改良马利兰/氟达拉滨方案治疗老年或不耐受性恶性血液疾病的安全性和疗效
The efficacy and safety of modified busulfan/fludarabine conditioning regimen in elderly or drug-intolerable patients with hematologic malignancies
目的 探讨减低毒性预处理(RIC)方案,改良马利兰(Bu,9.6 mg/kg)/氟达拉滨(Flu)方案治疗老年或不耐受性恶性血液疾病的安全性和疗效.方法 回顾性分析2008年1月至2012年1月23例老年( ≥55岁)或合并脏器功能损害的恶性血液病患者行同胞相合异基因造血干细胞移植的治疗情况.结果 23例患者分别输注中位单个核细胞(MNC)和CD34+细胞7.03(4.04~9.90)×108/kg和1.76(0.31 ~6.43)×106/kg.粒细胞植入中位时间为16(12 ~23)d,血小板植入中位时间为14(7~270)d.22例完全供者植入,1例未缓解患者为供受者嵌合状态.所有患者对预处理方案耐受良好,未发生严重预处理相关并发症,100 d和1年移植相关死亡率分别为0和4.3%.6例(26.1%)发生急性移植物抗宿主病(GVHD),Ⅰ度1例,Ⅱ度4例,Ⅳ度1例,21例可评估的患者中15例(71.4%)发生慢性GVHD,无GVHD相关死亡.中位随访时间1138(55 ~1747)d,3年总体生存率和无事件生存率分别为79.2%和69.6%.16例(69.6%)无复发存活,复发6例,肺部感染死亡1例.结论 改良Bu/Flu方案是一种新的安全、有效的RIC方案,尤其适合老年或不耐受标准清髓性预处理方案的恶性血液肿瘤患者.
更多Objective To evaluate the efficacy and safety of modified busulfan (Bu,9.6 mg/kg)/ fludarabine (Flu) conditioning regimen on malignant hematologic diseases in elderly and/or drug-intolerable patients.Methods We utilized a new reduced intensity conditioning (RIC) containing of new dosage of intravenous Bu (9.6 mg/kg),Flu (150 mg/m2),cytarabine and semustine but without antithymocyte globulin (ATG) in 23 aged and/or intolerable patients with malignancies.All 23 patients,with a median age of 49(8-66)years,received an allogenetic hematopoietic stem cell transplantation with human leukocyte antigen (HLA) identical sibling donors during January 2008 and January 2012.Stem cells were collected from granulocyte colony-stimulation factor (G-CSF) mobilized bone marrow plus G-CSF mobilized peripheral blood(G-PB) in 20 patients,G-PB alone in two,and non-mobilized BM in one.The graft had a median mononuclear cells (MNC) of 7.03 (4.04-9.9) × 108/kg and 1.76 (0.31-6.43) × 106/kg of CD34+ cells.Graft-versus-host disease (GVHD) prophylaxis included cyclosporin A,mycophenolate mofetil and methotrexate.Results All patients were well tolerated to the regimen without serious drug related toxicity.Transplant related mortality were 0 and 4.3% at day 100 and one year.All patients except one got full donor engraftment and achieved complete remission.Acute GVHD was observed in 6 patients (26.1%) including grade Ⅲ-Ⅳ in 5 patients.Chronic GVHD was reported in 15 of 21 evaluable patients (71.4%).With a median follow-up of 1138 (55-1747) days,16 of 23 patients were alive and disease-free.Three-year overall survival (OS) and event free survival (EFS) were 79.2% and 69.6%,respectively.Conclusion Modified Bu/Flu as a new RIC regimen is well tolerated and safe for patients who need allogeneic hematopoietic stem cell transplantation,especially in older patients and/or patients with severe comorbidities.
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