Randomized Controlled Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 26, 2022; 10(21): 7365-7375
Published online Jul 26, 2022. doi: 10.12998/wjcc.v10.i21.7365
Comparison of involved-field intensity-modulated radiotherapy combined with S-1 vs radiotherapy alone for elderly patients with esophageal cancer
Li-Hua Liu, Mao-Hui Yan, Yu-Peng Di, Zhi-Guang Fu, Xiao-Dan Zhang, Hong-Qi Li
Li-Hua Liu, Department of Radiotherapy, Heze Hospital of Traditional Chinese Medicine, Heze 274000, Shandong Province, China
Mao-Hui Yan, Yu-Peng Di, Zhi-Guang Fu, Xiao-Dan Zhang, Hong-Qi Li, Department of Radiotherapy, Air Force Medical Center, Chinese People’s Liberation Army, Beijing 100142, China
Author contributions: Yan MH and Liu LH contributed equally to this study; Yan MH, Liu LH and Li HQ designed the research study; Liu LH, Yan MH, Di YP, Fu ZG, Zhang XD and Li HQ performed the research; Di YP contributed new analytic tools; Yan MH, Liu LH, Di YP and Li HQ analyzed the data and wrote the manuscript; and all authors have read and approve the final manuscript.
Supported by the Youth PhD Advancement Project of Air Force Medical Center, PLA, No. 21ZT01; and the Clinical Project of Air Force Medical Center, PLA, No. 2021LC009.
Institutional review board statement: The study was reviewed and approved by the Chinese PLA General Hospital Institutional Review Board (Approval No. S2018-031-01).
Clinical trial registration statement: This study is registered at http://www.chictr.org.cn. The registration identification number is ChiCTR1800014739.
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: All the authors report no conflict of interest to this article.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at fmmuli3786@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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Hong-Qi Li, MD, Associate Chief Physician, Department of Radiotherapy, Air Force Medical Center, Chinese People’s Liberation Army, No. 30 Fucheng Road, Haidian District, Beijing 100142, China. fmmuli3786@163.com
Received: May 10, 2022
Peer-review started: May 10, 2022
First decision: May 30, 2022
Revised: June 5, 2022
Accepted: June 14, 2022
Article in press: June 14, 2022
Published online: July 26, 2022
Processing time: 60 Days and 4.3 Hours
ARTICLE HIGHLIGHTS
Research background

Esophageal cancer (EC) represents the second most common gastrointestinal cancer in China, with 320000 newly-diagnosed cases and 300000 new cancer deaths in 2020. It is estimated that about 30% of EC patients are over 70 years old. There is less evidence on the diagnosis and management of elderly EC patients.

Research motivation

It is important to explore how elderly EC patients benefit from radical radiochemotherapy regimens, including the target area of radiotherapy (RT), radiation dose and fraction, and choice of chemotherapy drugs. In this prospective, randomized, controlled trial, we attempted to compare the safety and efficacy of involved-field intensity-modulated RT (IF-IMRT) combined with tegafur-gimeracil-oteracil potassium capsules (S-1) vs RT alone in the treatment of elderly esophageal squamous cell carcinoma.

Research objectives

To compare the efficacy of IF-IMRT combined with S-1 vs RT alone in the treatment of elderly EC patients in terms of safety, short-term response, and survival.

Research methods

Patients with pathologically confirmed locally advanced EC. Based on the random number table, they were divided into an IF-IMRT + S-1 group and an IF-IMRT alone group, with 17 cases in each group.

Research results

The objective response rate was 88.2% vs 76.5%, respectively, in the IF-IMRT + S-1 group and the RT alone group, where as the disease control rate was 100% vs 82.4%, respectively. The rate of progressive disease (PD) was 52.9% (n = 9) in the IF-IMRT + S-1 group and 64.7% (n = 11) in the RT alone group. The median progression-free survival (PFS) was 23.4 mo vs 16.3 mo, and the 2-year PFS rate was 42% vs 41.2%. The median overall survival (OS) was 27.0 mo vs 23.0 mo, and the 2-year OS rate was 58.8% vs 47.1%.

Research conclusions

Compared with IF-IMRT alone, IF-IMRT + S-1 shows the benefits of preventing PD and prolonging survival without increasing adverse reactions. Therefore, this concurrent radiochemotherapy deserves clinical application.

Research perspectives

In addition, chemotherapy regimens, the optimal dose of radical RT, and the range/fractionation of the RT for EC in elderly patients require further clinical research.