Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial

作者：Jianjun Qin, Liyan Xue, Anlin Hao, Xiaofeng Guo, Tao Jiang, Yunfeng Ni, Shuoyan Liu, Yujie Chen, Hongjing Jiang, Chen Zhang, Mingqiang Kang, Jihong Lin, Hecheng Li, Chengqiang Li, Hui Tian, Lin Li, Junke Fu, Yong Zhang, Jianqun Ma, Xiaoyuan Wang, Maoyong Fu, Hao Yang, Zhaoyang Yang, Yongtao Han, Long-Qi Chen, Lijie Tan, Tianyang Dai, Yongde Liao, Weiguo Zhang, Bin Li, Qixun Chen, Guo Shiping, Yu Qi, Li Wei, Zhigang Li, Ziqiang Tian, Xiaozheng Kang, Ruixiang Zhang, Yong Li, Yong Li, Zhen Wang, Xiankai Chen, Zhiguo Hou, Rongrong Zheng, Wenqing Zhu, Jie He, Yin Li, Yin Li · 发表于：Nature Medicine · 年份：2024 · DOI：10.1038/s41591-024-03064-w · 被引用次数：232 · 研究领域：Esophageal Cancer Research and Treatment、Gastric Cancer Management and Outcomes、Pancreatic and Hepatic Oncology Research

Recent single-arm studies involving neoadjuvant camrelizumab, a PD-1 inhibitor, plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) have shown promising results. This multicenter, randomized, open-label phase 3 trial aimed to further assess the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy followed by adjuvant camrelizumab, compared to neoadjuvant chemotherapy alone. A total of 391 patients with resectable thoracic LA-ESCC (T1b-3N1-3M0 or T3N0M0) were stratified by clinical stage (I/II, III or IVA) and randomized in a 1:1:1 ratio to undergo two cycles of neoadjuvant therapy. Treatments included camrelizumab, albumin-bound paclitaxel and cisplatin (Cam+nab-TP group; n = 132); camrelizumab, paclitaxel and cisplatin (Cam+TP group; n = 130); and paclitaxel with cisplatin (TP group; n = 129), followed by surgical resection. Both the Cam+nab-TP and Cam+TP groups also received adjuvant camrelizumab. The dual primary endpoints were the rate of pathological complete response (pCR), as evaluated by a blind independent review committee, and event-free survival (EFS), as assessed by investigators. This study reports the final analysis of pCR rates. In the intention-to-treat population, the Cam+nab-TP and Cam+TP groups exhibited significantly higher pCR rates of 28.0% and 15.4%, respectively, compared to 4.7% in the TP group (Cam+nab-TP versus TP: difference 23.5%, 95% confidence interval (CI) 15.1-32.0, P < 0.0001; Cam+TP ver...