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Title: [A retrospective comparative study of haplotype hematopoietic stem cell transplantation and human leukocyte antigen-matched sibling donor hematopoietic stem cell transplantation in the treatment of acute B-lymphocyte leukemia].
Author: Wang ZD, Sun YQ, Yan CH, Wang FR, Mo XD, Lyu M, Zhao XS, Han W, Chen H, Chen YY, Wang Y, Xu LP, Wang YZ, Liu YR, Cheng YF, Zhang XH, Liu KY, Huang XJ, Chang YJ.
Journal: Zhonghua Xue Ye Xue Za Zhi; 2022 Mar 14; 43(3):221-228. PubMed ID: 35405780.
Abstract:
Objective: To investigate whether haplotype hematopoietic stem cell transplantation (haplo-HSCT) is effective in the treatment of pre transplant minimal residual disease (Pre-MRD) positive acute B lymphoblastic leukemia (B-ALL) compared with HLA- matched sibling donor transplantation (MSDT) . Methods: A total of 998 patients with B-ALL in complete remission pre-HSCT who either received haplo-HSCT (n=788) or underwent MSDT (n=210) were retrospectively analyzed. The pre-transplantation leukemia burden was evaluated according to Pre-MRD determinedusing multiparameter flow cytometry (MFC) . Results: Of these patients, 997 (99.9% ) achieved sustained, full donor chimerism. The 100-day cumulative incidences of neutrophil engraftment, platelet engraftment, and grades Ⅱ-Ⅳ acute graft-versus-host disease (GVHD) were 99.9% (997/998) , 95.3% (951/998) , and 26.6% (95% CI 23.8% -29.4% ) , respectively. The 3-year cumulative incidence of total chronic GVHD was 49.1% (95% CI 45.7% -52.4% ) . The 3-year cumulative incidence of relapse (CIR) and non-relapse mortality (NRM) of the 998 cases were 17.3% (95% CI 15.0% -19.7% ) and 13.8% (95% CI 11.6% -16.0% ) , respectively. The 3-year probabilities of leukemia-free survival (LFS) and overall survival (OS) were 69.1% (95% CI 66.1% -72.1% ) and 73.0% (95% CI 70.2% -75.8% ) , respectively. In the total patient group, cases with positive Pre-MRD (n=282) experienced significantly higher CIR than that of subjects with negative Pre-MRD [n=716, 31.6% (95% CI 25.8% -37.5% ) vs 14.3% (95% CI 11.4% -17.2% ) , P<0.001]. For patients in the positive Pre-MRD subgroup, cases treated with haplo-HSCT (n=219) had a lower 3-year CIR than that of cases who underwent MSDT [n=63, 27.2% (95% CI 21.0% -33.4% ) vs 47.0% (95% CI 33.8% -60.2% ) , P=0.002]. The total 998 cases were classified as five subgroups, including cases with negative Pre-MRD group (n=716) , cases with Pre-MRD<0.01% group (n=46) , cases with Pre-MRD 0.01% -<0.1% group (n=117) , cases with Pre-MRD 0.1% -<1% group (n=87) , and cases with Pre-MRD≥1% group (n=32) . For subjects in the Pre-MRD<0.01% group, haplo-HSCT (n=40) had a lower CIR than that of MSDT [n=6, 10.0% (95% CI 0.4% -19.6% ) vs 32.3% (95% CI 0% -69.9% ) , P=0.017]. For patients in the Pre-MRD 0.01% -<0.1% group, haplo-HSCT (n=81) also had a lower 3-year CIR than that of MSDT [n=36, 20.4% (95% CI 10.4% -30.4% ) vs 47.0% (95% CI 29.2% -64.8% ) , P=0.004]. In the other three subgroups, the 3-year CIR was comparable between patients who underwent haplo-HSCT and those received MSDT. A subgroup analysis of patients with Pre-MRD<0.1% (n=163) was performed, the results showed that cases received haplo-HSCT (n=121) experienced lower 3-year CIR [16.0% (95% CI 9.4% -22.7% ) vs 40.5% (95% CI 25.2% -55.8% ) , P<0.001], better 3-year LFS [78.2% (95% CI 70.6% -85.8% ) vs 47.6% (95% CI 32.2% -63.0% ) , P<0.001] and OS [80.5% (95% CI 73.1% -87.9% ) vs 54.6% (95% CI 39.2% -70.0% ) , P<0.001] than those of MSDT (n=42) , but comparable in 3-year NRM [5.8% (95% CI 1.6% -10.0% ) vs 11.9% (95% CI 2.0% -21.8% ) , P=0.188]. Multivariate analysis showed that haplo-HSCT was associated with lower CIR (HR=0.248, 95% CI 0.131-0.472, P<0.001) , and superior LFS (HR=0.275, 95% CI 0.157-0.483, P<0.001) and OS (HR=0.286, 95% CI 0.159-0.513, P<0.001) . Conclusion: Haplo HSCT has a survival advantage over MSDT in the treatment of B-ALL patients with pre MRD<0.1% . 目的： 探讨单倍型造血干细胞移植（haplo-HSCT）治疗移植前微小残留病（Pre-MRD）阳性急性B淋巴细胞白血病（B-ALL）是否较全相合同胞造血干细胞移植（MSDT）具有生存优势，以及该作用是否受Pre-MRD的影响。 方法： 对2009年6月至2018年6月在北京大学血液病研究所接受异基因造血干细胞移植（allo-HSCT）的998例移植前处于完全缓解（CR）的B-ALL患者进行回顾性分析，其中haplo-HSCT组788例、MSDT组210例，移植前用多参数流式细胞术（MFC）检测MRD水平。 结果： ①全部998例B-ALL患者中，997例获得持续的完全供者嵌合状态，移植后100 d中性粒细胞、血小板植入率分别为99.9%（997/998）、95.3%（951/998），Ⅱ~Ⅳ度急性移植物抗宿主病（GVHD）发生率为26.6%（95%CI 23.8%~29.4%），3年慢性GVHD累积发生率为49.1%（95%CI 45.7%~52.4%），移植后3年白血病累积复发率（CIR）为17.3%（95%CI 15.0%~19.7%），非复发死亡率（NRM）为13.8%（95% CI 11.6%~16.0%），移植后3年无白血病生存（LFS）率、总生存（OS）率分别为69.1%（95%CI 66.1%~72.1%）、73.0%（95%CI 70.2%~75.8%）。②Pre-MRD阳性组（282例）患者移植后3年CIR高于Pre-MRD阴性组（716例）[31.6%（95%CI 25.8%~37.5%）对14.3%（95%CI 11.4%~17.2%），P<0.001]。③在Pre-MRD阳性组中，haplo-HSCT患者（219例）移植后3年CIR低于MSDT患者（63例）[27.2%（95%CI 21.0%~33.4%）对47.0%（95%CI 33.8%~60.2%），P＝0.002]。④全部998例患者按照Pre-MRD结果分为阴性组（716例）、<0.01%组（46例）、0.01%~<0.1%组（117组）、0.1%~<1%组（87例）、≥1%组（32例）；5组患者中，<0.01%组haplo-HSCT患者（40例）移植后3年CIR低于MSDT患者（6例）[10.0%（95%CI 0.4%~19.6%）对32.3%（95%CI 0%~69.9%），P＝0.017]，0.01%~<0.1%组haplo-HSCT患者（81例）移植后3年CIR也低于MSDT患者（36例）[20.4%（95%CI 10.4%~30.4%）对47.0%（95%CI 29.2%~64.8%），P＝0.004]；其他三组中，haplo-HSCT和MSDT患者移植后3年CIR差异无统计学意义。⑤在Pre-MRD<0.1%组（163例）中，haplo-HSCT患者（121例）移植后3年CIR低于MSDT患者（42例）[16.0%（95%CI 9.4%~22.7%）对40.5%（95% CI 25.2%~55.8%），P<0.001]，3年LFS率、OS率均高于MSDT组[78.2%（95%CI 70.6%~85.8%）对47.6%（95%CI 32.2%~63.0%），P<0.001；80.5%（95%CI 73.1%~87.9%）对54.6%（95%CI 39.2%~70.0%），P<0.001]，两组3年NRM差异无统计学意义[5.8%（95%CI 1.6%~10.0%）对11.9%（95%CI 2.0%~21.8%），P＝0.188]。多因素分析显示，haplo-HSCT是Pre-MRD<0.1%组移植后低CIR（HR＝0.248，95%CI 0.131~0.472，P<0.001）、高LFS率（HR＝0.275，95%CI 0.157~0.483，P<0.001）和高OS率（HR＝0.286，95%CI 0.159~0.513，P<0.001）的独立影响因素。 结论： haplo-HSCT治疗Pre-MRD<0.1%的B-ALL患者较MSDT具有生存优势。.

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