一项关于大剂量噻替派、白消安和环磷酰胺作为异基因骨髓移植预处理方案的 I-II 期研究。
A phase I-II study of high-dose thiotepa, busulfan and cyclophosphamide as a preparative regimen for allogeneic marrow transplantation.
作者信息
Przepiorka D, Ippoliti C, Giralt S, van Beisen K, Mehra R, Deisseroth A B, Andersson B, Luna M, Cork A, Lee M
机构信息
Section of Bone Marrow Transplantation, University of Texas M.D. Anderson Cancer Center, Houston.
出版信息
Bone Marrow Transplant. 1994 Sep;14(3):449-53.
Thirty adults with hematologic malignancies at high-risk for relapse were treated on a phase I-II study of high-dose thiotepa, busulfan (BU) and cyclophosphamide (CY) as the preparative regimen for allogeneic marrow transplantation. Cyclosporine and methylprednisolone or anti-CD5 ricin A chain immunoconjugate were used as graft-versus-host disease prophylaxis. Filgrastim was given from day 1 to enhance engraftment. Median follow-up time is 16 months (range 9-29 months). Grades III-IV regimen-related toxicity occurred in 5 (26%) of 19 patients treated with thiotepa 250 mg/m2 x 3, BU 1 mg/kg x 12 and CY 60 mg/kg x 2 and this was considered the maximal tolerated dose-schedule. Stomatitis and hepatoxicity were dose-limiting. All patients engrafted and had complete donor chimerism. The actuarial rate of acute graft-versus-host disease was 71% (95% CI 62-80%). The relapse rate at 1 year was 38% (95% CI 25-50%) and the actuarial survival at 1 year was 30% (95% CI 22-38%). The combination of thiotepa, BU and CY is tolerable as a preparative regimen for allogeneic marrow transplantation.
30例有高复发风险的血液系统恶性肿瘤成人患者接受了一项Ⅰ-Ⅱ期研究，采用大剂量噻替派、白消安（BU）和环磷酰胺（CY）作为异基因骨髓移植的预处理方案。环孢素和甲泼尼龙或抗CD5蓖麻毒素A链免疫偶联物用于预防移植物抗宿主病。从第1天开始给予非格司亭以促进植入。中位随访时间为16个月（范围9 - 29个月）。19例接受噻替派250mg/m²×3、BU 1mg/kg×12和CY 60mg/kg×2治疗的患者中有5例（26%）发生Ⅲ-Ⅳ级方案相关毒性，这被认为是最大耐受剂量方案。口腔炎和肝毒性是剂量限制性毒性。所有患者均植入并具有完全供体嵌合。急性移植物抗宿主病的精算发生率为71%（95%可信区间62 - 80%）。1年时的复发率为38%（95%可信区间25 - 50%），1年时的精算生存率为30%（95%可信区间22 - 38%）。噻替派、BU和CY联合作为异基因骨髓移植的预处理方案是可耐受的。
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