Improved OutcomesWith Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial
Improved OutcomesWith Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial
复制标题
DOI：
10.1200/jco.2016.67.1982
复制
发表时间：
2017-02-01
影响因子：
45.3
通讯作者：
Lo-Coco, Francesco
中科院分区：
文献类型：
--
作者：
Platzbecker, Uwe;Avvisati, Giuseppe;Lo-Coco, Francesco
目的APL 0406临床试验的初步结果表明，全反式维甲酸（ATRA）联合三氧化二砷（ATO）一线治疗中、低危急性早幼粒细胞白血病（APL）至少不劣于标准ATRA联合化疗（CHT）。我们在此报告的最终分析的完整系列的患者入组到这个trial.Patients和方法的APL 0406研究是一个前瞻性的，随机的，多中心的，开放标签，III期非劣效性试验。符合条件的患者为年龄在18 - 71岁之间的新诊断的低风险或中等风险APL（诊断时WBC # 10 3 109/ L）成人。结果在263例可评价诱导应答的患者中，ATRA-ATO组和ATRA-CHT组分别有127例（100%）和132例（97%）患者达到完全缓解（CR）（P = 0.12）。中位随访40.6个月后，ATRA-ATO组与ATRA-CHT组患者的无事件生存率、累积复发率和50个月总生存率分别为97.3% vs80%、1.9% vs13.9%和99.2% vs92.6%（P
Purpose The initial results of the APL0406 trial showed that the combination of all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO) is at least not inferior to standard ATRA and chemotherapy (CHT) in firstline therapy of low-or intermediate-risk acute promyelocytic leukemia (APL). We herein report the final analysis on the complete series of patients enrolled onto this trial.Patients and Methods The APL0406 study was a prospective, randomized, multicenter, open-label, phase III noninferiority trial. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, low-or intermediate-risk APL (WBC at diagnosis # 10 3 109/ L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013.Results Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively (P =.12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3% v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively (P