F/C + AIECy预处理方案在自体造血干细胞移植治疗侵袭性B细胞 NHL的疗效观察

闫蓓; 李晓红; 汪海涛; 李松威; 高亚会; 张甜甜; 王丽; 吴亚妹; 吴晓雄

doi:10.12435/j.issn.2095-5227.2023.134

F/C + AIECy预处理方案在自体造血干细胞移植治疗侵袭性B细胞 NHL的疗效观察

Effect of auto-HSCT using conditioning regimen F/C + AIECy for aggressive B cell NHL

摘要

摘要:
背景自体造血干细胞移植(autologous hematopoietic stem cell transplantation，Auto-HSCT)在治疗年轻高危险度分层的侵袭性B细胞非霍奇金淋巴瘤(B-NHL)中作为一线巩固方案逐渐成为国内外专家的共识。现行预处理方案下，依然有超过30%患者移植后复发，故预处理方案仍有不断改进的空间。
目的探究预处理方案为氟达拉滨或克拉屈滨联合阿糖胞苷 + 伊达比星 + 依托泊苷 + 环磷酰胺(F/C + AIECy)的自体造血干细胞移植一线巩固治疗高危、中高危侵袭性B细胞非霍奇金淋巴瘤(non-Hodgkin's lymphoma，NHL)的安全性和有效性。
方法回顾性分析2015年1月至2020年1月我院应用本预处理方案的高危、中高危侵袭性B 细胞NHL患者临床资料，分析干细胞采集情况、预处理相关不良反应、植入情况、患者疗效及生存与复发情况。
结果共纳入32例患者，男20例，女12例，中位年龄42(15 ~ 60岁)。采集单个核细胞及CD34⁺细胞中位数分别为11.55(8.05 ~ 14.76) × 10⁸/kg、4.56(1.58 ~ 15.24) × 10⁶/kg。所有患者均获得造血重建，植入率为 100%；白细胞植入的中位时间为10(7 ~ 20)d，血小板植入的中位时间为14(12 ~ 30) d。移植期间感染发生率68.75%，其他2级及以上不良反应发生率：黏膜炎18.75%、呕吐或腹泻46.88%、肝损害15.63%、出血6.25%，无预处理相关脏器衰竭及死亡事件。移植后３个月评估总缓解率由移植前的56.25%提升至84.38%(P=0.027)。中位随访时间38.5(10 ~ 83)个月，8例复发，4例死亡，3年复发率为21.87%，32例患者1年OS率和PFS率分别为93.8%、86.9%，3年OS率和PFS率分别为86.5%、75.6%，5年OS率和PFS率分别为78.6%、68.0%。
结论 F/C + AIECy预处理方案的Auto-HSCT一线巩固治疗年轻高危险度分层的侵袭性B细胞NHL安全有效，对提高缓解率、降低移植后复发及改善生存有益。

Abstract:
Background High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (Auto-HSCT) is still a consolidation treatment choice for young patients with high-risk, high-intermediate-risk aggressive B-cell non-Hodgkin’s lymphoma (B-NHL) as frontline therapy. With the aim of obtaining a higher anti-lymphoma activity and/or reducing the toxic effects, a number of studies suggest the possibility of improving the outcomes of NHL patients through modifying the conditioning regimens.
Objective To investigate the safety and effectiveness of Auto-HSCT using tumor-ablative conditioning regimen F/C + AIECy (Fludarabine/Cladribine + Idarubicin + Cytarabine + Etoposide + Cytoxan) for patients with aggressive B cell non-Hodgkin's lymphoma (B-NHL).
Methods Clinical data about 32 patients with high-risk, high-intermediate-risk aggressive B-NHL received above-mentioned therapeutic regimen from January 2015 to January 2020 were analyzed retrospectively, and conditioning-related toxicity, engraftment, survival and relapse rate were evaluated.
Results The medians of collected mononuclear cells and CD34 + cells were 11.55(rang: 8.05-14.76) × 108/kg and 4.56 (rang: 1.58-15.24) × 106 /kg, respectively. All patients had successfully completed hematopoietic reconstruction, and the median time of neutrophil and platelet reconstitution time was 10 (rang: 7-20) days and 14 (rang: 12-30) days in these cases. The incidence of infection during transplantation was 68.75%, and during transplantation the incidence rates of adverse reaction in grade 2 or higher were as follows: mucositis 18.75%, nausea and vomiting 46.88%, liver injury 15.63%, bleeding 6.25%. No conditioning-related organs' failure and mortality events were found. The complete remission (CR) rate of all patients was significantly higher at 3 months after transplantation compared with before transplantation (56.25% vs 84.38%, P=0.027). The median follow-up time was 38.5 (0-83) months, during which disease progression occurred in 8 cases, death occurred in 4 cases, and the 3-year relapse rate of all patients was 21.87%. The 1-year overall survival (OS) rate and progression-free survival (PFS) rate was 93.8% and 86.9%, the 3-year OS rate and PFS rate was 86.5% and 75.6%, the 5-year OS rate and PFS rate was 78.6% and 68%. Conclusion Auto-HSCT using conditioning regimen F/C + AIECy is safe and effective for young patients with high-risk, high-intermediate-risk aggressive B- NHL, and it possess a certain effect for increasing CR rate after transplantation.

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