Performance of the GALAD Model in an Asian Cohort Undergoing Hepatocellular Carcinoma Surveillance: A Prospective Cohort Study.

BACKGROUND AND AIM

Current hepatocellular carcinoma (HCC) surveillance strategy has its limitations, consequently delaying early detection. The GALAD model has been validated in retrospective studies, with two published cut-off values yielding different sensitivities for HCCs of different etiologies. We evaluated the performance of GALAD model in HCC surveillance and determined the ideal cut-off value for our cohort.

METHODS

Patients undergoing 6-monthly HCC surveillance in Singapore General Hospital were recruited between December 2017-October 2018. Study serum specimens were prospectively collected and retrospectively tested using the μTASWako alpha-fetoprotein (AFP), AFP-L3, and protein induced by vitamin K antagonism-II (PIVKA-II) kits. GALAD score was calculated and compared with individual biomarkers using area under the curve (AUC) analysis. Published GALAD cut-offs of -0.63 and -1.95 were compared for their performance in HCC detection.

RESULTS

There were 207 patients (median age 59 years, 55.1% males). Hepatitis B was the commonest etiology (72.9%). By February 2023, with a median follow-up of 48.9 months, 20 patients had developed HCC. Eight patients developed HCC within 1 year from specimen collection. For HCC developing within 1 year, GALAD model detected HCC with an AUC of 0.84, greater than AFP (AUC 0.77), AFP-L3 (AUC 0.60), and PIVKA-II (AUC 0.67). GALAD at cut-off -1.95 achieved sensitivity and specificity of 75% and 92.5% for HCCs detected within 1 year, superior to cut-off -0.63 (sensitivity 12.5%, specificity 100%).

CONCLUSION

In this prospective study of HCC surveillance, the GALAD model performed better than individual biomarkers. The cut-off of -1.95 was more useful in our predominantly chronic hepatitis B cohort.