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

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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. [14]Department of Thoracic Surgery, West China Hospital Sichuan University, Chengdu, China. [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. [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. [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. [26]Department of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China
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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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出版当年[2023]版:
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
最新[2023]版:
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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出版当年[2023]版:
Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Q1 CELL BIOLOGY Q1 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Q1 CELL BIOLOGY Q1 MEDICINE, RESEARCH & EXPERIMENTAL

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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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