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首页> 美国卫生研究院文献>Haematologica >A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial
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A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial

机译：在AZA-001随机试验中使用阿扎胞苷或常规护理方案治疗的高危骨髓增生异常综合征患者的反应与生存之间关系的多变量分析

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The phase III AZA-001 study established that azacitidine significantly improves overall survival compared with conventional care regimens (hazard ratio 0.58 [95% confidence interval 0.43–0.77], P<0.001). This analysis was conducted to investigate the relationship between treatment response and overall survival. AZA-001 data were analyzed in a multivariate Cox regression analysis with response as a time-varying covariate. Response categories were “Overall Response” (defined as complete remission, partial remission, or any hematologic improvement) and “Stable Disease” (no complete or partial remission, hematologic improvement, or progression) or “Other” (e.g. disease progression). Achieving an Overall Response with azacitidine reduced risk of death by 95% compared with achieving an Overall Response with the conventional care regimens (hazard ratio 0.05 [95%CI: 0.01–0.43], P=0.006). Sensitivity analyses indicated that significantly improved overall survival remained manifest for patients with a hematologic improvement who had never achieved complete or partial remission (hazard ratio 0.19 [95%CI: 0.08–0.46], P<0.001). Stable Disease in both azacitidine-treated and conventional care-treated patients was also associated with a significantly reduced risk of death (hazard ratio 0.09, [95%CI: 0.06–0.15]; P<0.001). These results demonstrate azacitidine benefit on overall survival compared with conventional care regimens in patients with higher-risk myelodysplastic syndromes who achieve hematologic response but never attain complete or partial remission, in addition to the survival advantage conferred by achievement of complete or partial remission. This study was registered with ().
机译：AZA-001 III期研究确定，与传统护理方案相比，阿扎胞苷可显着提高总体生存率（危险比0.58 [95％置信区间0.43-0.77]，P <0.001）。进行该分析以研究治疗反应与总生存之间的关系。在多变量Cox回归分析中分析AZA-001数据，并将响应作为随时间变化的协变量。反应类别为“总体反应”（定义为完全缓解，部分缓解或任何血液学改善）和“稳定疾病”（没有完全缓解或部分缓解，血液学改善或进展）或“其他”（例如疾病进展）。与使用传统护理方案实现总体缓解相比，使用阿扎胞苷实现总体缓解可将死亡风险降低95％（危险比0.05 [95％CI：0.01-0.43]，P = 0.006）。敏感性分析表明，血液学改善但从未完全缓解或部分缓解的患者，总生存率仍有明显提高（危险比0.19 [95％CI：0.08-0.46]，P <0.001）。在阿扎胞苷治疗的患者和传统护理治疗的患者中，稳定的疾病也与死亡风险显着降低相关（危险比0.09，[95％CI：0.06-0.15]； P <0.001）。这些结果表明，与传统护理方案相比，阿扎胞苷在实现血液学应答但从未达到完全或部分缓解的高风险骨髓增生异常综合症患者中，除了通过完全或部分缓解所赋予的生存优势外，与传统护理方案相比，对总体生存具有益处。该研究已向（）注册。

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