Haematology, Hospital Universitario de Salamanca, Salamanca, Spain.
Institute of Biomedical Research of Salamanca (IBSAL), Salamanca, Spain.
Br J Haematol. 2018 May;181(3):350-359. doi: 10.1111/bjh.15190. Epub 2018 Apr 2.
Treatment with azacitidine (AZA) has been suggested to be of benefit for higher-risk myelodysplastic syndrome (HR-MDS) patients with chromosome 7 abnormalities (Abn 7). This retrospective study of 235 HR-MDS patients with Abn 7 treated with AZA (n = 115) versus best supportive care (BSC; n = 120), assessed AZA treatment as a time-varying variable in multivariable analysis. A Cox Regression model with time-interaction terms of overall survival (OS) at different time points confirmed that, while chromosome 7 cytogenetic categories (complex karyotype [CK] versus non-CK) and International Prognostic Scoring System risk (high versus intermediate-2) retained poor prognosis over time, AZA treatment had a favourable impact on OS during the first 3 years of treatment compared to BSC (Hazard ratio [HR] 0·5 P < 0·001 at 1 year, 0·7 P = 0·019 at 2 years; 0·73 P = 0·029 at 3 years). This benefit was present in all chromosome 7 categories, but tended to be greater in patients with CK (risk reduction of 82%, 68% and 53% at 1, 3 and 6 months in CK patients; 79% at 1 month in non-CK patients, P < 0·05 for all). AZA also significantly improved progression-free survival (P < 0·01). This study confirms a time-dependent benefit of AZA on outcome in patients with HR-MDS and cytogenetic abnormalities involving chromosome 7, especially for those with CK.
用阿扎胞苷（AZA）治疗已被证明对存在 7 号染色体异常（Abn 7）的高危骨髓增生异常综合征（HR-MDS）患者有益。这项回顾性研究纳入了 235 例存在 Abn 7 的 HR-MDS 患者，其中 115 例接受 AZA 治疗（AZA 组），120 例接受最佳支持治疗（BSC 组），在多变量分析中，AZA 治疗被视为一个随时间变化的变量。在不同时间点的总生存（OS）的 Cox 回归模型中，包含时间交互项的模型证实，尽管染色体 7 细胞遗传学分类（复杂核型[CK]与非 CK）和国际预后评分系统风险（高危与中危-2）随时间推移仍具有较差的预后，但与 BSC 相比，AZA 治疗在治疗的前 3 年内对 OS 具有有利影响（1 年时的危险比[HR]为 0.5，P<0.001；2 年时为 0.7，P=0.019；3 年时为 0.73，P=0.029）。这种获益在所有染色体 7 分类中均存在，但在 CK 患者中更为明显（CK 患者在 1、3 和 6 个月时的风险降低幅度分别为 82%、68%和 53%；非 CK 患者在 1 个月时的风险降低幅度为 79%，所有分类 P<0.05）。AZA 还显著改善了无进展生存期（P<0.01）。这项研究证实，在存在涉及 7 号染色体的细胞遗传学异常的 HR-MDS 患者中，AZA 对结局具有时间依赖性的获益，尤其在 CK 患者中获益更为显著。
