title: Randomized comparison of two different schedules of granulocyte colony-stimulating factor administration after allogeneic bone marrow transplantation.
abstract: We performed a randomized trial to determine whether there are differential effects of G-CSF when it is either started on the day (day 0 group) or on the 6th day of marrow infusion (day 5 group) in the allogeneic BMT setting. G-CSF 450 microg was given intravenously daily until the peripheral blood ANC was over 3000/microl. Between May 1995 and April 1998, 60 patients were enrolled (30 in each group). Median number of days of G-CSF administration was significantly longer for the day 0 group (18.5 vs 14.0 days, P < 0. 001). Median days to an ANC over 500/microl were the same in both groups (16 days). Median days to an unsupported platelet count of 20 000/microl did not show significant differences (29.5 vs 28 days, P = 0.202). The frequency of hepatic VOD was higher for the day 0 group (66.7 vs 40.0%, P = 0.038). Mean plasma antithrombin III level was significantly lower in the day 0 group on post-transplant day 7 (83.6 vs 93.9%, P = 0.009). Patients in the day 0 group showed significantly worse 100-day survival (25/30 vs 30/30 surviving respectively, P = 0.019). In conclusion, early initiation of G-CSF after allogeneic BMT did not facilitate marrow engraftment. In addition, early administration of G-CSF was associated with a higher frequency of VOD and a significant fall in plasma antithrombin III level.
authors.affiliation: Division of Oncology-Hematology, Department of Medicine, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: K H
authors.initials: KH
authors.lastname: Lee
authors.forename: J H
authors.initials: JH
authors.lastname: Lee
authors.forename: S J
authors.initials: SJ
authors.lastname: Choi
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: S H
authors.initials: SH
authors.lastname: Kim
authors.forename: W K
authors.initials: WK
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D001777:Blood Coagulation; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006504:Hepatic Veno-Occlusive Disease / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D014184:Transplantation, Homologous
chemical_list: D016179:Granulocyte Colony-Stimulating Factor