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
Abstract
BACKGROUND

Gastric cancer (GC) is the fifth most common and the fourth most lethal malignant tumour in the world. Most patients are already in the advanced stage when they are diagnosed, which also leads to poor overall survival. The effect of postoperative adjuvant chemotherapy for advanced GC is unsatisfactory with a high rate of distant metastasis and local recurrence.

AIM

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

METHODS

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

RESULTS

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

CONCLUSION

A PD-1 inhibitor combined with SOX could significantly improve the rate of tumour regression during NAT for patients with Borrmann large type III and IV GCs.

Keywords: Neoadjuvant therapy; Immunotherapy; Gastric cancer; Borrmann type; Tumor regression grade

Core Tip: Borrmann type III and IV gastric cancers (GCs) generally have a poor prognosis. JCOG0501 failed to demonstrate the efficacy of a preoperative neoadjuvant chemotherapy regimen (S-1 plus cisplatin) in patients with type IV or large type III GC. For these patients, we explored the possibility of chemotherapy combined with immunotherapy. The results showed that programmed cell death 1 inhibitors combined with oxaliplatin and S-1 significantly increased Tumor regression rate during neoadjuvant therapy in patients with type III and type IV GC. At the same time, chemotherapy side effects and surgical complications did not increase.