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

Abstract

BackgroundHepatectomy 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.MethodsIn 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).ResultsOf 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.ConclusionsNeoadjuvant TACE prolongs the survival of BCLC stage A/B HCC patients beyond the Milan criteria without increasing severe adverse events frequency.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2200055618.

Adjuvant therapy with Jianpi Huayu decoction improves overall and recurrence-free survival after hepatectomy for hepatocellular carcinoma: a retrospective propensity score-matching study

“…Hepatectomy was conducted as previously described ( Zhong et al, 2014 ; Fang et al, 2023 ). The resection margins met R0 resection criteria.…”

Effect of neoadjuvant transarterial chemoembolization followed by resection versus upfront liver resection on the survival of single large hepatocellular carcinoma patients: A systematic review and meta-analysis

“…Neither study focused exclusively on SLHCC, but included large HCCs with and without multiple nodules. The latest RCT conducted by Fang et al [19] in 2023, which also used epirubicin as their single chemotherapy agent, demonstrated improvement in 1-, 2-, and 3-year OS and DFS. Based on the outcomes of this current meta-analysis, it is evident that a combination chemotherapy regimen for N−TACE yields more favorable results than a single-agent N−TACE approach.…”

Adjuvant and Neoadjuvant Treatments for Resectable Hepatocellular Carcinoma

“…On the other hand, some studies suggest that neoadjuvant TACE may improve outcomes for patients. Notably, a phase 3 randomized trial by Fang et al reported improvements in OS and progression-free survival for patients who received neoadjuvant TACE followed by hepatectomy compared to patients who did not receive preoperative TACE [ 41 ]. Patients received TACE at least twice; patients who recorded stable disease, partial response, or complete response to TACE per modified Response Evaluation Criteria in Solid Tumors (RECIST) proceeded to resection.…”