[Long-Term Outcome of 940 Children with Newly Diagnosed Acute Lymphoblastic Leukemia Treated with CCLG-ALL 2008: A Prospective Single Center Study in China]

To study the long-term efficacy of CCLG-ALL2008 protocol used for treatment of childhood acute lymphoblastic leukemia (ALL).Nine hundred and forty children with newly diagnosed ALL from January 2008 to April 2015 were treated with CCLG-ALL2008 protocol. Overall survival (OS) and event-free survival (EFS) rates were estimated by the Kaplan-Meier method. Cox proportional hazards model was used for analyses of prognostic factors.Among the 940 newly diagnosed ALL patients, 570 patients were male, and 370 patients were female, the median age of onset was 5 years old (from 1 to 15 years old). The complete reaction rate (CR) was 96.7%. Survival analysis of 916 ALL patients with CR estimated by follow up [ (median follow up period 64 months (from 3 to 123 months) ] showed that, the expected 10 year OS rate was (78.6±1.5)% and the EFS rate was (66.0±1.8)%. The long-term OS rate of standard risk, intermediate risk and high risk patients was (93.0±1.5)%, (77.6±2.7)%, and (59.3±3.7)%, respectively, and the long-term EFS rate in standard risk, intermediate risk and high risk patients was (84.2±2.2)%. (67.8±2.9)%, and (42.1±3.9)% respectively. 10 year OS rate in B-ALL patients (79.8±1.6)% was significantly higher than that in T-ALL patients (53.5±6.3)% (P＜0.01). Among of all the patients, patients 201 (21.9%) relapsed, the median relapse time was 19 months (from 2 months to 81 months). The 10 year EFS rate was (81.7±3.7）% in the patients with MRD rate ＜0.01% after induction therapy, which was significantly higher than that in the patients with MRD rate＞0.01% (48.4±9.8)%.The therapeutic efficacy of the CCLG-ALL2008 protocol is closed to the level of supior study group in the world. Risk stratification can improve the outcome for childhood ALL. Immunophenotyping shows the outcome of B-ALL is better than that of T-ALL. MRD negative patients after induction therapy shows better prognosis compared with that of MRD positive patients.单中心应用CCLG-ALL2008方案治疗940例 儿童急性淋巴细胞白血病的长期疗效分析.分析应用CCLG-ALL2008方案治疗初诊急性淋巴细胞白血病（ALL）患儿的长期疗效.回顾性分析2008年1月至2015年4月期间，本院确诊为ALL的940例初诊患儿应用CCLG-ALL2008方案治疗的临床特征及疗效。采用Kaplan-Meier生存分析评估患儿总体生存（OS）率和无事件生存（EFS）率，运用COX回归比例风险模型分析影响预后的因素.940例初诊ALL患儿，男性570例，女性370例，中位年龄为5（1-15）岁。完全缓解（CR）率为96.7%。对获得完全缓解的916例患儿进行随访[中位随访时间为64（3-123）个月]的生存分析显示，预期10年OS率为（78.6±1.5）%，EFS率为（66.0±1.8）%。低危组10年OS率为（93.0±1.5）%，EFS率为（84.2±2.2）%；中危组10年OS率为（77.6±2.7）%，EFS率为（67.8±2.9）%；高危组10年OS率为（59.3±3.7）%，EFS率为（42.1±3.9）%。B-ALL的10年OS率（79.8±1.6）%、EFS率（67.7± 1.8）%，明显优于T-ALL的OS率为（63.6±5.6）%和EFS率为（53.5±6.3）%。复发201例（21.9%）中，复发中位时间为CR后19 （2-81） 个月。诱导缓解后微小残留病监测（MRD）≥0.01%者10年EFS为（48.4±9.8）%,明显低于＜0.01%患儿的EFS率（81.7±3.7）.CCLG-ALL2008方案对儿童初诊ALL疗效接近发达国家治疗的水平，危险分组是良好的个体化治疗指标。B-ALL预后优于T-ALL，诱导缓解后MRD阴性患者预后明显优于阳性患者.