CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Immunoprofiling at an Institutional Scale Reveals That High Numbers of Intratumoral CD8(+) and PD-1(+) Cells Predict Superior Patient Survival Across Major Cancer Types Independent of Major Risk Factors.
Immunoprofiling at an Institutional Scale Reveals That High Numbers of Intratumoral CD8(+) and PD-1(+) Cells Predict Superior Patient Survival Across Major Cancer Types Independent of Major Risk Factors.
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常规使用经临床验证的数字病理平台量化肿瘤内 CD8+和 PD-1+细胞，可预测主要癌症类型患者的生存，独立于临床分期，且不受治疗方案多样性的影响。
回顾性研究发现，在接受靶向治疗的特定癌症中，肿瘤内免疫细胞数量与患者预后存在关联。然而，在活跃的临床实验室中，使用数字病理学平台在泛癌背景下常规量化肿瘤内免疫生物标志物的临床价值尚未确立。
我们开发了ImmunoProfile，一种每日临床工作流程，整合了自动化多重免疫荧光组织染色、数字切片成像和机器学习辅助评分，以标准化和可重复的方式量化福尔马林固定、石蜡包埋组织样本中的肿瘤内CD8+、PD-1+、CD8+PD-1+和FOXP3+免疫细胞以及PD-L1表达。我们在临床实验室中前瞻性地将ImmunoProfile应用于3年期间从2,023名未选择的癌症患者收集的活检样本，并将结果与患者生存相关联。
在泛癌队列中，肿瘤内CD8+或PD-1+细胞数量高的患者与数量低的患者相比，死亡风险显著降低（CD8+：高 vs 低风险比[HR]，0.62 [95% CI，0.48至0.81]，Wald P = .002；PD-1+：高 vs 低HR，0.65 [95% CI，0.51至0.83]；P = .0009），此结果在调整了包括癌症类型在内的风险因素后得出。在亚组分析中，肿瘤内CD8+、PD-1+和/或CD8+PD-1+细胞数量高的患者，在考虑了包括美国癌症联合委员会分期在内的临床风险因素后，尽管治疗方案各异，其死于非小细胞肺癌、结直肠癌、乳腺癌、食管胃癌、头颈癌、胰腺癌和卵巢癌的风险均较低（所有P < .05）。
Retrospective studies have found associations between the number of intratumoral immune cells and patient outcomes for specific cancers treated with targeted therapies. However, the clinical value of routinely quantifying intratumoral immune biomarkers using a digital pathology platform in the pan-cancer setting within an active clinical laboratory has not been established.
We developed ImmunoProfile, a daily clinical workflow that integrates automated multiplex immunofluorescence tissue staining, digital slide imaging, and machine learning-assisted scoring to quantify intratumoral CD8 + , PD-1 + , CD8 + PD-1 + , and FOXP3 + immune cells and PD-L1 expression in formalin-fixed, paraffin-embedded tissue samples in a standardized and reproducible manner. We prospectively applied ImmunoProfile to biopsies collected from 2,023 unselected patients with cancer over a 3-year period in the clinical laboratory and correlated the results with patient survival.
In the pan-cancer cohort, patients with high numbers of intratumoral CD8 + or PD-1 + cells in had significantly lower risks of death compared with those with low numbers (CD8 + : high v low hazard ratio [HR], 0.62 [95% CI, 0.48 to 0.81], Wald P = .002; PD-1 + : high v low HR, 0.65 [95% CI, 0.51 to 0.83]; P = .0009) after adjusting for risk factors, including cancer type. In subset analyses, patients with high numbers of intratumoral CD8 + , PD-1 + , and/or CD8 + PD-1 + cells showed lower risks of death from non-small cell lung, colorectal, breast, esophagogastric, head and neck, pancreatic, and ovarian cancers after considering clinical risk factors, including American Joint Committee on Cancer stage, and despite varying therapies (all P < .05).
Routinely quantifying intratumoral CD8 + and PD-1 + cells with a clinically validated digital pathology platform predicts patient survival across major cancer types, independent of clinical stage and despite diverse treatment regimens.
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