Dynamic change in Epstein-Barr virus DNA predicts prognosis in early stage natural killer/T-cell lymphoma with pegaspargase-based treatment: long-term follow-up and biomarker analysis from the NHL-004 multicenter randomized study.

Here we report the long-term outcomes (median follow-up, 64 months) and biomarker analysis.

我们报告了长期结果（中位随访时间为64个月）和生物标志物分析。

A total of 256 eligible patients aged 14-70 years were randomly assigned (1:1) to the ESA or the MESA arm.

共有256名符合条件的患者，年龄在14至70岁之间，被随机分配（1:1）到ESA或MESA组。

The 5-year progression-free survival(PFS) rates were 80.3% and 74.9% in the ESA and MESA arms (hazard ratio[HR]=0.78 [95% CI: 0.46-1.33], P=0.371), and the 5-year overall survival(OS) rates were 85.1% and 80.9% (HR=0.74 [95% CI: 0.40-1.37], P=0.332), respectively.

ESA组和MESA组的5年无进展生存（PFS）率分别为80.3%和74.9%（风险比[HR]=0.78 [95% 置信区间: 0.46-1.33]，P=0.371），5年总生存（OS）率分别为85.1%和80.9%（HR=0.74 [95% 置信区间: 0.40-1.37]，P=0.332）。

No new safety signals related to treatments were observed.

未观察到与治疗相关的新的安全信号。

Interim plasma Epstein-Barr virus (EBV) DNA positivity and stable disease / progressive disease response were independent predictors of inferior PFS and OS.

中期血浆EB病毒（EBV）DNA阳性以及稳定疾病/进展疾病反应是较差的无进展生存（PFS）和总生存（OS）的独立预测因素。

No prognostic significance was observed according to molecular subtypes.

未观察到根据分子亚型的预后意义。

Interim EBV DNA positivity correlated with up-regulated chromatin remodeling alterations, immune escape-related genes, and decreased infiltrating monocytes / M1 macrophages.

中期EBV DNA阳性与上调的染色质重塑改变、免疫逃逸相关基因以及减少的浸润性单核细胞/M1巨噬细胞相关。

With low toxicity, non-intravenous administration, and an outpatient design, ESA with sandwiched radiotherapy achieved long-term durable response in patients with newly diagnosed early-stage NKTCL.

具有低毒性、非静脉给药和门诊设计的特点，ESA与夹心放疗相结合在新诊断的早期NKTCL患者中实现了长期持久的反应。

Dynamic monitoring of plasma EBV DNA provided a clinical rationale for future mechanism-based therapy in NKTCL.

动态监测血浆EBV DNA为未来基于机制的NKTCL治疗提供了临床依据。