The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
Centre for Cancer Research and Department of General Practice, University of Melbourne, Victoria, Australia.
Adv Ther. 2021 Feb;38(2):793-834. doi: 10.1007/s12325-020-01571-z. Epub 2020 Dec 11.
Detecting upper gastrointestinal (GI) cancers in primary care is challenging, as cancer symptoms are common, often non-specific, and most patients presenting with these symptoms will not have cancer. Substantial investment has been made to develop biomarkers for cancer detection, but few have reached routine clinical practice. We aimed to identify novel biomarkers for upper GI cancers which have been sufficiently validated to be ready for evaluation in low-prevalence populations.
We systematically searched MEDLINE, Embase, Emcare, and Web of Science for studies published in English from January 2000 to October 2019 (PROSPERO registration CRD42020165005). Reference lists of included studies were assessed. Studies had to report on second measures of diagnostic performance (beyond discovery phase) for biomarkers (single or in panels) used to detect pancreatic, oesophageal, gastric, and biliary tract cancers. We included all designs and excluded studies with less than 50 cases/controls. Data were extracted on types of biomarkers, populations and outcomes. Heterogeneity prevented pooling of outcomes.
We identified 149 eligible studies, involving 22,264 cancer cases and 49,474 controls. A total of 431 biomarkers were identified (183 microRNAs and other RNAs, 79 autoantibodies and other immunological markers, 119 other proteins, 36 metabolic markers, 6 circulating tumour DNA and 8 other). Over half (n = 231) were reported in pancreatic cancer studies. Only 35 biomarkers had been investigated in at least two studies, with reported outcomes for that individual marker for the same tumour type. Apolipoproteins (apoAII-AT and apoAII-ATQ), and pepsinogens (PGI and PGII) were the most promising biomarkers for pancreatic and gastric cancer, respectively.
Most novel biomarkers for the early detection of upper GI cancers are still at an early stage of matureness. Further evidence is needed on biomarker performance in low-prevalence populations, in addition to implementation and health economic studies, before extensive adoption into clinical practice can be recommended.
在初级保健中检测上消化道（GI）癌症具有挑战性，因为癌症症状常见且通常不具特异性，并且大多数出现这些症状的患者不会患有癌症。已经投入大量资金来开发癌症检测的生物标志物，但很少有达到常规临床实践的。我们旨在确定用于上消化道癌症检测的新型生物标志物，这些生物标志物已经经过充分验证，可以在低患病率人群中进行评估。
我们系统地检索了 MEDLINE、Embase、Emcare 和 Web of Science 数据库，以获取 2000 年 1 月至 2019 年 10 月期间以英文发表的研究（PROSPERO 注册号 CRD42020165005）。评估了纳入研究的参考文献列表。研究必须报告用于检测胰腺癌、食管癌、胃癌和胆道癌的生物标志物（单一或联合）的第二测量诊断性能（超出发现阶段）。我们纳入了所有设计，并排除了病例/对照少于 50 例的研究。提取了生物标志物类型、人群和结局的数据。异质性阻止了结局的汇总。
我们确定了 149 项符合条件的研究，涉及 22,264 例癌症病例和 49,474 例对照。共确定了 431 种生物标志物（183 种 microRNAs 和其他 RNA、79 种自身抗体和其他免疫标志物、119 种其他蛋白质、36 种代谢标志物、6 种循环肿瘤 DNA 和 8 种其他标志物）。其中一半以上（n=231）来自胰腺癌研究。只有 35 种生物标志物在至少两项研究中进行了研究，并针对相同肿瘤类型报告了该单个标志物的研究结果。载脂蛋白（apoAII-AT 和 apoAII-ATQ）和胃蛋白酶原（PGI 和 PGII）是胰腺癌和胃癌最有前途的生物标志物。
大多数用于上消化道癌症早期检测的新型生物标志物仍处于早期成熟阶段。在广泛推荐临床实践之前，需要在低患病率人群中进一步评估生物标志物性能，以及实施和健康经济学研究。
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