A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma

Abstract Pembrolizumab with cisplatin and 5‐fluorouracil showed survival benefit but relatively high occurrence of treatment‐related adverse events (TRAEs) for recurrent/metastatic oral squamous cell carcinoma (R/M OSCC). A more tolerable regime is needed. This trial enrolled 20 R/M OSCC patients wi...

Full description

Bibliographic Details
Main Authors: Houyu Ju, Dongliang Wei, Yunteng Wu, Yang Liu, Qi Ding, Mengyu Rui, Zongyu Fan, Yanli Yao, Jingzhou Hu, Guoxin Ren
Format: Article
Language:English
Published: Wiley 2023-08-01
Series:MedComm
Subjects:
Online Access:https://doi.org/10.1002/mco2.312
_version_ 1797693077072117760
author Houyu Ju
Dongliang Wei
Yunteng Wu
Yang Liu
Qi Ding
Mengyu Rui
Zongyu Fan
Yanli Yao
Jingzhou Hu
Guoxin Ren
author_facet Houyu Ju
Dongliang Wei
Yunteng Wu
Yang Liu
Qi Ding
Mengyu Rui
Zongyu Fan
Yanli Yao
Jingzhou Hu
Guoxin Ren
author_sort Houyu Ju
collection DOAJ
description Abstract Pembrolizumab with cisplatin and 5‐fluorouracil showed survival benefit but relatively high occurrence of treatment‐related adverse events (TRAEs) for recurrent/metastatic oral squamous cell carcinoma (R/M OSCC). A more tolerable regime is needed. This trial enrolled 20 R/M OSCC patients with previously untreated and PD‐L1 positive. Patients were administered camrelizumab with docetaxel and cisplatin every 3 weeks for six cycles, followed by camrelizumab monotherapy every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was occurrence of grade ≥ 3 TRAEs, secondary endpoints included overall survival (OS), progression‐free survival (PFS), and overall response rate (ORR). 45% patients experienced grade ≥ 3 TRAEs, which the most common were anemia (15%), stomatitis (15%), and neutropenia (10%). The most common potential immune‐related adverse events were reactive cutaneous capillary endothelial proliferation (RCCEP; 60%), hypothyroidism (35%), and pneumonitis (15%). No treatment‐related deaths occurred. The median OS, PFS, and ORR was 14.4 months, 5.35 months, and 40.0% respectively. The study also found RCCEP occurrence, lower FOXP3+ cells, and higher density of intratumor tertiary lymphoid structure were associated with improved efficacy. Our data suggest that camrelizumab with docetaxel/cisplatin as first‐line therapy was well tolerable and had potentially favorite efficacy in PD‐L1‐positive patients with R/M OSCC.
first_indexed 2024-03-12T02:38:22Z
format Article
id doaj.art-77f31d554da740e3903d08f5f86ade96
institution Directory Open Access Journal
issn 2688-2663
language English
last_indexed 2024-03-12T02:38:22Z
publishDate 2023-08-01
publisher Wiley
record_format Article
series MedComm
spelling doaj.art-77f31d554da740e3903d08f5f86ade962023-09-04T11:20:36ZengWileyMedComm2688-26632023-08-0144n/an/a10.1002/mco2.312A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinomaHouyu Ju0Dongliang Wei1Yunteng Wu2Yang Liu3Qi Ding4Mengyu Rui5Zongyu Fan6Yanli Yao7Jingzhou Hu8Guoxin Ren9Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai ChinaAbstract Pembrolizumab with cisplatin and 5‐fluorouracil showed survival benefit but relatively high occurrence of treatment‐related adverse events (TRAEs) for recurrent/metastatic oral squamous cell carcinoma (R/M OSCC). A more tolerable regime is needed. This trial enrolled 20 R/M OSCC patients with previously untreated and PD‐L1 positive. Patients were administered camrelizumab with docetaxel and cisplatin every 3 weeks for six cycles, followed by camrelizumab monotherapy every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was occurrence of grade ≥ 3 TRAEs, secondary endpoints included overall survival (OS), progression‐free survival (PFS), and overall response rate (ORR). 45% patients experienced grade ≥ 3 TRAEs, which the most common were anemia (15%), stomatitis (15%), and neutropenia (10%). The most common potential immune‐related adverse events were reactive cutaneous capillary endothelial proliferation (RCCEP; 60%), hypothyroidism (35%), and pneumonitis (15%). No treatment‐related deaths occurred. The median OS, PFS, and ORR was 14.4 months, 5.35 months, and 40.0% respectively. The study also found RCCEP occurrence, lower FOXP3+ cells, and higher density of intratumor tertiary lymphoid structure were associated with improved efficacy. Our data suggest that camrelizumab with docetaxel/cisplatin as first‐line therapy was well tolerable and had potentially favorite efficacy in PD‐L1‐positive patients with R/M OSCC.https://doi.org/10.1002/mco2.312camrelizumabfirst‐line treatmentimmunotherapyoral cancer
spellingShingle Houyu Ju
Dongliang Wei
Yunteng Wu
Yang Liu
Qi Ding
Mengyu Rui
Zongyu Fan
Yanli Yao
Jingzhou Hu
Guoxin Ren
A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma
MedComm
camrelizumab
first‐line treatment
immunotherapy
oral cancer
title A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma
title_full A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma
title_fullStr A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma
title_full_unstemmed A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma
title_short A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma
title_sort pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent metastatic oral squamous cell carcinoma
topic camrelizumab
first‐line treatment
immunotherapy
oral cancer
url https://doi.org/10.1002/mco2.312
work_keys_str_mv AT houyuju apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT dongliangwei apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT yuntengwu apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT yangliu apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT qiding apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT mengyurui apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT zongyufan apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT yanliyao apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT jingzhouhu apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT guoxinren apilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT houyuju pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT dongliangwei pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT yuntengwu pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT yangliu pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT qiding pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT mengyurui pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT zongyufan pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT yanliyao pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT jingzhouhu pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma
AT guoxinren pilotstudyofcamrelizumabwithdocetaxelandcisplatinforthefirstlinetreatmentinrecurrentmetastaticoralsquamouscellcarcinoma