Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 21, 2024; 30(43): 4620-4635
Published online Nov 21, 2024. doi: 10.3748/wjg.v30.i43.4620
Lenvatinib, sintilimab combined interventional treatment vs bevacizumab, sintilimab combined interventional treatment for intermediate-advanced unresectable hepatocellular carcinoma
Ru-Yu Han, Lei-Juan Gan, Meng-Ran Lang, Shao-Hua Ren, Dong-Ming Liu, Guang-Tao Li, Ya-Yue Liu, Xin-Di Tian, Kang-Wei Zhu, Li-Yu Sun, Lu Chen, Tian-Qiang Song
Ru-Yu Han, Lei-Juan Gan, Shao-Hua Ren, Dong-Ming Liu, Guang-Tao Li, Ya-Yue Liu, Xin-Di Tian, Kang-Wei Zhu, Li-Yu Sun, Lu Chen, Tian-Qiang Song, Department of Hepatobiliary Cancer, Liver Cancer Center, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin Key Laboratory of Digestive Cancer, Tianjin 300060, China
Meng-Ran Lang, Department of Hepatobiliary Surgery, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Co-first authors: Ru-Yu Han and Lei-Juan Gan.
Co-corresponding authors: Tian-Qiang Song and Lu Chen.
Author contributions: Song TQ, Chen L, Han RY, Gan LJ and Lang MR conceptualized and designed the research; Gan LJ, Han RY and Lang MR screened patients and acquired clinical data; Gan LJ, Chen L, Han RY, Lang MR, Ren SH, Li GT, Liu YY, Tian XD, Zhu KW, Sun LY, and Liu DM performed Data analysis; Song TQ, Chen L and Han RY wrote the paper. All the authors have read and approved the final manuscript. Han RY designed, acquired clinical data, performed data analysis and prepared the first draft of the manuscript. Gan LJ was responsible for patient screening, enrollment, collection and analysis of clinical data. Both authors have made crucial and indispensable contributions towards the completion of the project and thus qualified as the co-first authors of the paper. Both Song TQ and Chen L have played important and indispensable roles in the experimental design and manuscript preparation as the co-corresponding authors. Song TQ applied for and obtained the funds for this research project. Song TQ conceptualized, designed, and supervised the whole process of the project. Chen L was instrumental and responsible for data re-analysis and re-interpretation and figure plotting. This collaboration between Song TQ and Chen L is crucial for the publication of this manuscript and other manuscripts still in preparation.
Supported by The National Natural Science Foundation of China, No. 82173317; The Scientific Research Projects of Tianjin Education Commission, No. 2022KJ227; and The Doctoral Start-up Fund of Tianjin Medical University Cancer Institute & Hospital, No. B2208.
Institutional review board statement: The ethical clearance of the study was obtained from the Institutional Review Board of Tianjin Medical University Cancer Institute & Hospital, No. EK20240802.
Informed consent statement: The retrospective study was ethically reviewed and waived the need for informed consent.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The dataset is available from the corresponding author upon request at songtianqiangtj@163.com.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Tian-Qiang Song, MD, PhD, Chief Doctor, Professor, Department of Hepatobiliary Cancer, Liver Cancer Center, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin Key Laboratory of Digestive Cancer, West Huanhu Road, Tiyuanbei, Hexi District, Tianjin 300060, China. songtianqiangtj@163.com
Received: July 12, 2024
Revised: September 21, 2024
Accepted: October 21, 2024
Published online: November 21, 2024
Processing time: 111 Days and 9.4 Hours
Abstract
BACKGROUND

Bevacizumab and sintilimab combined interventional treatment (BeSiIT) and L envatinib and sintilimab combined interventional treatment (LeSiIT) are two commonly used therapeutic regimens for intermediate-advanced hepatocellular carcinoma (HCC) in clinical practice.

AIM

To compare the clinical efficacy and safety of BeSiIT and LeSiIT for the treatment of intermediate and advanced HCC.

METHODS

Patients diagnosed with intermediate-advanced HCC and initially treated with BeSiIT or LeSiIT in the Tianjin Medical University Cancer Institute and Hospital between February 2020 and July 2021 were included. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), conversion rate, and treatment-related adverse events.

RESULTS

Total 127 patients met the inclusion criteria and were divided into BeSiIT and LeSiIT groups. Twenty-eight and fifty patients in the BeSiIT and LeSiIT groups, respectively, were assessed after 1:2 propensity score matching. PFS and OS rates were not significantly different between the two groups. No significant variations were noted in ORRs or DCRs according to the Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST. BeSiIT group showed a better conversion rate than the LeSiIT group (P = 0.043). Both groups showed manageable toxicity profiles. Multivariate analysis showed that the independent factors associated with PFS were alpha-fetoprotein levels and carcinoembryonic antigen score.

CONCLUSION

In intermediate-to-advanced HCC, the BeSiIT and LeSiIT groups exhibited acceptable toxicities and comparable PFS, OS, and ORR.

Keywords: Hepatocellular carcinoma; Molecular targeted therapy; Immunotherapy; Interventional treatment; Propensity score matching

Core Tip: In this study, we compared the efficacy and safety of two treatments [bevacizumab plus sintilimab plus interventional treatment (BeSiIT) and lenvatinib plus sintilimab plus interventional treatment (LeSiIT)] in intermediate to advanced hepatocellular carcinoma (HCC). In this study, we found that the triple combination of BeSiIT and LeSiIT improved the prognosis of intermediate- and advanced-stage HCC, with comparable efficacy and acceptable toxicity for both treatments. And a novel marker was identified: Alpha-fetoprotein and carcinoembryonic antigen score. It was shown to be an independent prognostic factor associated with progression-free survival in multivariate analysis.