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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
No long-term survival benefit with sustained-release 5-fluorouracil implants in patients with stages II and III gastric cancer
Yun-Zi Wu, Ming Wu, Xiao-Hao Zheng, Bing-Zhi Wang, Li-Yan Xue, Shi-Kang Ding, Lin Yang, Jian-Song Ren, Yan-Tao Tian, Yi-Bin Xie
Yun-Zi Wu, Xiao-Hao Zheng, Shi-Kang Ding, Yan-Tao Tian, Yi-Bin Xie, Department of Pancreatic and Gastric Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Ming Wu, Department of Gastrointestinal Surgery, Yun Cheng Center Hospital, Yuncheng 044000, Shanxi Province, China
Bing-Zhi Wang, Li-Yan Xue, Department of Pathology, National Cancer Center/National Clinical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Lin Yang, Department of Medical Oncology, National Cancer Center/National Clinical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Jian-Song Ren, Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Yi-Bin Xie, Department of Pancreatic and Gastric Surgery, National Cancer Center/National Clinical Research Center for Cancer/Hebei Cancer Hospital, Chinese Academy of Medical Sciences, Langfang 065001, Hebei Province, China
Author contributions: Wu YZ and Xie YB contributed to the manuscript writing; Wu YZ, Zheng XH, Ming Wu, and Ding SK contributed to the data collection; Wu YZ and Ren JS contributed to the data analysis; Wang BZ and Xue LY contributed to the pathological diagnosis; Xie YB, Tian YT, and Yang L contributed to the clinical treatment and manuscript modification; all the authors contributed to the manuscript and approved the submitted version.
Supported by the CAMS Initiative for Innovative Medicine, No. 2016-I2M-1-007.
Institutional review board statement: This study was approved by the ethics committee of the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College.
Informed consent statement: Informed consent from patients was waived by the ethics committee of the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College.
Conflict-of-interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Data sharing statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
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: Yi-Bin Xie, MD, Doctor, Department of Pancreatic and Gastric Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuan South Lane, Chaoyang District, Beijing 100021, China. yibinxie_2003@163.com
Received: June 8, 2022
Peer-review started: June 8, 2022
First decision: September 2, 2022
Revised: September 10, 2022
Accepted: September 23, 2022
Article in press: September 23, 2022
Published online: October 14, 2022
BACKGROUND
The prognosis of gastric cancer in an advanced stage remains poor. The exact efficacy of the use of intraoperative sustained-release chemotherapy with 5-fluorouracil (5-FU) in advanced-stage gastric cancer is still unelucidated.
AIM
To explore the long-term survival benefit of using sustained-release 5-FU implants in stage II and stage III gastric cancer patients.
METHODS
Patients with gastric cancer in a locally advanced stage and who underwent an R0 radical resection between Jan 2014, to Dec 2016, in this single institution were included. Patients with pathological diagnoses other than adenocarcinoma were excluded. All included patients were grouped according to whether intraoperative sustained-release (SR) chemotherapy with 5-FU was used or not (NSR). The primary end-point was 5-year overall survival. Kaplan–Meier method with log-rank test was used to analyze the overall survival of patients and Cox analysis was used to analyze prognosis factors of these patients.
RESULTS
In total, there were 563 patients with gastric cancer with locally advanced stage, who underwent an R0 radical resection. 309 patients were included in the final analysis. 219 (70.9%) were men, with an average age of 58.25 years. Furthermore, 56 (18.1%) received neoadjuvant chemotherapy, and 191 (61.8%) were in TNM stage III. In addition, 158 patients received intraoperative sustained-release chemotherapy with 5-FU and were included in the SR group, while the other 161 patients were included in the NSR group. The overall complication rate was 12.94% in the whole group and 10.81%, 16.46% in SR and NSR groups, respectively. There were no significant differences between the two groups in overall survival and complication rate (P > 0.05). The multivariate cox analysis indicated that only N Stage and neoadjuvant therapy were independent influencing factors of survival.
CONCLUSION
Intraoperative sustained-release chemotherapy usage with 5-FU, did not improve the survival of patients who underwent an R0 radical resection in locally advanced stage of gastric cancer.
Core Tip: Intraoperative drug administration shows promise in preventing the recurrence of gastric cancer. Sustained-release 5-fluorouracil (5-FU) implant is a new convenient and continuous drug release method that ensures locally high drug concentration for approximately 1 mo. 5-FU implants are widely used to treat various gastric tumors. However, presently, only retrospective research and a small-scale clinical study conducted in China have reported on its use in patients with gastric cancer. In our real-world study, we collected complete datasets, making this the largest study in China. Unfortunately, 5-FU implants did not improve the long-term survival of gastric cancer patients.
