Liquid Biopsy Test Based on a Sensitive DNA Methylation Assay for Diagnosing Early-Stage Hepatocellular Carcinoma: Which Is Better as a Combination Marker of AFP and PIVKA-II, Methylated SEPT9 or HOXA1?

MATSUI Koki, YAMASAKI  Ayano, SUEHIRO Yutaka, HOSHIDA Tomomi, SAEKI Issei, YAMAUCHI Yurika, MATSUMOTO Toshihiko, HIGAKI Shingo, FUJII Ikuei, SUZUKI Chieko, TAKAMI Taro, SAKAIDA Isao, YAMASAKI Takahiro

doi:10.2342/ymj.72.85

<p>Although a combination test of alpha-fetoprotein（AFP）and protein induced by vitamin K absence or antagonist-II（PIVKA-II）is covered by public insurance in Japan for the screening of hepatocellular carcinoma（HCC）in patients with chronic hepatitis and/or cirrhosis, its diagnostic performance for early-stage HCC is limited. To resolve this, we investigated whether a liquid biopsy of methylated SEPT9 and methylated HOXA1 may complement the diagnostic performance of AFP and PIVKA-II for early-stage HCC. We measured AFP, PIVKA-II, and copy numbers of methylated SEPT9 and HOXA1 in serum from 25 healthy controls, 30 patients with chronic liver disease, and 78 patients with HCC（including 44 patients with early-stage HCC）．Sensitivity and specificity for early-stage HCC were, respectively, 56.8% and 94.5% for the combination of AFP and PIVKA-II；77.3% and 89.1% for the combination of AFP, PIVKA-II, and methylated SEPT9；and 63.6% and 90.9% for the combination of AFP, PIVKA-II, and methylated HOXA1. Having the highest sensitivity and considerable specificity, the combination of AFP, PIVKA-II, and methylated SEPT9 appeared to be the best companion test for detecting early-stage HCC.</p>

Liquid Biopsy Test Based on a Sensitive DNA Methylation Assay for Diagnosing Early-Stage Hepatocellular Carcinoma: Which Is Better as a Combination Marker of AFP and PIVKA-II, Methylated SEPT9 or HOXA1?

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