Concurrent chemoradiotherapy using gemcitabine and nedaplatin in recurrent or locally advanced head and neck squamous cell carcinoma

doi:10.12998/wjcc.v10.i11.3414

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World Journal of Clinical Cases

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Clinical Trials Study

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.

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
Processing time: 199 Days and 22.9 Hours

Abstract

BACKGROUND

Patients with recurrent or locally advanced head and neck squamous cell carcinoma (HNSCC) typically have limited treatment options and poor prognosis.

AIM

To evaluate the efficacy and safety of two drugs with potent radio-sensitization properties including gemcitabine and nedaplatin as concurrent chemoradiotherapy regimens in treating HNSCC.

METHODS

This single-arm prospective study enrolled patients with HNSCC to receive gemcitabine on days 1 and 8 and nedaplatin on days 1 to 3 for 21 days. Intensity-modulated radiation therapy with a conventional fraction was delivered 5 days per week. Objective response rate (ORR), disease control rate, and toxicity were observed as primary endpoints. Overall survival (OS) and progression free survival were recorded and analyzed as secondary endpoints.

RESULTS

A total of 24 patients with HNSCC were enrolled. During the median 22.4-mo follow-up, both ORR and disease control rate were 100%. The one-year OS was 75%, and one-year progression-free survival (PFS) was 66.7% (median PFS was 15.1 mo). Recurrent HNSCC patients had a poorer prognosis than the treatment-naïve patients, and patients who achieved complete response had better survival than those in the PR group (all P < 0.05). The most common grade 1-4 (100%) or grade 3-4 toxicities (75%) were hematological, and the most common grade 3-4 non-hematological toxicity was mucositis in 17 (71%) patients.

CONCLUSION

Gemcitabine plus nedaplatin with concurrent chemoradiotherapy is a therapeutic option for HNSCC with predictable tolerability. Considering the high adverse event rate, the optimized dose and schedule must be further explored.

Keywords: Chemoradiotherapy; Gemcitabine; Nedaplatin; Head and neck cancer; Recurrent; Locally advanced

Core Tip: Our article focuses on the comprehensive treatments of head and neck squamous cell carcinoma, especially for recurred tumors after surgery or tumor lesions that could not be surgically removed.