Prospective Randomized Controlled Phase III Trial Comparing the Efficacy of Sorafenib versus Sorafenib in Combination with Low-Dose Cisplatin/Fluorouracil Hepatic Arterial Infusion Chemotherapy in Patients with Advanced Hepatocellular Carcinoma

Kudo, Masatoshi; Ueshima, Kazuomi; Yokosuka, Osamu; S, Obi; Izumi, Namiki; Aikata, Hiroshi; Nagano, Hiroko; Hatano, Etsuro; Sasaki, Yōichi; Hino, Kaori; Kumada, Takashi; Yamamoto, Katsuhiko; Imai, Yohji; Iwadou, Shouta; Ogawa, Chikara; Okusaka, Takuji; Arai, Yasuhiko; Kanai, Fumihiko; Akazawa, Kohei

doi:10.1016/s0168-8278(16)00173-2

Cited by 18 publications

(16 citation statements)

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“…Although sorafenib has been approved for the treatment of similar subjects with advanced HCC in Japan, HAIC is nonetheless still often adopted for patients with highly advanced HCC. To elucidate the usefulness of HAIC, several studies of sorafenib vs. HAIC, including randomized controlled trials of sorafenib plus HAIC using CDDP (HAIC[CDDP]) vs. sorafenib alone (65) and of sorafenib plus HAIC using 5-FU+cisplatin (HAIC[CDDP + 5-FU]) vs. sorafenib alone (66) in Japanese patients with advanced HCC have been reported recently.…”

Section: Haicmentioning

confidence: 99%

Chemotherapy for hepatocellular carcinoma: current status and future perspectives

Ikeda

Morizane

Ueno

et al. 2017

Japanese Journal of Clinical Oncology

222

154

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Chemotherapy is one of the most important treatment modalities for advanced hepatocellular carcinoma (HCC). On the basis of the results of two pivotal Phase III placebo-controlled studies, sorafenib is currently acknowledged worldwide as the standard therapeutic agent for advanced HCC. Following the introduction of sorafenib for the treatment of HCC, Phase III trials of numerous other agents as first-line or second-line chemotherapy have been conducted to determine if any of these agents might offer superior survival benefit to sorafenib. In 2016, a clear survival benefit of regorafenib over placebo was demonstrated in HCC patients showing disease progression after sorafenib treatment. A year later, in 2017, lenvatinib has been shown to be non-inferior to sorafenib, in terms of the overall survival, in chemo-naïve patients with advanced HCC. More recently, promising outcomes have also been reported with new agents, such as nivolumab and cabozantinib. At present, various novel combination regimens including these agents are currently under development. Hepatic arterial infusion chemotherapy (HAIC) is frequently adopted for the treatment of locally advanced HCC in Japan, based on reports of high response rates and favorable long-term outcomes. Although some randomized controlled trials of HAIC plus sorafenib vs. sorafenib alone as first-line therapy have been conducted in patients with advanced HCC, no firm evidence of the superiority of one over the other has been established yet. In the future, demonstration of the survival advantage of HAIC and the recognition of HAIC as one of the standard treatments for patients with advanced HCC are expected.

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Section: Haicmentioning

confidence: 99%

Chemotherapy for hepatocellular carcinoma: current status and future perspectives

Ikeda

Morizane

Ueno

et al. 2017

Japanese Journal of Clinical Oncology

222

154

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“…Following these results, a phase III randomized trial comparing sorafenib alone with sorafenib plus HAIC using low-dose cisplatin and 5-fluorouracil has been conducted. Although not yet published, preliminary results were recently released [44]. The combination strategy did not significantly improve overall survival in the whole study population compared with sorafenib.…”

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

150

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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Prospective Randomized Controlled Phase III Trial Comparing the Efficacy of Sorafenib versus Sorafenib in Combination with Low-Dose Cisplatin/Fluorouracil Hepatic Arterial Infusion Chemotherapy in Patients with Advanced Hepatocellular Carcinoma

Cited by 18 publications

References 0 publications

Chemotherapy for hepatocellular carcinoma: current status and future perspectives

Chemotherapy for hepatocellular carcinoma: current status and future perspectives

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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