نبذة مختصرة : Hepatocellular carcinoma (HCC) is often detected at advanced stages among patients with hepatitis B virus (HBV), underscoring the urgency for more precise surveillance tests. Here, we compare the clinical performance of the novel - GAAD (gender [biological sex], age, alpha-fetoprotein [AFP], protein-induced by vitamin K absence-II [PIVKA-II]) and GALAD (gender [biological sex], age, AFP, Lens-culinaris AFP [AFP-L3]), PIVKA-II) algorithms to assess the utility of AFP-L3 for distinguishing HCC from benign chronic liver disease (CLD) in Chinese patients with predominantly chronic HBV infection. Eligible adults were enrolled, and biomarkers were measured using Elecsys (Cobas) or µTASWAKO assays. In total, 411 participants provided serum samples (HCC, n = 176 [early-stage, n = 110]; CLD, n = 136; specificity n = 101). HBV was the underlying disease etiology for most participants (HCC, 95%; benign CLD, 72%). For GAAD (Cobas), GALAD (Cobas), and GALAD (µTASWAKO), AUCs were 93.1% (95% CI: 90.0-96.2), 93.2% (90.0-96.3), and 92.7% (88.4-96.9) for early-stage, and 95.6% (93.6-97.6), 95.6% (93.6-97.7), and 95.8% (93.2-98.3) for all-stage HCC, versus CLD, respectively. Interestingly, both GAAD and GALAD algorithms demonstrated comparable diagnostic performance regardless of disease etiology (HBV vs. non-HBV), presence of cirrhosis, geographic region, and within pan-tumor specificity panels (p < 0.001), indicating AFP-L3 may have a negligible role in HCC surveillance.
Competing Interests: Declarations. Competing interests: HLYC reports consultancy fees from Arbutus Biopharma, Gilead Sciences, Glaxo-Smith-Kline, Roche, Vir Biotechnology, Aligos Therapeutics, Vaccitech, and Virion Therapeutics; and speaker’s bureau participation for Echosens, Gilead Sciences, Roche, and Viatris. YH has no conflicts of interest to declare. KMad, KK, and AS are employees of Roche Diagnostics International AG. KMal is an employee of Microcoat Biotechnologie, contracted by Roche Diagnostics. JH reports speaker’s bureau participation for Glaxo-Smith-Kline, Gilead Sciences, and Roche Diagnostics; has received grant/research support from Gilead Sciences and BMS; and has served on an advisory committee or review panel for Aligos, Assembly, Glaxo-Smith-Kline, Gilead Sciences, Johnson Pharmaceutica, and Roche.
(© 2024. The Author(s).)
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