title: A prospective randomised trial of cyclosporin versus methotrexate after HLA-identical sibling marrow transplantation for patients with acute leukemia in first remission: analysis 2.5 years after last patient entry.
abstract: The results of a prospective randomised trial comparing cyclosporin (CSP) with methotrexate (MTX) as immunosuppressive therapy after HLA-identical sibling marrow transplantation for patients with acute leukemia in first remission were analysed 2.5 years after entry of the last patient into the trial. Patients given cyclosporin showed a faster rate of marrow engraftment, less oro-pharyngeal mucositis, more azotemia and more diastolic hypertension than those receiving methotrexate. Actuarial four-year survival was 69% for patients receiving MTX and 43% for those receiving cyclosporin (not significant). Actuarial four-year survival in continuous complete remission from the time of transplant was 69% and 38% respectively (not significant, p = 0.09). While there was no difference in the incidence or severity of acute or chronic graft-versus-host disease, the actuarial rate of leukemic recurrence was 0% in the MTX and 36% in the GSP group (p = 0.02). This finding emphasises the importance of long-term follow up for the full assessment of new therapeutic protocols of marrow transplantation in the treatment of hematological malignancy.
authors.affiliation: Department of Haematology, St Vincent's Hospital, Darlinghurst, NSW, Australia.
authors.forename: K
authors.initials: K
authors.lastname: Atkinson
authors.forename: J C
authors.initials: JC
authors.lastname: Biggs
authors.forename: A
authors.initials: A
authors.lastname: Concannon
authors.forename: A
authors.initials: A
authors.lastname: Dodds
authors.forename: K
authors.initials: K
authors.lastname: Downs
authors.forename: M
authors.initials: M
authors.lastname: Ashby
mesh_terms: D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D002648:Child; D002986:Clinical Trials as Topic; D003524:Cyclosporins / Q000008:administration & dosage*; D005260:Female; D006085:Graft Survival / Q000187:drug effects; D006086:Graft vs Host Disease / Q000517:prevention & control; D006650:Histocompatibility Testing; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000628:therapy*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000628:therapy*; D011446:Prospective Studies; D011897:Random Allocation; D012074:Remission Induction
chemical_list: D003524:Cyclosporins; D008727:Methotrexate