FABC预处理异基因造血干细胞移植治疗难治未缓解急性白血病临床研究

Successful treatment of refractory,unremitting acute leukemia by allogeneic hematopoietic stem cell transplantation with FABC conditioning regimen

目的观察FABC预处理异基因造血干细胞移植治疗未缓解急性白血病(AL)患者的疗效及安全性。方法收集2005年11月至2010年8月广东省人民医院采用FABC预处理方案进行异基因造血干细胞移植治疗18例难治未缓解AL患者。观察造血恢复、植入率、急慢性移植物抗宿主病发生率、移植相关病死率、复发、总存活率和无病存活率及预后因素分析。结果所有患者均于移植后14～21 d获得完全供者植入,中性粒细胞>0.5×109/L和血小板>20×109/L中位时间分别为12(7～72)d和13(7～60)d;急性移植物抗宿主病(GVHD)及慢性GVHD累积发生率分别为50%和73.3%。中位随访10.5(3.1～66.6)个月,移植相关病死率5.6%(1/18),复发率为36.8%(7/18)。1年的预期总生存(OS)率和无病生存(DFS)率分别是(58.9±13.2)%和(53.6±15.5%)。COX逐步回归模型分析显示,慢性GVHD是DFS独立有利因素。结论 FABC预处理异基因造血干细胞移植是治疗难治性未缓解AL安全有效的方法。

Objective To explore the efficacy and safety of allogeneic hematopoietic stem cell transplantation （allo-HSCT） with FABC conditioning regimen for treatment of refractory unremitting acute leukemia patients. Methods Eighteen patients with refractory unremitting acute leukemia underwent allo-HSCT with FABC condi- tioning regimen. Hemopoietic recovery, engraftment, acute/chronic graft versus host disease （GVHD） , transplanta- tion-related mortality （TRM）, relapse, overall survival （OS） and disease free survival （DFS） post-HSCT were analyzed. Results All of these patients attained fully donor engraftment between days 14 and 21 post transplantation. The median time to ANC 〉 0. 5 × 10^9/L and PLT 〉 20 × 10^9/L was 12（range 7 -72） and 13（range 7 - 60） days after transplantation, respectively. The cumulative incidence of acute and chronic GVHD was 50% （9/18） and 73.3% （11/15 ）, respectively. During follow-up for a mean of 10. 5 （range 3. 1 -66. 6 ） months post transplantation, the TRM was 5.6% （ 1/18 ） and the relapse rate was 38. 6% （7/18）. The one-year overall survival （OS） probability and disease-free survival （DFS） was （58.9 ± 13.2）% and （53.6 ±15.5 ）% , respectively. Multivariate analyses by the stepwise Cox regression, chronic GVHD was shown to be an independent factor favoring DFS. Conclusion Allo-HSCT by FABC conditioning regimen is a safe and effective option for refractory unremitting acute leukemia patients.