A phase III multicenter randomized clinical trial of 60 Gy vs 50 Gy radiation dose in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma.
机构：[1]Department of Radiation Oncology, Cancer Hospital of The University of Chinese Academy of Science, Zhejiang Cancer Hospital, Institute of Cancer and Basic Medicine, Chinese Academy of Science, Zhejiang Key Laboratory of Radiation Oncology, Hangzhou, China浙江省肿瘤医院[2]Department of Radiation Oncology, Huai'an First People's Hospital, Huai’an, China[3]Department of Radiation Oncology, Fujian Cancer Hospital, Fuzhou, China[4]Department of Radiation Oncology, The First People's Hospital of Foshan, Foshan, China[5]Department of Radiation Oncology, Jining NO.1 people's hospital, Jining, China[6]Department of Radiation Oncology, The First Hospital of Jiaxing, Jiaxing, China[7]Department of Radiation Oncology, The University of Taxes, M.D. Anderson Cancer Center, Houston, United States[8]Department of Medical Statistics, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China[9]Department of Radiation Oncology, Quzhou People's Hospital, Quzhou, China[10]Department of Radiation Oncology, Sichuan Provincial People's Hospital, Chengdu, China四川省人民医院[11]Department of Radiation Oncology, Lianshui People's Hospital, Huai’an, China[12]Department of Radiation Oncology, Jinhua Municipal Central Hospital, Jinhua, China[13]Department of Radiation Oncology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China中山大学附属第一医院[14]Department of Radiation Oncology, Hunan Cancer Hospital, Changsha, China[15]Department of Radiation Oncology, Anhui Provincial Hospital, Hefei, China[16]Department of Radiation Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China[17]Department of Radiation Oncology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China[18]Department of Radiation Oncology, Cancer Hospital of Shantou University Medical College, Shantou, China[19]Department of Radiation Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China[20]Department of Radiation Oncology, The First People's Hospital of Changzhou, Changzhou, China[21]Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing, China[22]Department of Radiation Oncology, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, China[23]Department of Radiation Oncology, Zhejiang Provincial People’s Hospital, Hangzhou, China[24]Department of Radiation Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China[25]Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, China
In this multicenter, phase 3 trial, the efficacy and safety of 60 Gy and 50 Gy doses delivered with modern radiation technology for definitive concurrent chemoradiation (CCRT) in patients with inoperable esophageal squamous cell carcinoma (ESCC) were evaluated.Patients with pathologically confirmed stage IIA‒IVA ESCC were randomized 1:1 to receive conventional fractionated 60 Gy or 50 Gy to the tumor and regional lymph nodes. Concurrent weekly chemotherapy (docetaxel 25 mg/m2; cisplatin 25 mg/m2) and two cycles of consolidation chemotherapy (docetaxel 70 mg/m2; cisplatin 25 mg/m2 d1‒3) were administered.A total of 319 patients were finally analyzed for survival, and the median follow-up was 34.0 months. The 1-, and 3-year locoregional progression-free survival rates for the 60 Gy group were 75.6% and 49.5% vs 72.1% and 48.4%, respectively, for the 50 Gy group (HR, 1.00; 95%CI, 0.75‒1.35; <em>P </em>= 0.98). The overall survival rates were 83.7% and 53.1% vs 84.8% and 52.7%, respectively (HR, 0.99; 95%CI, 0.73‒1.35; <em>P </em>= 0.96), while the progression-free survival rates were 71.2% and 46.4% vs 65.2% and 46.1%, respectively (HR, 0.97; 95%CI, 0.73‒1.30; <em>P </em>= 0.86). The incidence of grade 3+ radiation pneumonitis was higher in the 60 Gy group (nominal <em>P</em> = 0.03) than in the 50 Gy group.The 60 Gy arm had similar survival endpoints but a higher severe pneumonitis rate compared with the 50 Gy arm. 50 Gy should be considered as the recommended dose in CCRT for ESCC.
基金：
This research was supported by the Basic Public Welfare Research Program of Zhejiang Province under
award number LGF21H160005 to Yujin Xu.
第一作者机构：[1]Department of Radiation Oncology, Cancer Hospital of The University of Chinese Academy of Science, Zhejiang Cancer Hospital, Institute of Cancer and Basic Medicine, Chinese Academy of Science, Zhejiang Key Laboratory of Radiation Oncology, Hangzhou, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Radiation Oncology, Cancer Hospital of The University of Chinese Academy of Science, Zhejiang Cancer Hospital, Institute of Cancer and Basic Medicine, Chinese Academy of Science, Zhejiang Key Laboratory of Radiation Oncology, Hangzhou, China[25]Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, China[*1]Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, No. 1, East Banshan Road, Gongshu District, Hangzhou 310022, China[*2]Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Yuexiu District, Guangzhou 510060, China.
推荐引用方式(GB/T 7714)：
Yujin Xu,Baiqiang Dong,Weiguo Zhu,et al.A phase III multicenter randomized clinical trial of 60 Gy vs 50 Gy radiation dose in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma.[J].CLINICAL CANCER RESEARCH.2022,28(9):1792-1799.doi:10.1158/1078-0432.CCR-21-3843.
APA：
Yujin Xu,Baiqiang Dong,Weiguo Zhu,Jiancheng Li,Rong Huang...&Ming Chen.(2022).A phase III multicenter randomized clinical trial of 60 Gy vs 50 Gy radiation dose in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma..CLINICAL CANCER RESEARCH,28,(9)
MLA：
Yujin Xu,et al."A phase III multicenter randomized clinical trial of 60 Gy vs 50 Gy radiation dose in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma.".CLINICAL CANCER RESEARCH 28..9(2022):1792-1799
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