Pathology & Data Analytics, Leeds Institute of Medical Research, University of Leeds and Department of Histopathology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
The Christie NHS Foundation Trust, Manchester, UK.
Clin Oncol (R Coll Radiol). 2024 Nov;36(11):701-709. doi: 10.1016/j.clon.2024.08.002. Epub 2024 Aug 8.
Oesophago-gastric cancers (OGCs) are amongst the most commonly diagnosed malignancies worldwide and are associated with high disease-related mortality. Predictive biomarkers are molecules that can be objectively measured and used to indicate a likely response to therapeutic intervention, thus facilitating individualised cancer therapy. However, there remains variation in uptake and implementation of biomarker testing across the UK.
We conducted a modified Delphi study to formulate consensus recommendations for best-practice biomarker testing of OGC in the UK. We employed two rounds of online questionnaires followed by a virtual consensus meeting. Biomarkers for discussion included HER2, MSI/MMR, and PD-L1. Topics comprised the overall biomarker pathway, pre-analytical, analytical, and post-analytical considerations, including challenges in current practice.
Twenty-six and eighteen participants completed the first and second round Delphi questionnaire, respectively, with an even split of pathologists and oncologists from across the UK. There was consensus (>80% agreement) across several topics, including the requirements for standardisation of the pathway, which must include coordination throughout the tissue journey, requirements for a quality-assured process to ensure accuracy and validity of testing, plus the need for clear, detailed information on the pathology report to support treatment decisions. There was consensus amongst oncologists regarding reflex testing of all biomarkers depending on histology; however, concerns over capacity in relation to workload and availability of pathologists were evident among the pathologists. Overall, participants were in the opinion that reflex testing improves the speed of treatment decisions and improves patient care.
The recommendations reflect best-practices and should be implemented to support rapid multidisciplinary team decision-making within oesophago-gastric cancer. Results reflect the need for standardisation and demonstrate the challenges faced in clinical practice by those requesting and testing biomarkers for oesophago-gastric cancer, suggesting significant concerns relating to pathologist capacity.
食管胃交界部癌症（OGC）是全球最常见的诊断恶性肿瘤之一，与高疾病相关死亡率相关。预测生物标志物是可以客观测量并用于指示对治疗干预可能反应的分子，从而促进癌症的个体化治疗。然而，在英国，生物标志物检测的采用和实施仍然存在差异。
我们进行了一项改良 Delphi 研究，以制定英国 OGC 最佳实践生物标志物检测的共识建议。我们采用了两轮在线问卷，随后进行了一次虚拟共识会议。讨论的生物标志物包括 HER2、MSI/MMR 和 PD-L1。主题包括整体生物标志物途径、分析前、分析和分析后考虑因素，包括当前实践中的挑战。
26 名和 18 名参与者分别完成了第一轮和第二轮 Delphi 问卷，来自英国各地的病理学家和肿瘤学家各占一半。在几个主题上达成了共识（>80%的一致性），包括标准化途径的要求，该途径必须包括整个组织学旅程的协调、确保测试准确性和有效性的质量保证过程的要求，以及病理报告中清晰、详细的信息以支持治疗决策的需求。肿瘤学家一致认为根据组织学对所有生物标志物进行反射性检测；然而，病理学家明显关注与工作量和病理学家可用性相关的能力问题。总体而言，参与者认为反射性测试可以提高治疗决策的速度并改善患者护理。
这些建议反映了最佳实践，应予以实施，以支持食管胃交界部癌症的快速多学科团队决策。结果反映了标准化的必要性，并展示了那些请求和测试食管胃交界部癌症生物标志物的人在临床实践中面临的挑战，表明与病理学家能力相关的重大问题。
