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- Xiaojin Cai, Jialing Wei, Yi He, Dongling Yang, Erlie Jiang, Yong Huang, Mingzhe Han, and Sizhou Feng.
- Center of Hematopoietic Stem Cell Transplantation, Blood Disease Hospital, Institute of Hematology, Peking Union College, Chinese Academy of Medical Sciences, Tianjin, China.
- Int J Clin Pharm. 2015 Feb 1; 37 (1): 44-52.
BackgroundBusulfan/cyclophosphamide (Bu/Cy) is commonly used as a standard conditioning regimen without total body irradiation for patients with hematological myeloid malignancies undergoing hematopoietic stem cell transplantation (HSCT).ObjectiveTo develop a new myeloablative conditioning regimen incorporating fludarabine (Flu) and cytarabine (Ara-c).SettingA tertiary blood disease hospital in Tianjin, China.MethodsA Bu/Cy preparative regimen was used, modified by Flu 90 mg/m(2) and Ara-c 6 g/m(2) in 57 unselected patients (median age 37 years) with hematological myeloid malignancies. The patients were to receive allogeneic hematopoietic stem cell transplantation (allo-HSCT). Thirteen patients had high-risk leukemia, fifty patients had HLA matched sibling donors while seven patients had HLA mismatched sibling donors. Cy was given 50 mg/kg/day for 2 days while Bu was given 3.2 mg/kg/day intravenously for 3 days.Main Outcome MeasurePost-transplant donor chimerism, relapse tendency and minimal residual disease.ResultsExtramedullar toxicity was relatively limited; the incidence of treatment-related mortality (TRM) within 100 days was 3.5 %. The incidence of grade II-IV, grade III-IV acute graft versus host disease (GVHD) and chronic GVHD of the evaluable patients were 21.1, 8.8 and 36.4 %, respectively. With a median follow up of 59 (13-96.5) months, TRM and relapse rate (RR) at eight years were 24.1 ± 5.8 and 14.7 ± 4.8 %, respectively. Disease free survival at eight years was 67.9 ± 6.2 % for the entire group, 60.0 ± 8.9 % for patients with AML, 77.3 ± 8.9 % for patients with CML, 70.0 ± 6.5 and 42.9 ± 18.7 % or matched sibling and mismatched sibling HSCT respectively.ConclusionThe new regimen was associated with a low relapse rate, low incidence and severity of graft versus host disease and satisfactory survival for patients with myeloid malignancies.
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