Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Jun 15, 2020; 12(6): 663-676
Published online Jun 15, 2020. doi: 10.4251/wjgo.v12.i6.663
Sorafenib combined with embolization plus hepatic arterial infusion chemotherapy for inoperable hepatocellular carcinoma
Bao-Jiang Liu, Song Gao, Xu Zhu, Jian-Hai Guo, Xin Zhang, Hui Chen, Xiao-Dong Wang, Ren-Jie Yang
Bao-Jiang Liu, Song Gao, Xu Zhu, Jian-Hai Guo, Xin Zhang, Hui Chen, Xiao-Dong Wang, Ren-Jie Yang, Department of Interventional Therapy, Peking University Cancer Hospital and Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing 100142, China
Author contributions: Liu BJ, Gao S, and Zhu X are the guarantors of integrity of the entire study, and they contributed to the statistical analysis and manuscript editing; all authors contributed to the study concept/design, data acquisition or analysis/interpretation, manuscript drafting or revision for important intellectual content, and approval of the final version of submitted manuscript; and agreed to ensure that any questions related to the work were appropriately resolved; Liu BJ, Gao S, Zhu X, and Zhang X contributed to the literature research; Liu BJ, Gao S, Zhu X, Zhang X, Chen H, Wang XD, and Yang RJ contributed to the clinical studies; Zhu X contributed to the experimental study. Liu BJ and Gao S contributed equally to this work.
Supported by Beijing Municipal Science and Technology Commission (Z181100010118001), Foundation of Chinese Geriatric Oncology Society (CGOS-01-2012-1-00800), National Key R and D Program of China (2017YFC0114004) and National Natural Science Foundation of China (81971717).
Institutional review board statement: This was a single-arm, single-institution, open-label phase II trial that was approved by the Research Ethics Committee of Peking University Cancer Hospital (2011110803).
Informed consent statement: All participants provided written informed consent for treatment according to the standard practices at our institution.
Conflict-of-interest statement: The authors have no conflicts of interest to disclose.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Xu Zhu, MD, PhD, Chief Doctor, Full Professor, Department of Interventional Therapy, Peking University Cancer Hospital and Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), No. 52, Fucheng Road, Haidian District, Beijing 100142, China. drzhuxu@163.com
Received: February 20, 2020
Peer-review started: February 20, 2020
First decision: April 18, 2020
Revised: May 8, 2020
Accepted: May 27, 2020
Article in press: May 27, 2020
Published online: June 15, 2020
Processing time: 115 Days and 23.3 Hours
ARTICLE HIGHLIGHTS
Research background

Sorafenib has been proven effective for advanced hepatocellular carcinoma (HCC), transarterial chemoembolization (TACE) is the standard therapy for intermediate HCC, and hepatic arterial infusion chemotherapy (HAIC) is a safe and effective treatment for advanced HCC. Herein, we aimed to identify the safety and efficacy of combining sorafenib with HAIC after TACE for intermediate and advanced HCC.

Research motivation

Although there are many treatment methods for HCC, the therapeutic effect is very limited and does not significantly prolong patient survival. Safer and more effective protocols need to be developed to improve therapeutic effects.

Research objectives

To provide an effective combined treatment protocol based on previous studies.

Research methods

All patients initially received the standard 400 mg dose of sorafenib twice daily before TACE-HAIC. Participants at our institute with intermediate and advanced HCC underwent routine TACE. Then, the catheter used for embolization was kept in place in the feeding artery of the tumor, and oxaliplatin was intra-arterially administered for 6 h, followed by 5-fluorouracil (5-FU) for 18 h, and folinic acid was intravenously administered for 2 h.

Research results

The overall response rate was 42.4%. The disease control rate was 87.9%. The grade 3-4 toxicities consisted of thrombocytopenia (4.5%), neutropenia (3.0%), and elevated aspartate aminotransferase (12.2%). Hand-foot skin reaction was also observed (40.9%). The median progression-free survival was 13.1 mo, (13.5 mo in participants with Barcelona Clinic Liver Cancer (BCLC) stage B disease and 9.4 mo in participants with BCLC stage C disease). The 6-mo, 12-mo, and 24-mo PFS rates were 75.0%, 54.7%, and 30.0%, respectively. The median overall survival was 21.8 mo.

Research conclusions

Sorafenib combined with HAIC (folinic acid, 5-FU, and oxaliplatin) after TACE may be a feasible treatment choice for intermediate and advanced HCC based on patient tolerance and survival.

Research perspectives

The combination of sorafenib and TACE-HAIC has been shown to be effective with limited complications. Prospective randomized controlled trials are needed to confirm the effect of this combination therapy.