Neoadjuvant transarterial chemoembolization (TACE) plus PD-1 inhibitor bridging to tumor resection in intermediate-stage hepatocellular carcinoma patients.

Abstract

Programmed cell death protein 1 (PD-1) inhibitor is widely utilized in advanced-stage carcinomas including hepatocellular carcinoma (HCC), while its neoadjuvant application plus transarterial chemoembolization (TACE) in HCC remains unexplored. Thereby, the current study aimed to investigate the efficacy and safety of TACE plus PD-1 inhibitor as neoadjuvant therapy bridging to surgical resection in intermediate-stage HCC patients. Twenty intermediate-stage HCC (China Liver Cancer (CNLC) stage II) patients treated with neoadjuvant TACE plus PD-1 inhibitor (camrelizumab or sintilimab) bridging to surgery were consecutively enrolled. The objective response rate (ORR) and disease control rate (DCR) to neoadjuvant therapy were 75.0% and 100.0%, respectively; meanwhile, alpha-fetoprotein (AFP) was decreased after the neoadjuvant therapy (P < 0.001). Moreover, 14 (70.0%) patients had successful downstaging (patients converted to CNLC stage I). Neither median disease-free survival (DFS) nor median overall survival (OS) was reached; additionally, the 1-year accumulating DFS rate was 86.6%; meanwhile, the 1-year and 2-year accumulating OS rates were 100.0% and 76.4%, separately. Moreover, patients with successful downstaging had a prolonged DFS (P = 0.014) compared to patients with failed downstaging; meanwhile, this trend was also observed in assessing accumulating OS (P = 0.067) (without statistical significance). Main adverse events included pain (50.0%), fever (25.0%), neutropenia (25.0%), nausea and vomiting (25.0%), fatigue (25.0%), peripheral neuropathy (20.0%), anemia (15.0%), thrombopenia (15.0%), diarrhea (15.0%), anorexia (15.0%), and rash (15.0%). Neoadjuvant TACE plus PD-1 inhibitor realizes a satisfying downstaging rate, acceptable survival profile, and tolerance in intermediate-stage HCC patients.