Activity of Azacitidine in Chronic Myelomonocytic Leukemia
Activity of Azacitidine in Chronic Myelomonocytic Leukemia
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DOI：
10.1002/cncr.25759
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发表时间：
2011-06-15
期刊：
影响因子：
6.2
通讯作者：
Lister, John
中科院分区：
文献类型：
--
作者：
Costa, Rubens;Abdulhaq, Haifaa;Lister, John
背景：去甲基化药物在骨髓增生异常综合征(MDS)的治疗中是有用的。其中两种药物，阿扎替丁和地西他滨，已获得FDA批准用于治疗MDS和慢性粒单核细胞白血病(CMML)。然而，在MDS中评估这些药物的2期和3期研究只包括一小部分CMML患者。本研究的目的是评价阿扎替丁治疗慢性粒细胞白血病的疗效和安全性。方法：回顾分析本院38例经阿扎替丁治疗的CMML患者的临床资料。阿扎替丁75 mg/m(2)/d，连服7d或100 mg/m(2)/d，连用5天，每4周1次。接受至少1个周期药物治疗的患者被认为是可评估的反应。结果：按修改后的国际工作组(IWG)标准评价疗效。总有效率为39%(14/36)，完全缓解(CR)率为11%(4/36)，部分缓解(PR)率为3%(1/36)，血液学改善(HI)为25%(9/36)。中位总生存期为12个月。与无反应者相比，有反应者的总体生存优势显著：分别为15.5个月和9个月(P=0.04)。治疗总体上耐受性良好。2例患者中有1例因单核细胞浸润性皮疹完全消退。结论：阿扎替丁治疗慢性粒细胞白血病疗效显著。治疗相关的毒性是可以接受的。我们的结果支持进一步研究氮杂替丁在CMML中的应用，特别是与其他药物的联合应用。癌症杂志2011；117：2690-6。(C)2010年美国癌症协会。
BACKGROUND: Hypomethylating drugs are useful in the management of myelodysplastic syndrome (MDS). Two of these drugs, azacitidine and decitabine, have received FDA approval for the treatment of MDS and chronic myelomonocytic leukemia (CMML). However, phase 2 and 3 studies that assessed these agents in MDS included only a small number of patients with CMML. The objective of this study was to evaluate the efficacy and safety of azacitidine in the treatment of CMML. METHODS: The records of thirty-eight patients diagnosed with CMML and treated with azacitidine at our institution were reviewed. Azacitidine was administered at 75 mg/m(2)/day for 7 days or 100 mg/m(2)/day for 5 days every 4 weeks. Patients who received at least 1 cycle of the drug were considered evaluable for response. RESULTS: Response was assessed by the modified International Working Group (IWG) criteria. The overall response rate was 39% (14 of 36); complete response (CR) rate was 11% (4 of 36); partial response (PR) rate was 3% (1 of 36); hematologic improvement (HI) was 25% (9 of 36). The median overall survival was 12 months. There was a statistically significant overall survival advantage in responders compared with nonresponders: 15.5 months versus 9 months, respectively (P=.04). Treatment was generally well tolerated. One of 2 patients had complete resolution of a skin rash that was due to monocytic infiltration. CONCLUSIONS: Azacitidine is active in the treatment of CMML. The therapy-associated toxicity is acceptable. Our results support further investigation of azacitidine in CMML, particularly in combination with other agents. Cancer 2011; 117: 2690-6. (C) 2010 American Cancer Society.