Pancreatic ductal adenocarcinoma (PDAC) presents significant challenges in diagnosis, prevention, and treatment. Predictive biomarkers offer the potential to revolutionize clinical management, particularly in the preoperative setting, but their implementation requires careful consideration of ethical implications. This scoping review analyzes the ethical landscape of using immunohistochemistry (IHC) for molecular subtyping in PDAC, focusing on its utility, accessibility, and potential impact on patient care. We conducted a systematic literature search in the PubMed, Scopus and Google Scholar databases (2015–2025) using COVIDENCE, which identified 130 references. Of these, 79 were reviewed in a full-text format, and 9 ultimately met the inclusion criteria for our analysis. IHC offers several advantages as a companion diagnostic tool. It is relatively inexpensive, widely available in most pathology laboratories, and can be readily integrated into existing clinical workflows. This contrasts with more complex molecular subtyping methods, such as gene expression profiling, which can be costly, require specialized equipment and expertise, and may not be readily accessible in all clinical settings. Furthermore, accurate analysis of gene expression requires the localized targeting of individual cells; therefore, digesting the sample for bulk analysis would be less informative than using spatial localization techniques such as IHC. Because biomarker regulation can occur at the level of transcription or translation, protein-level assessment via IHC is often more accurate than mRNA analysis. Standardized IHC protocols for biomarker assessment are therefore essential for translating the molecular subtyping of PDAC into clinically actionable treatment strategies, especially for aggressive subtypes like basal-like tumors. This readily deployable IHC-based approach can optimize therapy selection, maximizing patient benefits and minimizing exposure to ineffective and potentially toxic treatments. This review critically analyzes the ethical dimensions of this method, grounded in the principles of autonomy, beneficence, non-maleficence, and justice. The review urges the medical community to fully utilize the potential of IHC-driven molecular subtyping to improve outcomes in PDAC, while ensuring equitable and responsible access to the benefits of precision oncology for all patients.
胰腺导管腺癌（PDAC）在诊断、预防和治疗方面面临重大挑战。预测性生物标志物有望革新临床管理，尤其在术前阶段，但其应用需审慎考量伦理影响。本范围综述系统分析了免疫组化（IHC）用于PDAC分子分型的伦理图景，重点关注其临床应用价值、可及性及对患者诊疗的潜在影响。通过COVIDENCE系统对PubMed、Scopus和Google Scholar数据库（2015-2025年）进行文献检索，共获得130篇文献。经全文审查后，最终9篇文献符合纳入标准。IHC作为伴随诊断工具具有多重优势：成本相对较低，在多数病理实验室普及度高，且易于整合至现有临床工作流程。这与基因表达谱分析等复杂分子分型方法形成鲜明对比——后者成本高昂、需专用设备与专业技术支持，且并非所有临床机构都能便捷开展。此外，基因表达的精准分析需定位至单个细胞水平，因此样本消化后的批量分析所获信息量远不及IHC等空间定位技术。鉴于生物标志物的调控可发生在转录或翻译层面，通过IHC进行的蛋白质水平评估通常比mRNA分析更为准确。建立标准化的IHC生物标志物检测方案，对于将PDAC分子分型转化为临床可操作的诊疗策略至关重要，尤其对于基底样肿瘤等高侵袭性亚型。这种基于IHC的便捷检测方案能优化治疗方案选择，在最大化患者获益的同时，减少无效及潜在毒性治疗的暴露风险。本综述基于自主、有利、不伤害与公正四大伦理原则，对该方法的伦理维度进行批判性分析，呼吁医学界在充分利用IHC驱动分子分型潜力以改善PDAC预后的同时，确保所有患者都能公平、负责任地获得精准肿瘤学的诊疗获益。
肿瘤(癌症)患者之家