已经提出，病理学反应是非小细胞肺癌新辅助治疗临床试验中生存的早期终点。国际肺癌研究协会（IASLC）发布了关于新辅助治疗后切除肺癌的病理评估的建议。本研究的目的是使用IASLC标准评估病理学反应的观察者间一致性。 由11位肺部病理学家组成的国际专家组对6个临床试验中84例接受新辅助免疫检查点抑制剂治疗的患者切除的非小细胞肺癌的血红染色切片进行了评估。评估了存活组织的百分比、坏死和基质的病理学反应。对于每张切片，通过显微镜测量肿瘤床面积，并使用预嵌入的公式计算了不加权和加权主要病理学反应（MPR）平均值，以反映不同肿瘤床比例。 病理学家对于MPR的一致性在68名患者中观察到了一致，达到81%，不加权和加权平均值的间观者一致性（IRA）分别为0.84（95%置信区间[CI]：0.76-0.92）和0.86（95% CI：0.79-0.93）。总体而言，不加权和加权方法在MPR的分类中没有显示出显著差异。无论是不加权还是加权方法，对于具有超过95%存活肿瘤（IRA = 0.98，95% CI：0.96-1）和0%存活肿瘤（IRA = 0.94，95% CI：0.89-0.98）的病例，两种方法的一致性最高。造成差异的最常见原因包括对肿瘤床的解释、突出的基质炎症的存在、反应和肿瘤样肺细胞之间的区分以及浸润性黏液腺癌的评估。 我们的研究揭示了无残留存活肿瘤的病例具有出色的可靠性，并且在新辅助治疗后对于MPR的IASLC推荐值小于或等于10%的可靠性较好。 版权所有©2023。Elsevier Inc.出版。

Pathologic response has been proposed as an early clinical trial end point of survival after neoadjuvant treatment in clinical trials of NSCLC. The International Association for the Study of Lung Cancer (IASLC) published recommendations for pathologic evaluation of resected lung cancers after neoadjuvant therapy. The aim of this study was to assess pathologic response interobserver reproducibility using IASLC criteria.An international panel of 11 pulmonary pathologists reviewed hematoxylin and eosin-stained slides from the lung tumors of resected NSCLC from 84 patients who received neoadjuvant immune checkpoint inhibitors in six clinical trials. Pathologic response was assessed for percent viable tumor, necrosis, and stroma. For each slide, tumor bed area was measured microscopically, and pre-embedded formulas calculated unweighted and weighted major pathologic response (MPR) averages to reflect variable tumor bed proportion.Unanimous agreement among pathologists for MPR was observed in 68 patients (81%), and inter-rater agreement (IRA) was 0.84 (95% confidence interval [CI]: 0.76-0.92) and 0.86 (95% CI: 0.79-0.93) for unweighted and weighted averages, respectively. Overall, unweighted and weighted methods did not reveal significant differences in the classification of MPR. The highest concordance by both methods was observed for cases with more than 95% viable tumor (IRA = 0.98, 95% CI: 0.96-1) and 0% viable tumor (IRA = 0.94, 95% CI: 0.89-0.98). The most common reasons for discrepancies included interpretations of tumor bed, presence of prominent stromal inflammation, distinction between reactive and neoplastic pneumocytes, and assessment of invasive mucinous adenocarcinoma.Our study revealed excellent reliability in cases with no residual viable tumor and good reliability for MPR with the IASLC recommended less than or equal to 10% cutoff for viable tumor after neoadjuvant therapy.Copyright © 2023. Published by Elsevier Inc.