Yang Jinsong, Liu Cui, Zuo Zhigang, Cao Fengjun, Zhang Zhanjie, Wu Bian, Qin You, Wen Lu, Wei Jielin, Xiao Guangqin, Xing Shijie, Qu Yue, Huang Lei, Wang Xiaolin, Wang Buhai, Yang Kunyu, Jiang Ke
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China.
Department of Pathology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Radiother Oncol. 2025 May;206:110797. doi: 10.1016/j.radonc.2025.110797. Epub 2025 Feb 18.
To explore the efficacy and safety of neoadjuvant chemoradiotherapy (NCRT) plus sequential tislelizumab followed by surgery for esophageal squamous cell carcinoma (ESCC).
This single-arm, bicentric, phase 2 trial enrolled patients with resectable or potentially resectable thoracic ESCC to receive neoadjuvant radiotherapy (41.4 Gy in 23 fractions) with concurrent chemotherapy (albumin-bound paclitaxel, 50-100 mg/m, and carboplatin, area under the curve of 2 mg/ml/min, once weekly, five times) plus sequential tislelizumab (200 mg Q3W, three cycles) followed by surgery. The primary endpoint was pathologic complete response (pCR) rate. The secondary endpoints included safety, R0 resection rate, major pathologic response (MPR) rate, disease-free survival (DFS), and overall survival (OS).
Of the 30 patients enrolled from January 2021 to October 2022, 24 (80.0 %) completed planned surgery and gained R0 resection (100 %). Among the 24 patients, nine (37.5 %) achieved pCR and 21 (87.5 %) achieved MPR. Ten patients (35.7 %) developed grade 3-4 toxicities during tislelizumab therapy, including lymphopenia (32.1 %), neutropenia (3.6 %), and thrombocytopenia (3.6 %). Grade 5 hematemesis occurred in two patients and both were attributed to aortic invasion. Three patients (12.5 %) developed grade 3 postoperative complications, including pulmonary infection (8.3 %) and hoarseness (4.2 %). After a median follow-up of 35.4 months, the 2-year OS and DFS rates were 83.3 % and 79.2 %, respectively.
Sequential tislelizumab after NCRT in ESCC is safe and feasible. Further study is warranted to validate the efficacy of this combination mode.
探讨新辅助放化疗（NCRT）联合序贯替雷利珠单抗治疗后行手术治疗食管鳞状细胞癌（ESCC）的疗效与安全性。
本单臂、双中心2期试验纳入可切除或潜在可切除的胸段ESCC患者，接受新辅助放疗（23次分割，共41.4 Gy）联合同步化疗（白蛋白结合型紫杉醇，50 - 100 mg/m²，卡铂，曲线下面积为2 mg/ml/min，每周1次，共5次）加序贯替雷利珠单抗（200 mg，每3周1次，共3个周期），随后行手术治疗。主要终点为病理完全缓解（pCR）率。次要终点包括安全性、R0切除率、主要病理缓解（MPR）率、无病生存期（DFS）和总生存期（OS）。
2021年1月至2022年10月共纳入30例患者，其中24例（80.0%）完成计划手术并实现R0切除（100%）。在这24例患者中，9例（37.5%）达到pCR，21例（87.5%）达到MPR。10例患者（35.7%）在替雷利珠单抗治疗期间出现3 - 4级毒性反应，包括淋巴细胞减少（32.1%）、中性粒细胞减少（3.6%）和血小板减少（3.6%）。2例患者发生5级呕血，均归因于主动脉侵犯。3例患者（12.5%）出现3级术后并发症，包括肺部感染（8.3%）和声音嘶哑（4.2%）。中位随访35.4个月后，2年OS率和DFS率分别为83.3%和79.2%。
ESCC患者NCRT后序贯替雷利珠单抗治疗安全可行。有必要进一步研究以验证这种联合模式的疗效。
