Prospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Oct 15, 2021; 13(10): 1532-1543
Published online Oct 15, 2021. doi: 10.4251/wjgo.v13.i10.1532
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).
Clinical trial registration statement: The clinical trial is registered with ClinicalTrials.gov, using identifier NCT01674959. Details can be found at https://clinicaltrials.gov/ct2/show/NCT01674959?term=NCT01674959&rank=1.
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
ARTICLE HIGHLIGHTS
Research background

Capecitabine has been widely used for chemotherapy and concurrent with radiotherapy in gastric cancer (GC) treatment, while modern intensity-modulated radiotherapy (IMRT) has also been confirmed to be superior to two- or three-dimensional radiotherapy (RT). In our previous phase I study, we found out adjuvant chemoradiotherapy (ACRT) regimen of IMRT concurrent with oral capecitabine was well tolerated in patients with locally advanced GC who had received partial or total gastrectomy.

Research motivation

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 (LND) for locally advanced GC patients.

Research objectives

The aim of this study was to evaluate the efficacy and toxicity of IMRT combined with capecitabine after radical resection and D1/D2 LND for patients with locally advanced GC.

Research methods

Forty patients with locally advanced GC, who underwent radical resection and D1/D2 LNDwere 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 RT). The primary study endpoint was disease-free survival (DFS) and the secondary endpoints were overall survival (OS), toxic effects, and treatment compliance.

Research results

The 3-year DFS and OS were 66.2% and 75%, respectively. Nine patients developed grade 3 or 4 toxicities during ACRT. Two patients discontinued ACRT, while 11 underwent ACRT without receiving the entire course of capecitabine.

Research conclusions

ACRT with oral capecitabine and IMRTwas safe and efficacious.

Research perspectives

The use of IMRT and low-toxicity single-agent chemotherapy regimens such as capecitabine is highly recommended in patients who had undergone partial or total gastrectomy for locally advanced GC. Moreover, to further determine the efficacy of this combination therapy, a randomized phase III study in our hospital is ongoing.