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Randomized, prospective, comparative study on the effects and safety of sorafenib vs. hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma with portal vein tumor thrombosis

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Abstract

Background/aims

Treatment responses of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) remain unacceptably low and treatment modalities are limited. We compared the efficacy and safety of sorafenib and hepatic arterial infusion chemotherapy (HAIC).

Methods

In this randomized, prospective, comparative study, data on 58 patients with advanced HCC with PVTT, with Child–Turcotte–Pugh (CTP) scores of 5–7, were collected from six university hospitals between January 2013 and October 2015. Twenty-nine patients were treated with sorafenib and twenty-nine with HAIC.

Results

The median overall survival (OS) and time to progression (TTP) were significantly longer in the HAIC group than in the sorafenib group (14.9 vs.7.2 months, p = 0.012 and 4.4 vs. 2.7 months, p = 0.010). The objective response (OR) rates were 27.6 and 3.4% in the HAIC and sorafenib groups, respectively (p = 0.001). In univariate analysis, sex, main portal vein invasion and treatment modality were significant prognostic factors of OS (p = 0.044, 0.040, 0.015), whereas cause of HCC, tumor number, tumor location and treatment modality were significant prognostic factors of TTP (p = 0.040, 0.002, 0.034, 0.014). In multivariate analysis, sex and treatment modality were significant prognostic factors of OS (p = 0.008, 0.005), whereas cause of HCC, tumor number, tumor location and treatment modality were significant prognostic factors of TTP (p = 0.038, 0.038, 0.015, 0.011). Major complications included hyperbilirubinemia (44.8%), AST elevation (34.5%), ascites (13.8%) and catheter-related complications (3.4%) in the HAIC group and hyperbilirubinemia (34.5%), hand-foot syndrome (31.0%) and AST elevation (27.6%) in the sorafenib group.

Conclusions

For managing advanced HCC with PVTT, HAIC may be a valuable treatment modality.

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Abbreviations

HCC:

Hepatocellular carcinoma

PVTT:

Portal vein tumor thrombosis

HAIC:

Hepatic arterial infusion chemotherapy

CTP:

Child–Turcotte–Pugh

HBV:

Hepatitis B virus

HCV:

Hepatitis C virus

mUICC:

Modified Union for International Cancer Control

AFP:

Alphafetoprotein

ECOG:

Eastern Cooperative Oncology Group

ANC:

Absolute neutrophil count

OS:

Overall survival

TTP:

Time to progression

OR:

Objective response

BCLC:

Barcelona Clinic Liver Cancer

EASL:

European Association for the Study of Liver

CT:

Computed tomography

MRI:

Magnetic resonance imaging

mRECIST:

Modified Response Evaluation Criteria in Solid Tumors

AST:

Aspartate transaminase

ALT:

Alanine aminotransferase

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Authors and Affiliations

  1. Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Republic of Korea

    Jong Hwan Choi & Woo Jin Chung

  2. Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Si Hyun Bae, Do Seon Song & Myeong Jun Song

  3. Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea

    Young Seok Kim

  4. Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea

    Hyung Joon Yim, Young Kul Jung & Sang Jun Suh

  5. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

    Jun Yong Park, Do Young Kim & Seung Up Kim

  6. Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Republic of Korea

    Sung Bum Cho

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  1. Jong Hwan Choi
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Correspondence to Woo Jin Chung or Si Hyun Bae.

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The authors have no conflicts of interest to declare.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Choi, J., Chung, W.J., Bae, S.H. et al. Randomized, prospective, comparative study on the effects and safety of sorafenib vs. hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma with portal vein tumor thrombosis. Cancer Chemother Pharmacol 82, 469–478 (2018). https://doi.org/10.1007/s00280-018-3638-0

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