Concurrent chemoradiotherapyof different radiation doses and different irradiation fields for locally advanced thoracic esophageal squamous cell carcinoma:A randomized,multicenter,phase Ⅲ clinical trial  

作　　者：Jian Zhang Minghao Li Kaixian Zhang Anping Zheng Guang Li Wei Huang Shaoshui Chen Xiangming Chen Xiaomin Li Yanxing Sheng Xinchen Sun Liping Liu Xiaowei Liu Jie Li Jun Wang Hong Ge Shucheng Ye Qingsong Pang Xianwen Zhang Shengbin Dai Richard Yu Wendong Gu Mingming Dai Gaowa Siqin Yunwei Han Xiaolin Ge Xin Yuan Yongjing Yang Haiwen Zhu Juan Pu Lihua Dong Xiangdong Sun Jundong Zhou Weidong Mao Fei Gao Haiqun Lin Heyi Gong Tao Zhou Zhenjiang Li Hongsheng Li Zhongtang Wang Baosheng Li 

机构地区：[1]Department of Oncology,Central Hospital Affiliated to Shandong First Medical University,Jinan,Shandong,P.R.China [2]Department of Radiation Oncology,Shandong Cancer Hospital and Institute,Shandong First Medical University and Shandong Academy of Medical Sciences,Jinan,Shandong,P.R.China [3]Department of Oncology,Tengzhou Central People’s Hospital,Tengzhou,Shandong,P.R.China [4]Department of Radiation Oncology,Anyang Tumor Hospital,Anyang,Henan,P.R.China [5]Department of Radiation Oncology,the First Hospital of China Medical University,Shenyang,Liaoning,P.R.China [6]Department of Oncology,Binzhou Medical University Hospital,Binzhou,Shandong,P.R.China [7]Department of Oncology,Taian CentralHospital,Taian,Shandong,P.R.China [8]Department of Radiation Oncology,Shanxi Province Cancer Hospital,Taiyuan,Shanxi,P.R.China [9]Department of Oncology,Liaocheng People’s Hospital,Liaocheng,Shandong,P.R.China [10]Department of Radiation Oncology,the First Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu,P.R.China [11]Department of Oncology,Jining First People′s Hospital,Jining,Shandong,P.R.China [12]Department of Oncology,the Affiliated Hospital of Jining Medical University,Jining,Shandong,P.R.China [13]Department of Radiation Oncology,the Fourth Hospital of Hebei Medical University,Hebei Clinical Research Center for Radiation Oncology,Shijiazhuang,Hebei,P.R.China [14]Department of Radiation Oncology,the Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou,Henan,P.R.China [15]Department of Radiation Oncology,Tianjin Medical University Cancer Institute and Hospital,National Clinical Research Center for Cancer,Key Laboratory ofCancer Prevention and Therapy,Tianjin’s ClinicalResearch Center for Cancer,Tianjin,P.R.China [16]Department of Oncology,Subei People’s Hospital of Jiangsu Province,Yangzhou,Jiangsu,P.R.China [17]Department of Oncology,Taizhou People’s Hospital of Jiangsu Province,Taizhou,Zhejiang,P.R.China [18]Department of Radiation Oncology,the Affiliated Hospital of Inner Mongolia M

出　　处：《Cancer Communications》2024年第10期1173-1188,共16页癌症通讯（英文）

基　　金：Key Research and Development Program of Shandong Province of China,Grant/Award Number:2017CXZC1206;National Natural Science Foundation of China,Grant/Award Number:81874224;Academic promotion program of Shandong First Medical University,China,Grant/Award Number:2019LJ004;Key Research and Development Program of Shandong Province,Grant/Award Numbers:2021LCZX04,2021SFGC0501。

摘　　要：Background:Concurrent chemoradiotherapy(CCRT)is the standard treatment for locally advanced esophageal squamous cell carcinoma(ESCC).However,the optimal radiotherapy regimen,particularly in terms of total dose and planned range of irradiation field,remains unclear.This phase III clinical trial aimed to compare the survival benefits between different radiation doses and different target fields.Methods:This trial compared two aspects of radiation treatment,total dose and field,using a two-by-two factorial design.The high-dose(HD)group received 59.4 Gy radiation,and the standard-dose(SD)group received 50.4 Gy.The involved field irradiation(IFI)group and elective nodal irradiation(ENI)group adopted different irradiation ranges.The participants were assigned to one of the four groups(HD+ENI,HD+IFI,SD+ENI and SD+IFI).The primary endpoint was overall survival(OS),and the secondary endpoints included progressionfree survival(PFS).The synergy indexwas used to measure the interaction effect between dose and field.Results:The interaction analysis did not reveal significant synergistic effects between the dose and irradiation field.In comparison to the target field,patients in IFI or ENI showed similar OS(hazard ratio[HR]=0.99,95%CI:0.80-1.23,p=0.930)and PFS(HR=1.02,95%CI:0.82–1.25).TheHDtreatment did not show significantly prolonged OS compared with SD(HR=0.90,95%CI:0.72–1.11,p=0.318),but it suggested improved PFS(25.2 months to 18.0 months).Among the four groups,the HD+IFI group presented the best survival,while the SD+IFI group had the worst prognosis.No significant difference in the occurrence of severe adverse events was found in dose or field comparisons.Conclusions:IFI demonstrated similar treatment efficacy to ENI in CCRT of ESCC.The HD demonstrated improved PFS,but did not significantly improve OS.The dose escalation based on IFI(HD+IFI)showed better therapeutic efficacy than the current recommendation(SD+ENI)and is worth further validation.

关 键 词：clinical trial concurrent chemoradiotherapy elective nodal radiation esophageal squamous cell carcinoma high dose radiation involved field radiation overall survival standard dose radiation 

分 类 号：R735.1[医药卫生—肿瘤]