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Proposal for Modified Alpha Fetoprotein Use in Hepatocellular Carcinoma Surveillance: Analysis of the 2018-2020
Shinae Yu1, Sollip Kim2,3, Hyeongsu Kim4
1Department of Laboratory Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.
Background:
Hepatocellular carcinoma (HCC) is a major health concern, highlighting the need for effective surveillance. Republic of Korea's (South Korea's) National Cancer Screening Program (NCSP) uses ultrasound and serum alpha fetoprotein (AFP) tests for high-risk populations, but its performance remains unevaluated. The AFP result is only used when a mass under 1 cm is detected on ultrasound, raising concerns about its appropriateness.
Methods:
We analyzed data from 820,380 participants in Korea's NCSP for HCC between 2018 and 2020, comparing the ultrasound-alone protocol, current criteria, and the modified criteria newly proposed in this study. The current criteria define surveillance positivity as positive ultrasound findings or equivocal findings with elevated AFP, while the modified criteria consider either positive ultrasound findings or elevated AFP. Sensitivity, specificity, and area under the receiver operating characteristic (AUROC) curve for detecting HCC with various AFP cutoffs were evaluated.
Results:
Ultrasound alone had a sensitivity of 44.26% and a specificity of 97.38%. The current criteria achieved a sensitivity of 44.82-46.51% and a specificity of 97.18-97.38% for detecting HCC with various AFP cutoffs ranging from 5 to 100 ng/mL. The AUROC for the modified criteria was 0.8728, significantly higher than that of the current criteria (0.7209, P < 0.001). An AFP cutoff of 7 ng/mL was identified as the optimal threshold based on Youden's index. An AFP cutoff of 7 ng/mL slightly reduced specificity from 97.28% to 92.24%, whereas sensitivity markedly increased from 46.22% to 76.72%. Additionally, an AFP cutoff of 20 ng/mL yielded an increased sensitivity of 63.25% with maintaining specificity of 96.71%.
Conclusion:
The modified NCSP criteria we proposed, which incorporate AFP more proactively, identified an optimal cutoff for the Korean NCSP by balancing both sensitivity and specificity. This approach may contribute to improving the effectiveness HCC surveillance in the future.
