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5 天地西他滨与 7 天地阿扎胞苷治疗伴有不良预后特征的低危骨髓增生异常综合征的比较:一项回顾性多中心队列研究。

Comparison between 5-day decitabine and 7-day azacitidine for lower-risk myelodysplastic syndromes with poor prognostic features: a retrospective multicentre cohort study.

机构信息

Department of Internal Medicine, Korea University College of Medicine, Anam Hospital, Seoul, Korea.

Department of Internal Medicine, Korea University College of Medicine, Guro Hospital, Seoul, Korea.

出版信息

Sci Rep. 2020 Jan 8;10(1):39. doi: 10.1038/s41598-019-56642-1.

Abstract

Numerous studies have analysed the clinical efficacies of hypomethylating agents (HMAs) in patients with myelodysplastic syndromes (MDS). However, reports that compare the two HMAs, decitabine and azacitidine, in patients with lower-risk (low and intermediate-1) MDS are limited. We compared 5-day decitabine and 7-day azacitidine regimens in terms of treatment responses, survival outcomes, and adverse events in patients with lower-risk MDS with poor prognostic features. The overall response rates (ORRs) were 67.2% and 44.0% in the patients treated with decitabine and azacitidine, respectively (P = 0.014). While the median progression-free survival (PFS) was significantly better in the patients treated with decitabine than in those treated with azacitidine (P = 0.019), no significant differences in event-free and overall survival rates were observed between the two groups. Multivariate analysis revealed that compared with azacitidine treatment, decitabine treatment is significantly associated with a higher ORR (P = 0.026) and longer PFS (P = 0.037). No significant differences were observed in the incidence of grade 3 or higher haematologic adverse events in response to the two HMAs. In conclusion, in lower-risk MDS, especially with poor prognostic features, ORR and PFS were significantly better with 5-day decitabine treatment than with 7-day azacitidine treatment, with comparable safety.

摘要

许多研究分析了低甲基化剂(HMAs)在骨髓增生异常综合征(MDS)患者中的临床疗效。然而,关于两种 HMA,地西他滨和阿扎胞苷,在低危(低危和中危-1)MDS 患者中的比较报告有限。我们比较了 5 天的地西他滨和 7 天的阿扎胞苷方案在具有不良预后特征的低危 MDS 患者中的治疗反应、生存结局和不良事件。地西他滨和阿扎胞苷治疗的患者总缓解率(ORR)分别为 67.2%和 44.0%(P=0.014)。虽然地西他滨治疗的患者无进展生存期(PFS)明显长于阿扎胞苷治疗的患者(P=0.019),但两组的无事件生存期和总生存期无显著差异。多变量分析显示,与阿扎胞苷治疗相比,地西他滨治疗与更高的 ORR(P=0.026)和更长的 PFS(P=0.037)显著相关。两种 HMA 治疗的 3 级或更高血液学不良事件发生率无显著差异。总之,在低危 MDS 中,特别是具有不良预后特征的患者中,5 天的地西他滨治疗比 7 天的阿扎胞苷治疗具有更好的 ORR 和 PFS,且安全性相当。

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