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

医学 肿瘤科 化疗 食管鳞状细胞癌 内科学 基底细胞 随机对照试验 新辅助治疗 癌症 乳腺癌
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,Zhen Wang,Xiankai Chen,Zhiguo Hou,Rongrong Zheng,Wenqing Zhu,Jie He,Yin Li
出处
期刊:Nature Medicine [Springer Nature]
卷期号:30 (9): 2549-2557 被引量:5
标识
DOI:10.1038/s41591-024-03064-w
摘要

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 versus TP: difference 10.9%, 95% CI 3.7-18.1, P = 0.0034). The study met its primary endpoint of pCR; however, EFS is not yet mature. The incidence of grade ≥3 treatment-related adverse events during neoadjuvant treatment was 34.1% for the Cam+nab-TP group, 29.2% for the Cam+TP group and 28.8% for the TP group; the postoperative complication rates were 34.2%, 38.8% and 32.0%, respectively. Neoadjuvant camrelizumab plus chemotherapy demonstrated superior pCR rates compared to chemotherapy alone for LA-ESCC, with a tolerable safety profile. Chinese Clinical Trial Registry identifier: ChiCTR2000040034 .
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