非小细胞肺癌 (NSCLC) 标本的完整生物标志物检查对于做出适当、及时的临床管理决策至关重要。由于所需的分子和免疫组织化学生物标志物数量不断增加，从小型细胞学和组织学标本中实现这一目标可能具有挑战性。我们对我们机构的病例进行了为期 5 年的回顾性审计，以评估诊断和生物标志物检测的充分率，特别是由细胞病理学家和细胞学科学家或病理学实习生进行的快速现场评估 (ROSE) 获得的样本，包括所有支气管内超声引导下经支气管针吸活检 (EBUS-TBNA)、CT 引导下肺细针穿刺活检 (FNA) 和 CT 引导下肺核心活检。共发现5354例病例，其中92.2%有足够的诊断材料。在 1506 例有肺腺癌或 NSCLC 诊断记录的病例中（未另有说明），有 1001 例（66.5%）需要进行生物标志物检测。 89.5% 的病例中有足够的材料可用于完整的生物标志物检查，其中包括 EGFR 和 KRAS 突变检测（所有病例）、ALK、ROS1 和 PD-L1 免疫组织化学（所有病例）以及 ALK 和 ROS1 FISH（根据需要）。对于细胞学和组织学标本的 EGFR 和 KRAS 突变检测，99% 的病例是足够的。在无法进行完整生物标志物检查的样本中，大约一半的样本仅因用于 PD-L1 免疫组织化学的肿瘤细胞数量不足而无法进行。排除 PD-L1 IHC，使用 ROSE 获得的 952 个（95.1%）样本足以满足其余测试要求。使用 33 基因定制 AmpliSeq panel 进行下一代测序的成功率高达 72%。总之，使用 ROSE 获得的小细胞学和组织学标本适合用于 NSCLC 的预测性生物标志物检测，但需要注意获得足够的细胞 (>100) 进行 PD-L1 免疫组织化学。版权所有 © 2023 澳大利亚皇家病理学家学院。由 Elsevier B.V. 出版。保留所有权利。

Complete biomarker workup of non-small cell lung cancer (NSCLC) specimens is essential for appropriate and timely clinical management decisions. This can be challenging to achieve from small cytology and histology specimens, with increasing numbers of molecular and immunohistochemical biomarkers required. We conducted a 5 year retrospective audit of cases at our institution to assess the diagnostic and biomarker testing adequacy rates, particularly those specimens obtained with rapid onsite evaluation (ROSE), performed by a cytopathologist and a cytology scientist or pathology trainee, including all endobronchial ultrasound guided transbronchial needle aspirations (EBUS-TBNA), CT guided lung fine needle aspirations (FNA) and CT guided lung core biopsies. A total of 5,354 cases were identified, of which 92.2% had sufficient material for diagnosis. Of the 1506 cases identified with a recorded diagnosis of lung adenocarcinoma or NSCLC, not otherwise specified, 1001 (66.5%) had biomarker testing requested. Sufficient material was available in 89.5% of cases for a complete biomarker workup which included EGFR and KRAS mutational testing (all cases), ALK, ROS1 and PD-L1 immunohistochemistry (all cases), and ALK and ROS1 FISH (as required). For EGFR and KRAS mutational testing across both cytology and histology specimens, 99% of cases were sufficient. Of the samples in which a complete biomarker workup was unable to be performed, approximately half were only insufficient due to inadequate numbers of tumour cells for PD-L1 immunohistochemistry. Excluding PD-L1 IHC, 952 (95.1%) of samples obtained with ROSE were sufficient for the remainder of the testing requirements. Next generation sequencing using a 33 gene custom AmpliSeq panel was achieved in up to 72% of cases. In conclusion, small cytology and histology specimens obtained with ROSE are suitable for predictive biomarker testing in NSCLC, although attention needs to be paid to obtaining sufficient cells (>100) for PD-L1 immunohistochemistry.Copyright © 2023 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.