Wu FD, Zhou HF, Yang W, Zhu D, Wu BF, Shi HB, Liu S, Zhou WZ. Transarterial chemoembolization combined with lenvatinib and sintilimab vs lenvatinib alone in intermediate-advanced hepatocellular carcinoma. World J Gastrointest Oncol 2025; 17(1): 96267 [DOI: 10.4251/wjgo.v17.i1.96267]
Corresponding Author of This Article
Wei-Zhong Zhou, MD, PhD, Department of Interventional Radiology, The First Affiliated Hospital of Nanjing Medical University, No. 300 Guangzhou Road, Gulou District, Nanjing 210029, Jiangsu Province, China. xmjbq007@163.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Cohort Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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/
Fei-Da Wu, Hai-Feng Zhou, Wei Yang, Di Zhu, Bi-Fei Wu, Hai-Bin Shi, Sheng Liu, Wei-Zhong Zhou, Department of Interventional Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu Province, China
Co-first authors: Fei-Da Wu and Hai-Feng Zhou.
Co-corresponding authors: Sheng Liu and Wei-Zhong Zhou.
Author contributions: Wu FD and Zhou HF contributed equally to this article, they are the co-first authors of this manuscript. Wu FD analyzed the data and wrote the manuscript; Wu FD, Zhou HF, and Zhou WZ designed the research study; Wu FD, Zhu D, Yang W, and Wu BF performed the research; Shi HB, Liu S, and Zhou WZ provided financial support; Liu S and Zhou WZ made equally important contributions to the design, implementation and writing of this study, they are the co-corresponding authors of this manuscript; and all authors have read and approve the final manuscript.
Institutional review board statement: The study was reviewed and approved by the First Affiliated Hospital of Nanjing Medical University Institutional Review Board, approval No. 2023-SR-902.
Informed consent statement: The study was a retrospective study and therefore no informed consent was obtained from the participants.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at xmjbq007@163.com.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Wei-Zhong Zhou, MD, PhD, Department of Interventional Radiology, The First Affiliated Hospital of Nanjing Medical University, No. 300 Guangzhou Road, Gulou District, Nanjing 210029, Jiangsu Province, China. xmjbq007@163.com
Received: May 1, 2024 Revised: October 16, 2024 Accepted: November 5, 2024 Published online: January 15, 2025 Processing time: 225 Days and 5.2 Hours
Abstract
BACKGROUND
Hepatocellular carcinoma (HCC) is the most common form of liver cancer that has limited treatment options and a poor prognosis. Transarterial chemoembolization (TACE) is the first-line treatment for intermediate-stage HCC but can induce tumour hypoxia, thereby promoting angiogenesis. Recent studies suggested that combining TACE with anti-angiogenic therapies and immunotherapy might improve efficacy. Lenvatinib, a tyrosine kinase inhibitor, has demonstrated superior outcomes compared to sorafenib, while immune checkpoint inhibitors such as sintilimab show potential when combined with TACE. However, the efficacy and safety of TACE combined with lenvatinib and sintilimab (TACE + SL) compared to TACE with lenvatinib alone (TACE + L) in patients with intermediate-advanced HCC has not yet been investigated.
AIM
To evaluate the efficacy and safety of TACE + SL therapy in comparison to TACE + L therapy in patients with intermediate-advanced HCC.
METHODS
A retrospective analysis was performed on patients with intermediate-advanced HCC who received TACE plus lenvatinib with or without sintilimab between September 2019 and September 2022. Baseline characteristics were compared, and propensity score matching was applied. Overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) were evaluated between the two groups, and adverse events were analyzed.
RESULTS
The study included 57 patients, with 30 in the TACE + SL group and 27 in the TACE + L group. The TACE + SL group demonstrated significantly improved median PFS and OS compared to the TACE + L group (PFS: 14.1 months vs 9.6 months, P = 0.016; OS: 22.4 months vs 14.1 months, P = 0.039), along with a higher ORR (70.0% vs 55.6%). After propensity score matching, 30 patients were included, with the TACE + SL group again showing longer median PFS and a trend toward improved OS (PFS: 14.6 months vs 9.2 months, P = 0.012; OS: 23.9 months vs 16.3 months, P = 0.063), and a higher ORR (73.3% vs 53.3%). No severe adverse events were reported.
CONCLUSION
TACE + SL demonstrated superior outcomes in terms of OS and PFS, compared to TACE + L. These findings suggest that the addition of sintilimab might enhance the therapeutic response in patients with intermediate-advanced HCC.
Core Tip: This study evaluates the efficacy and safety of combining transarterial chemoembolization (TACE) with lenvatinib and sintilimab compared to TACE with lenvatinib alone in patients with intermediate-advanced hepatocellular carcinoma. The results indicate that TACE with lenvatinib and sintilimab significantly improves overall survival (22.4 months vs 14.1 months) and progression-free survival (14.1 months vs 9.6 months), with a higher objective response rate (70% vs 55.6%). Notably, no severe adverse events were reported, suggesting that the combination therapy is effective and safe. These findings support the inclusion of sintilimab in hepatocellular carcinoma treatment regimens.
