Published online Apr 16, 2022. doi: 10.12998/wjcc.v10.i11.3414
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
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.
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.
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.
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.
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.
This study provided a new chemotherapy regimen (GN) in concurrent radiochemotherapy for HNSCC.
It is necessary to explore more effective and safer chemoradiotherapy regimens for the treatment of HNSCC in the future.