Arsenic trioxide versus Realgar-Indigo naturalis formula in non-high-risk acute promyelocytic leukemia: a multicenter, randomized trial.

IF 8.2 1区 医学 Q1 HEMATOLOGY
Shu Chen, Weiwei Qin, Xiaohong Lu, Li Liu, Yinsuo Zheng, Xinhua Lu, Xiaohui Wang, Xiaojuan Zhang, Sha Gong, Suhua Wei, Huiyun Zhang, Hanru Ding, Ranjbarha Seifollah, Jing Li, Haitao Zhang, Di Wu, Olubukola Abiona, Pengcheng He, Rong Zhang, David Wald, Huaiyu Wang
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引用次数: 0

Abstract

Realgar-Indigo Naturalis Formula (RIF) is an oral form of arsenic that is effective against acute promyelocytic leukemia (APL). This multicenter, randomized, controlled trial compared the efficacy of all-trans retinoic acid (ATRA) plus RIF with ATRA plus arsenic trioxide (ATO) in a simplified regimen for non-high-risk APL. Following induction therapy with ATRA and ATO, participants were randomly assigned to receive either ATRA plus ATO or ATRA plus RIF both in a 2-week on 2-week off schedule for consolidation therapy. Once achieving molecular complete remission, the regimen was administered for a total of 6 cycles. All of 108 eligible patients achieved hematological complete remission after induction therapy. The median follow-up time was 29 months. The primary endpoint of two-year disease-free survival was 97% in the ATRA-RIF arm and 98% in the ATRA-ATO arm, respectively. (The ATRA-RIF arm was found to be non-inferior to the ATRA-ATO arm, (P < .01), with a percentage difference of -1% (95%CI, -4.8 to 6.9). No deaths have been observed. Most adverse events were moderate. This study confirms the noninferiority of RIF to ATO for non-high-risk APL, while also offering a more favorable regimen schedule for post-remission therapy. (ClinicalTrials gov. Identifier: as NCT02899169).

三氧化二砷与 Realgar-Indigo naturalis 配方治疗非高危急性早幼粒细胞白血病:一项多中心随机试验。
Realgar-Indigo Naturalis Formula(RIF)是一种口服砷剂,对急性早幼粒细胞白血病(APL)有效。这项多中心随机对照试验比较了全反式维甲酸(ATRA)加 RIF 与 ATRA 加三氧化二砷(ATO)在非高危 APL 简化方案中的疗效。在使用ATRA和ATO进行诱导治疗后,参试者被随机分配接受ATRA加ATO或ATRA加RIF的巩固治疗,两种疗法均采用2周开2周关的治疗方案。一旦达到分子完全缓解,该方案将连续使用 6 个周期。108名符合条件的患者均在诱导治疗后获得了血液学完全缓解。中位随访时间为 29 个月。ATRA-RIF治疗组和ATRA-ATO治疗组两年无病生存率的主要终点分别为97%和98%。(ATRA-RIF治疗组与ATRA-ATO治疗组相比无劣效(P < .01),百分比差异为-1% (95%CI, -4.8 to 6.9)。未观察到死亡病例。大多数不良反应为中度。这项研究证实了RIF对非高危APL的治疗效果优于ATO,同时也为缓解后治疗提供了更有利的治疗方案。(ClinicalTrials gov. Identifier: as NCT02899169)。
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来源期刊
Haematologica
Haematologica 医学-血液学
CiteScore
14.10
自引率
2.00%
发文量
349
审稿时长
3-6 weeks
期刊介绍: Haematologica is a journal that publishes articles within the broad field of hematology. It reports on novel findings in basic, clinical, and translational research. Scope: The scope of the journal includes reporting novel research results that: Have a significant impact on understanding normal hematology or the development of hematological diseases. Are likely to bring important changes to the diagnosis or treatment of hematological diseases.
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