Wang H L, Yue K, Wu Y S, Duan Y S, Jing C, Wang X D
Department of Maxillofacial and Otorhinolaryngological Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Laboratory of Basic and Translational Medicine on Head & Neck Cancer, Tianjin 300060, China.
Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Apr 7;59(4):335-342. doi: 10.3760/cma.j.cn115330-20231114-00207.
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. 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. 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 (>0.05). The major pathological response rate of 13/14 in experimental group was higher than that of 2/9 in control group (<0.05). The incidence of grade 3-4 adverse reactions related to treatment was low in both groups (4/23 . 3/18, χ=0.13, =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% . 77.78%, χ=0.62, =0.42), with a relative decrease of 87% in the risk of disease progression or death (=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 . 0/4, =0.03). 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.
探讨程序性死亡受体1（PD-1）抑制剂联合化疗作为局部晚期可切除口腔鳞状细胞癌新辅助治疗的有效性和安全性。本研究为随机对照Ⅱ期试验。2021年7月至2023年2月从天津医科大学肿瘤医院招募的患者按1∶1比例随机分为两组：试验组（托瑞帕利单抗联合白蛋白紫杉醇和顺铂）和对照组（白蛋白紫杉醇和顺铂）；两组患者均接受三个周期的新辅助治疗。新辅助治疗完成后，对患者进行评估并进行后续手术治疗。根据治疗完成情况，对全分析集和符合方案集进行分析。评估治疗的有效性和安全性。采用SPSS 20.0软件进行统计分析。共纳入41例口腔癌患者，其中男性26例，女性15例，年龄34～74岁。试验组23例，对照组18例。共有23例患者按方案完成新辅助治疗和手术。试验组和对照组的完全缓解率分别为1/19和0/17，部分缓解率分别为13/19和8/17，降期率分别为4/19和3/17，病理完全缓解率分别为8/14和2/9，两组各率比较差异无统计学意义（>0.05）。试验组主要病理缓解率为13/14，高于对照组的2/9（<0.05）。两组治疗相关3～4级不良反应发生率均较低（4/23、3/18，χ=0.13，P=0.72），试验组最常见的严重不良反应为粒细胞缺乏和电解质紊乱。未出现影响后续手术治疗或导致死亡的不良反应，安全性和耐受性良好。中位随访时间为15个月，试验组1年无病生存率高于对照组（92.86%、77.78%，χ=0.62，P=0.42），疾病进展或死亡风险相对降低87%（P=0.029）。对于程序性死亡配体1（PD-L1）蛋白表达联合阳性评分≥20的患者，试验组主要病理缓解率高于对照组（5/5、0/4，P=0.03）。免疫治疗联合化疗的新辅助治疗可提高口腔鳞状细胞癌的病理缓解率及患者的长期生存获益和预后。
