title: Busulfex (i.v. BU) and CY regimen before SCT: Japanese-targeted phase II pharmacokinetics combined study.
abstract: To evaluate the toxicity and efficacy of an i.v. preparation of BU (12.8 mg/kg), combined with CY (120 mg/kg), a prospective study was performed on 30 Japanese patients (median age, 30 years) with hematologic malignancies undergoing hematopoietic SCT (28 allogeneic transplants from an HLA-matched donor and 2 autologous transplants). There were no significant toxicities, and all but one patient showed evidence of granulocyte engraftment at a median of 14 days for allogeneic and 11 days for autologous transplantation. Grades II-IV acute and chronic GVHD occurred in 9 (9/27, 33%) and 16 patients (16/27, 59%), respectively. Non-relapse mortality at days 100 and 365 was 3 and 17%, respectively. The pharmacokinetics of i.v. BU showed close inter- and intrapatient consistency; the area under the plasma concentration-time curve of the first administration remained at less than 1500 micromol min/l in 27 of the 29 patients (93%), and between 900 and 1350 micromol min/l in 22 patients (73%). As all of the profiles overlap with data from non-Japanese patients, we conclude that racial factors may not seriously influence the bioactivity of i.v. BU.
authors.affiliation: Hematology and Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: S-W
authors.initials: SW
authors.lastname: Kim
authors.forename: S-i
authors.initials: SI
authors.lastname: Mori
authors.forename: R
authors.initials: R
authors.lastname: Tanosaki
authors.forename: T
authors.initials: T
authors.lastname: Fukuda
authors.forename: M
authors.initials: M
authors.lastname: Kami
authors.forename: H
authors.initials: H
authors.lastname: Sakamaki
authors.forename: T
authors.initials: T
authors.lastname: Yamashita
authors.forename: Y
authors.initials: Y
authors.lastname: Kodera
authors.forename: S
authors.initials: S
authors.lastname: Terakura
authors.forename: S
authors.initials: S
authors.lastname: Taniguchi
authors.forename: S
authors.initials: S
authors.lastname: Miyakoshi
authors.forename: N
authors.initials: N
authors.lastname: Usui
authors.forename: S
authors.initials: S
authors.lastname: Yano
authors.forename: Y
authors.initials: Y
authors.lastname: Kawano
authors.forename: Y
authors.initials: Y
authors.lastname: Nagatoshi
authors.forename: M
authors.initials: M
authors.lastname: Harada
authors.forename: Y
authors.initials: Y
authors.lastname: Morishima
authors.forename: S
authors.initials: S
authors.lastname: Okamoto
authors.forename: A M
authors.initials: AM
authors.lastname: Saito
authors.forename: Y
authors.initials: Y
authors.lastname: Ohashi
authors.forename: R
authors.initials: R
authors.lastname: Ueda
authors.forename: Y
authors.initials: Y
authors.lastname: Takaue
mesh_terms: D000293:Adolescent; D000328:Adult; D002066:Busulfan / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003520:Cyclophosphamide / Q000008:administration & dosage*; D005260:Female; D006086:Graft vs Host Disease; D006098:Granulocytes / Q000166:cytology; D019337:Hematologic Neoplasms / Q000188:drug therapy*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D033581:Stem Cell Transplantation / Q000379:methods*; D014182:Transplantation, Autologous / Q000379:methods; D014184:Transplantation, Homologous / Q000379:methods; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D002066:Busulfan