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

• Published in: Journal of clinical oncology Vol. 36; no. 27; pp. 2796 - 2803
• Main Authors: Yang, Hong, Liu, Hui, Chen, Yuping, Zhu, Chengchu, Fang, Wentao, Yu, Zhentao, Mao, Weimin, Xiang, Jiaqing, Han, Yongtao, Chen, Zhijian, Yang, Haihua, Wang, Jiaming, Pang, Qingsong, Zheng, Xiao, Yang, Huanjun, Li, Tao, Lordick, Florian, D’Journo, Xavier Benoit, Cerfolio, Robert J., Korst, Robert J., Novoa, Nuria M., Swanson, Scott J., Brunelli, Alessandro, Ismail, Mahmoud, Fernando, Hiran C., Zhang, Xu, Li, Qun, Wang, Geng, Chen, Baofu, Mao, Teng, Kong, Min, Guo, Xufeng, Lin, Ting, Liu, Mengzhong, Fu, Jianhua
• Format: Journal Article
• Language: English
• Published: United States American Society of Clinical Oncology 20.09.2018
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Chemoradiotherapy, Adjuvant - methods; Cisplatin - administration & dosage; Disease-Free Survival; Esophageal Neoplasms - mortality; Esophageal Neoplasms - therapy; Esophageal Squamous Cell Carcinoma - mortality; Esophageal Squamous Cell Carcinoma - therapy; Esophagectomy; Female; Humans; Incidence; Male; Middle Aged; Neoadjuvant Therapy - methods; ORIGINAL REPORTS; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Treatment Outcome; Vinorelbine - administration & dosage
• ISSN: 0732-183X; 1527-7755; 1527-7755
• DOI: 10.1200/JCO.2018.79.1483

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/m intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m IV day 1, or 25 mg/m 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.