Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 28, 2024; 30(40): 4367-4375
Published online Oct 28, 2024. doi: 10.3748/wjg.v30.i40.4367
Inetetamab combined with S-1 and oxaliplatin as first-line treatment for human epidermal growth factor receptor 2-positive gastric cancer
Ying Kong, Qi Dong, Peng Jin, Ming-Yan Li, Li Ma, Qi-Jun Yi, Yu-E Miao, Hai-Yan Liu, Jian-Gang Liu
Ying Kong, Qi Dong, Peng Jin, Ming-Yan Li, Li Ma, Qi-Jun Yi, Yu-E Miao, Hai-Yan Liu, Department of Oncology, The Second Affiliated Hospital of Shandong First Medical University, Tai’an 271000, Shandong Province, China
Jian-Gang Liu, Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Shandong First Medical University, Tai’an 271000, Shandong Province, China
Co-first authors: Ying Kong and Qi Dong.
Co-corresponding authors: Hai-Yan Liu and Jian-Gang Liu.
Author contributions: Kong Y and Dong Q designed the study and wrote the manuscript, they are co-first authors of this manuscript; Jin P, Li MY, and Ma L performed the experiments and acquired the data; Yi QJ and Miao YE analyzed the data and interpreted the data; Liu HY and Liu JG contributed to the drafting of the article and critical revision of the manuscript, they are co-corresponding authors of this manuscript; and all the authors read and approved the final manuscript.
Supported by China Scientific Research Fund for HER2 Target from China Anti-Cancer Association, No. CORP-239-M9.
Institutional review board statement: The study was approved by the Ethics Committee of the Second Affiliated Hospital of Shandong First Medical University (Ethics Approval Number: 2021-001).
Clinical trial registration statement: This study is registered at the China Clinical Trials Center website (http://www.chictr.org.cn). The registration identification number is ChiCTR2100051574.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The data used in the current study are available from the corresponding author upon reasonable request.
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: Hai-Yan Liu, MD, Chief Physician, Professor, Department of Oncology, The Second Affiliated Hospital of Shandong First Medical University, No. 366 Taishan Street, Tai’an 271000, Shandong Province, China. liuhaiyan@sdfmu.edu.cn
Received: August 8, 2024
Revised: September 7, 2024
Accepted: September 23, 2024
Published online: October 28, 2024
Processing time: 68 Days and 21.9 Hours
Abstract
BACKGROUND

Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer have poor outcomes. Trastuzumab combined with chemotherapy is the first-line standard treatment for HER2-positive advanced gastric cancer. Inetetamab is a novel anti-HER2 drug, and its efficacy and safety in gastric cancer have not yet been reported.

AIM

To evaluate the efficacy and safety of the S-1 plus oxaliplatin (SOX) regimen combined with inetetamab as a first-line treatment for HER2-positive advanced gastric cancer.

METHODS

Thirty-eight patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma were randomly divided into two groups: One group received inetetamab combined with the SOX regimen, and the other group received trastuzumab combined with the SOX regimen. After 4-6 cycles, patients with stable disease received maintenance therapy. The primary endpoints were progression-free survival (PFS) and overall survival (OS), and the secondary endpoints were the objective response rate, disease control rate, and adverse events (AEs).

RESULTS

Thirty-seven patients completed the trial, with 18 patients in the inetetamab group and 19 patients in the trastuzumab group. In the inetetamab group, the median PFS was 8.5 months, whereas it was 7.3 months in the trastuzumab group (P = 0.046); this difference was significant. The median OS in the inetetamab group vs the trastuzumab group was 15.4 months vs 14.3 months (P = 0. 33), and the objective response rate was 50% vs 42% (P = 0.63), respectively; these differences were not significant. Common AEs included leukopenia, thrombocytopenia, nausea, and vomiting. The incidence rates of grade ≥ 3 AEs were 56% in the inetetamab group and 47% in the trastuzumab group (P = 0.63), with no significant difference.

CONCLUSION

In the first-line treatment of HER2-positive advanced gastric cancer, inetetamab and trastuzumab showed comparable efficacy. The inetetamab group showed superior PFS, and both groups had good safety.

Keywords: Human epidermal growth factor receptor 2-positive; Advanced gastric cancer; Inetetamab; Trastuzumab; Efficacy; Safety

Core Tip: Trastuzumab combined with the S-1 plus oxaliplatin (SOX) regimen is the standard first-line treatment for human epidermal growth factor receptor 2-positive advanced gastric cancer. This study demonstrated that the efficacy of inetetamab combined with the SOX regimen is similar to that of trastuzumab combined with the SOX regimen, and the inetetamab group exhibited superior progression-free survival without any additional adverse events.