Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Jun 15, 2024; 16(6): 2504-2519
Published online Jun 15, 2024. doi: 10.4251/wjgo.v16.i6.2504
Impact of baseline hepatitis B virus viral load on the long-term prognosis of advanced hepatocellular carcinoma treated with immunotherapy
Di Pan, Hao-Nan Liu, Zhi-Yuan Yao, Xiao-Xiao Chen, Yu-Qi Li, Jing-Jing Zhu, Zheng-Xiang Han, Xiao-Bing Qin
Di Pan, Hao-Nan Liu, Zhi-Yuan Yao, Xiao-Xiao Chen, Yu-Qi Li, Jing-Jing Zhu, Zheng-Xiang Han, Xiao-Bing Qin, Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221000, Jiangsu Province, China
Co-first authors: Di Pan and Hao-Nan Liu.
Co-corresponding authors: Zheng-Xiang Han and Xiao-Bing Qin.
Author contributions: Qin XB and Han ZX designed the study; Pan D, Liu HN and Yao ZY collected the clinical data; Chen XX, Li YQ and Zhu JJ analyzed the data; Pan D, Liu HN and Yao ZY wrote the paper; Qin XB and Han ZX revised the paper; all authors contributed to the article and approved the submitted version. There are several reasons for designating Pan D and Liu HN as co-first authors, Qin XB and Han ZX as co-corresponding authors. Firstly, this study is a collaborative study, the setting of co-first authors and co-corresponding authors accurately reflects the distribution of responsibilities and burdens related to the time, effort required to complete the study and the final paper. This also ensures effective communication and management of post submission matters, ultimately improving the quality and reliability of the paper. Secondly, the completion of this study requires research design, conceptualization, and implementation (including data collection, data processing, and chart making), which require authors with different professional knowledge and skills. The designation of co-first authors and co-corresponding authors best reflects this diversity. Most importantly, Pan D and Liu HN made equally substantial efforts throughout the entire research process. Choose these researchers as co-first authors, acknowledge and respect this equal contribution, while recognizing the team spirit and collaborative spirit of this study. Qin XB and Han ZX developed detailed ideas for this study, reviewed the specific implementation process, supervised the overall quality and reliability of the paper. In summary, we believe that designating Pan D and Liu HN as co- first authors, Qin XB and Han ZX as co-corresponding authors, is suitable for our manuscript as it accurately reflects the collaborative spirit, equal contribution, and diversity of our team.
Institutional review board statement: The studies involving human participants were reviewed and approved by the Ethics Committee of Clinical Trials (Approval No. XYFY2022-KL207-01).
Informed consent statement: Due to the retrospective nature of this study, we waived the requirement for written informed consent.
Conflict-of-interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at qin_xiaobing@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: Xiao-Bing Qin, MD, Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, No. 99 West Huaihai Road, Quanshan District, Xuzhou 221000, Jiangsu Province, China. qin_xiaobing@163.com
Received: February 18, 2024
Revised: April 21, 2024
Accepted: April 26, 2024
Published online: June 15, 2024
Processing time: 117 Days and 11.9 Hours
Abstract
BACKGROUND

Although the combination of lenvatinib and PD-1 inhibitors has become the standard regimen for the treatment of advanced hepatocellular carcinoma (HCC), real data on the impact of baseline hepatitis B virus (HBV)-DNA levels on the clinical efficacy of this regimen is still limited.

AIM

To evaluate the effectiveness of camrelizumab combined with lenvatinib in patients with HCC at varying levels of HBV-DNA.

METHODS

One hundred and twenty patients with HCC who received camrelizumab and lenvatinib treatment were categorized into two cohorts: HBV-DNA ≤ 2000 (n = 66) and HBV-DNA > 2000 (n = 54). The main outcomes measured were overall survival (OS) and progression-free survival (PFS), while additional outcomes included the rate of objective response rate (ORR), disease control rate (DCR), and any negative events. Cox proportional hazards regression analysis revealed independent predictors of OS, leading to the creation of a nomogram incorporating these variables.

RESULTS

The median PFS was 8.32 months for the HBV-DNA ≤ 2000 group, which was similar to the 7.80 months observed for the HBV DNA > 2000 group (P = 0.88). Likewise, there was no notable variation in the median OS between the two groups, with durations of 13.30 and 14.20 months respectively (P = 0.14). The ORR and DCR were compared between the two groups, showing ORR of 19.70% vs 33.33% (P = 0.09) and DCR of 72.73% vs 74.07% (P = 0.87). The nomogram emphasized the importance of antiviral treatment as the main predictor of patient results, with portal vein tumor thrombus and Barcelona Clinic Liver Cancer staging following closely behind.

CONCLUSION

The clinical outcomes of patients with HBV-associated HCC treated with camrelizumab in combination with lenvatinib are not significantly affected by HBV viral load.

Keywords: Hepatitis B virus, Hepatocellular carcinoma, Camrelizumab, Lenvatinib, Efficacy

Core Tip: In this manuscript, we revisited the different clinical outcomes of hepatocellular carcinoma (HCC) patients treated with camrelizumab in combination with lenvatinib, explored the different clinical outcomes of HCC patients with different baseline hepatitis B virus viral load, and developed a predictive model with nomograms based on the results of COX regression.