title: Low-dose cyclosporin A with short-term methotrexate for graft-versus-host disease prophylaxis in allogeneic bone marrow transplantation from human leukocyte antigen-identical siblings: a prospective phase II study in Japanese patients.
abstract: We hypothesized that reducing the dosage of prophylaxis for graft-versus-host disease (GVHD) would reduce the risk of relapse and toxicity after bone marrow transplantation (BMT) from human leukocyte antigen (HLA)-identical siblings. In a prospective phase II trial, 21 patients with leukemia and myelodysplastic syndrome underwent BMT from HLA-identical siblings and received GVHD prophylaxis consisting of low-dose (1.5 mg/kg per day) cyclosporin A (CSP) with short-term methotrexate (MTX) treatment. This low-dose group was compared with a group of retrospective control patients (n = 22) who received a standard CSP dosage (3.0 mg/kg per day) and MTX. One patient died of transplantation-related causes within 100 days. The regimen-related toxicity was quite tolerable. Although acute GVHD of grades II to III was more frequent in the low-dose group (47.6%) than in the control group (22.7%), the increase in acute GVHD did not significantly contribute to morbidity or mortality. There were no differences between the groups in the incidence and severity of chronic GVHD. The probabilities of relapse and survival of the groups were similar according to the risk for relapse at the time of transplantation. A prospective randomized study is required to determine whether low-dose or standard-dose CSP in combination with MTX is optimal for Japanese patients who undergo allogeneic BMT from HLA-identical siblings.
authors.affiliation: Division of Hematology, JA Aichi Showa Hospital, Konan, Aichi, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Kohno
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Morishita
authors.forename: Hiroatsu
authors.initials: H
authors.lastname: Iida
authors.forename: Hisashi
authors.initials: H
authors.lastname: Sakamaki
authors.forename: Toshiya
authors.initials: T
authors.lastname: Yokozawa
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Kitaori
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Ozeki
authors.forename: Keitaro
authors.initials: K
authors.lastname: Matsuo
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sao
mesh_terms: D000293:Adolescent; D000328:Adult; D044466:Asian People; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000401:mortality; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D006680:HLA Antigens; D019337:Hematologic Neoplasms / Q000150:complications / Q000401:mortality / Q000628:therapy; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007564:Japan; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D035781:Siblings; D014184:Transplantation, Homologous
chemical_list: D006680:HLA Antigens; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D008727:Methotrexate