FAST-FNA immune cell profiling in HNSCC

目前，对抗PD1单一治疗反应最好的预测生物标记物是PD-L1表达为 通过对存档或新鲜组织进行免疫组织化学染色进行评估。PD-L1的当前工作流程 组织评估费时费力，并不是万无一失的(在一小部分中没有确定的结果 影像引导活检)，并且与发病率有关，因此很少连续进行。快速上门 通过细针抽吸(FNA)获得的细胞样本而不是组织样本的评估不能 不仅绕过了这些瓶颈，而且还能对肿瘤进行更全面和连续的分析 微环境，以获取快速变化的微环境的最新信息 肿瘤的演变和治疗。本项目的目标是进一步开发和验证新的FAST-FNA 在HNSCC中快速发现和验证生物标志物的技术。有两个主要目标。在目标1中，我们将 开发和验证HNSCC患者(n=100)的FNA样本中现有的和新的生物标记物。具体来说，我们 一)开发和验证新的预测性免疫治疗生物标记物，二是确定新的 FAST-FNA评分与PD-L1的CPS评分相关。第二个目标的目标是将 FAST-FNA技术在抗PD1免疫治疗HNSCC患者连续FNA分析中的应用 (接受或不接受化疗；n=100)。将在处理前和处理后进行FNA采样，以便 捕捉肿瘤微环境的变化。随着HNSCC领域向增加的生物标志物转移 在测试中，我们发现在HNSCC中开发先进的细胞诊断技术的临床需求尚未得到满足，这将 促进快速生物标记物分析，指导治疗，并提供临床反应的“实时”评估。

Currently, the single best predictive biomarker of response to anti-PD1 monotherapy is PD-L1 expression as assessed by immunohistochemical staining of archived or fresh tissue. Current workflows for PD-L1 assessment in tissue are labor and time consuming, are not infallible (inconclusive results in a fraction of image guided biopsies) and are associated with morbidity and are thus rarely performed serially. Rapid on site assessment of cellular, rather than tissue, specimens obtained through fine needle aspiration (FNA) could not only circumvent these bottlenecks but also enable more comprehensive and serial profiling of the tumor microenvironment to obtain the most up-to-date information of a rapidly changing microenvironment during tumor evolution and therapy. The goal of this project is to further develop and validate the new FAST-FNA technology for rapid biomarker discovery and validation in HNSCCs. There are two main aims. In aim 1 we will develop and validate existing and new biomarkers in FNA samples of HNSCC patients (n=100). Specifically we will I) develop and validate new predictive immunotherapeutic biomarkers and ii to determine how well the new FAST-FNA scores correlate with the CPS scores of PD-L1. The goal of the second aim is to translate the above FAST-FNA technology to serial FNA analyses in HNSCC patients receiving anti-PD1 immunotherapy (with or without chemotherapy; n=100). FNA sampling will be performed pre- and on-treatment in order to capture changes in the tumor microenvironment. As the HNSCC field shifts toward increased biomarker testing, we find an unmet clinical need to develop advanced cellular diagnostics in HNSCCs, which will facilitate rapid biomarker analysis, guide therapies and provide “real time” assessment of clinical response.