Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial.,JAMA

当前位置： X-MOL 学术 › JAMA › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial.
JAMA ( IF 120.7 ) Pub Date : 2021-09-14 , DOI: 10.1001/jama.2021.12836
Huiyan Luo _{1,

2} , Jin Lu ₃ , Yuxian Bai ₄ , Teng Mao ₅ , Jun Wang ₆ , Qingxia Fan ₇ , Yiping Zhang ₈ , Kuaile Zhao ₉ , Zhendong Chen ₁₀ , Shegan Gao ₁₁ , Jiancheng Li ₁₂ , Zhichao Fu ₁₃ , Kangsheng Gu ₁₄ , Zhihua Liu ₁₅ , Lin Wu ₁₆ , Xiaodong Zhang ₁₇ , Jifeng Feng ₁₈ , Zuoxing Niu ₁₉ , Yi Ba ₂₀ , Helong Zhang ₂₁ , Ying Liu ₂₂ , Li Zhang ₂₃ , Xuhong Min ₂₄ , Jing Huang ₂₅ , Ying Cheng ₂₆ , Dong Wang ₂₇ , Yu Shen ₂₈ , Qing Yang ₂₈ , Jianjun Zou ₂₈ , Rui-Hua Xu _{1,

2} ,

Affiliation

Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China.
Sichuan Cancer Hospital, Chengdu, China.
Harbin Medical University Cancer Hospital, Harbin, China.
Shanghai Chest Hospital, Shanghai, China.
The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Zhejiang Cancer Hospital, Hangzhou, China.
Fudan University Shanghai Cancer Center, Shanghai, China.
The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, China.
Fujian Provincial Cancer Hospital, Fuzhou, China.
900 Hospital of the Joint Logistics Support Force, Fuzhou, China.
The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Jiangxi Provincial Cancer Hospital, Nanchang, China.
Hunan Cancer Hospital, Changsha, China.
Peking University Cancer Hospital and Institute, Beijing, China.
Jiangsu Cancer Hospital, Nanjing, China.
Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China.
Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
The Second Affiliated Hospital of Air Force Medical University, Xi'an, China.
Henan Cancer Hospital, Zhengzhou, China.
Chongqing Three Gorges Central Hospital, Chongqing, China.
Anhui Chest Hospital, Hefei, China.
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.
Jilin Cancer Hospital, Changchun, China.
Army Medical Center of PLA, Chongqing, China.
Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China.

Importance Standard first-line therapy for advanced or metastatic esophageal carcinoma is chemotherapy, but the prognosis remains poor. Camrelizumab (an anti-programmed death receptor 1 [PD-1] antibody) showed antitumor activity in previously treated advanced or metastatic esophageal squamous cell carcinoma. Objective To evaluate the efficacy and adverse events of camrelizumab plus chemotherapy vs placebo plus chemotherapy as a first-line treatment in advanced or metastatic esophageal squamous cell carcinoma. Design, Setting, and Participants This randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) enrolled patients from 60 hospitals in China between December 3, 2018, and May 12, 2020 (final follow-up, October 30, 2020). A total of 751 patients were screened and 596 eligible patients with untreated advanced or metastatic esophageal squamous cell carcinoma were randomized. Interventions Patients were randomized 1:1 to receive either camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with up to 6 cycles of paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). All treatments were given intravenously every 3 weeks. Main Outcomes and Measures Coprimary end points were overall survival (significance threshold, 1-sided P < .02) and progression-free survival (significance threshold, 1-sided P < .005). Results Of the 596 patients randomized (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.8%]), 1 patient in the placebo-chemotherapy group did not receive planned treatment. A total of 490 patients (82.2%) had discontinued the study treatment. The median follow-up was 10.8 months. The overall survival for the camrelizumab-chemotherapy group was a median of 15.3 months (95% CI, 12.8-17.3; 135 deaths) vs a median of 12.0 months (95% CI, 11.0-13.3; 174 deaths) for the placebo-chemotherapy group (hazard ratio [HR] for death, 0.70 [95% CI, 0.56-0.88]; 1-sided P = .001). Progression-free survival for camrelizumab plus chemotherapy was a median of 6.9 months (95% CI, 5.8-7.4; 199 progression or deaths) vs 5.6 months (95% CI, 5.5-5.7; 229 progression or deaths) for the placebo-chemotherapy group (HR for progression or death, 0.56 [95% CI, 0.46-0.68]; 1-sided P < .001). Treatment-related adverse events of grade 3 or higher occurred in 189 patients (63.4%) in the camrelizumab-chemotherapy group and 201 (67.7%) in the placebo-chemotherapy group, including treatment-related deaths among 9 patients (3.0%) and 11 patients (3.7%), respectively. Conclusions and Relevance Among patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of camrelizumab to chemotherapy, compared with placebo and chemotherapy, significantly improved overall survival and progression-free survival. Trial Registration ClinicalTrials.gov Identifier: NCT03691090.

更新日期：2021-09-14

点击分享查看原文

点击收藏

阅读更多本刊最新论文

全部期刊列表>>