Randomized Trial of Myeloablative Conditioning Regimens: Busulfan Plus Cyclophosphamide Versus Busulfan Plus Fludarabine

Title
Randomized Trial of Myeloablative Conditioning Regimens: Busulfan Plus Cyclophosphamide Versus Busulfan Plus Fludarabine
Author(s)
현명수Je-Hwan Lee[Je-Hwan Lee]Jung-Hee Lee[Jung-Hee Lee]Dae-Young Kim[Dae-Young Kim]Sung-Doo Kim[Sung-Doo Kim]Kyoo-Hyung Lee[Kyoo-Hyung Lee]김민경Young-Don Joo[Young-Don Joo]Won-Sik Lee[Won-Sik Lee]Hawk Kim[Hawk Kim]
Keywords
STEM-CELL TRANSPLANTATION; BONE-MARROW-TRANSPLANTATION; HEPATIC VENOOCCLUSIVE DISEASE; DAILY INTRAVENOUS BUSULFAN; TOTAL-BODY IRRADIATION; ACUTE MYELOID-LEUKEMIA; HLA-MISMATCHED MARROW; VERSUS-HOST-DISEASE; DAILY IV-BUSULFAN; HIGH-RISK
Issue Date
201302
Publisher
AMER SOC CLINICAL ONCOLOGY
Citation
JOURNAL OF CLINICAL ONCOLOGY, v.31, no.6, pp.701 - 709
Abstract
Purpose We conducted a phase III randomized clinical trial to compare two myeloablative conditioning regimens for allogeneic hematopoietic cell transplantation (HCT) in patients with leukemia and myelodysplastic syndrome. Patients and Methods After randomization, 64 patients received busulfan (3.2 mg/kg per day x 4 days) plus cyclophosphamide (60 mg/kg per day x 2 days; BuCy), and 62 patients received busulfan (same dose and schedule) plus fludarabine (30 mg/m(2) per day x 5 days; BuFlu). Results The median age was 41 years (range, 17 to 59 years). Five patients in the BuFlu arm experienced graft failure (primary, n = 1; secondary, n = 4). At 4 weeks after HCT, the median percentage of recipient hematopoietic chimerism was significantly greater in the BuFlu arm (0% v 5.5%; P < .001), and complete donor chimerism was greater in the BuCy arm (97.2% v 44.4%; P < .001). Severe (grade 3 or higher) infection and gastrointestinal adverse events were significantly more common in the BuCy arm, but the frequencies of hepatic adverse events were similar in the two arms. Nonrelapse mortality was similar in the two arms, but the BuCy arm had better overall survival (OS), relapse-free survival (RFS), and event-free survival (EFS; OS at 2 years, 67.4% v 41.4%, P = .014; RFS, 74.7% v 54.9%, P = .027; EFS, 60.7% v 36.0%, P = .014). Conclusion Our results indicate that the BuFlu regimen is not a suitable replacement for the BuCy regimen in young adults who are eligible for myeloablative conditioning therapy for allogeneic HCT. J Clin Oncol 31:701-709. (c) 2012 by American Society of Clinical Oncology
URI
http://hdl.handle.net/YU.REPOSITORY/26519http://dx.doi.org/10.1200/JCO.2011.40.2362
ISSN
0732-183X
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의과대학 > 내과학교실 > Articles
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