leukodystrophy were given marrow transplants following intensive cytoreductive therapy. The patients were then randomized in a double‐blind fashion to receive either cyclophosphamide (CY) and methylprednisolone (MP) (n = 40) or cyclosporine (CsA) and MP (n = 42) as post‐grafting prophylaxis for graft‐versus‐host disease (GVHD). All but 2 patients showed evidence of sustained hematopoietic engraftment. Eight of 40 patients receiving CY and MP and 16 of 42 patients receiving CsA and MP are alive at between 2.4 and 4.0 yr and 1.9 and 3.8 yr, respectively. The actuarial survival at 4 yr is 20% and 38% respectively (p = 0.03). The probability of developing acute GVHD on the CY and MP arm was 0.68 and 0.32 for those on the CsA and MP arm (p = 0.005). The probability of developing chronic GVHD was 18% on the CY and MP arm and 40% on the CsA and MP arm. This difference was not significant. The speed of granulocyte and platelet recovery was significantly faster for the CsA and MP arm (p = 0.01 and 0.02, respectively). Although the mean duration of hospitalization was less for the CsA and MP arm it was not significantly so. The cumulative incidence of renal failure was higher on the CsA and MP arm (p < 0.01). The causes of death were comparable in both arms of the study. With the transplant regimens used in this study CsA and MP reduced the incidence of acute GVHD and improved survival as compared to the patients on CY and MP.
Funding Information
  • National Cancer Institute (CA 15396, CAO‐6973)