The efficacy and safety of donafenib-containing regimens as first-line therapy for hepatocellular carcinoma (HCC): A multicenter retrospective study.

e16243 Background: HCC is a common malignant tumor worldwide, safer and more potent treatments are desperately needed to increase the survival rates of HCC patients. Some studies have shown that transcatheter arterial chemoembolization/hepatic arterial infusion chemotherapy (TACE/HAIC) combined with systemic therapies shows potential synergistic effects in patients with HCC, the ZGDH3-III RCT's findings showed that donafenib(D) is highly safe and effective as first-line treatment for uHCC. This study aimed to evaluate the efficacy and safety of donafenib-containing regimens (D+TACE/HAIC, D+TACE/HAIC+ICI, D+ICI, D) as first-line systemic treatments for HCC patients in the real world. Methods: We retrospectively analyzed patient data from January 2022 to December 2023 in seven Chinese institutions with first-line therapeutic regimens based on donafenib. Donafenib-based treatments were administered to eligible patients until the point of disease progression, death, or intolerable toxicity. We examined the progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) per the modified Response Evaluation Criteria in Solid Tumors, and safety (CTCAE5.0). Results: There were 102 patients in this study (Table). The median age was 60 years (IQR: 52, 68) at the data cut-off in January 2024, with 87.3% of the population being male and 78.4% having HBV infection. Most patients received D+TACE/HAIC therapy (59.8%), D+TACE/HAIC+ICI therapy (35.3%), or other treatments. Median PFS and OS not yet been achieved, respectively, the 12-month PFS and OS rates were 87.0% (95%CI: 79.7%-95.0%) and 91.4% (95%CI: 84.9%-98.4%). The ORR was 68.6% and DCR was 88.2%, with complete response in 14 patients, partial response in 56 patients, stable disease in 20 patients, and progressive disease in 12 patients. Among the population, 51 patients (50.0%) had treatment-related adverse events (TRAE) of any grade, and the incidence of grade 3 TRAE was 13.7% (14/102), none of the patients experienced grade 4 or 5 TRAE. Conclusions: These results preliminarily showed that donafenib-containing treatment regimens exhibited encouraging efficacy and favorable safety profile in patients with HCC. [Table: see text]