The efficacy and safety of donafenib combined with TACE as adjuvant therapy in patients with hepatocellular carcinoma at high risk of recurrence after radical resection: A retrospective study.

Abstract

e16272 Background: The recurrence rate of hepatocellular carcinoma (HCC) after hepatectomy is still high. Despite the advance in treatment , there is no globally recognized standard adjuvant therapy for HCC after radical resection.Exploration of treatment strategies that are both efficacious and safe has been extensively performed in the recent years. This study aimed to evaluate the efficacy and safety of donafenib combined with TACE as adjuvant therapy in HCC patients with high-risk recurrence factors after radical resection. Methods: This single-center retrospective study enrolled primary HCC patients with high-risk recurrence factors who underwent surgical resection at Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from August 2020 to October 2024, All patients exhibited at least one of the following high-risk recurrence factors：preoperative AFP level＞400ng/mL, the number of tumors≥2, the maximum diameter of tumors＞5cm, Edmondson stage III~IV, microvascular invasion (MVI) and satellite lesions. Patients received adjuvant therapy of donafenib combined with TACE after surgery. Patients’ demographic characteristics, etiological characteristics, 1-year recurrence-free survival rate (RFSR), overall survival rate (OSR), and treatment-related safety were analyzed. The primary endpoint was 1-year RFSR. Secondary endpoints included OSR and safety. Results: A total of 44 patients were enrolled with a median age of 61.5 (range 26-85). 26 patients (59.1%) in BCLC stage A and 18 patient (40.9%) in BCLC stage B. 35 patients (70.5%) were co-infected with HBV. 36 patients (81.8%) had Child-Pugh scores of A, 8 patients (18.2%) had Child-Pugh scores of B. All 44 patients had ECOG PS scores of 0. All patients exhibited a high risk factor of recurrence at least (preoperative AFP level within 400/above 400 ng/mL, 38/6; number of tumors single/multiple, 20/24; the maximum diameter of tumors within 5.0/above 5.0 cm, 25/19; Edmondson stage Ⅰ~Ⅱ/III~IV, 12/32; MVI yes/no, 25/19; satellite nodules yes/no, 3/41). All patients received at least one TACE treatment after surgery. The initial dose of donafenib was 100mg bid. The median follow-up time was 23 months (95%CI: 21.91-27.46), 26 patients relapsed and 5 patients died. The median RFS was 16 months (95% CI: 14.33-18.67), the 1-year RFSR was 81.8%, and the 1-year OSR was 97.7%. 36 (81.8%) patients had at least one treatment-related AE (TRAE). Grade 3 and 4 TRAEs all occurred in 4 (9.1%) patients, no grades 5 were reported. The most Common TRAEs included hand-foot syndrome (47.7%), hypertension (36.4%), and rash (29.5%). Conclusions: Donafenib combined with TACE was used for adjuvant therapy in patients with high-risk recurrence of HCC, which has a high 1-year RSFR and exhibited favorable safety. This finding deserves further exploration.