Liang Bin, Zheng Zhouyi, Shi Yifen, Chen Jingjing, Hu Xudong, Qian Honglan, Shen Zhijian, Jiang Songfu, Yu Kang, Feng Jianhua
Division of Hematology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou.
Division of Hematology-Oncology, Traditional Chinese Medical Hospital of Zhuji, Shaoxing.
Onco Targets Ther. 2017 Apr 26;10:2305-2313. doi: 10.2147/OTT.S135013. eCollection 2017.
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 (AsO) 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 AsO 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 AsO regimen (ATRA+AsO 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+AsO group (N=0) (=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+AsO group, whereas seven relapses occurred in the ATRA+chemotherapy group. The risk of relapse in the patients administered ATRA+AsO maintenance was significantly lower than that in those administered ATRA+chemotherapy maintenance (=0.004). Based on log-rank analysis, only maintenance therapy with ATRA and AsO was associated with a significantly higher relapse-free survival (=0.0159).
Maintenance therapy with ATRA and AsO 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.
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）后的最佳维持治疗仍存在争议。全反式维甲酸（ATRA）联合三氧化二砷（AsO）维持治疗策略与经典的ATRA联合化疗的相对有效性尚未得到评估。在本研究中，我们比较了ATRA联合AsO与经典ATRA联合化疗维持治疗在诱导和巩固治疗后达到首次CR的低至中危APL患者中的疗效和毒性。
对58例诊断为APL的成年患者进行回顾性分析。在接受巩固治疗并达到CR后，30例患者接受ATRA联合AsO方案的维持治疗（ATRA+AsO组），而28例患者接受每3个月1周期的ATRA联合化疗方案（ATRA+化疗组）。
ATRA+化疗组3-4级中性粒细胞减少症的发生率（N=9，32.1%）显著高于ATRA+AsO组（N=0）（P=0.001）。从巩固治疗完成后的中位随访49.1个月（范围：9.7-97.4个月）来看，ATRA+AsO组未观察到复发，而ATRA+化疗组发生了7例复发。接受ATRA+AsO维持治疗的患者复发风险显著低于接受ATRA+化疗维持治疗的患者（P=0.004）。基于对数秩分析，只有ATRA和AsO维持治疗与显著更高的无复发生存率相关（P=0.0159）。
ATRA和AsO维持治疗对有效治疗达到CR的低至中危APL患者有益。需要进一步进行设计可靠的临床试验来证实这些观察结果。
