CIO 2021-23 Propensity–Score-Matched Evaluation of Efficacy and Safety of TACE With Nivolumab Vs Nivolumab Monotherapy

Purpose: To assess the efficacy and safety of immune checkpoint inhibition (ICI) combined with transarterial chemoembolization (TACE) versus ICI alone for hepatocellular carcinoma (HCC).

Material and Methods: In a retrospective chart review, thirty-one patients underwent sixty-six TACE treatments sixty days before, or concurrently, while receiving nivolumab at a single tertiary care hospital. Propensity score matching (PSM) with 106 patients receiving nivolumab alone from a multinational, multi-institutional registry for Child-Pugh Score (CPS), portal vein thrombosis (PVT), extrahepatic metastases (EHM) and alpha-fetoprotein (AFP) at ICI initiation were used as controls to assess a primary end-point of overall survival (OS). Secondary end-points were safety and progression-free survival (PFS), as well as local objective response after each TACE according to modified RECIST (mRECIST) in the multimodal arm.

Results: Over a median (interquartile range) follow-up of 9.1 (4.0-16.4) months multimodal immunotherapy with TACE did not demonstrate significantly longer OS compared to ICI monotherapy with a median 24.6 (16.4-47.8) vs 35.1 (16.1-NE) months (Log-rank 0.57; p=0.18). However, there was a significantly longer median PFS of 8.8 (6.2-23.2) versus 4.0 (2.7-5.4) months (Log-rank 0.20; p=0.03). In the multimodal treatment group there were 4 (13%) grade 3 or higher adverse events (AEs) attributed to immunotherapy compared to six (5.7%) in the ICI monotherapy arm. There were no AEs grade 3 or higher attributed to TACE in the multimodal treatment arm. At three months following each TACE in the multimodal arm there was an overall objective response rate of 84%. There were no significant changes in liver function labs one-month following each TACE. Four patients receiving multimodal treatment were successfully bridged to transplant.

Conclusions: Multimodal immunotherapy combined with TACE may enhance PFS in patients with HCC.