Medizinische Klinik und Poliklinik I, Universitätsklinikum Dresden, Dresden, Germany.
Medizinische Klinik A, Universitätsklinikum Münster, Münster, Germany.
Blood. 2020 Aug 13;136(7):823-830. doi: 10.1182/blood.2019004583.
In fit patients with newly diagnosed acute myeloid leukemia (AML), immediate treatment start is recommended due to the poor prognosis of untreated acute leukemia. We explored the relationship between time from diagnosis to treatment start (TDT) and prognosis in a large real-world data set from the German Study Alliance Leukemia-Acute Myeloid Leukemia (SAL-AML) registry. All registered non-acute promyelocytic leukemia patients with intensive induction treatment and a minimum 12 months of follow-up were selected (n = 2263). We analyzed influence of TDT on remission, early death, and overall survival (OS) in univariable analyses for each day of treatment delay, in groups of 0 to 5, 6 to 10, 11 to 15, and >15 days of TDT, adjusted for influence of established prognostic variables on outcomes. Median TDT was 3 days (interquartile range, 2-7). Unadjusted 2-year OS rates, stratified by TDT of 0 to 5, 6 to 10, 11 to 15, and >15 days, were 51%, 48%, 44%, and 50% (P = .211). In multivariable Cox regression analysis accounting for established prognostic variables, the TDT hazard ratio as a continuous variable was 1.00 (P = .617). In OS analyses, separately stratified for age ≤60 and >60 years and for high vs lower initial white blood cell count, no significant differences between TDT groups were observed. Our study suggests that TDT is not related to survival. As stratification in intensive first-line AML treatment evolves, TDT data suggest that it may be a feasible approach to wait for genetic and other laboratory test results so that clinically stable patients are assigned the best available treatment option. This trial was registered at www.clinicaltrials.gov as #NCT03188874.
在新诊断为急性髓系白血病(AML)的健康患者中,由于未经治疗的急性白血病预后较差,建议立即开始治疗。我们在德国研究联盟白血病-急性髓系白血病(SAL-AML)注册中心的大型真实世界数据集中探索了从诊断到开始治疗的时间(TDT)与预后之间的关系。选择了所有接受强化诱导治疗且随访时间至少为 12 个月的非急性早幼粒细胞白血病患者(n = 2263)。我们分析了 TDT 对缓解、早期死亡和总生存(OS)的影响,在每天治疗延迟的单变量分析中,将 TDT 分为 0 至 5、6 至 10、11 至 15 和 >15 天,同时调整了对预后的影响。中位 TDT 为 3 天(四分位距,2-7)。未调整的 2 年 OS 率,按 TDT 为 0 至 5、6 至 10、11 至 15 和 >15 天分层,分别为 51%、48%、44%和 50%(P =.211)。在考虑到既定预后因素的多变量 Cox 回归分析中,TDT 风险比作为连续变量为 1.00(P =.617)。在 OS 分析中,分别按年龄≤60 岁和>60 岁以及初始白细胞计数高与低进行分层,未观察到 TDT 组之间存在显著差异。我们的研究表明,TDT 与生存无关。随着强化一线 AML 治疗的分层演变,TDT 数据表明,等待遗传和其他实验室检测结果可能是一种可行的方法,以便为临床稳定的患者提供最佳可用的治疗选择。该试验在 www.clinicaltrials.gov 上注册,编号为 #NCT03188874。