Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial

Author:

Yang Hong1,Liu Hui1,Chen Yuping1,Zhu Chengchu1,Fang Wentao1,Yu Zhentao1,Mao Weimin1,Xiang Jiaqing1,Han Yongtao1,Chen Zhijian1,Yang Haihua1,Wang Jiaming1,Pang Qingsong1,Zheng Xiao1,Yang Huanjun1,Li Tao1,Lordick Florian1,D’Journo Xavier Benoit1,Cerfolio Robert J.1,Korst Robert J.1,Novoa Nuria M.1,Swanson Scott J.1,Brunelli Alessandro1,Ismail Mahmoud1,Fernando Hiran C.1,Zhang Xu1,Li Qun1,Wang Geng1,Chen Baofu1,Mao Teng1,Kong Min1,Guo Xufeng1,Lin Ting1,Liu Mengzhong1,Fu Jianhua1,

Affiliation:

1. Hong Yang, Hui Liu, Xu Zhang, Qun Li, Ting Lin, Mengzhong Liu, and Jianhua Fu, Sun Yat-sen University Cancer Center, Guangzhou; Yuping Chen, Zhijian Chen, and Geng Wang, Cancer Hospital of Shantou University Medical College, Shantou; Zhijian Chen, The University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong Province; Chengchu Zhu, Haihua Yang, Baofu Chen, and Min Kong, Taizhou Hospital, Wenzhou Medical University, Linhai; Weimin Mao and Xiao Zheng, Zhejiang Cancer Hospital, Hangzhou, Zhejiang...

Abstract

Purpose The efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC. Patients and Methods From June 2007 to December 2014, 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0, were randomly allocated to NCRT plus surgery (group CRT; n = 224) and surgery alone (group S; n = 227). In group CRT, patients received vinorelbine 25 mg/m2 intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m2 IV day 1, or 25 mg/m2 IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week. In both groups, patients underwent McKeown or Ivor Lewis esophagectomy. The primary end point was overall survival. Results The pathologic complete response rate was 43.2% in group CRT. Compared with group S, group CRT had a higher R0 resection rate (98.4% v 91.2%; P = .002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P = .025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001). Leukopenia (48.9%) and neutropenia (45.7%) were the most common grade 3 or 4 adverse events during chemoradiotherapy. Incidences of postoperative complications were similar between groups, with the exception of arrhythmia (group CRT: 13% v group S: 4.0%; P = .001). Peritreatment mortality was 2.2% in group CRT versus 0.4% in group S ( P = .212). Conclusion This trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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