Background: The Immunoscore (IS) is a quantitative digital pathology assay that evaluates the immune response in cancer patients. This study reports on the reproducibility of pathologists’ visual assessment of CD3+- and CD8+-stained colon tumors, compared to IS quantification. Methods: An international group of expert pathologists evaluated 540 images from 270 randomly selected colon cancer (CC) cases. Concordance between pathologists’ T-score, corresponding hematoxylin–eosin (H&E) slides, and the digital IS was evaluated for two- and three-category IS. Results: Non-concordant T-scores were reported in more than 92% of cases. Disagreement between semi-quantitative visual assessment of T-score and the reference IS was observed in 91% and 96% of cases before and after training, respectively. Statistical analyses showed that the concordance index between pathologists and the digital IS was weak in two- and three-category IS, respectively. After training, 42% of cases had a change in T-score, but no improvement was observed with a Kappa of 0.465 and 0.374. For the 20% of patients around the cut points, no concordance was observed between pathologists and digital pathology analysis in both two- and three-category IS, before or after training (all Kappa < 0.12). Conclusions: The standardized IS assay outperformed expert pathologists’ T-score evaluation in the clinical setting. This study demonstrates that digital pathology, in particular digital IS, represents a novel generation of immune pathology tools for reproducible and quantitative assessment of tumor-infiltrated immune cell subtypes.
背景：免疫评分（IS）是一种定量数字病理学检测方法，用于评估癌症患者的免疫反应。本研究报道了病理学家对CD3+和CD8+染色结肠肿瘤视觉评估与IS定量分析之间的可重复性比较。方法：国际专家组病理学家评估了来自270例随机选择的结肠癌（CC）病例的540张图像。针对两分类和三分类IS，评估了病理学家的T评分、对应苏木精-伊红（H&E）切片与数字IS之间的一致性。结果：超过92%的病例报告了不一致的T评分。在培训前后，分别有91%和96%的病例中观察到半定量视觉T评分评估与参考IS之间存在差异。统计分析显示，病理学家与数字IS在两分类和三分类IS中的一致性指数均较弱。培训后，42%的病例T评分发生变化，但未观察到改善（Kappa值分别为0.465和0.374）。对于切点附近20%的患者，在培训前后的两分类和三分类IS中，病理学家与数字病理学分析之间均未观察到一致性（所有Kappa值<0.12）。结论：在临床环境中，标准化IS检测优于专家病理学家的T评分评估。本研究表明，数字病理学，特别是数字IS，代表了新一代免疫病理学工具，可用于肿瘤浸润免疫细胞亚型的可重复定量评估。
Multi-Institutional Evaluation of Pathologists’ Assessment Compared to Immunoscore
肿瘤(癌症)患者之家