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PO.CL01.18 · 临床研究

Circulating tumor DNA (ctDNA) for molecular residual disease (MRD) detection and recurrence monitoring in hepatocellular carcinoma (HCC); COSMOS-HCC01

海报缩略图：Circulating tumor DNA (ctDNA) for molecular residual disease (MRD) detection and recurrence monitoring in hepatocellular carcinoma (HCC); COSMOS-HCC01
编号 1094 展板 4 时间 4/19 02:00–05:00 区域 Section 43 主讲 Masashi Kudo
分会场 Early Detection Biomarkers 1
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作者与单位

Masashi Kudo1, Mitsuhito Sasaki2, Shinji Itoh3, Teiichi Sugiura4, Tsuyoshi Kobayashi5, Keishi Sugimachi6, Shinichi Nakanuma7, Yuta Abe8, Hisashi Kosaka9, Nobuhiro Nakamoto10, Naoto Yamamoto11, Makoto Ueno12, Takuji Okusaka13, Atsushi Takebe14, Minoru Esaki15, Kazuyoshi Ohkawa16, Hisateru Komatsu17, Yu Takahashi18, Masatake Tanaka19, Takeshi Aramaki20, Tomokazu Kawaoka21, Rie Sugimoto22, Taro Yamashita23, Takashi Yamaguchi24, Masatoshi Kudo25, Masato Ozaka26, Chiemi Notake27, Hiroshi Uchigata27, Masafumi Ikeda2, Naoto Gotohda1, Yoshiaki Nakamura27

1Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Chiba, Japan,2Department of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital East, Chiba, Japan,3Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan,4Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, Shizuoka, Japan,5Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan,6Department of Hepatobiliary and Pancreatic Surgery, NHO Kyushu Cancer Center, Fukuoka, Japan,7Department of Hepato-Biliary-Pancreatic Surgery and Transplantation, Kanazawa University, Ishikawa, Japan,8Department of Surgery, Keio University School of Medicine, Tokyo, Japan,9Department of Hepatobiliary Surgery, Kansai Medical University, Osaka, Japan,10Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan,11Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan,12Department of Gastroenterology and Hepatology, Kanagawa Cancer Center, Kanagawa, Japan,13Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan,14Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan,15Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, Tokyo, Japan,16Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute, Osaka, Japan,17Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan,18Division of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan,19Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan,20Division of Interventional Radiology, Shizuoka Cancer Center, Shizuoka, Japan,21Department of Gastroenterology, Hiroshima University Hospital, Hiroshima, Japan,22Department of Hepato-Biliary-Pancreatology, NHO Kyushu Cancer Center, Fukuoka, Japan,23Department of Gastroenterology, Kanazawa University Graduate School of Medical Science, Ishikawa, Japan,24Department of Gastroenterology and Hepatology, Kansai Medical University, Osaka, Japan,25Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan,26Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan,27Translational Research Support Office, National Cancer Center Hospital East, Chiba, Japan

摘要 Abstract

Background: Surgery and ablation can be curative for early-stage HCC, but up to 70% recur or develop new primary HCC. ctDNA-based MRD assessment may improve risk assessment and identify recurrence earlier than current tools. Because HCC is often diagnosed radiologically and ablation yields no tissue, tumor-informed assays may be infeasible and unable to detect new primaries. Methods: Patients with completely resected or ablated stage I-III HCC were prospectively enrolled across 13 Japanese sites (Mar 2021-May 2022). Plasma was collected pre- and 4 weeks post-procedure and every 3-6 months with standard imaging and biomarker assessment. ctDNA was analyzed retrospectively using a tissue-free epigenomic assay (Guardant Reveal) evaluating ~20,000 differentially methylated/control regions. Samples are classified as ctDNA detected/not detected based on a pre-defined threshold. Associations between ctDNA status and recurrence were analyzed. Results: Among 95 patients eligible for this interim analysis, (87% resected, 57% stage I, median age 74), 610/611 samples were successfully analyzed. At 36.9 months median follow-up, 42 recurred. Pre-procedure ctDNA was detected in 75% (70/94) and correlated with shorter time to recurrence (HR 4.4; 95% CI 1.7-14.6; p < 0.001). Post-surgery ctDNA detection at 4 weeks also correlated (HR 3.8; 95% CI 1.7-7.8; p = 0.002) and was the only variable that remained statistically associated with recurrence on multivariate analysis at this timepoint. Surveillance ctDNA sensitivity was 60% (25/42), specificity was 98% (52/53), and median lead time was 63 days. ctDNA outperformed other biomarkers evaluated in this cohort (Table 1). Conclusions: Epigenomic ctDNA analysis enabled tissue-free MRD detection with high accuracy and superior performance vs conventional biomarkers, supporting its use for individualized recurrence risk assessment and surveillance. Table 1. Performance of biomarkers (ever/never detected) to predict HCC recurrence during post-treat ctDNA AFP (>10ng/mL) AFP-L3 (>9.9%) PIVKA-II (>39mAU/mL) Sensitivity (positive/recurrence) 60% (25/42) 33% (14/42) 54% (13/24) 44% (18/41) Specificity (negative/no recurrence) 98% (52/53) 87% (46/53) 68% (15/22) 87% (45/52) Median lead time 63 days 55 days 12 days 32 days HR (95% CI) 10.1 (5.3-20.3), P < 0.001 2.2 (1.1-4.1), P = 0.024 1.7 (0.7-3.9), P = 0.213 3.6 (1.9-6.7), P < 0.001
利益披露 Disclosure
M. Kudo, None.. M. Sasaki, None. S. Itoh, Chugai Pharma Other, Lecture fees. AstraZeneca Other, Lecture fees. Eisai Other, Lecture fees. T. Sugiura, None.. T. Kobayashi, None.. K. Sugimachi, None.. S. Nakanuma, None.. Y. Abe, None.. H. Kosaka, None.. N. Nakamoto, None.. N. Yamamoto, None. M. Ueno, Astellas Pharma ). AstraZeneca ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Chugai Pharmaceutical ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. DFP ). Eisai ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Incyte ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. MSD ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Ono Pharmaceutical ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Taiho Pharmaceutical, ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Novartis ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. J-pharma ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Novocure ). Chiome Bioscience ). Revolution Medicine ). Jazz Pharmaceuticals ). Nihon servier ), Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Boehringer Ingelheim ). Amgen ). Nippon Boehringer Ingelheim Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Daiichi Sankyo, Takeda Pharmaceutical, Yakult Honsha, Aska, Viatris, Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. T. Okusaka, AstraZeneca ), Other, Consulting fees / Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Syneos ). Incyte ). CHIOME Bioscience Inc. ). Sysmex Corporation ). Amgen Inc. ), Other, Consulting fees. Linical ). Labcorp Genetics ). Eisai Other, Consulting fees / Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Nihon Medi-Physics Co.,Ltd Other, Consulting fees. Jazz Pharmaceuticals Other, Consulting fees. OHARA Pharmaceutical Co.,Ltd. Other, Consulting fees. MSD Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Taiho Pharmaceutical Co.,Ltd. Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Ono Pharmaceutical Co., Ltd. Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Daiichi Sankyo Co., Ltd. Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Nihon Servier Co., Ltd. Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Chugai Pharmaceutical Co., Ltd. Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Johnson & Johnson K.K. Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Kyowa Kirin ,Novartis Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. A. Takebe, None.. M. Esaki, None.. K. Ohkawa, None.. H. Komatsu, None.. Y. Takahashi, None.. M. Tanaka, None.. T. Aramaki, None. T. Kawaoka, Chugai Pharmaceutical Co., Ltd. Other, speakers’ bureau. Eisai Co., Ltd. Other, speakers’ bureau. AstraZeneca Other, speakers’ bureau. R. Sugimoto, Esai Co. Other, lecture fee. Chugai Pharma, Other, lecture fee. AstraZeneca Other, lecture fee. T. Yamashita, Chugai Pharmaceutical Co., Ltd. ), Other, Lecture fee. Esai Co. ), Other, Lecture fee. AstraZeneca ), Other, Lecture fee. T. Yamaguchi, None. M. Kudo, Chugai ), Other, Lecture/ Honoraria. Eisai Other, Lecture/ Honoraria, Advisory Consulting. AstraZeneca Other, Lecture/ Honoraria, Advisory Consulting. Otsuka ). M. Ozaka, Taiho Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Ono Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. MSD Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Novartis Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Servier Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. AstraZeneca Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. C. Notake, None.. H. Uchigata, None. M. Ikeda, AbbVie ), Other, Consulting fees. AstraZeneca ), Other, Consulting fees / Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Bristol Myers Squibb ), Other, Consulting fees. Chugai ), Other, Consulting fees / Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Eisai ), Other, Consulting fees / Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. MSD ), Other, Consulting fees / Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. GlaxoSmithKline Other, Consulting fees. Ono Other, Consulting fees / Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. EA Pharma Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. Takeda Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events. N. Gotohda, None. Y. Nakamura, Guardant Health Pte Ltd. Other, reports advisory role. Natera,Inc. Other, reports advisory role. Exact Sciences Corporation, Tempus AI, Inc. Other, reports advisory role. Pfizer Inc. Other, reports advisory role. Shionogi & Co., Ltd. Inc. Other, reports advisory role. MSD K.K. Other, speakers’ bureau. Merck Biopharma Co., Ltd. Other, speakers’ bureau. Daiichi Sankyo Co., Ltd. Other, speakers’ bureau. Chugai Pharmaceutical Co., Ltd. Other, speakers’ bureau. Guardant Health Japan Corp. Other, speakers’ bureau.

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