Clinical Trials Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Apr 16, 2022; 10(11): 3414-3425
Published online Apr 16, 2022. doi: 10.12998/wjcc.v10.i11.3414
Concurrent chemoradiotherapy using gemcitabine and nedaplatin in recurrent or locally advanced head and neck squamous cell carcinoma
Rui-Xue Huo, Ying-Ying Jin, Yong-Xue Zhuo, Xiao-Tong Ji, Yu Cui, Xiao-Jing Wu, Yi-Jia Wang, Long Zhang, Wen-Hua Zhang, Yu-Mei Cai, Cheng-Cheng Zheng, Rui-Xue Cui, Qian-Ye Wang, Zhen Sun, Feng-Wei Wang
Rui-Xue Huo, Yu Cui, Long Zhang, Wen-Hua Zhang, Yu-Mei Cai, Cheng-Cheng Zheng, Rui-Xue Cui, Qian-Ye Wang, Zhen Sun, Feng-Wei Wang, Department of Oncology, Tianjin Union Medical Center, Tianjin 300000, China
Ying-Ying Jin, Yong-Xue Zhuo, Xiao-Tong Ji, School of Medicine, Nankai University, Tianjin 300000, China
Xiao-Jing Wu, Yi-Jia Wang, Laboratory of Oncologic Molecular Medicine, Tianjin Union Medical Center, Tianjin 300000, China
Author contributions: Wang FW contributed to the conception of the study; Huo RX performed the Clinical trial; Jin JY, Zhuo YX, and Ji XT contributed significantly to follow-up, analysis and manuscript preparation; Cui Y, Wu XJ, Wang YJ, Zhang L, Zhang WH, and Cai YM performed the data analyses and wrote the manuscript; Zheng CC, Cui RX, Wang QY, and Sun Z helped perform the analysis with constructive discussions.
Supported by Tianjin Science and Technology Plan Project, No. 19YFZCSY00170; Tianjin Union Medical center, No. 2019YJ007; and Beijing medical and health foundation, No. F1814B.
Institutional review board statement: The study was reviewed and approved by the China Ethics Committee of Registering Clinical Trials (No. ChiECRCT20170178).
Conflict-of-interest statement: The authors have no conflict of interests to disclose.
Data sharing statement: Technical appendix, statistical code, and dataset are available from the corresponding author at wfengwei2004@163.com. Participants gave informed consent for data sharing.
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: Feng-Wei Wang, MD, PhD, Chief Doctor, Department of Oncology, Tianjin Union Medical Center, No. 190 jieyuan Road, Hongqiao District, Tianjin 300000, China. wfengwei2004@163.com
Received: September 20, 2021
Peer-review started: September 20, 2021
First decision: January 10, 2022
Revised: January 14, 2022
Accepted: March 6, 2022
Article in press: March 6, 2022
Published online: April 16, 2022
ARTICLE HIGHLIGHTS
Research background

As one of the most common malignant tumors, head and neck squamous cell carcinoma (HNSCC) seriously affects the survival and quality of life of patients. At present, in addition to surgery, chemoradiotherapy is the main treatment modality. However, the chemotherapy regimens of concurrent chemoradiotherapy are limited. The activity of gemcitabine and nedaplatin in treating HNSCC has been confirmed.

Research motivation

Our study focused on the efficacy and safety of gemcitabine combined with nedaplatin in concurrent chemoradiotherapy for the treatment of recurrent or metastatic HNSCC. This study provided another therapeutic option of concurrent chemoradiotherapy for HNSCC in the future.

Research objectives

The main objective of this study was to evaluate the effect of gemcitabine combined with nedaplatin on PFS and overall survival (OS) in HNSCC patients who received concurrent radiochemotherapy, and to explore the most suitable dose. The protocol and dose used in our study have proved to be effective and safe for these patients. These results can provide reference for concurrent chemoradiotherapy in the future.

Research methods

This study was a prospective single arm clinical trial. In this study, GN regimen chemotherapy and concurrent radiotherapy were used, imaging and laboratory examination were performed regularly, and RECIST 1.1 was used to evaluate treatment efficacy. The adverse effects were recorded simultaneously. The efficacy evaluation indexes included objective response rate (ORR), disease control rate (DCR), OS and progression free survival (PFS). Kaplan-Meier method was used for survival analysis by SPSS Version 23. These methods can truly and effectively reflect the effectiveness and safety of treatment schemes and are common methods in the world currently. The main objective of this study was to evaluate the effect of gemcitabine combined with nedaplatin on PFS and OS in HNSCC patients who received concurrent radiochemotherapy, and to explore the most suitable dose. The protocol and dose used in our study have proved to be effective and safe for these patients. These results can provide reference for concurrent chemoradiotherapy in the future.

Research results

The ORR and DCR were both 100%. The one-year OS was 75%, and one-year PFS was 66.7%. The most common toxicities were hematological diseases, and the most common non-hematological toxicity was mucositis. The results showed the treatment regimen in this trial was effective and the safety was acceptable, which might provide new choice for HNSCC treatment. However, the results need more large-scale randomized clinical trial to confirm.

Research conclusions

This study provided a new chemotherapy regimen (GN) in concurrent radiochemotherapy for HNSCC.

Research perspectives

It is necessary to explore more effective and safer chemoradiotherapy regimens for the treatment of HNSCC in the future.