Hepatectomy versus transcatheter arterial chemoembolization for resectable BCLC stage A/B hepatocellular carcinoma beyond Milan criteria: A randomized clinical trial

Chongkai Fang; Rui Luo; Ying Zhang; Jinan Wang; Kunliang Feng; Silin Liu; Chuyao Chen; Ruiwei Yao; Hanqian Shi; Chong Zhong

doi:10.3389/fonc.2023.1101162

Hepatectomy versus transcatheter arterial chemoembolization for resectable BCLC stage A/B hepatocellular carcinoma beyond Milan criteria: A randomized clinical trial

Front Oncol. 2023 Feb 27:13:1101162. doi: 10.3389/fonc.2023.1101162. eCollection 2023.

Authors

Chongkai Fang^{1

2

3}, Rui Luo^{1

2

3}, Ying Zhang^{1

2

3}, Jinan Wang^{1

2

3}, Kunliang Feng^{1

2

3}, Silin Liu^{1

2

3}, Chuyao Chen^{1

2

3}, Ruiwei Yao^{1

2

3}, Hanqian Shi^{1

2

3}, Chong Zhong^{1

2

3}

Affiliations

¹ The First Clinical Medical School, Guangzhou University of Chinese Medicine, Guangzhou, China.
² The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
³ Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou, China.

Abstract

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.

Keywords: Milan criteria; hepatectomy; hepatocellular carcinoma; neoadjuvant treatment; survival; transcatheter arterial chemoembolization.

Grants and funding

This work was supported by the National Natural Science Foundation of China (NSFC 82274526), “First-class universities and disciplines of the world” and high-level university discipline reserve talent cultivation project of Guangzhou University of Chinese Medicine (A1-2601-22-415-023), the Guangzhou Municipal Science and Technology Project (202102010406), the Innovation Project of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (2019IIT18) and the Natural Science Foundation of Guangdong Province (2023A1515011069).