Department of Hematology/Oncology, Hyogo Prefectural Children's Hospital, Kobe, Japan.
Department of Pediatrics, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.
Blood Cancer J. 2020 Feb 27;10(2):23. doi: 10.1038/s41408-020-0287-4.
This study was a second multicenter trial on childhood ALL by the Japan Childhood Leukemia Study Group (JACLS) to improve outcomes in non-T ALL. Between April 2002 and March 2008, 1138 children with non-T ALL were enrolled in the JACLS ALL-02 trial. Patients were stratified into three groups using age, white blood cell count, unfavorable genetic abnormalities, and treatment response: standard risk (SR), high risk (HR), and extremely high risk (ER). Prophylactic cranial radiation therapy (PCRT) was abolished except for CNS leukemia. Four-year event-free survival (4yr-EFS) and 4-year overall survival (4yr-OS) rates for all patients were 85.4% ± 1.1% and 91.2% ± 0.9%, respectively. Risk-adjusted therapy resulted in 4yr-EFS rates of 90.4% ± 1.4% for SR, 84.9% ± 1.6% for HR, and 66.5% ± 4.0% for ER. Based on NCI risk classification, 4yr-EFS rates were 88.2% in NCI-SR and 76.4% in NCI-HR patients, respectively. Compared to previous trial ALL-97, 4yr-EFS of NCI-SR patients was significantly improved (88.2% vs 81.2%, log rank p = 0.0004). The 4-year cumulative incidence of isolated (0.9%) and total (1.5%) CNS relapse were significantly lower than those reported previously. In conclusion, improved EFS in NCI-SR patients and abolish of PCRT was achieved in ALL-02.
本研究是日本儿童白血病研究组（JACLS）进行的第二次儿童急性淋巴细胞白血病（ALL）多中心试验，旨在改善非 T 细胞 ALL 的预后。2002 年 4 月至 2008 年 3 月，共有 1138 例非 T 细胞 ALL 患儿入组 JACLS ALL-02 试验。患者按年龄、白细胞计数、不良遗传异常和治疗反应分为三组：标准风险（SR）、高风险（HR）和极高风险（ER）。除中枢神经系统白血病外，取消预防性颅脑放疗（PCRT）。所有患者的 4 年无事件生存（4yr-EFS）率和 4 年总生存（4yr-OS）率分别为 85.4%±1.1%和 91.2%±0.9%。风险调整治疗使 SR 组的 4yr-EFS 率达到 90.4%±1.4%，HR 组为 84.9%±1.6%，ER 组为 66.5%±4.0%。根据 NCI 风险分类，NCI-SR 患者的 4yr-EFS 率为 88.2%，NCI-HR 患者为 76.4%。与之前的 ALL-97 试验相比，NCI-SR 患者的 4yr-EFS 显著提高（88.2% vs 81.2%，对数秩检验 p=0.0004）。孤立性（0.9%）和总（1.5%）中枢神经系统复发的 4 年累积发生率明显低于以往报道。总之，ALL-02 实现了 NCI-SR 患者 EFS 的改善和 PCRT 的废除。
