Copyright
©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
Efficacy and toxicity of capecitabine combined with intensity-modulated radiotherapy after D1/D2 lymph node dissection in patients with gastric cancer
Xin Wang, Wei-Hu Wang, Shu-Lian Wang, Yong-Wen Song, Yue-Ping Liu, Yuan Tang, Ning Li, Wen-Yang Liu, Hui Fang, Ye-Xiong Li, Dong-Bing Zhao, Yihebali Chi, Lin Yang, Jing Jin
Xin Wang, Shu-Lian Wang, Yong-Wen Song, Yue-Ping Liu, Yuan Tang, Wen-Yang Liu, Hui Fang, Ye-Xiong Li, Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Wei-Hu Wang, Department of Radiation Oncology, Peking University Cancer Hospital and Institute, Beijing 100001, China
Ning Li, Jing Jin, Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, Guangdong Province, China
Dong-Bing Zhao, 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
Yihebali Chi, Lin Yang, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Author contributions: Jin J and Zhao DB contributed to study concepts and design and were major guarantors of integrity of the entire study; Jin J participated in funding acquisition and revised the manuscript; Wang X, Wang WH, Wang SL, Song YW, Liu YP, Tang Y, Li N, Liu WY, Fang H, Li YX, Zhao DB, Chi Y, and Yang L contributed to patient recruitment and clinical studies; Wang X performed the statistical and data analyses, and drafted the manuscript; All authors have read and agreed to the published version of the manuscript.
Supported by Beijing Hope Run Special Fund of Cancer Foundation of China, No. LC2018L03; Sanming Project of Medicine in Shenzhen, No. SZSM201612063; and Shenzhen High-level Hospital Construction Fund.
Institutional review board statement: This study was approved by the Independent Ethics Committees of Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Approved No. 11-72/507).
Informed consent statement: All patients signed informed consent.
Conflict-of-interest statement: The authors of this work have nothing to disclose.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at
jingjin1025@163.com. Participants gave informed consent for data sharing.
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:
http://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Jing Jin, MD, Doctor, Professor, Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 113 Baohe Avenue, Longgang District, Shenzhen 518116, Guangdong Province, China.
jingjin1025@163.com
Received: April 15, 2021
Peer-review started: April 15, 2021
First decision: June 4, 2021
Revised: June 11, 2021
Accepted: August 16, 2021
Article in press: August 16, 2021
Published online: October 15, 2021
Processing time: 181 Days and 11.6 Hours
BACKGROUND
Adjuvant chemoradiotherapy (ACRT) with oral capecitabine and intensity-modulated radiotherapy (IMRT) were well tolerated in a phase I study in patients who had undergone partial or total gastrectomy for locally advanced gastric cancer (GC). This phase II study aimed to further determine the efficacy and toxicity of this combination after radical resection and D1/D2 lymph node dissection (LND) for patients with locally advanced GC.
AIM
To further determine the efficacy and toxicity of this combination after radical resection and D1/D2 LND for patients with locally advanced GC.
METHODS
Forty patients (median age, 53 years; range, 24-71 years) with pathologically confirmed adenocarcinoma who underwent D1/D2 LND were included in this study. The patients received ACRT comprising IMRT (total irradiation dose: 45 Gy delivered in daily 1.8-Gy fractions on 5 d a week over 5 wk) and capecitabine chemotherapy (dose: 800 mg/m² twice daily throughout the duration of radiotherapy). The primary study endpoint was disease-free survival (DFS), and the secondary endpoints were overall survival (OS), toxic effects, and treatment compliance.
RESULTS
The 3-year DFS and OS were 66.2% and 75%, respectively. The median time to recurrence was 19.5 mo (range, 6.1-68 mo). Peritoneal implantation (n = 10) was the most common recurrence pattern, and the lung was the most common site of extra-abdominal metastases (n = 5). Nine patients developed grade 3 or 4 toxicities during ACRT. Two patients discontinued ACRT, while eleven underwent ACRT without receiving the entire course of capecitabine. There were no treatment-related deaths.
CONCLUSION
The ACRT protocol described herein showed acceptable safety and efficacy for patients with locally advanced GC who received radical gastrectomy and D1/2 LND.
Core Tip: In our previous phase I study, we found that an adjuvant chemoradiotherapy (ACRT) regimen of 45 Gy radiotherapy concurrent with oral capecitabine was well tolerated in patients with locally advanced gastric cancer who had received partial or total gastrectomy. The maximum tolerated and recommended dose of capecitabine was 800 mg/m2 twice daily with oral administration. We performed this phase II study to further assess the efficacy and toxicity of this ACRT regimen as an adjuvant therapy after radical resection and D1/D2 lymph node dissection for patients with locally advanced gastric cancer.
