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三氧化二砷单药或联合全反式维甲酸用于非高危急性早幼粒细胞白血病诱导治疗的比较

Comparison of induction therapy in non-high risk acute promyelocytic leukemia with arsenic trioxide or in combination with ATRA.

作者信息

Ghavamzadeh Ardeshir, Jalili Mahdi, Rostami Sharbanoo, Yaghmaie Marjan, Aliabadi Leyla Sharifi, Mousavi Seyed Asadollah, Vaezi Mohammad, Fumani Hossein Kamranzadeh, Jahani Mohammad, Alimoghaddam Kamran

机构信息

Hematology-Oncology and Stem Cell Transplantation Research Center/Tehran University of Medical Sciences, Tehran, Iran.

Hematology-Oncology and Stem Cell Transplantation Research Center/Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Leuk Res. 2018 Mar;66:85-88. doi: 10.1016/j.leukres.2018.01.019. Epub 2018 Feb 3.

Abstract

BACKGROUND

Acute promyelocytic leukemia (APL) is a curable form of acute myeloid leukemia; in recent years, the use of new treatment strategies, such as combination therapy, have led to improved APL outcomes. Here, outcomes of patients treated with a combination of arsenic trioxide (ATO) and all-trans-retinoic acid (ATRA) are compared against patients treated with single ATO therapy.

PATIENTS AND METHODS

In total, 67 patients with non-high-risk APL were evaluated. A group of 30 patients received ATO, and another group of 37 patients received ATO plus ATRA. ATO infusion at a dose of 0.15 mg/kg/day was continued till complete remission was achieved or till 60 days of consumption, and after 28 days of rest, second ATO course was initiated for 28 days as consolidation. Four courses separated by 28-day rest were planned. In the second group, 45 mg/m/day ATRA was added to ATO protocol.

RESULTS

All patients except one in the ATO group and all patients in the ATO plus ATRA group were alive after a median follow-up of 18 and 17 months, respectively; 2.5-year overall survival in the ATO group was 86% (p-value = .32). Five patients in the ATO group experienced relapse, and 2.5-year leukemia-free survival in this group was 60%. No relapse occurred in the ATO plus ATRA group (p-value = .01). Differences in the mean of white blood cell (p-value = .67), platelet (p-value = .15), liver (p-value = .37), and renal (p-value = .95) dysfunctions were not significant.

CONCLUSION

Although ATO has been considered a first-line therapy in patients with APL, several studies have reported improved outcomes with a combination of ATO plus ATRA. This study demonstrated a significant decrease in relapse with this combination compared with single ATO therapy and supported the importance of ATRA in APL treatment.

摘要

背景

急性早幼粒细胞白血病(APL)是一种可治愈的急性髓系白血病;近年来,联合治疗等新治疗策略的应用使APL的治疗效果得到改善。在此,将接受三氧化二砷(ATO)与全反式维甲酸(ATRA)联合治疗的患者的治疗效果与接受单一ATO治疗的患者进行比较。

患者与方法

总共评估了67例非高危APL患者。一组30例患者接受ATO治疗,另一组37例患者接受ATO加ATRA治疗。以0.15mg/kg/天的剂量持续输注ATO,直至达到完全缓解或直至用药60天,休息28天后,开始第二个ATO疗程,为期28天进行巩固治疗。计划进行四个疗程,每个疗程间隔28天休息。在第二组中,在ATO方案中加入45mg/m/天的ATRA。

结果

ATO组除1例患者外所有患者以及ATO加ATRA组所有患者在中位随访18个月和17个月后均存活;ATO组的2.5年总生存率为86%(p值 = 0.32)。ATO组有5例患者复发,该组的2.5年无白血病生存率为60%。ATO加ATRA组未发生复发(p值 = 0.01)。白细胞(p值 = 0.67)、血小板(p值 = 0.15)、肝脏(p值 = 0.37)和肾脏(p值 = 0.95)功能障碍均值的差异不显著。

结论

尽管ATO一直被认为是APL患者的一线治疗方法,但多项研究报告称ATO与ATRA联合使用可改善治疗效果。本研究表明,与单一ATO治疗相比,这种联合治疗可显著降低复发率,并支持了ATRA在APL治疗中的重要性。

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