Hernando-Calvo Alberto, Mirallas Oriol, Marmolejo David, Saavedra Omar, Vieito María, Assaf Pastrana Juan David, Aguilar Susana, Bescós Coro, Lorente Juan, Giralt Jordi, Benavente Sergi, Temprana-Salvador Jordi, Alberola Margarita, Dienstmann Rodrigo, Garralda Elena, Felip Enriqueta, Villacampa Guillermo, Brana Irene
Department of Medical Oncology, Vall D'Hebron University Hospital, Barcelona, Spain; Vall d'Hebron Institute of Oncology. Barcelona. Spain; Princess Margaret Cancer Centre, University Health Network. Toronto. Canada.
Department of Medical Oncology, Vall D'Hebron University Hospital, Barcelona, Spain.
Oral Oncol. 2023 May;140:106364. doi: 10.1016/j.oraloncology.2023.106364. Epub 2023 Mar 28.
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.
除了通过综合阳性评分（CPS）和肿瘤突变负荷（TMB）评估的程序性死亡配体1（PD-L1）外，尚无其他生物标志物被批准用于免疫治疗干预。在此，我们研究了其他临床和病理变量是否可能影响复发或转移性（R/M）头颈部鳞状细胞癌（HNSCC）患者的免疫治疗结果。
回顾了接受免疫治疗的R/M HNSCC患者。基线时分析的变量包括：临床病理、实验室指标，以及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期（PFS）。次要终点是总生存期（OS）和客观缓解率（ORR）。拟合单变量和多变量Cox模型，并使用随机森林算法估计每个预后变量的重要性。
共有100例患者接受了免疫治疗；50%接受单药治疗，50%接受实验性免疫治疗联合方案。在多变量分析中，ECOG体能状态（HR：1.73；95%CI 1.07 - 2.82；p = 0.03）和PNI水平（10分增量，HR：0.66；0.46 - 0.95；p = 0.03）均与PFS显著相关。然而，得出的中性粒细胞与淋巴细胞比值（dNLR）和乳酸脱氢酶（LDH）与PFS无显著相关性（p值>0.15）。在OS分析中，白蛋白和PNI是多变量模型中唯一具有统计学意义的因素（p < 0.001）。
在我们的队列中，PNI和ECOG体能状态与接受免疫治疗的R/M HNSCC患者的PFS相关性最强。这些结果表明，在免疫治疗前应考虑反映营养状况的参数。
