Adjuvant nivolumab in muscle-invasive urothelial carcinoma: exploratory biomarker analysis of the randomized phase 3 CheckMate 274 trial.

Identification of biomarkers associated with treatment outcomes can help refine patient selection, and inform on the immunobiology of disease.

识别与治疗结果相关的生物标志物可以帮助优化患者选择，并为疾病的免疫生物学提供信息。

To assess the relevance of key biomarkers in the adjuvant MIUC setting, extensive exploratory analyses of tumor biomarkers, including associations with DFS, were performed.

为了评估辅助性肌肉使用设置中关键生物标志物的相关性，进行了广泛的肿瘤生物标志物探索性分析，包括与无病生存期（DFS）的关联。

Differential gene expression and gene signature analysis found that immune-related genes and pathways, in particular a high interferon-γ signature, were predictive of improved DFS in nivolumab-treated patients.

差异基因表达和基因签名分析发现，免疫相关基因和通路，特别是高干扰素-γ签名，是预测nivolumab治疗患者无病生存期（DFS）改善的指标。

Positive predictive and prognostic associations, respectively, were found for CD4 gene expression and measures of CD8 T cell infiltration.

分别发现了CD4基因表达与CD8 T细胞浸润指标的阳性预测和预后关联。

A composite predictive model suggested that high tumor cell PD-L1 expression, high CD4 gene expression, high tumor mutational burden score, receipt of neoadjuvant cisplatin and low transforming growth factor-β gene signature score made the greatest contributions to predicting improved outcomes in nivolumab-treated patients.

一个综合预测模型表明，高肿瘤细胞PD-L1表达、高CD4基因表达、高肿瘤突变负荷评分、接受新辅助顺铂治疗以及低转化生长因子-β基因签名评分，对预测接受nivolumab治疗患者改善结果的贡献最大。

These results reinforce studies establishing the importance of tumor biomarkers of adaptive immunity in influencing response to PD-1-PD-L1 blockade, indicating the potential predictive rather than solely prognostic nature of such findings.

这些结果强化了确立肿瘤适应性免疫生物标志物在影响PD-1-PD-L1阻断反应中的重要性的研究，表明这些发现可能具有预测性而非仅仅是预后性。

ClinicalTrials.gov identifier: NCT02632409 .

ClinicalTrials.gov注册号：NCT02632409。