先前的经验表明，在使用组蛋白脱乙酰酶抑制剂诱导急性髓系白血病（AML）期间使用较高剂量的阿糖胞苷可产生较高的缓解率。 S1203 是一项随机多中心试验，对象为 18-60 岁未经治疗的 AML 患者，比较了柔红霉素和阿糖胞苷 (DA)、伊达比星和高剂量阿糖胞苷 (IA) 以及 IA 和伏立诺他 (IA  V)。主要终点是无事件生存期（EFS）。 738 名患者被随机分配：DA 组和 IA 组各 261 名，IA  V 组各 216 名。分别有 96、456 和 150 名患者具有有利、中等和不利风险的细胞遗传学。 152 个发生 NPM1 突变，158 个发生 FLT3 突变。总缓解率为 77.5%，其中 CR 为 62.5%，CRi 为 15.0%。除了细胞遗传学良好的亚群通过 DA 和缓解后高剂量阿糖胞苷改善了预后外，3 个组之间在缓解、EFS 或总生存率方面没有观察到差异。在 IA 和 IA  V 组中观察到毒性增加的趋势。在年轻 AML 患者的诱导治疗过程中使用较高剂量的阿糖胞苷，无论是否使用伏立诺他，都不会改善预后。 （由美国国立卫生研究院和其他机构资助，ClinicalTrials.gov 编号，NCT01802333。）。© 2023。作者，获得 Springer Nature Limited 的独家许可。

Prior experience indicated that use of higher doses of cytarabine during induction for acute myeloid leukemia (AML) with a histone deacetylase inhibitor resulted in high response rates. S1203 was a randomized multicenter trial for previously untreated patients aged 18-60 with AML which compared daunorubicin and cytarabine (DA), idarubicin with higher dose cytarabine (IA) and IA with vorinostat (IA + V). The primary endpoint was event free survival (EFS). 738 patients were randomized: 261 to each DA and IA arms and 216 to the IA + V arm. 96, 456, and 150 patients had favorable-, intermediate-, and unfavorable-risk cytogenetics, respectively. 152 were NPM1 and 158 FLT3 mutated. The overall remission rate was 77.5% including 62.5% CR and 15.0% CRi. No differences in remission, EFS, or overall survival were observed among the 3 arms except for the favorable cytogenetics subset who had improved outcomes with DA and postremission high dose cytarabine. A trend towards increased toxicity was observed with the IA and IA + V arms. The use of higher dose cytarabine during induction therapy in younger patients with AML, with or without vorinostat, does not result in improved outcomes. (Funded by the US National Institutes of Health and others, ClinicalTrials.gov number, NCT01802333.).© 2023. The Author(s), under exclusive licence to Springer Nature Limited.