Cyclosporine alone vs cyclosporine plus methotrexate for post-transplant immunosuppression after HLA-identical sibling bone marrow transplantation: a randomized prospective study.
The role of methotrexate (MTX), given with cyclosporine (CS), after HLA-identical sibling bone marrow transplantation needs to be defined. In all, 80 patients with hematologic malignancies were enrolled in a prospective randomized trial. All were given BuCy conditioning. The 40 patients in the CS arm received CS 3 mg/kg/day intravenously, with subsequent oral dosing. Patients in the CS + MTX arm received, in addition to CS, MTX intravenously, 15 mg/m2 on day 1, and 10 mg/m2 on days 3, 6, and 11. Transplantation-related mortality was low in both groups of patients (13 vs 11% for CS vs CS + MTX groups, P = 0.94). The CS group had a significantly higher frequency of chronic graft-versus-host disease (56 vs 32%, P = 0.05). After a median follow-up of 22.1 months (5.1-47.8 months), three of 30 vs 10 of 28 patients with acute leukemia/myelodysplastic syndrome (MDS) in CS group vs CS + MTX group relapsed (P = 0.01) yielding better overall survival for patients with acute leukemia/MDS treated with CS (P = 0.02). After HLA-identical sibling bone marrow transplantation, immunosuppression with CS, with or without MTX, resulted in similarly low transplantation-related mortality. In acute leukemia/MDS, decreased relapse with patient survival prolongation was observed in the CS group.
Sections of Hematology and Oncology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. khlee2@amc.seoul.kr
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D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D002908:Chronic Disease; D016572:Cyclosporine / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy*; D006680:HLA Antigens / Q000235:genetics; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000401:mortality / Q000628:therapy; D007951:Leukemia, Myeloid / Q000401:mortality / Q000628:therapy*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000401:mortality / Q000628:therapy; D011446:Prospective Studies; D012008:Recurrence; D035781:Siblings; D015996:Survival Rate; D014019:Tissue Donors
D006680:HLA Antigens; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D008727:Methotrexate