Tyrosine-kinase inhibitor combined with iodine-125 seed brachytherapy for hepatocellular carcinoma refractory to transarterial chemoembolization: a propensity-matched study.

PURPOSE: To investigate the efficacy and safety of tyrosine-kinase inhibitor (TKI) combined with iodine-125 seed brachytherapy (TKI-I) versus TKI alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE). METHODS: Data of patients with TACE-refractory HCC who received TKI (sorafenib or lenvatinib) or TKI-I from September 2018 to December 2020 were retrospectively analyzed. A propensity score matching (PSM) was performed to diminish potential bias. The primary endpoints were overall survival (OS) and time to progression (TTP). Tumor responses and treatment-related adverse events (TRAEs) were also compared between the two groups. RESULTS: A total of 132 patients were included in this study. Under PSM, 48 paired patients were selected for comparison. The median OS was 23.2 (95% CI 20.9-25.1) months in the TKI-I group versus 13.9 (95% CI 11.1-16.7) months in the TKI group (P < 0.001). The median TTP was 12.8 (95% CI 10.1-15.5) months in the TKI-I group versus 5.8 (95% CI 5.0-6.6) months in the TKI group (P < 0.001). Patients in the TKI-I group had higher objective response rate (68.8% vs. 33.3%, P = 0.001) and disease control rate (89.6% vs. 66.7%, P = 0.007) than those in the TKI group. The incidence and severity of TRAEs in the TKI-I group were comparable to those in the TKI group (any grade, 89.7% vs. 92.2%, P = 0.620; ≥grade 3, 33.8% vs. 32.8%, P = 0.902). CONCLUSIONS: TKI-I was safe and significantly improved survival over TKI alone in HCC patients with TACE refractoriness.

Drug-Eluting Bead Transarterial Chemoembolization Combined with FOLFOX-Based Hepatic Arterial Infusion Chemotherapy for Large or Huge Hepatocellular Carcinoma.

PURPOSE: To evaluate the safety and efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with oxaliplatin plus fluorouracil and leucovorin (FOLFOX)-based hepatic arterial infusion chemotherapy (D-TACE-HAIC) for unresectable large (5.1-10 cm) or huge (>10 cm) hepatocellular carcinoma (HCC). METHODS: This retrospective study evaluated consecutive patients with unresectable large or huge HCC who underwent D-TACE-HAIC (D-TACE-HAIC group) or DEB-TACE (DEB-TACE group) from January 2017 to December 2020. At imaging, tumor infiltrating appearance was classified into smooth tumor margin, non-smooth tumor margin, and macrovascular invasion. Adverse events, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were compared between the two groups. RESULTS: A total of 133 patients (mean age, 53 years ± 12; 117 men) were included: 69 underwent D-TACE-HAIC and 64 underwent DEB-TACE. The patients who underwent D-TACE-HAIC had higher ORR (71.0% vs 53.1%; P = 0.033), longer PFS (median, 9.3 vs 6.3 months; P = 0.005), and better OS (median, 19.0 vs 14.0 months; P = 0.008) than those who underwent DEB-TACE. In subgroup analysis, patients with non-smooth tumor margin (median, 20.8 vs 13.0 months; P = 0.031) or macrovascular invasion (median, 15.0 vs 11.0 months; P = 0.015) had significantly longer OS in D-TACE-HAIC group than in DEB-TACE group; but in patients with smooth tumor margin, OS between the two groups was similar (median, 37.0 vs 35.0 months; P = 0.458). DEB-TACE, non-smooth tumor margin, and macrovascular invasion were independent prognostic factors for poor OS in uni- and multivariable analyses. The incidence of grade 3/4 adverse events was not statistically different between the two groups (37.7% vs 28.1%; P = 0.242). CONCLUSION: D-TACE-HAIC was tolerable and led to better OS than DEB-TACE in patients with large or huge HCC, especially in those with non-smooth tumor margin or macrovascular invasion.

Efficacy and Safety of CalliSpheres® Drug-Eluting Beads Transarterial Chemoembolization in Barcelona Clinic Liver Cancer Stage C Patients.

This study aimed to investigate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) treatment in Barcelona Clinic Liver Cancer (BCLC) stage C liver cancer patients. In 39 patients with BCLC stage C liver cancer, after the first cycle of DEB-TACE, 2 (5.1%) and 24 (61.5%) patients achieved complete response (CR) and partial response (PR) to give an overall objective response rate (ORR) of 66.7%. With respect to the second cycle of therapy, the ORR was higher in patients receiving DEB-TACE compared with those receiving cTACE (57.1% vs. 11.1%). After the first cycle of DEB-TACE treatment, the percentages of abnormal albumin (ALB), total protein (TP), total bilirubin (TBIL), and alanine aminotransferase (ALT) worsened at 1 week and recovered at 1 month. The number of patients with abnormal aspartate aminotransferase (AST) did not increase at 1 week but elevated at 1 month. After the second cycle of DEB-TACE or cTACE treatment, no difference was observed between cTACE and DEB-TACE in terms of all adverse events (AEs) at all visits, and most of the AEs did not change after the second cycle in both groups. The most common AEs after the first and second treatment cycles were pain, fever, and nausea/vomiting. These results demonstrate that DEB-TACE offers patients with BCLC stage C liver cancer a clinically active short-term treatment that is safe and relatively well tolerated.