Outcome of children with newly diagnosed acute lymphoblastic leukemia treated with CCLG-ALL 2008: The first nation-wide prospective multicenter study in China
Outcome of children with newly diagnosed acute lymphoblastic leukemia treated with CCLG-ALL 2008: The first nation-wide prospective multicenter study in China
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DOI：
10.1002/ajh.25124
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发表时间：
2018-07-01
影响因子：
12.8
通讯作者：
Wu, Min-Yuan
中科院分区：
文献类型：
--
作者：
Cui, Lei;Li, Zhi-Gang;Wu, Min-Yuan
急性淋巴细胞白血病（ALL）是儿童中最常见的恶性肿瘤。中国儿童白血病研究组（CCLG）-ALL 2008是一项前瞻性临床试验，旨在通过中国首个全国范围的合作研究改善儿童ALL的治疗结局。共从8个城市的10家三级医院招募了2231名患者。根据临床生物学特征和早期治疗反应对患者进行分层。标准风险（SR）和中等风险（IR）组采用基于改良BFM的方案进行治疗，SR组在强化阶段的剂量减少25%-50%。高危组患者接受更强化的维持治疗。在两家医院（MRD组）进行微小残留病（MRD）监测和治疗调整。2100例患者（94.1%）达到完全缓解（CR）。5年时，整个组的总生存率（OS）和无事件生存率（EFS）估计分别为85.3%和79.9%。5年累积复发率（CIR）为15.3%。SR组的OS、EFS和CIR分别为91.5%、87.9%和9.7%。MRD组的结局优于非MRD组（5年EFS：82.4% vs 78.3%，P= 0.038; 5年CIR：10.7% vs 18.0%，P
Acute lymphoblastic leukemia (ALL) is the most common malignancy among children. The trial Chinese Children Leukemia Group (CCLG)-ALL 2008 was a prospective clinical trial designed to improve treatment outcome of childhood ALL through the first nation-wide collaborative study in China. Totally 2231 patients were recruited from ten tertiary hospitals in eight cities. The patients were stratified according to clinical-biological characteristics and early treatment response. Standard risk (SR) and intermediate risk (IR) groups were treated with a modified BFM based protocol, and there was 25%-50% dose reduction during intensification phases in the SR group. Patients in high risk (HR) group received a more intensive maintenance treatment. Minimal residual disease (MRD) monitoring with treatment adjustment was performed in two hospitals (the MRD group). Complete remission (CR) was achieved in 2100 patients (94.1%). At five years, the estimate for overall survival (OS) and event-free survival (EFS) of the whole group was 85.3% and 79.9%, respectively. The cumulative incidence of relapse (CIR) was 15.3% at five years. The OS, EFS and CIR for the SR group were 91.5%, 87.9%, and 9.7%, respectively. The outcome of the MRD group is better than the non-MRD group (5y-EFS: 82.4% vs 78.3%, P=.038; 5y-CIR: 10.7% vs 18.0%, P