| 刘姝宏,孙一德,王军,等.照射预处理在单倍型造血干细胞移植中治疗高危髓系恶性肿瘤的临床疗效观察[J].中华放射医学与防护杂志,2025,45(5):438-445.Liu Shuhong,Sun Yide,Wang Jun,et al.Clinical efficacy of irradiation conditioning regimen in haploidentical hematopoietic stem cell transplantation for high-risk myeloid malignancies[J].Chin J Radiol Med Prot,2025,45(5):438-445 |
| 照射预处理在单倍型造血干细胞移植中治疗高危髓系恶性肿瘤的临床疗效观察 |
| Clinical efficacy of irradiation conditioning regimen in haploidentical hematopoietic stem cell transplantation for high-risk myeloid malignancies |
| 投稿时间：2024-11-13 |
| DOI：10.3760/cma.j.cn112271-20241113-00438 |
| 中文关键词: 照射 单倍型造血干细胞移植 预处理方案 急性髓系白血病 骨髓增生异常综合征 |
| 英文关键词:Irradiation Haploidentical hematopoietic stem cell transplantation (Haplo-HSCT) Conditioning regimen Acute myeloid leukemia (AML) Myelodysplastic syndrome (MDS) |
| 基金项目:国家重点研发计划(2023YFC2309000);北京市科技新星计划(20220484120) |
| 作者 | 单位 | E-mail | | 刘姝宏 | 解放军总医院第五医学中心血液病医学部, 北京 100071
解放军总医院研究生院, 北京 100853 | | | 孙一德 | 解放军总医院第五医学中心血液病医学部, 北京 100071
解放军总医院研究生院, 北京 100853 | | | 王军 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 扈江伟 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 李欲航 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 苏永锋 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 刘娜 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 乔卓青 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 胡亮钉 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 徐磊 | 解放军总医院第五医学中心血液病医学部, 北京 100071 | | | 宁红梅 | 解放军总医院第五医学中心血液病医学部, 北京 100071
解放军总医院研究生院, 北京 100853 | ninghongmei72@sina.com |
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| 中文摘要: |
| 目的 比较含照射和仅基于化疗的清髓性预处理方案在单倍型造血干细胞移植(Haplo-HSCT)中治疗高危髓系恶性肿瘤患者的有效性及安全性。方法 回顾性收集2015年1月至2019年12月在解放军总医院第五医学中心连续接受Haplo-HSCT的63例高危急性髓系白血病(AML)和骨髓增生异常综合征(MDS)患者临床资料,根据预处理方案不同分为照射组(17例)和化疗组(46例)。比较两组在造血重建、急性移植物抗宿主病(aGVHD)和慢性移植物抗宿主病(cGVHD)累积发生率、非复发死亡(NRM)、复发率(RR)、总生存(OS)、无病生存(DFS)等方面的差异,并对预后影响因素进行分析。结果 照射组和化疗组中位随访时间分别为78.5和72.3个月,两组中性粒细胞植入中位时间分别为14.0和14.5 d,血小板植入中位时间分别为15.0和13.0 d,两组在造血重建方面差异无统计学意义(P>0.05)。照射组aGVHD和cGVHD的累积发生率要高于化疗组,照射组和化疗组100 dⅡ~Ⅳ级aGVHD累积发生率分别为29.4%和21.7%,Ⅲ~Ⅳ级aGVHD累积发生率分别为 23.5%和13.0%,5年重度cGVHD的累积发生率照射组和化疗组分别为11.8%和8.7%,差异无统计学意义(P>0.05)。在远期生存方面,照射组和化疗组5年累积RR和NRM率分别为20.2%、28.4%和5.9%、23.9%,差异无统计学意义(P>0.05),5年DFS率和OS率分别为73.9%、47.7%和81.1%、54.4%,差异亦无统计学意义(P>0.05),但照射组DFS和OS生存曲线趋势要优于化疗组。生存曲线显示,含照射方案具有更好的OS、DFS以及无cGVHD无复发生存(GRFS)趋势,但多因素分析未发现照射预处理是影响生存预后的独立因素[HR=0.532(0.163~1.735)、0.370(0.091~1.516)、0.683(0.248~1.882), P > 0.05]。结论 在行Haplo-HSCT治疗高危髓系恶性肿瘤的患者中,含照射预处理方案与基于化疗的预处理方案相比,RR和NRM较低,DFS和OS较高,含照射预处理方式具有潜在更好的生存结局,提示在该类移植中可作为优先选择的预处理方案。 |
| 英文摘要: |
| Objective To compare the efficacy and safety of irradiation-incorporated and chemotherapy only-based myeloablative conditioning regimens in haploidentical hematopoietic stem cell transplantation (haplo-HSCT) for patients with high-risk myeloid malignancies. Methods This study retrospectively collected clinical data from 63 high-risk acute myeloid leukemia/myelodysplastic syndrome (AML/MDS) patients who underwent haplo-HSCT at the Fifth Medical Center of the Chinese PLA General Hospital from January 2015 to December 2019. These patients were classified into the irradiation (n = 17) and chemotherapy (n = 46) groups based on different conditioning regimens. The differences between the two groups were compared in terms of hematopoietic reconstitution, cumulative incidence of acute/chronic graft-versus-host diseases (aGVHD and cGVHD), non-relapse mortality (NRM), relapse rate (RR), overall survival (OS), and disease-free survival (DFS), followed by the analysis of prognostic factors. Results The median follow-up time for the irradiation and chemotherapy groups was 78.5 and 72.3 months, respectively. The median time for neutrophil engraftment was 14.0 days in the irradiation group and 14.5 d in the chemotherapy group, and for platelet engraftment was 15.0 and 13.0 d, respectively. As a result, the two groups showed no statistically significant differences in hematopoietic reconstitution (P > 0.05). The cumulative incidence of aGVHD and cGVHD was higher in the irradiation group compared to the chemotherapy group, yet showing no statistically significant differences (P > 0.05). Specifically, the cumulative incidence of grade Ⅱ-Ⅳ aGVHD within 100 d was 29.4% and 21.7% for the irradiation and chemotherapy groups, respectively. The cumulative incidence of grade Ⅲ-Ⅳ aGVHD was 23.5% and 13.0%, respectively. The cumulative incidence of severe cGVHD within five years was 11.8% in the irradiation group and 8.7% in the chemotherapy group. In terms of long-term survival, the cumulative 5\｜year RR and NRM were 20.2% and 28.4% in the irradiation group, 5.9% and 23.9% in the chemotherapy group, respectively, showing no statistically significant differences (P > 0.05). The 5-year DFS and OS rates were 73.9% and 47.7% in the irradiation group, and 81.1% and 54.4% in the chemotherapy group, respectively, without statistically significant differences (P > 0.05). Notably, the irradiation group manifested more favorable DFS and OS survival curves compared to the chemotherapy group. The survival curves indicate that the irradiation-incorporated regimen exhibited better trends in OS, DFS, and cGVHD-free relapse-free survival (GRFS). However, multivariate analysis did not reveal that irradiation conditioning is an independent prognostic factor affecting survival [HR = 0.532 (0.163-1.735), 0.370 (0.091-1.516), 0.683 (0.248-1.882), P > 0.05]. Conclusions In haplo-HSCT for high-risk myeloid malignancies, the irradiation-incorporated conditioning regimen demonstrates lower RR and NRM, higher DFS and OS, and potentially superior survival outcomes compared to the chemotherapy only-based regimen. Therefore, the irradiation-incorporated conditioning regimen may be preferentially considered in haplo-HSCT. |
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