• Je-Hwan Lee, Young-Don Joo, Hawk Kim, Hun Mo Ryoo, Min Kyoung Kim, Gyeong-Won Lee, Jung-Hee Lee, Won-Sik Lee, Jae-Hoo Park, Sung-Hwa Bae, Myung Soo Hyun, Dae-Young Kim, Sung-Doo Kim, Young Joo Min, and Kyoo-Hyung Lee.
• Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. jhlee3@amc.seoul.kr
• J. Clin. Oncol. 2013 Feb 20;31(6):701-9.

PurposeWe 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 MethodsAfter randomization, 64 patients received busulfan (3.2 mg/kg per day × 4 days) plus cyclophosphamide (60 mg/kg per day × 2 days; BuCy), and 62 patients received busulfan (same dose and schedule) plus fludarabine (30 mg/m(2) per day × 5 days; BuFlu).ResultsThe 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).ConclusionOur 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.

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