Objective: To analyze the efficacy of children with B-cell acute lymphoblastic leukemia (B-ALL) without prognostic fusion genes treated by CCLG-ALL 2008, and investigate the related factors affecting the recurrence of the patients.
Methods: B-ALL patients without prognostic fusion genes treated by the protocol of CCLG-ALL 2008 in our hospital from March 2008 to December 2012 were retrospectively analyzed. Follow-up time was ended in August 31, 2019. The median follow-up time was 92 months (range 0-136 months). Kaplan-Meier was used to detect the RFS, and COX multivariate regression analysis was employed to identify the independent factors affecting the recurrence of the patients.
Results: There were 140 males and 99 females enrolled in this study. The ratio of male to female was 1.41∶1. The median age was 4.4 years old and the median number of WBC at initial stage was 4.98×109/L. There were 77 cases relapsed during the observation while 162 without relapsed, 16 cases lost to follow-up and 72 cases died. The recurrence and mortality rate was 32.22% and 30.1%, respectively, in which 45 cases died of recurrence (62.5% of the total deaths). Univariate analysis showed that the age≥6 years old, WBC >100×109/L, the bone marrow blasts on day 15≥25%, the bone marrow minimal residual disease (MRD) at week 12 >10-4, and the higher risk were the main factors affecting the recurrence of the patients (P<0.05). Multivariate COX regression analysis showed that age≥6 years old, WBC >100×109/L, bone marrow MRD >10-4 at the 12th week were the independent risk factors affecting recurrence of the patients.
Conclusion: Age, initial WBC, and bone marrow MRD at the 12th week were correlated with recurrence in children with B-ALL without prognostic fusion genes, which can be used as prognostic indices of recurrence risk in clinical.
题目: 无预后标志性基因的急性B淋巴细胞白血病患儿 随访10年复发因素的分析.
目的: 通过分析CCLG-ALL 2008方案治疗无预后标志性融合基因的急性B淋巴细胞白血病（B-ALL）患儿的疗效，并分析影响复发的相关因素.
方法: 回顾性分析239例于2008年3月至2012年12月在苏州大学附属儿童医院诊断为B-ALL、多重RT-PCR未检测到预后标志性融合基因，且接受CCLG-ALL 2008方案化疗的患儿，随防到2019年8月31日，中位随访时间92（0-136）个月。Kaplan-Meier分析无复发生存时间（RFS），COX多因素回归分析复发相关的独立因素.
结果: 239例患儿中男性140例，女性99例，男女比例1.41∶1，中位诊断年龄4.4岁，初诊白细胞中位数是4.98×109/L，复发77例，非复发162例，失访16例，死亡72例。复发率和死亡率分别为32.22%和 30.1%，其中45例死于复发（占总死亡人数62.5%）。对复发危险因素进行单因素分析，发现初诊年龄≥6岁、初诊白细胞计数>100×109/L、d15骨髓原始细胞≥25%、第12周骨髓微小残留病（MRD）>10-4以及最终危险度为高危是影响复发的主要因素（P<0.05)。多因素COX回归分析显示,年龄≥6岁、初诊白细胞数>100×109/L、第12周骨髓MRD>10-4是复发的独立危险因素.
结论: 年龄、初诊白细胞计数、第12周骨髓MRD与无预后标志性融合基因B-ALL患儿复发相关，在临床工作中可作为评估患儿复发风险的预后指标.
Keywords: acute lymphoblastic leukemia; children; prognosis; prognostic fusion gene; relapse.