Abstract
BackgroundHepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) portends a worse prognosis. The objective of this study was to compare the efficacy of percutaneous radiofrequency ablation (RFA) combined with transarterial chemoembolization (TACE) plus sorafenib to that of the most commonly utilized regimen of TACE plus sorafenib in large HCCs with type I/II PVTT.MethodsAn open-label, single-center, prospective, randomized trial of participants with tumors ≥5 cm and type I/II PVTT was performed. Participants with previously untreated HCCs were divided into two groups: RFA + cTACE + sorafenib (study group, n = 40) and cTACE + sorafenib (control group, n = 40). The primary endpoint was the objective response rate (ORR), the secondary endpoints included the overall survival (OS); time to progression (TTP); and toxicity. Prognostic factors were analyzed using cox-regression analysis.Results80 patients were enrolled into this study with integrated clinical data. Under a median follow-up of 506 days, the median age was 57.5 years (range: 28–80 years). The ORR of study group was higher than control group (70% vs 22.5%, p<0.001). Furthermore, the median OS of study group was superior to that of control group (468 days vs 219 days, HR: 0.44 [95% CI: 0.25–0.78], P = 0.005). Adverse events occurred with 100% probability in both groups (p>0.99), but no treatment-related deaths were recorded. Tumor encapsulation and attaining treatment response predict favorable OS in a multivariate Cox model. The rates of adverse events in both groups were 100% (p>0.99). There were no treatment-related deaths.ConclusionsRFA combined with TACE plus sorafenib is a safe, well-tolerated three-modality treatment for large HCCs with types I/II PVTT, and it demonstrated better efficacy than TACE plus sorafenib alone.
Highlights
Hepatocellular carcinoma (HCC), which is categorized as primary liver cancer, is a hotspot in cancer research worldwide due to its high mortality rate [1]
We hypothesize that radiofrequency ablation (RFA) combined with transarterial chemoembolization (TACE) plus sorafenib will likely result in favorable prognosis in patients with portal vein tumor thrombus (PVTT) compared with the regimen of TACE plus sorafenib alone
RFA was not recommended in the American Association for the Study of Liver Disease [21] and European Society for Medical Oncology clinical practice guidelines [22] for HCC with PVTT, two studies showed that TACE plus sorafenib and RFA plus sorafenib are safe and effective regimens [23, 24]
Summary
Hepatocellular carcinoma (HCC), which is categorized as primary liver cancer, is a hotspot in cancer research worldwide due to its high mortality rate [1]. 44% to 62% of patients with HCC progress to portal vein invasion, namely portal vein tumor thrombus (PVTT), which has a worse prognosis [2]. For Barcelona Clinic Liver Cancer (BCLC)-stage C HCC without PVTT, the median overall survival is approximately 1 year [4,5,6]. Sorafenib or lenvatinib, transarterial chemoembolization (TACE), TACE plus sorafenib, percutaneous radiofrequency ablation (RFA), and radiotherapy, among others, are used in the clinical treatment of PVTT, but these treatment options remain unsatisfactory [8,9,10]. The objective of this study was to compare the efficacy of percutaneous radiofrequency ablation (RFA) combined with transarterial chemoembolization (TACE) plus sorafenib to that of the most commonly utilized regimen of TACE plus sorafenib in large HCCs with type I/II PVTT
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