风险调整疗法可改善儿童非T细胞ALL标危患者预后:JACLS ALL-02研究结果
Risk-adjusted therapy for pediatric non-T cell ALL improves outcomes for standard risk patients: results of JACLS ALL-02
原文发布日期:2020-02-27
DOI: 10.1038/s41408-020-0287-4
类型: Article
开放获取: 是
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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)针对儿童急性淋巴细胞白血病的第二项多中心试验,旨在改善非T细胞ALL的预后。在2002年4月至2008年3月期间,1138名非T细胞ALL患儿被纳入JACLS ALL-02试验。根据年龄、白细胞计数、不良遗传异常和治疗反应,患者被分为三组: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,预防性颅脑放射治疗(PCRT)被废除。所有患者的四年无事件生存率(4yr-EFS)和四年总生存率(4yr-OS)分别为85.4%±1.1%和91.2%±0.9%。风险调整治疗后,SR组的4yr-EFS为90.4%±1.4%,HR组为84.9%±1.6%,ER组为66.5%±4.0%。基于NCI风险分类,NCI-SR患者的4yr-EFS为88.2%,NCI-HR患者为76.4%。与之前的试验ALL-97相比,NCI-SR患者的4yr-EFS显著改善(88.2% vs 81.2%,对数秩检验p=0.0004)。四年孤立性中枢神经系统复发累积发病率(0.9%)和总中枢神经系统复发累积发病率(1.5%)显著低于先前报道。总之,在ALL-02试验中,实现了NCI-SR患者EFS的改善和PCRT的废除。
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