A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma
Houyu Ju,
Dongliang Wei,
Yunteng Wu,
Yang Liu,
Qi Ding,
Mengyu Rui,
Zongyu Fan,
Yanli Yao,
Jingzhou Hu,
Guoxin Ren
Affiliations
Houyu Ju
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Dongliang Wei
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Yunteng Wu
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Yang Liu
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Qi Ding
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Mengyu Rui
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Zongyu Fan
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Yanli Yao
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Jingzhou Hu
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
Guoxin Ren
Department of Oral Maxillofacial‐Head and Neck Oncology Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
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.
