Xu Ruohao, Chen Xiaomei, Deng Chengxin, Wu Ping, Li Minming, Geng Suxia, Lai Peilong, Lu Zesheng, Weng Jianyu, Du Xin
Department of Hematology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangzhou 510080, Guangdong, P. R. China.
School of Medicine, South China University of Technology Guangzhou 510006, Guangdong, P. R. China.
Am J Transl Res. 2019 Jul 15;11(7):4533-4541. eCollection 2019.
The aim of the present study was to conduct a retrospective analysis of efficacy and safety profiles of azacitidine (AZA) decitabine (DAC) in Chinese patients with intermediate or higher-risk MDS, which was based on two clinical trials in a single center. A total of 40 included MDS patients diagnosed with refractory anemia with excess blast (RAEB) were from two independent clinic trials. Patients in each trial received either AZA (n = 19) or DAC (n = 21) respectively, and the effectiveness as well as the safety profile of the two drugs were compared. Patients treated with AZA showed a comparative efficacy to DAC group with regard to the overall response rate (73.7% 76.2%, = 0.86), overall survival (median: 19.3 20.8 months, = 0.56), progression-free survival (median: 12.3 9.3 months, = 0.43) and leukemia-free survival (median: 22.8 26.6 months, = 0.62). Patients treated with DAC showed slightly higher incidence of severe hematological adverse events during the whole treatment. Comparing hematological AEs in each observation interval, a trend of higher percentage of neutropenia, leukopenia and anemia as well as treatment delays were seen during the first 6 cycles in the DAC group.
本研究旨在基于单中心的两项临床试验,对阿扎胞苷(AZA)和地西他滨(DAC)在中国中高危骨髓增生异常综合征(MDS)患者中的疗效和安全性进行回顾性分析。共有40例被诊断为难治性贫血伴原始细胞增多(RAEB)的MDS患者来自两项独立的临床试验。每项试验中的患者分别接受AZA(n = 19)或DAC(n = 21)治疗,并比较两种药物的有效性和安全性。在总缓解率(73.7%对76.2%,P = 0.86)、总生存期(中位数:19.3对20.8个月,P = 0.56)、无进展生存期(中位数:12.3对9.3个月,P = 0.43)和无白血病生存期(中位数:22.8对26.6个月,P = 0.62)方面,接受AZA治疗的患者与DAC组显示出相当的疗效。接受DAC治疗的患者在整个治疗期间严重血液学不良事件的发生率略高。比较每个观察期的血液学不良事件,DAC组在前6个周期中出现中性粒细胞减少、白细胞减少和贫血的百分比以及治疗延迟的趋势更高。