接受PD-L1抑制剂治疗的复发或转移性鼻咽癌患者血浆EB病毒DNA轨迹与临床结局：一项多中心II期研究的事后分析
Trajectories of Plasma Epstein-Barr Virus DNA and Clinical Outcomes in Recurrent or Metastatic Nasopharyngeal Carcinoma Treated With PD-L1 Inhibitors: A Post-Hoc Analysis of a Multicenter, Phase II Study.
文献信息
| PMID | 42860770 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Zhen Pan |
| 作者单位 | Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China. |
| 期刊 | Head & neck |
| SCI 分区 | Q1 |
| IF | 2.5 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻咽癌 |
中文摘要
背景： 用于预测接受免疫治疗的复发或转移性鼻咽癌（R/M NPC）患者临床结局的可靠生物标志物仍然有限。本研究评估了纵向EBV DNA轨迹与接受免疫检查点抑制剂的R/M NPC患者临床结局之间的关联。
方法： 这项事后分析使用了评估程序性死亡配体1（PD-L1）抑制剂KL-A167的多中心、单臂II期试验数据，研究对象为既往接受过治疗的R/M NPC患者。在基线和每六周进行一次的预定疗效评估时检测血浆EBV DNA，直至疾病进展。通过logistic轨迹模型区分EBV DNA轨迹。使用多变量Cox模型计算生存结局的校正风险比（HR）和95%置信区间（CI）。
结果： 我们识别出三种不同的轨迹：持续不可检测（n=17，13.8%）、波动（n=40，32.5%）和持续可检测（n=66，53.7%）。与持续不可检测组相比，波动组和持续可检测组的死亡HR分别为4.96（95% CI，1.60-15.40）和12.59（95% CI，4.01-39.51）。疾病进展的HR分别为1.96（95% CI，0.97-3.96）和3.22（95% CI，1.56-6.67）。
结论： 本研究表明，血浆EBV DNA轨迹可能是监测治疗反应和纵向风险分层的有前景的生物标志物。
英文摘要
BACKGROUND: Reliable biomarkers for predicting clinical outcomes in patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) treated with immunotherapy remain limited. This study evaluated the association between longitudinal EBV DNA trajectories and clinical outcomes in patients with R/M NPC receiving immune checkpoint inhibitors.
METHODS: This post hoc analysis used data from a multicenter, single-arm, Phase II trial evaluating the programmed cell death-ligand 1 (PD-L1) inhibitor KL-A167 in patients with previously treated R/M NPC. Plasma EBV DNA was measured at baseline and at each scheduled efficacy assessment, which was conducted every six weeks until disease progression. EBV DNA trajectories were distinguished through a logistic trajectory model. Multivariable Cox models were used to calculate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for survival outcomes.
RESULTS: We identified three distinct trajectories: persistently undetectable (n = 17, 13.8%), fluctuating (n = 40, 32.5%), and persistently detectable (n = 66, 53.7%). Compared with the persistently undetectable group, HRs of death were 4.96 (95% CI, 1.60-15.40) and 12.59 (95% CI, 4.01-39.51) for the fluctuating and persistently detectable groups, respectively. HRs of disease progression were 1.96 (95% CI, 0.97-3.96) and 3.22 (95% CI, 1.56-6.67), respectively.
CONCLUSION: This study suggests that plasma EBV DNA trajectories could be a promising biomarker for monitoring treatment response and longitudinal risk stratification.