Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy for locally advanced esophageal squamous cell carcinoma: a prospective multicenter randomized clinical trial

作者全名："Tang, H.; Wang, H.; Fang, Y.; Zhu, J. Y.; Yin, J.; Shen, Y. X.; Zeng, Z. C.; Xiang, D. X.; Hou, Y. Y.; Du, M.; Lian, C. H.; Zhao, Q.; Jiang, H. J.; Gong, L.; Li, Z. G.; Liu, J.; Xie, D. Y.; Li, W. F.; Chen, C.; Zheng, B.; Chen, K. N.; Dai, L.; Liao, Y. D.; Li, K.; Li, H. C.; Zhao, N. Q.; Tan, L. J."

作者地址："[Tang, H.; Wang, H.; Fang, Y.; Yin, J.; Shen, Y. X.; Tan, L. J.] Fudan Univ, Zhongshan Hosp, Dept Thorac Surg, Shanghai, Peoples R China; [Tang, H.; Wang, H.; Fang, Y.; Zhu, J. Y.; Yin, J.; Shen, Y. X.; Zeng, Z. C.; Xiang, D. X.; Hou, Y. Y.; Tan, L. J.] Fudan Univ, Zhongshan Hosp, Canc Ctr, Shanghai, Peoples R China; [Zhu, J. Y.; Zeng, Z. C.; Chen, C.; Zheng, B.] Fudan Univ, Zhongshan Hosp, Dept Radiotherapy, Shanghai, Peoples R China; [Xiang, D. X.; Hou, Y. Y.] Fudan Univ, Zhongshan Hosp, Dept Pathol, Shanghai, Peoples R China; [Du, M.] Chongqing Med Univ, Affiliated Hosp 1, Dept Cardiothorac Surg, Chongqing, Peoples R China; [Zhao, Q.] Heping Hosp, Changzhi Med Coll, Dept Gen Surg, Changzhi, Peoples R China; [Jiang, H. J.] Tianjin Med Univ Canc Inst & Hosp, Minimally Invas Esophageal Surg, Tianjin, Peoples R China; [Gong, L.] Tianjin Med Univ Canc Inst & Hosp, Esophageal Canc, Tianjin, Peoples R China; [Li, Z. G.] Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Thorac Surg, Shanghai, Peoples R China; [Liu, J.] Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Radiotherapy, Shanghai, Peoples R China; [Xie, D. Y.] Wenzhou Med Univ, Affiliated Hosp 1, Dept Thorac Surg, Wenzhou, Peoples R China; [Li, W. F.] Wenzhou Med Univ, Affiliated Hosp 1, Radiat Oncol, Wenzhou, Peoples R China; [Chen, C.; Zheng, B.] Fujian Med Univ Union Hosp, Dept Thorac Surg, Fuzhou, Peoples R China; [Chen, K. N.; Dai, L.] Peking Univ, Sch Oncol, Dept Thorac Surg 1, Key Lab Carcinogenesis & Translat Res,Minist Educ,, Beijing, Peoples R China; [Liao, Y. D.; Li, K.] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Thorac Surg, Wuhan, Peoples R China; [Li, H. C.] Shanghai Jiao Tong Univ, Ruijin Hosp, Dept Thorac Surg, Sch Med, Shanghai, Peoples R China; [Zhao, N. Q.] Fudan Univ, Sch Publ Hlth, Dept Biostat, Shanghai, Peoples R China; [Tan, L. J.] Fudan Univ, Zhongshan Hosp, Dept Thorac Surg, 180 Fenglin Rd, Shanghai 200032, Peoples R China"

通信作者："Tan, LJ (通讯作者)，Fudan Univ, Zhongshan Hosp, Dept Thorac Surg, 180 Fenglin Rd, Shanghai 200032, Peoples R China."

来源：ANNALS OF ONCOLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000930673700001

JCR分区：Q1

影响因子：50.5

年份：2023

卷号：34

期号：2

开始页：163

结束页：172

文献类型：Article

关键词：neoadjuvant chemoradiotherapy; neoadjuvant chemotherapy; esophageal squamous cell carcinoma; minimally invasive esophagectomy; survival

摘要："Background: Neoadjuvant therapy is recommended for locally advanced esophageal cancer, but the optimal strategy remains unclear. We aimed to evaluate the safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) versus neoadjuvant chemotherapy (nCT) followed by minimally invasive esophagectomy (MIE) for locally advanced esophageal squamous cell carcinoma (ESCC). Patients and methods: Eligible patients staged as cT3-4aN0-1M0 ESCC were randomly assigned (1 : 1) to the nCRT or nCT group stratified by age, cN stage, and centers. The chemotherapy, based on paclitaxel and cisplatin, was administered to both groups, while concurrent radiotherapy was added for the nCRT group; then MIE was carried out. The primary endpoint was 3-year overall survival. This study is registered with ClinicalTrials.gov (NCT03001596). Results: A total of 264 patients were eligible for the intention-to-treat analysis. By 30 November 2021, 121 deaths had occurred. The median follow-up was 43.9 months (interquartile range 36.6-49.3 months). The overall survival in the intention-to-treat population was comparable between the nCRT and nCT strategies [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.58-1.18; P = 0.28], with a 3-year survival rate of 64.1% (95% CI 56.4% to 72.9%) versus 54.9% (95% CI 47.0% to 64.2%), respectively. There were also no differences in progression-free survival (HR 0.83, 95% CI 0.59-1.16; P = 0.27) and recurrence-free survival (HR 1.07, 95% CI 0.71-1.60; P = 0.75), although the pathological complete response in the nCRT group (31/112, 27.7%) was significantly higher than that in the nCT group (3/104, 2.9%; P < 0.001). Besides, a trend of lower risk of recurrence was observed in the nCRT group (P = 0.063), while the recurrence pattern was similar (P = 0.802). Conclusions: NCRT followed by MIE was not associated with significantly better overall survival than nCT among patients with cT3-4aN0-1M0 ESCC. The results underscore the pending issue of the best strategy of neoadjuvant for advanced ESCC."

基金机构："National Natural Science Foundation of China, China [81902396]; Science and Technology Commission of Shanghai Municipality, China [16411965900]; Zhongshan Hospital, Fudan University, China [2016ZSLC15, 2021ZSYQ27]"

基金资助正文："This work was supported by National Natural Science Foundation of China, China [grant number 81902396]; Science and Technology Commission of Shanghai Municipality, China [grant number 16411965900]; Zhongshan Hospital, Fudan University, China [grant numbers 2016ZSLC15 and 2021ZSYQ27]; respectively."