Maintenance therapy with all-trans retinoic acid and arsenic trioxide improves relapse-free survival in adults with low- to intermediate-risk acute promyelocytic leukemia who have achieved complete remission after consolidation therapy.
Maintenance therapy with all-trans retinoic acid and arsenic trioxide improves relapse-free survival in adults with low- to intermediate-risk acute promyelocytic leukemia who have achieved complete remission after consolidation therapy.
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DOI：
10.2147/ott.s135013
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发表时间：
2017
影响因子：
4
通讯作者：
Feng J
中科院分区：
文献类型：
--
作者：
Liang B;Zheng Z;Shi Y;Chen J;Hu X;Qian H;Shen Z;Jiang S;Yu K;Feng J
目前，急性早幼粒细胞白血病（APL）患者在完成巩固化疗后达到完全缓解（CR）的最佳维持治疗仍存在争议。全反式维甲酸（ATRA）加三氧化二砷（As 2 O3）维持策略与经典ATRA加化疗的比较有效性尚未评估。在这项研究中，我们比较了ATRA联合As 2 O3维持治疗和经典ATRA联合化疗在诱导和巩固治疗后首次达到CR的中、低危APL患者中的疗效和毒性。对58例确诊为APL的成人患者进行了回顾性分析。在巩固治疗达到CR后，30例患者接受ATRA + As 2 O3方案维持治疗（ATRA+ As 2 O3组），28例患者接受ATRA+化疗方案（ATRA+化疗组），3个月为1周期。ATRA+化疗组3-4级中性粒细胞减少发生率（N=9，32.1%）显著高于ATRA+ As 2 O3组（N=0）（P=0.001）。在巩固完成后的中位随访49.1个月（范围：9.7-97.4个月）时，ATRA+ As 2 O3组未观察到复发，而ATRA+化疗组发生了7例复发。ATRA+ As 2 O3维持组复发风险明显低于ATRA+化疗维持组（P=0.004）。基于对数秩分析，只有ATRA和As 2 O3维持治疗与显著更高的无复发生存率相关（P=0.0159）。ATRA和As 2 O3的维持治疗对低至中危APL患者有益，这些患者经有效治疗后达到CR。需要采用可靠设计的进一步临床试验来证实这些观察结果。
Currently, the optimal maintenance therapy for patients with acute promyelocytic leukemia (APL) who have achieved complete remission (CR) after completing consolidation chemotherapy remains controversial. The comparative effectiveness of the all-trans retinoic acid (ATRA) plus arsenic trioxide (As2O3) maintenance strategy with classic ATRA plus chemotherapy has not been evaluated. In this study, we compared the efficacy and toxicity of maintenance therapy with ATRA plus As2O3 and classic ATRA plus chemotherapy in low- to intermediate-risk APL patients reaching the first CR after induction and consolidation therapy. A retrospective review of 58 adult patients diagnosed with APL was conducted. After receiving consolidation therapy and achieving CR, 30 patients were administered maintenance therapy with an ATRA plus As2O3 regimen (ATRA+As2O3 group), whereas 28 patients were administered 3-monthly cycles of an ATRA plus chemotherapy regimen (ATRA+chemotherapy group). Grade 3–4 neutropenia was significantly more frequent in the ATRA+chemotherapy group (N=9, 32.1%) than in the ATRA+As2O3 group (N=0) (P=0.001). At a median follow-up of 49.1 months (range: 9.7–97.4 months) from the completion of consolidation, no relapses were observed in the ATRA+As2O3 group, whereas seven relapses occurred in the ATRA+chemotherapy group. The risk of relapse in the patients administered ATRA+As2O3 maintenance was significantly lower than that in those administered ATRA+chemotherapy maintenance (P=0.004). Based on log-rank analysis, only maintenance therapy with ATRA and As2O3 was associated with a significantly higher relapse-free survival (P=0.0159). Maintenance therapy with ATRA and As2O3 was beneficial in low- to intermediate-risk APL patients who were effectively treated to achieve CR. Further clinical trials with reliable designs are needed to confirm these observations.