Long-term Results of the Risk-adapted Treatment for Childhood B-Cell Acute Lymphoblastic Leukemia: Report From the Japan Association of Childhood Leukemia Study ALL-97 Trial
Long-term Results of the Risk-adapted Treatment for Childhood B-Cell Acute Lymphoblastic Leukemia: Report From the Japan Association of Childhood Leukemia Study ALL-97 Trial
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DOI：
10.1097/mph.0000000000000760
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发表时间：
2017-03-01
影响因子：
1.2
通讯作者：
Hori, Hiroki
中科院分区：
文献类型：
--
作者：
Horibe, Keizo;Yumura-Yagi, Keiko;Hori, Hiroki
目的：本研究是日本儿童白血病研究协会为改善B细胞急性淋巴细胞白血病的转归，探索毒性较低的再诱导药物而进行的首个临床试验。将患者分为标准、中危、高危、极高危4个危险组，根据危险程度采取强化治疗方案。我们进行了两项随机试验，以比较标准风险组中再诱导治疗和不再诱导治疗的两种方案，并比较中风险组和高风险组中吡柔比星和柔红霉素的疗效。结果：所有患者10年无事件生存率(EFS)为77.0%。标准风险到极高风险组分别为79.3%、72.5%、71.7%和66.3%。诱导/巩固15周后不再诱导，10年后产生76.4%的EFS，与再诱导治疗方案相当。在整个治疗过程中，吡柔比星25 mg/m(2)给药11次可产生与30 mg/m(2)柔红霉素相当的EFS。结论：该试验在NCI-HR患者中产生了较高的存活率，尽管NCI-SR患者的结果并不令人满意，可能是因为中枢神经系统指导治疗的强度较小。
Purpose: This study was conducted as the first clinical trial by Japan Association of Childhood Leukemia Study to improve the outcome of B-cell acute lymphoblastic leukemia and explore a less toxic reinduction block.Patients and Methods: From 1997 to 2002, 563 patients with B-cell acute lymphoblastic leukemia aged 1 to 15 years were enrolled. The patients were assigned into 4 risk groups (standard, intermediate, high, or extremely high risk) and treated with regimens intensified according to the risk. Two randomized trials were conducted to compare 2 regimens with and without a 3-week reinduction therapy in the standard-risk group, and to compare the efficacy of pirarubicin with daunorubicin in the intermediate-risk and high-risk groups. Prophylactic cranial irradiation was restricted in patients with high or extremely high risk.Results: The event-free survival (EFS) rate at 10 years for all patients was 77.0%. Those in the standard-risk to extremely high-risk groups were 79.3%, 72.5%, 71.7%, and 66.3%, respectively. The 15-week induction/consolidation not followed by reinduction produced 76.4% of the EFS at 10 years comparable with the regimen with reinduction therapy. Pirarubicin at 25 mg/m(2) administered 11 times throughout the treatment produced the EFS comparable with daunorubicin at 30 mg/m(2).Conclusion: The trial produced high survival rates in NCI-HR patients, although the outcomes in NCI-SR patients were not satisfactory possibly due to less intensive central nervous system-directed therapy.