Azacitidine Prolongs Overall Survival Compared With Conventional Care Regimens in Elderly Patients With Low Bone Marrow Blast Count Acute Myeloid Leukemia
Azacitidine Prolongs Overall Survival Compared With Conventional Care Regimens in Elderly Patients With Low Bone Marrow Blast Count Acute Myeloid Leukemia
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DOI：
10.1200/jco.2009.23.8329
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发表时间：
2010-02-01
影响因子：
45.3
通讯作者：
Silverman, Lewis R.
中科院分区：
文献类型：
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作者：
Fenaux, Pierre;Mufti, Ghulam J.;Silverman, Lewis R.
目的在一项III期随机试验中，阿扎胞苷与常规治疗方案（CCR）相比，可显著延长中危和高危骨髓增生异常综合征患者的总生存期（OS）。这些患者中约有三分之一根据目前的WHO标准被归类为急性髓性白血病（AML）。本分析比较了阿扎胞苷与CCR对该亚组OS的影响。患者和方法患者随机分为皮下注射阿扎胞苷75 mg/m2/d或CCR组（仅最佳支持治疗[BSC]、低剂量阿糖胞苷（LDAC）或强化化疗[IC]）。（中位年龄，70岁）随机分配接受阿扎胞苷（n = 55）或CCR（n = 58; 47% BSC，34% LDAC，19% IC），86%被认为不适合IC。在中位随访20.1个月时，阿扎胞苷治疗患者的中位OS为24.5个月，CCR治疗患者为16.0个月（风险比= 0.47; 95% CI，0.28 - 0.79; P = 0.005），2年OS率分别为50%和16%（P = 0.001）。在认为不适合IC的患者中，阿扎胞苷组的2年OS率高于CCR组（P = .0003）。阿扎胞苷与较少的总天数在医院（P = .0001）比CCR。ConclusionIn老年人低骨髓原始细胞计数（20%至30%）WHO定义的AML患者，阿扎胞苷显着降低OS和显着改善几个患者的发病率措施相比，CCR。
PurposeIn a phase III randomized trial, azacitidine significantly prolonged overall survival (OS) compared with conventional care regimens (CCRs) in patients with intermediate-2- and high-risk myelodys-plastic syndromes. Approximately one third of these patients were classified as having acute myeloid leukemia (AML) under current WHO criteria. This analysis compared the effects of azacitidine versus CCR on OS in this subgroup.Patients and MethodsPatients were randomly assigned to receive subcutaneous azacitidine 75 mg/m(2)/d or CCR (best supportive care [BSC] only, low-dose cytarabine (LDAC), or intensive chemotherapy [IC]).ResultsOf the 113 elderly patients (median age, 70 years) randomly assigned to receive azacitidine (n = 55) or CCR (n = 58; 47% BSC, 34% LDAC, 19% IC), 86% were considered unfit for IC. At a median follow-up of 20.1 months, median OS for azacitidine-treated patients was 24.5 months compared with 16.0 months for CCR-treated patients (hazard ratio = 0.47; 95% CI, 0.28 to 0.79; P = .005), and 2-year OS rates were 50% and 16%, respectively (P = .001). Two-year OS rates were higher with azacitidine versus CCR in patients considered unfit for IC (P = .0003). Azacitidine was associated with fewer total days in hospital (P = .0001) than CCR.ConclusionIn older adult patients with low marrow blast count (20% to 30%) WHO-defined AML, azacitidine significantly prolongs OS and significantly improves several patient morbidity measures compared with CCR.