Retrospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 21, 2025; 31(7): 101672
Published online Feb 21, 2025. doi: 10.3748/wjg.v31.i7.101672
CRAFITY score and nomogram predict the clinical efficacy of lenvatinib combined with immune checkpoint inhibitors in hepatocellular carcinoma
Xue Yin, Na Deng, Xiao-Yan Ding, Jing-Long Chen, Wei Sun
Xue Yin, Na Deng, Xiao-Yan Ding, Jing-Long Chen, Wei Sun, Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
Co-corresponding authors: Jing-Long Chen and Wei Sun.
Author contributions: Sun W and Chen JL designed the research study and acquired the funding, they contributed equally as co-corresponding authors; Yin X, Deng N, and Ding XY performed the research and contributed to data collection; Yin X contributed to data analysis, visualization, and manuscript preparation; and all authors have reviewed and agreed to the published version of the manuscript.
Supported by the Capital’s Funds for Health Improvement and Research, No. SF202222175.
Institutional review board statement: The study was reviewed and approved by the Institutional Ethics Committee of Beijing Ditan Hospital, Capital Medical University (approval No. KY2022014).
Informed consent statement: The requirement to obtain informed written consent was waived due to the retrospective nature of the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The source data for this study are available from the corresponding author upon reasonable request.
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 Sun, MD, Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, No. 8 Jingshun East Street, Chaoyang District, Beijing 100015, China. sunwei2134@163.com
Received: September 23, 2024
Revised: December 3, 2024
Accepted: December 30, 2024
Published online: February 21, 2025
Processing time: 118 Days and 23.4 Hours
Abstract
BACKGROUND

The CRAFITY score is mainly utilized for hepatocellular carcinoma (HCC) patients receiving atezolizumab and bevacizumab, with little investigation in its predictive capacity for alternative regimens, such as lenvatinib and programmed cell death protein 1 (PD-1) inhibitors, which are widely utilized in Chinese clinical practice.

AIM

To look at the predictive significance of the CRAFITY score in HCC patients taking lenvatinib and PD-1 inhibitors.

METHODS

The retrospective investigation consisted of 192 patients with incurable HCC who received lenvatinib and PD-1 inhibitors between January 2018 and January 2022. Patients were stratified according to CRAFITY score (based on baseline alpha-fetoprotein and C-reactive protein levels) into CRAFITY-low, CRAFITY-intermediate, and CRAFITY-high groups. Overall survival (OS) and progression-free survival (PFS) were assessed using Kaplan-Meier analysis, and independent prognostic factors were identified through Cox regression analysis. Nomograms were created to forecast survival for a year.

RESULTS

The median PFS and OS were the longest for patients in the CRAFITY-low group, followed by those in the CRAFITY-intermediate and CRAFITY-high groups (median PFS: 8.4 months, 6.0 months, and 3.1 months, P < 0.0001; median OS: 33.4 months, 19.2 months, and 6.6 months, P < 0.0001). Both the objective response rate (5%, 19.6%, and 22%, P = 0.0669) and the disease control rate (50%, 76.5%, and 80%, P = 0.0023) were considerably lower in the CRAFITY-high group. The findings from the multivariate analysis showed that a nomogram which included the tumor number, prior transarterial chemoembolization history, and CRAFITY score predicted 12-month survival with an area under the curve of 0.788 (95% confidence interval: 0.718-0.859), which was in good agreement with actual data.

CONCLUSION

The CRAFITY score is a valuable predictor of survival and treatment outcomes in patients receiving lenvatinib and PD-1 inhibitors.

Keywords: Hepatocellular carcinoma; Lenvatinib; Immune checkpoint inhibitors; C-reactive protein; Alpha-fetoprotein

Core Tip: The CRAFITY score, integrating baseline alpha-fetoprotein and C-reactive protein levels, has been limitedly investigated in patients receiving lenvatinib and programmed cell death protein 1 (PD-1) inhibitors. This study found significant differences in progression-free survival and overall survival across CRAFITY score strata in patients treated with lenvatinib and PD-1 inhibitors. Lower CRAFITY scores were associated with better objective response rates and disease control rates. These findings suggest that the CRAFITY score is a promising predictive tool for treatment response and survival in patients with unresectable hepatocellular carcinoma receiving lenvatinib and PD-1 inhibitors.