Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Apr 15, 2024; 16(4): 1281-1295
Published online Apr 15, 2024. doi: 10.4251/wjgo.v16.i4.1281
Safety and efficacy of a programmed cell death 1 inhibitor combined with oxaliplatin plus S-1 in patients with Borrmann large type III and IV gastric cancers
Zhe-Han Bao, Can Hu, Yan-Qiang Zhang, Peng-Cheng Yu, Yi Wang, Zhi-Yuan Xu, Huan-Ying Fu, Xiang-Dong Cheng
Zhe-Han Bao, Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou 310004, Zhejiang Province, China
Can Hu, Yan-Qiang Zhang, Zhi-Yuan Xu, Huan-Ying Fu, Xiang-Dong Cheng, Department of Gastric Surgery, Zhejiang Cancer Hospital, Hangzhou 310022, Zhejiang Province, China
Peng-Cheng Yu, Department of Colonic Surgery, Jinhua Central Hospital, Jinhua 321000, Zhejiang Province, China
Yi Wang, Department of Breast Surgery, Lin’an People’s Hospital, Hangzhou 311300, Zhejiang Province, China
Co-first authors: Zhe-Han Bao and Can Hu.
Co-corresponding authors: Xiang-Dong Cheng and Huan-Ying Fu.
Author contributions: Cheng XD, Fu HY, and Xu ZY conceived the study and acquired the funding; Bao ZH and Hu C carried out clinical research, collected clinical samples and analyzed clinical data, and wrote articles; Zhang YQ, Yu PC, and Wang Y participated in clinical samples collection; and all authors have read and approved the final manuscript.
Supported by Medical Science and Technology Project of Zhejiang Province (2022KY085).
Institutional review board statement: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Clinical trial registration statement: Our study was a retrospective study, not a clinical trial registry study. Therefore, the clinical registration statement does not apply to our study.
Informed consent statement: All patients provided written informed consent to participate.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: All the data are available without resection. Researchers can obtain data by contacting the corresponding.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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: Xiang-Dong Cheng, MD, Dean, Full Professor, Surgeon, Department of Gastric Surgery, Zhejiang Cancer Hospital, No. 1 Mid-level East Road, Hangzhou 310004, Zhejiang Province, China. chengxd@zjcc.org.cn
Received: October 31, 2023
Peer-review started: October 31, 2023
First decision: November 24, 2023
Revised: December 26, 2023
Accepted: February 7, 2024
Article in press: February 7, 2024
Published online: April 15, 2024
Processing time: 162 Days and 16.2 Hours
ARTICLE HIGHLIGHTS
Research background

Gastric cancer (GC) is the fifth most common and fourth deadliest malignancy in the world. Due to the lack of typical symptoms and an effective screening program, most patients are already at an advanced stage when diagnosed, which also leads to poor overall survival. Surgery has always been the core treatment of the gastrointestinal tract. Radical gastrectomy is suitable for patients with early GC. Postoperative adjuvant chemotherapy for advanced GC is not satisfactory, with high rate of distant metastasis and local recurrence.

Research motivation

Borrmann major type III and IV GCs are generally characterized by low early diagnosis rate, easy metastasis, poor prognosis, and high mortality. The objective of this study was to investigate the efficacy and safety of programmed cell death 1 (PD-1) inhibitors combined with platinum + S-1 in the treatment of Borrmann type IV and large type III GC.

Research objectives

To investigate the safety and efficacy of PD-1 inhibitor combined with oxaliplatin and S-1 (SOX) in the treatment of Borrmann large type III and IV GC.

Research methods

A retrospective analysis (IRB-2022-371) was performed on 89 patients with Borrmann III who received neoadjuvant therapy (NAT) between January 2020 and December 2021. Patients with type I and type IV GC were retrospectively analyzed. According to different neoadjuvant treatment regimens, patients were divided into SOX group (61 cases) and PD-1 + SOX (P-SOX) group (28 cases).

Research results

The pathological response (tumor regression grade 0/1) in P-SOX group was significantly higher than that in SOX group (42.86% vs 18.03%, P = 0.013). The incidence of ypN0 in P-SOX group was higher than that in SOX group (39.29% vs 19.67%, P = 0.05). The use of PD-1 inhibitors was an independent factor affecting tumor regression grade. At the same time, the use of PD-1 did not increase postoperative complications or adverse effects of NAT.

Research conclusions

PD-1 inhibitors combined with SOX significantly improved the rate of tumor regression during NAT in Borrmann’s large type III and IV GC patients.

Research perspectives

To find new treatment options to improve the prognosis of patients with Borrmann large type III and IV GC.