PMID- 36923427 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230316 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 13 DP - 2023 TI - Hepatectomy versus transcatheter arterial chemoembolization for resectable BCLC stage A/B hepatocellular carcinoma beyond Milan criteria: A randomized clinical trial. PG - 1101162 LID - 10.3389/fonc.2023.1101162 [doi] LID - 1101162 AB - BACKGROUND: Hepatectomy is the recommended option for radical treatment of BCLC stage A/B hepatocellular carcinoma (HCC) that has progressed beyond the Milan criteria. This study evaluated the efficacy and safety of preoperative neoadjuvant transcatheter arterial chemoembolization (TACE) for these patients. METHODS: In this prospective, randomized, open-label clinical study, BCLC stage A/B HCC patients beyond the Milan criteria were randomly assigned (1:1) to receive either neoadjuvant TACE prior to hepatectomy (NT group) or hepatectomy alone (OP group). The primary outcome was overall survival (OS), while the secondary outcomes were progression-free survival (PFS) and adverse events (AEs). RESULTS: Of 249 patients screened, 164 meeting the inclusion criteria were randomly assigned to either the NT group (n = 82) or OP group (n = 82) and completed follow-up requirements. Overall survival was significantly greater in the NT group compared to the OP group at 1 year (97.2% vs. 82.4%), two years (88.4% vs. 60.4%), and three years (71.6% vs. 45.7%) (p = 0.0011) post-treatment. Similarly, PFS was significantly longer in the NT group than the OP group at 1 year (60.1% vs. 39.9%), 2 years (53.4% vs. 24.5%), and 3 years (42.2% vs. 24.5%) (p = 0.0003). No patients reported adverse events of grade 3 or above in either group. CONCLUSIONS: Neoadjuvant TACE prolongs the survival of BCLC stage A/B HCC patients beyond the Milan criteria without increasing severe adverse events frequency. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, identifier ChiCTR2200055618. CI - Copyright (c) 2023 Fang, Luo, Zhang, Wang, Feng, Liu, Chen, Yao, Shi and Zhong. FAU - Fang, Chongkai AU - Fang C AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Luo, Rui AU - Luo R AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Zhang, Ying AU - Zhang Y AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Wang, Jinan AU - Wang J AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Feng, Kunliang AU - Feng K AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Liu, Silin AU - Liu S AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Chen, Chuyao AU - Chen C AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Yao, Ruiwei AU - Yao R AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Shi, Hanqian AU - Shi H AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Zhong, Chong AU - Zhong C AD - The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. AD - Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China. LA - eng PT - Journal Article DEP - 20230227 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC10010190 OTO - NOTNLM OT - Milan criteria OT - hepatectomy OT - hepatocellular carcinoma OT - neoadjuvant treatment OT - survival OT - transcatheter arterial chemoembolization COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/03/17 06:00 MHDA- 2023/03/17 06:01 PMCR- 2023/01/01 CRDT- 2023/03/16 02:22 PHST- 2022/11/17 00:00 [received] PHST- 2023/02/03 00:00 [accepted] PHST- 2023/03/16 02:22 [entrez] PHST- 2023/03/17 06:00 [pubmed] PHST- 2023/03/17 06:01 [medline] PHST- 2023/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2023.1101162 [doi] PST - epublish SO - Front Oncol. 2023 Feb 27;13:1101162. doi: 10.3389/fonc.2023.1101162. eCollection 2023.