Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Apr 15, 2024; 16(4): 1268-1280
Published online Apr 15, 2024. doi: 10.4251/wjgo.v16.i4.1268
Prognostic analysis of related factors of adverse reactions to immunotherapy in advanced gastric cancer and establishment of a nomogram model
Xu-Xu He, Bang Du, Tao Wu, Hao Shen
Xu-Xu He, Department of Surgery, Fudan University Affiliated Zhongshan Hospital (Qingpu Branch), Shanghai 201700, China
Bang Du, Hao Shen, Department of Surgery, Anhui Provincial Red Cross Society Hospital, Hefei 230031, Anhui Province, China
Tao Wu, Department of General Surgery, West China Hospital of Sichuan University, Chengdu 610044, Sichuan Province, China
Co-first authors: Xu-Xu He and Bang Du.
Author contributions: He XX and Du B wrote the manuscript, and are the co-first authors of this manuscript; Wu T and Shen H collected the data and guided the study; and all authors reviewed, edited, and approved the final manuscript and revised it critically for important intellectual content, gave final approval of the version to be published, and agreed to be accountable for all aspects of the work.
Institutional review board statement: Our study has been approved by Medical Research Ethics Approval Committee (2023010122HN11C).
Informed consent statement: Informed written consent was obtained from the patients for publication of this report and any accompanying images.
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 email address: xuxu19930318@126.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: Xu-Xu He, MD, Doctor, Department of Surgery, Fudan University Affiliated Zhongshan Hospital (Qingpu Branch), No. 1158 Xiayang Street Park East Road, Qingpu District, Shanghai 201700, China. xuxu19930318@126.com
Received: December 14, 2023
Peer-review started: December 14, 2023
First decision: January 6, 2024
Revised: January 10, 2024
Accepted: March 4, 2024
Article in press: March 4, 2024
Published online: April 15, 2024
Processing time: 118 Days and 17 Hours
Abstract
BACKGROUND

Immunotherapy for advanced gastric cancer has attracted widespread attention in recent years. However, the adverse reactions of immunotherapy and its relationship with patient prognosis still need further study. In order to determine the association between adverse reaction factors and prognosis, the aim of this study was to conduct a systematic prognostic analysis. By comprehensively evaluating the clinical data of patients with advanced gastric cancer treated by immunotherapy, a nomogram model will be established to predict the survival status of patients more accurately.

AIM

To explore the characteristics and predictors of immune-related adverse reactions (irAEs) in advanced gastric cancer patients receiving immunotherapy with programmed death protein-1 (PD-1) inhibitors and to analyze the correlation between irAEs and patient prognosis.

METHODS

A total of 140 patients with advanced gastric cancer who were treated with PD-1 inhibitors in our hospital from June 2021 to October 2023 were selected. Patients were divided into the irAEs group and the non-irAEs group according to whether or not irAEs occurred. Clinical features, manifestations, and prognosis of irAEs in the two groups were collected and analyzed. A multivariate logistic regression model was used to analyze the related factors affecting the occurrence of irAEs, and the prediction model of irAEs was established. The receiver operating characteristic (ROC) curve was used to evaluate the ability of different indicators to predict irAEs. A Kaplan-Meier survival curve was used to analyze the correlation between irAEs and prognosis. The Cox proportional risk model was used to analyze the related factors affecting the prognosis of patients.

RESULTS

A total of 132 patients were followed up, of whom 63 (47.7%) developed irAEs. We looked at the two groups’ clinical features and found that the two groups were statistically different in age ≥ 65 years, Ki-67 index, white blood cell count, neutrophil count, and regulatory T cell (Treg) count (all P < 0.05). Multivariate logistic regression analysis showed that Treg count was a protective factor affecting irAEs occurrence (P = 0.030). The ROC curve indicated that Treg + Ki-67 + age (≥ 65 years) combined could predict irAEs well (area under the curve = 0.753, 95% confidence interval: 0.623-0.848, P = 0.001). Results of the Kaplan-Meier survival curve showed that progression-free survival (PFS) was longer in the irAEs group than in the non-irAEs group (P = 0.001). Cox proportional hazard regression analysis suggested that the occurrence of irAEs was an independent factor for PFS (P = 0.006).

CONCLUSION

The number of Treg cells is a separate factor that affects irAEs in advanced gastric cancer patients receiving PD-1 inhibitor immunotherapy. irAEs can affect the patients’ PFS and result in longer PFS. Treg + Ki-67 + age (≥ 65 years old) combined can better predict the occurrence of adverse reactions.

Keywords: Advanced gastric cancer; Prognostic analysis; Immunotherapy; Nomogram model

Core Tip: To explore the characteristics and predictors of immune-related adverse reactions (irAEs) in advanced gastric cancer patients receiving immunotherapy with programmed death protein-1 (PD-1) inhibitors, and to analyze the correlation between irAEs and patient prognosis. A total of 132 patients were followed up, of whom 63 (47.7%) developed irAEs. The clinical characteristics of the two groups were compared, and there were statistically significant differences in age ≥ 65 years, Ki-67 index, white blood cell count, neutrophil count, and regulatory T cell (Treg) count between the two groups (all P < 0.05). Multivariate logistic regression analysis showed that Treg count was a protective factor affecting irAEs occurrence (P = 0.030).