Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial
机构:[1]Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.[2]Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.[3]Department of Thoracic Surgery, Anyang Cancer Hospital, Anyang, China.[4]Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, Xi’an, China.[5]Department of Thoracic Surgery, Fujian Provincial Cancer Hospital, Fuzhou, China.[6]Department of Esophageal Minimal Invasive Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.[7]Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, China.[8]Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.[9]Department of Thoracic Surgery, Qilu Hospital of Shandong University, Jinan, China.[10]Department of Thoracic Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China.[11]Department of Thoracic Surgery, Harbin Medical University Cancer Hospital, Harbin, China.[12]Department of Thoracic Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.[13]Department of Thoracic Surgery, Sichuan Cancer Hospital, Chengdu, China.外科中心胸外科中心四川省肿瘤医院[14]Department of Thoracic Surgery, West China Hospital Sichuan University, Chengdu, China.四川大学华西医院[15]Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.[16]Department of Thoracic Surgery, The Affiliated Hospital of Southwest Medical University, Luzhou, China.[17]Department of Thoracic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.华中科技大学同济医学院附属协和医院[18]Surgery of Esophageal Cancer, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.[19]Department of Thoracic Surgery, The Second Hospital & Clinical Medical School, Lanzhou University, Lanzhou, China.[20]Department of Thoracic Surgery, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.浙江省肿瘤医院[21]Department of Thoracic Surgery, Shanxi Provincial Cancer Hospital, Taiyuan, China.[22]Department of Thoracic Surgery, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.[23]Department of Thoracic Surgery, Henan Provincial People’s Hospital, Zhengzhou, China.[24]Department of Esophageal Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.[25]Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.河北医科大学第四医院[26]Department of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China
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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Jiangsu Hengrui Pharmaceuticals
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外文
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大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学:研究与实验
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无
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Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构:[1]Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
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推荐引用方式(GB/T 7714):
Qin Jianjun,Xue Liyan,Hao Anlin,et al.Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial[J].NATURE MEDICINE.2024,30(9):doi:10.1038/s41591-024-03064-w.
APA:
Qin, Jianjun,Xue, Liyan,Hao, Anlin,Guo, Xiaofeng,Jiang, Tao...&Li, Yin.(2024).Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial.NATURE MEDICINE,30,(9)
MLA:
Qin, Jianjun,et al."Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial".NATURE MEDICINE 30..9(2024)