A multicenter nonrandomized controlled trial to evaluate the efficacy of surgery versus radiofrequency ablation for small hepatocellular carcinoma (SURF cohort trial).

Authors

null

Ryosuke Tateishi

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

Ryosuke Tateishi , Kiyoshi Hasegawa , Yoshikuni Kawaguchi , Tadatoshi Takayama , Namiki Izumi , Naoki Yamanaka , Masatoshi Kudo , Mitsuo Shimada , Masafumi Inomata , Shuichi Kaneko , Kazuhiko Koike , Masao Omata , Masatoshi Makuuchi , Yutaka Matsuyama , Norihiro Kokudo

Organizations

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Gradiate School of Medicine,The University of Tokyo, Tokyo, Japan, Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan, Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan, Department of Surgery, Meiwa Hospital, Nishinomiya, Japan, Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan, Department of Surgery, Tokushima University, Tokushima, Japan, Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Yufu, Japan, Department of Gastroenterology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan, Yamanashi Prefectural Central Hospital, Kofu, Japan, Koto Hospital, Tokyo, Japan, Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, National Center for Global Health and Medicine, Tokyo, Japan

Research Funding

Other Government Agency
Health Labour Sciences Research Grant from The Ministry of Health Labour and Welfare of Japan

Background: In parallel with a multicenter randomized controlled trial that reported an equal recurrence-free survival (RFS) of early-stage hepatocellular carcinoma (HCC) patients who underwent either surgery (SUR) or radiofrequency ablation (RFA), we also enrolled HCC patients who fulfilled the enrollment criteria but did not give consent to participate in the RCT. Methods: All patients gave informed consent to participate in this study. Inclusion criteria were as follows: primary HCC with less than or equal to 3 tumors, each measuring 3 cm or smaller; without vascular invasion or extrahepatic metastasis; Child-Pugh score of 7 or less; and ages between 20 and 79 years. The feasibility for both treatments was confirmed by a joint chart review by surgeons and hepatologists. The primary endpoint was RFS and overall survival. A pre-specified interim analysis was performed to compare RFS. Results: Between April 2009 and August 2015, 740 patients (371 in SUR, 369 in RFA) were enrolled from 49 participating hospitals in Japan. The SUR group had significantly fewer patients with chronic hepatitis C (56.6% vs. 69.4%), higher median value of platelet count (145 vs. 120 × 109/L), and more patients with > 2 cm tumors (49.9% vs. 27.9%); most patients had a single tumor (91.1% vs. 88.3%). During the median follow-up period of 5 years, tumor recurrence was observed in 192 of SUR and 218 of RFA with 3-year RFS being 66.0% and 61.7%, respectively (P = 0.091). In subgroup analysis, RFS was significantly better in SUR in patients with ≤ 2 cm tumors (62.9% vs. 51.7% in 3 years; hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.56-0.93; P = 0.014), whereas the difference was not significant in those with > 2 cm tumors (52.7% vs. 46.4%; HR 0.85, 95% CI 0.63-1.18; P = 0.34). The adjusted HR for RFS using inversed probability of treatment weighting was 0.89 (95% CI, 0.72-1.10; P = 0.287). Conclusions: The imbalance in patient characteristics reflected a real-world practice. Factors related to background liver disease rather than tumor characteristics might have a larger impact on the recurrence in early HCC. Clinical trial information: C000001796.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Hepatobiliary Cancer

Clinical Trial Registration Number

C000001796

Citation

J Clin Oncol 38: 2020 (suppl; abstr 4581)

DOI

10.1200/JCO.2020.38.15_suppl.4581

Abstract #

4581

Poster Bd #

189

Abstract Disclosures