Augmented use of L-asparaginase markedly improves AYA ALL outcomes: FBMTG prospective MRD2014 study

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Abstract

The enhanced utilization of native L-asparaginase (L-Asp) aims to improve treatment outcomes for adult patients with non-Philadelphia chromosome (Ph) acute lymphoblastic leukemia (ALL). In this measurable residual disease 2014 (MRD2014) study, we modified our protocol to include an augmented dose of native L-Asp. Compared with former MRD2008, the total dose of L-Asp was raised from 36 000 U/m2 to 232 000 U/m2 in patients aged 16 to 35 and from 36 000 U/m2 to 132 000 U/m2 in patients aged 36 to 65 years. Adult patients with ALL were enrolled between January 2014 and December 2019 based on the following eligibility criteria: non-L3 ALL, age 16 to 65 years, Eastern Cooperative Oncology Group performance status of 0 to 2, and adequate liver and kidney functions (serum bilirubin ≤ 2.0 mg/dL; serum creatinine ≤ 2.0 mg/dL). The median follow-up time was 1128 days (range, 35-2400). A total of 81 patients with non-Ph ALL (40 males and 41 females; median age, 39 years [range, 16-64]) in whom MRD status was assessed were included. Complete remission was achieved in 72 patients (89%). The probability of 3-year event-free survival (EFS) and overall survival (OS) in these patients were 55% and 72%, respectively. The outcomes for patients aged 16 to 35 years demonstrated remarkable improvement. The 3-year EFS of MRD2008 at 45% significantly increased to 71% for MRD2014. Our study unequivocally demonstrated the beneficial effects of augmented use of L-Asp in this adolescent and young adult population. This trial was registered at UMIN Clinical Trials Registry as #UMIN000012382.

加强使用 L-天冬酰胺酶可显著改善 AYA ALL 的预后:FBMTG前瞻性MRD2014研究
摘要提高原生L-天冬酰胺酶(L-Asp)的使用率旨在改善非费城染色体(Ph)急性淋巴细胞白血病(ALL)成人患者的治疗效果。在这项可测量残留疾病2014(MRD2014)研究中,我们修改了治疗方案,增加了原生L-Asp的剂量。与之前的MRD2008相比,16至35岁患者的L-Asp总剂量从36000 U/m2提高到232000 U/m2,36至65岁患者的L-Asp总剂量从36000 U/m2提高到132000 U/m2。2014年1月至2019年12月期间,成人ALL患者根据以下资格标准入组:非L3 ALL、年龄16至65岁、东部合作肿瘤学组表现状态为0至2、肝肾功能正常(血清胆红素≤2.0 mg/dL;血清肌酐≤2.0 mg/dL)。中位随访时间为 1128 天(35-2400 天不等)。共纳入了81例评估了MRD状态的非Ph ALL患者(男性40例,女性41例;中位年龄39岁[16-64岁])。72名患者(89%)获得了完全缓解。这些患者的 3 年无事件生存率(EFS)和总生存率(OS)分别为 55% 和 72%。16 至 35 岁患者的疗效显著改善。MRD2008的3年无事件生存率为45%,而MRD2014的3年无事件生存率则大幅提高到71%。我们的研究明确显示,在青少年和年轻成年人群体中增加使用 L-Asp 有益。该试验已在 UMIN 临床试验注册中心注册,注册号为 #UMIN000012382。
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