Irradiation stent with 125I plus TACE versus sorafenib plus TACE for hepatocellular carcinoma with major portal vein tumor thrombosis: a multicenter randomized trial

Abstract

Background and Aim: Treatment strategy for hepatocellular carcinoma (HCC) and Vp4 [main trunk] portal vein tumor thrombosis (PVTT) remains limited due to posttreatment liver failure. We aimed to assess the efficacy of irradiation stent placement with 125I plus transcatheter arterial chemoembolization (TACE) (ISP-TACE) compared to sorafenib plus TACE (Sora-TACE) in these patients. Methods: In this multicenter randomized controlled trial, participants with HCC and Vp4 PVTT without extrahepatic metastases were enrolled from November 2018 to July 2021 at 16 medical centers. The primary endpoint was overall survival (OS). The secondary endpoints were hepatic function, time to symptomatic progression, patency of portal vein, disease control rate, and treatment safety. Results: Of 105 randomized participants, 51 were assigned to the ISP-TACE group, and 54 were assigned to the Sora-TACE group. The median OS was 9.9 months versus 6.3 months (95% CI: 0.27–0.82; P=0.01). Incidence of acute hepatic decompensation was 16% (8 of 51) versus 33% (18 of 54) (P=0.036). The time to symptomatic progression was 6.6 months versus 4.2 months (95% CI: 0.38–0.93; P=0.037). The median stent patency was 7.2 months (interquartile range, 4.7–9.3) in the ISP-TACE group. The disease control rate was 86% (44 of 51) versus 67% (36 of 54) (P=0.018). Incidences of adverse events at least grade 3 were comparable between the safety populations of the two groups: 16 of 49 (33%) versus 18 of 50 (36%) (P=0.73). Conclusion: Irradiation stent placement plus TACE showed superior results compared with sorafenib plus TACE in prolonging OS in patients with HCC and Vp4 PVTT.

Endovascular brachytherapy with iodine-125 seed strand for extensive portal vein tumor thrombus in patients with hepatocellular carcinoma

“…Moreover, compared to the patients in those studies, the majority of the patients included in our study were relatively more late-staged with tumor burden exceeding 50% of the liver volume (52.5%). Moreover, we included patients who were not eligible for irradiation stent placement ( 25 ), and all included patients in this study with bilateral first portal branches had complete occlusion and major portal vein invasion. The more tumor thrombus burden and worse insufficient portal vein blood flow perfusion may lead to a bad prognosis ( 2 ).…”

“…Compared with TACE monotherapy, the combined therapy can significantly improve the median survival (9.8 vs. 5.2 months, p = 0.024). Our center has reported that portal vein irradiation stent was a safe and effective method for the treatment of HCC with major portal vein tumor thrombus ( 8 , 9 , 25 ). However, stents cannot be implanted effectively into the portal vein for HCC patients with extensive PVTT in this study.…”

Locoregional therapies for hepatocellular carcinoma: The current status and future perspectives

“… 4 , 68 Portal irradiation stent loaded with iodine 125 seeds placement plus TACE resulted in better OS than sorafenib plus TACE in patients with advanced HCC and portal vein tumour thrombosis. 69 …”

Transarterial Chemoembolization Plus Sorafenib versus Transarterial Chemoembolization Alone for Advanced Hepatocellular Carcinoma: An Umbrella Review of Meta-Analyses and Systematic Reviews

“… 9–12 In addition to systemic therapy, transarterial chemoembolization (TACE), an approach that can embolize the hepatic artery and reduce the blood supply to HCC tissues, is a standard therapy recommended for some BCLC intermediate-stage HCC subgroups with normal liver function. 13–15 In contrast, various anticancer drugs, such as 5-fluorouracil and cisplatin, can be used in TACE, which provides opportunities to control intermediate/advanced-stage HCC. 16 , 17 Sorafenib, an oral polykinase inhibitor that can inhibit tumor angiogenesis and tumor cell proliferation, has been widely used over past years as the first-line treatment for unresectable advanced HCC.…”