Establishing alpha-fetoprotein reference ranges in patients with chronic liver disease and hepatocellular carcinoma.

IF 2.4 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Hpb Pub Date : 2025-08-28 DOI:10.1016/j.hpb.2025.08.011

Anton Kalyuzhnyy, Hidenori Toyoda, Philip J Johnson

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引用次数: 0

Abstract

Background: Alpha-fetoprotein (AFP) is the primary serum biomarker for hepatocellular carcinoma (HCC). However, the current diagnostic AFP thresholds for HCC are arbitrary and the definitive reference range has never been identified. Furthermore, some HCCs are AFP-negative, implying that these tumours do not synthesise AFP, making them difficult to characterise and diagnose.

Methods: By analysing AFP distribution in over 4500 patients with chronic liver disease (CLD) from Japan and UK with and without HCC, as well as in a population of healthy patients without CLD, we defined accurate AFP reference ranges for HCC and characterised a group of AFP-negative HCC patients.

Results: We identified 40 ng/mL as the upper AFP limit for CLD patients without HCC, indicating that HCC can be accurately diagnosed above this threshold with minimal risk of false positives. Furthermore, the upper AFP limit for the healthy population was 5 ng/mL which was used to characterise AFP-negative HCC patients. By this definition, 15 % of HCC patients were AFP-negative. Those patients had significantly better survival after diagnosis compared to their AFP-positive counterparts irrespective of treatment.

Discussion: Our established AFP reference ranges provide an accurate cutoff for HCC diagnosis and can also be used to identify AFP-negative HCCs.

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慢性肝病和肝细胞癌患者甲胎蛋白参考范围的建立

背景：甲胎蛋白（AFP）是肝细胞癌（HCC）的主要血清生物标志物。然而，目前诊断HCC的AFP阈值是任意的，并且从未确定明确的参考范围。此外，一些hcc是AFP阴性的，这意味着这些肿瘤不合成AFP，这使得它们难以表征和诊断。方法：通过分析来自日本和英国的4500多名慢性肝病（CLD）患者的AFP分布，包括有和没有HCC的患者，以及没有CLD的健康人群，我们定义了HCC准确的AFP参考范围，并对一组AFP阴性的HCC患者进行了表征。结果：我们确定40 ng/mL为无HCC的CLD患者的AFP上限，表明超过该阈值可以准确诊断HCC，假阳性风险最小。此外，健康人群的AFP上限为5 ng/mL，用于表征AFP阴性的HCC患者。根据这一定义，15%的HCC患者为afp阴性。与afp阳性的患者相比，这些患者在诊断后的生存率显著提高，无论治疗方式如何。讨论：我们建立的AFP参考范围为HCC诊断提供了准确的界限，也可用于鉴定AFP阴性HCC。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Hpb GASTROENTEROLOGY & HEPATOLOGY-SURGERY

CiteScore

5.60

自引率

3.40%

发文量

244

审稿时长

57 days

期刊介绍： HPB is an international forum for clinical, scientific and educational communication. Twelve issues a year bring the reader leading articles, expert reviews, original articles, images, editorials, and reader correspondence encompassing all aspects of benign and malignant hepatobiliary disease and its management. HPB features relevant aspects of clinical and translational research and practice. Specific areas of interest include HPB diseases encountered globally by clinical practitioners in this specialist field of gastrointestinal surgery. The journal addresses the challenges faced in the management of cancer involving the liver, biliary system and pancreas. While surgical oncology represents a large part of HPB practice, submission of manuscripts relating to liver and pancreas transplantation, the treatment of benign conditions such as acute and chronic pancreatitis, and those relating to hepatobiliary infection and inflammation are also welcomed. There will be a focus on developing a multidisciplinary approach to diagnosis and treatment with endoscopic and laparoscopic approaches, radiological interventions and surgical techniques being strongly represented. HPB welcomes submission of manuscripts in all these areas and in scientific focused research that has clear clinical relevance to HPB surgical practice. HPB aims to help its readers - surgeons, physicians, radiologists and basic scientists - to develop their knowledge and practice. HPB will be of interest to specialists involved in the management of hepatobiliary and pancreatic disease however will also inform those working in related fields. Abstracted and Indexed in: MEDLINE® EMBASE PubMed Science Citation Index Expanded Academic Search (EBSCO) HPB is owned by the International Hepato-Pancreato-Biliary Association (IHPBA) and is also the official Journal of the American Hepato-Pancreato-Biliary Association (AHPBA), the Asian-Pacific Hepato Pancreatic Biliary Association (A-PHPBA) and the European-African Hepato-Pancreatic Biliary Association (E-AHPBA).