An increased risk of relapse in cyclosporin-treated compared with methotrexate-treated patients: long-term follow-up of a randomized trial.
Patients with haematological malignancies and HLA-identical marrow donors were randomized to treatment with cyclosporin A (CSA, n = 30) or methotrexate (MTX, n = 29) with a follow-up ranging from 32 to 70 months. The two groups were comparable regarding disease status and age. Acute graft-versus-host disease (GVHD) was similar and the cumulative incidences of chronic GVHD was 42% in both groups. The overall incidence of cytomegalovirus (CMV) infection and other late infections were also the same in the two groups. Interstitial CMV pneumonitis occurred in 13% in the CSA group compared with 32% in the MTX group (ns). The probability of relapse was 42% after 4 years among the CSA patients and was significantly higher than the probability of relapse in the MTX patients which was found to be 10% (p = 0.03). The actuarial survival after 5 years was 53% for the CSA patients and 57% for the MTX patients (ns). The relapse-free survival was 41% and 59%, respectively (ns). There were no differences between the two groups in terms of renal or hepatic function, incidence of cataracts, blood cell counts, bone marrow cellularity or Karnofsky scores at 2 and 4 years after transplantation.
Bäckman
L
L
Department of Transplantation Surgery, Karolinska Institute, Huddinge Hospital, Stockholm, Sweden.
Ringdén
O
O
Tollemar
J
J
Lönnqvist
B
B
D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D002386:Cataract / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003524:Cyclosporins / Q000009:adverse effects / Q000627:therapeutic use*; D003586:Cytomegalovirus Infections / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival; D006086:Graft vs Host Disease / Q000517:prevention & control; D006801:Humans; D007223:Infant; D007668:Kidney / Q000187:drug effects; D008099:Liver / Q000187:drug effects; D008232:Lymphoproliferative Disorders / Q000628:therapy; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011897:Random Allocation
D003524:Cyclosporins; D008727:Methotrexate