A retrospective study of the efficacy and safety of donafenib combined with TACE as adjuvant therapy in patients with high-risk recurrence factors after hepatocellular carcinoma surgery.

e16300 Background: Adjuvant therapy may have an important role in decreasing recurrence rates and improve survival in selected patients with HCC following surgical resection. However, there is no standard treatment options or strategies. 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 Eastern Hepatobiliary Hospital Affiliated to Naval Medical University from February 2021 to December 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, microvascular invasion (MVI) , satellite lesions and surgical margin≤1cm. Patients received adjuvant therapy of donafenib combined with TACE after surgery. The primary endpoint was 1-year recurrence-free survival rate (RFSR). Secondary endpoints included overall survival rate (OSR) and safety. Results: A total of 40 patients were enrolled with a median age of 56.0 (range 21-71). 26 patients (65.0%) in BCLC stage A, 6 patients (15.0%) in BCLC stage B and 8 patients (20.0%) in BCLC stage C. 35 patients (87.5%) were co-infected with HBV. All 40 patients had ECOG PS scores of 0 and Child-Pugh scores of A. All patients exhibited a high risk factor of recurrence at least (preoperative AFP level within 400/above 400 ng/mL, 26/14; number of tumors single/multiple, 30/10; the maximum diameter of tumors within 5.0/above 5.0 cm, 17/23; MVI yes/no, 8/32; satellite nodules yes/no, 25/15; surgical margin within1.0/above 1.0 cm, 20/20). All patients received at least one TACE treatment after surgery. The initial dose of donafenib was 200mg qd. The median follow-up time was 36 months (95%CI: 34-39), 14 patients relapsed and 6 patients died. The median RFS was not reached, the 1-year RFSR was 78.8%, and the 1-year OSR was 90.0%. 24 (72.7%) patients had at least one treatment-related AE (TRAE). Grade 3 TRAEs occurred in 3 (9.1%) patients, no grades 4 or 5 were reported. The most Common TRAEs included hand-foot syndrome (42.4%), diarrhea (30.3%), and rash (12.1%). Conclusions: The combination of donafinib and TACE as adjuvant therapy was well tolerated and demonstrated promising efficacy in HCC patients with high risks of recurrence. This finding deserves further exploration.