Efficacy and safety of transarterial chemoembolization combined with donafenib for hepatocellular carcinoma with rupture and bleeding: A retrospective, cohort study.

Abstract

4107 Background: The incidence of hepatocellular carcinoma (HCC) ranks 6th in the world, and rupture and bleeding of HCC is its fatal complication. Transarterial chemoembolization (TACE) is an effective measure for acute hemostasis, but the prognosis of TACE alone is limited. The ZGDH3 study showed that donafenib was the only targeted agent with better overall survival (OS) than sorafenib in monotherapy for HCC. This study aims to investigate the efficacy and safety of TACE combined with donafenib compared with TACE monotherapy in the treatment of HCC with rupture and bleeding. Methods: This study retrospectively analyzed patients with rupture and bleeding of HCC who received TACE combined with donafenib or TACE monotherapy in Qinghai University Affiliated Hospital from January 2022 to August 2024. Patient criteria for inclusion: (1) Definitive diagnosis of HCC with rupture and bleeding by imaging and laboratory examination; (2) Child-Pugh class A and B; (3) No previous systemic therapy. The efficacy and safety were evaluated by mRECIST and CTCAE 5.0. Results: A total of 62 patients were included in the study, of whom 35 in the TACE monotherapy group and 27 in the TACE plus donafinib group, and there was no significant difference in baseline characteristics between the two groups. Patients in TACE plus donafenib group demonstrated a significantly higher objective response rate (ORR) compared with TACE monotherapy group (55.6%vs 25.7%, P=0.008). The median progression-free survival (PFS) significantly better than TACE monotherapy group (13.6 months [95%CI: 4.354 - 22.846] vs 4.6 months [95% CI: 1.637 - 7.563]; HR=0.404, P=0.003). The median OS was longer in the TACE plus donafenib group compared to TACE monotherapy group (17.4 months [95%CI: 8.478 - 26.322] vs 7.6 months [95%CI: 1.301 - 13.899]; HR=0.479, P=0.012). Additionally, multivariate COX regression analysis showed that PVTT, Child-Pugh grade, tumor diameter and total bilirubin were independent prognostic factors for OS. The incidence of treatment-related adverse events (TRAEs) significantly higher in TACE plus donafenib group, the most common were skin-related adverse events (37% vs 0%), diarrhea (29.6% vs 0%) and alopecia (18.5% vs 0%), which can be controlled by symptomatic treatment. There were no grade ≥3 TRAEs. But there was no significant difference in the incidence of rebleeding, stomachache and fever. Conclusions: TACE combined with donafenib showed significant efficacy and controllable safety in HCC with rupture and bleeding.