Efficacy and safety assessment of drug-eluting bead transarterial chemoembolization combined with molecular targeted agents or immunotherapy in unresectable hepatocellullar carcinoma: Real-world evaluation.
Authors: Liu Baojiang , Gao Song , Guo Jianhai , Kou Fuxin , Liu Shaoxing , Zhang Xin , Feng Aiwei , Wang Xiaodong , Cao Guang , Chen Hui , Liu Peng , Xu Haifeng , Gao Qinzong , Yang Renjie , Zhu Xu 
Published: July 2024

e16164

Background: Drug-eluting bead transarterial chemoembolization (DEB-TACE) is established as a safe and effective treatment for advanced hepatocellular carcinoma (HCC). Recent advancements in molecular targeted agents and immunotherapy have led to exploration of combining DEB-TACE with tyrosine kinase inhibitors (TKIs) or immunotherapy. However, real-world evaluations of DEB-TACE in combination with TKIs or immunotherapy are limited. This study aimed to assess the efficacy and safety of DEB-TACE alone, DEB-TACE with TKIs, and DEB-TACE with TKIs and immunotherapy. Methods: This study retrospectively enrolled 124 patients with unresectable HCC treated at Peking University Cancer Hospital from April 2018 to April 2023. Patients were divided into three groups: DEB-TACE alone (DTACE, 45 patients), DEB-TACE plus TKI (DTACE+TKI, 51 patients), and DEB-TACE plus TKI and immunotherapy (DTACE+TKI+IM, 28 patients). Propensity score matching (PSM) was used to compare efficacy and safety between DTACE and DTACE+TKI. Primary endpoints were progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), disease control rate (DCR), assessed by RECIST Version 1.1. Adverse events were graded according to CTCAE version 5.0. Results: Among the patients, 99 were male and 25 were female, with 88.7% in BCLC-B or C stage. Before enrollment, 50.8% had received other treatments. In the DTACE+TKI+IM group, mPFS and mOS were higher compared to DTACE or DTACE+TKI alone (mPFS: 15.2 vs 9.2 for DTACE, 8.7 for DTACE+TKI; mOS: 32.3 vs 25.0 for DTACE, 20.9 for DTACE+TKI), though not statistically significant. ORR and DCR were 31.3% and 86.7% in DTACE, 35.3% and 84.3% in DTACE+TKI, and 39.3% and 96.4% in DTACE+TKI+IM, respectively. PSM analysis for DTACE and DTACE+TKI showed slightly better mPFS and mOS in DTACE+TKI (mPFS: 9.5 vs 9.2 months; mOS: 26.2 vs 19.4 months). No treatment-related deaths occurred, and serious adverse events (AEs) were comparable among the groups, with pain being the most common. AE. Notably, the frequency and severity of pain were closely related to the type of drug-eluting beads used, with the incidence of severe pain significantly lower in the HepaSphere DEB-TACE group compared to the CalliSphere or DCB group (0% versus 12.4% versus 19.7%, respectively; p < 0.001). Conclusions: DEB-TACE has been demonstrated as a safe, feasible, and efficacious treatment option for patients with unresectable HCC. There is a notable trend towards prolonged progression-free survival (PFS) and overall survival (OS) when DEB-TACE is combined with TKIs and immunotherapy. Moreover, HepaSphere DEB-TACE shows a lower incidence of severe pain compared to other types of drug-eluting beads, further highlighting its potential advantages in managing HCC.