除了联合阳性评分（CPS）和肿瘤突变负荷（TMB）所评估的程序性死亡配体-1（PD-L1）外，没有其他生物标志物获得免疫治疗干预的批准。在这里，我们调查了额外的临床和病理变量是否会影响复发或转移性头颈部鳞状细胞癌（HNSCC）患者的免疫治疗结果。回顾接受免疫治疗的R / M HNSCC患者。基线分析的变量包括：临床病理学、实验室和反映宿主营养状况的变量，如预后营养指数（PNI）和白蛋白。主要终点是无进展生存（PFS），次要终点是总体生存（OS）和客观反应率（ORR）。拟合了单变量和多变量Cox模型，并使用随机森林算法估计了每个预后变量的重要性。共有100名患者接受了免疫治疗；50％接受单一药物治疗，50％接受实验性免疫疗法联合治疗。在多变量分析中，ECOG表现状态（HR：1.73；95％CI 1.07-2.82；p = 0.03）和PNI水平（10点递增，HR：0.66；0.46-0.95；p = 0.03）与PFS显著相关。然而，衍生的中性粒细胞/淋巴细胞比值（dNLR）和乳酸脱氢酶（LDH）与PFS不显著相关（p值> 0.15）。在OS分析中，白蛋白和PNI是多变量模型中唯一的统计显著因素（p <0.001）。在我们的队列中，PNI和ECOG表现状态与接受免疫治疗的R / M HNSCC患者的PFS关联最强。这些结果表明，在免疫治疗之前应考虑反映营养状况的参数。版权所有©2023年。由爱思唯尔出版。

Beyond programmed death-ligand 1 (PD-L1) assessed by the combined positive score (CPS) and tumor mutational burden (TMB), no other biomarkers are approved for immunotherapy interventions. Here, we investigated whether additional clinical and pathological variables may impact on immunotherapy outcomes in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients.R/M HNSCC patients treated with immunotherapy were reviewed. Analyzed variables at baseline included: clinicopathological, laboratory, and variables reflecting the host nutritional status such as the prognostic nutritional index (PNI) and albumin. The primary endpoint was progression free survival (PFS). The secondary endpoints were overall survival (OS) and objective response rate (ORR). Univariable and multivariable Cox models were fitted and random forest algorithm was used to estimate the importance of each prognostic variable.A total of 100 patients were treated with immunotherapy; 50% with single agent and 50% with experimental immunotherapy combinations. In the multivariable analysis, both ECOG performance status (HR: 1.73; 95%CI 1.07-2.82; p = 0.03) and PNI levels (10-point increments, HR: 0.66; 0.46-0.95; p = 0.03) were significantly associated with PFS. However, the derived neutrophil to lymphocyte ratio (dNLR) and lactate dehydrogenase (LDH) were not significantly associated with PFS (p-values > 0.15). In the OS analysis, albumin and PNI were the only statistically significant factors in the multivariable model (p < 0.001).In our cohort, PNI and ECOG performance status were most strongly associated with PFS in R/M HNSCC patients treated with immunotherapy. These results suggest that parameters informative of nutritional status should be considered before immunotherapy.Copyright © 2023. Published by Elsevier Ltd.