Survival in Patients With Recurrent Intermediate-Stage Hepatocellular Carcinoma,JAMA Oncology

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Survival in Patients With Recurrent Intermediate-Stage Hepatocellular Carcinoma
JAMA Oncology ( IF 22.5 ) Pub Date : 2024-06-20 , DOI: 10.1001/jamaoncol.2024.1831
Wenzhe Fan ₁ , Bowen Zhu ₁ , Shuling Chen ₂ , Yanqin Wu ₁ , Xiao Zhao ₃ , Liangliang Qiao ₄ , Zhen Huang ₅ , Rong Tang ₆ , Jinghua Chen ₇ , Wan Yee Lau ₈ , Minshan Chen ₉ , Jiaping Li ₁ , Ming Kuang ₁₀ , Zhenwei Peng ₃

Affiliation

Department of Interventional Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
Cancer Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
Department of Interventional Oncology, Jinshazhou Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China
Department of Interventional Angiology, Huizhou First People’s Hospital, Huizhou, China
Department of Hepatopancreatobiliary Surgery, Hainan General Hospital, Haikou, China
Cancer Center, Guangzhou Twelfth People’s Hospital, Guangzhou, China
Faculty of Medicine, the Chinese University of Hong Kong, Prince of Wale Hospital, Shatin, New Territories, Hongkong, SAR, China
Department of Liver Surgery, Cancer Center of Sun Yat-sen University, Guangzhou, China
Center of Hepato-PancreatoBiliary Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China

ImportanceTransarterial chemoembolization (TACE) is commonly used to treat patients with recurrent intermediate-stage hepatocellular carcinoma (HCC) and positive microvascular invasion (MVI); however, TACE alone has demonstrated unsatisfactory survival benefits. A previous retrospective study suggested that TACE plus sorafenib (SOR-TACE) may be a better therapeutic option compared with TACE alone.ObjectiveTo investigate the clinical outcomes of SOR-TACE vs TACE alone for patients with recurrent intermediate-stage HCC after R0 hepatectomy with positive MVI.Design, Setting, and ParticipantsIn this phase 3, open-label, multicenter randomized clinical trial, patients with recurrent intermediate-stage HCC and positive MVI were randomly assigned in a 1:1 ratio via a computerized minimization technique to either SOR-TACE treatment or TACE alone. This trial was conducted at 5 hospitals in China, and enrolled patients from October 2019 to December 2021, with a follow-up period of 24 months. Data were analyzed from June 2023 to September 2023.InterventionsRandomization to on-demand TACE (conventional TACE: doxorubicin, 50 mg, mixed with lipiodol and gelatin sponge particles [diameter: 150-350 μm]; drug-eluting bead TACE: doxorubicin, 75 mg, mixed with drug-eluting particles [diameter: 100-300 μm or 300-500 μm]) (TACE group) or sorafenib, 400 mg, twice daily plus on-demand TACE (SOR-TACE group) (conventional TACE: doxorubicin, 50 mg, mixed with lipiodol and gelatin sponge particles [diameter, 150-350 μm]; drug-eluting bead TACE: doxorubicin, 75 mg, mixed with drug-eluting particles [diameter: 100-300 μm or 300-500 μm]).Main Outcomes and MeasuresThe primary end point was overall survival by intention-to-treat analysis. Safety was assessed in patients who received at least 1 dose of study treatment.ResultsA total of 162 patients (median [range] age, 55 [28-75] years; 151 males [93.2%]), were randomly assigned to be treated with either SOR-TACE (n = 81) or TACE alone (n = 81). The median overall survival was significantly longer in the SOR-TACE group than in the TACE group (22.2 months vs 15.1 months; hazard ratio [HR], 0.55; P &lt; .001). SOR-TACE also prolonged progression-free survival (16.2 months vs 11.8 months; HR, 0.54; P &lt; .001), and improved the objective response rate when compared with TACE alone based on the modified Response Evaluation Criteria in Solid Tumors criteria (80.2% vs 58.0%; P = .002). Any grade adverse events were more common in the SOR-TACE group, but all adverse events responded well to treatment. No unexpected adverse events or treatment-related deaths occurred in this study.Conclusions and RelevanceThe results of this randomized clinical trial demonstrated that SOR-TACE achieved better clinical outcomes than TACE alone. These findings suggest that combined treatment should be used for patients with recurrent intermediate-stage HCC after R0 hepatectomy with positive MVI.Trial RegistrationClinicalTrials.gov Identifier: NCT04103398

更新日期：2024-06-20

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