Sorafenib Combined with Radio-frequency Ablation Compared with Sorafenib Alone in Treatment of Hepatocellular Carcinoma Invading Portal Vein: A Western Randomized Controlled Trial

Giorgio, Antonio; Merola, Maria Gabriella; Montesarchio, Luca; Merola, Francesca Reduzzi; Santoro, B.; Coppola, Carmine; Gatti, Pietro; Amendola, F.; Sarno, Antonella Di; Calvanese, Andrea; Matteucci, Paolo; Giorgio, Valentina

doi:10.21873/anticanres.11211

Cited by 37 publications

(42 citation statements)

References 11 publications

(19 reference statements)

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“…While responsive patients had a significantly prolonged OS, the general benefits of sorafenib in HCC patients with PVTT are only modest. 17,[91][92][93] Beyond sorafenib, development of new targeted drugs has been surprisingly slow. Many promising phase II agents subsequently failed phase III trials.…”

Section: Cytotoxic Chemotherapy and Hormone Therapymentioning

confidence: 99%

Hepatocellular Carcinoma with Portal Vein Tumor Involvement: Best Management Strategies

2018

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Portal vein tumor thrombosis (PVTT) commonly occurs in patients with hepatocellular carcinoma (HCC). Patients with PVTT usually have an aggressive disease course, decreased liver function reserve, limited treatment options, higher recurrence rates after treatment, and, therefore, worse overall survival. Among untreated HCC patients with PVTT, the median overall survival has been reported as low as 2 to 4 months. Historically, many aspects of PVTT have impacted the theoretical and practical safety and efficacy of treatment, for example, disordered blood flow and associated impairment of liver function, heat-sink effects of blood flow in the area of the PVTT, and risk of recurrence due to tumor location in the blood vessel. The current Barcelona Clinic Liver Cancer staging system categorizes HCC patients with PVTT as advanced stage, for which the standard of care is targeted therapy with sorafenib. However, sorafenib is associated with only marginal benefits among patients with PVTT. First-line lenvatinib, which was shown to be noninferior to sorafenib, excluded patients with main portal trunk invasion. Regorafenib and nivolumab, an immune-based therapy, were recently approved in the United States for second-line therapy after sorafenib. Preliminary results for cabozantinib suggest a benefit in the second-/third-line after sorafenib failure. In addition, rapid advances in many fields (surgery, interventional radiology, nuclear medicine, and immunotherapy) have increased the potential treatment options for the management of this complex disease entity. A large portion of the emerging evidence focuses on the broader category of advanced HCC of which PVTT is a subgroup. While many of these studies show promising results, the efficacy among PVTT patients requires validation in prospective studies. Real-world data may help fill the evidence gap for patients not eligible for clinical trials due to common hepatic function requirements. The variety of new treatment advances for the heterogeneous and complex disease entity of HCC with PVTT means that personalized, multidisciplinary management may be necessary to achieve optimal outcomes. In this narrative review, we summarize the evolving management strategies for patients with HCC and PVTT.

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Section: Cytotoxic Chemotherapy and Hormone Therapymentioning

confidence: 99%

Hepatocellular Carcinoma with Portal Vein Tumor Involvement: Best Management Strategies

2018

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“…In a randomized controlled trial, Giorgio et al [46] compared patients with HCC and PVTT treated with sorafenib plus percutaneous radiofrequency ablation of both intraparenchymal HCC and PVTT versus sorafenib alone. Ninety-nine patients with Child A cirrhosis were included (49 in the combination group and 50 in the sorafenib-alone group).…”

Section: Alternative Treatment Strategiesmentioning

confidence: 99%

Hepatocellular Carcinoma with Macrovascular Invasion: Defining the Optimal Treatment Strategy

Costentin

Ferrone²,

Arellano

et al. 2017

Liver Cancer

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Background: Tumoral macrovascular invasion (MVI) of hepatic and/or portal vein branches is a common phenomenon in hepatocellular carcinoma (HCC) and is associated with poorer prognosis when compared to HCC without MVI. Summary: Current international guidelines for the management of HCC recommend sorafenib as the only treatment option in case of MVI. Despite guideline recommendations, several alternative options have been tested to manage HCC with MVI: surgery, transarterial chemoembolization, external or internal radiation, hepatic arterial infusion chemotherapy, percutaneous treatment, cryotherapy, or the combination of two or more of these strategies, with or without sorafenib. Here we will provide a comprehensive state-of-the-art review for the management of this challenging clinical entity based on the most recent available data. Key Messages: There is a growing body of evidence suggesting that alternative strategies to standard-of-care sorafenib might improve survival in patients with advanced HCC with MVI but the level of evidence remains weak. Randomized phase III trials are ongoing and will hopefully provide information leading towards a more personalized treatment algorithm.

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“…In patients with advanced HCC, sorafenib, the first approved oral multityrosine kinase inhibitor, is the standard first-line therapy; [4][5][6][7][8][9] however, outcomes of most patients remain unsatisfactory. To augment or improve the modest effects of sorafenib, several trials have studied the effects of combining it with other systemic therapies [10][11][12] or locoregional treatments, including radiofrequency ablation, 13 transarterial chemoembolization (TACE), 14,15 and radiotherapy. 16 Conventional TACE (cTACE) is an effective treatment for unresectable HCC, and most guidelines for HCC management recommend cTACE for intermediate stage or multifocal HCC.…”

mentioning

confidence: 99%

Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial

Park

Kim

et al. 2019

Journal of Hepatology

153

159

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Graphical abstract AuthorsSorafenib vs. sorafenib + cTACE in patients with advanced HCC vs. HighlightsSorafenib combined with concurrent chemoembolization did not improve overall survival.Combination therapy significantly improved tumor response and secondary outcomes.Sorafenib alone remains first-line standard of care for advanced hepatocellular carcinoma. Lay summaryFor patients with advanced hepatocellular carcinoma requiring sorafenib therapy, co-administration with conventional transarterial chemoembolization did not improve overall survival compared to sorafenib alone. Therefore, sorafenib alone remains the first-line standard of care for patients with advanced hepatocellular carcinoma.http://dx.improved time to progression, progression-free survival, and tumor response rate. Sorafenib alone remains the first-line standard of care for patients with advanced HCC.Lay summary: For patients with advanced hepatocellular carcinoma requiring sorafenib therapy, co-administration with conventional transarterial chemoembolization did not improve overall survival compared to sorafenib alone. Therefore, sorafenib alone remains the first-line standard of care for patients with advanced hepatocellular carcinoma. Clinical Trial Number: NCT01829035. Ó 2018 European Association for the Study of the Liver. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Sorafenib Combined with Radio-frequency Ablation Compared with Sorafenib Alone in Treatment of Hepatocellular Carcinoma Invading Portal Vein: A Western Randomized Controlled Trial

Abstract: Use of RFA of both HCC and MPVTT plus sorafenib significantly increases 3-year survival compared to sorafenib alone.

Cited by 37 publications

References 11 publications

Hepatocellular Carcinoma with Portal Vein Tumor Involvement: Best Management Strategies

Hepatocellular Carcinoma with Portal Vein Tumor Involvement: Best Management Strategies

Hepatocellular Carcinoma with Macrovascular Invasion: Defining the Optimal Treatment Strategy

Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial

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