Phase Ⅱ clinical trial of PD-1 inhibitor combined with chemotherapy for locally advanced resectable oral squamous cell carcinoma
10.3760/cma.j.cn115330-20231114-00207
- VernacularTitle:PD-1单抗联合化疗新辅助治疗局部晚期可切除口腔鳞癌的Ⅱ期临床研究
- Author:
Hongling WANG
1
;
Kai YUE
;
Yansheng WU
;
Yuansheng DUAN
;
Chao JING
;
Xudong WANG
Author Information
1. 天津医科大学肿瘤医院颌面耳鼻喉肿瘤科 国家恶性肿瘤临床医学研究中心 天津市肿瘤防治重点实验室 天津市恶性肿瘤临床医学研究中心 天津市头颈肿瘤基础与转化医学重点实验室，天津300060
- Keywords:
Mouth neoplasms;
Neoadjuvant therapy;
Immunotherapy combined with chemotherapy;
Locally advanced resectable
- From:
Chinese Journal of Otorhinolaryngology Head and Neck Surgery
2024;59(4):335-342
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the effectiveness and safety of programmed death 1(PD-1) inhibitory combined with chemotherapy as a neoadjuvant therapy for locally advanced resectable oral squamous cell carcinoma.Methods:This study was a randomized controlled phase Ⅱ trial. Patients recruited from Tianjin Medical University Cancer Institute and Hospital from July 2021 to February 2023 were randomly divided into two groups in a 1∶1 ratio: the experimental group (Toripalimab combined with albumin paclitaxel and cisplatin) and the control group (albumin paclitaxel and cisplatin); patients in both groups underwent three cycles of neoadjuvant therapy. After completion of neoadjuvant therapy, patients were evaluated and subsequent surgical treatment was performed. According to the completion of treatment, the analysis was conducted on both the full analysis set and the protocol set. The effectiveness and safety of treatments were evaluated. SPSS 20.0 software was used for statistical analysis.Results:A total of 41 cases with oral cancer were enrolled, including 26 males and 15 females, aged between 34 and 74 years old. There were 23 cases in the experimental group and 18 cases in the control group. A total of 23 cases completed neoadjuvant therapy and surgery according to the protocol. Experimental group and control group showed respectively the complete response rates of 1/19 and 0/17, the partial response rates of 13/19 and 8/17, the stage-down rates of 4/19 and 3/17, the pathologic complete response rate of 8/14 and 2/9, with no statistically significant differences in individual rates between two groups ( P>0.05). The major pathological response rate of 13/14 in experimental group was higher than that of 2/9 in control group ( P<0.05). The incidence of grade 3-4 adverse reactions related to treatment was low in both groups (4/23 vs. 3/18, χ 2=0.13, P=0.72), and the most common serious adverse reactions in the experimental group were granulocyte deficiency and electrolyte disorder. There were no adverse reactions that affected subsequent surgical treatment or caused death, and the safety and tolerability were good. The median follow-up time was 15 months, and the one-year disease-free survival rate of the experimental group was higher than that of control group (92.86% vs. 77.78%, χ 2=0.62, P=0.42), with a relative decrease of 87% in the risk of disease progression or death ( P=0.029). For patients with programmed death-ligand 1(PD-L1) protein expression combined positive score≥20, the experimental group showed higher major pathological response rate than control group (5/5 vs. 0/4, P=0.03). Conclusion:The neoadjuvant therapy of immunotherapy combined with chemotherapy can improve the pathological remission of oral squamous cell carcinoma and the long-term survival benefits and the prognosis of patients.
