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.

J Clin Oncol 2018 09 8;36(27):2796-2803. Epub 2018 Aug 8.

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 Province; Wentao Fang, Jiaming Wang, Teng Mao, and Xufeng Guo, Shanghai Chest Hospital, Shanghai Jiaotong University; Jiaqing Xiang and Huanjun Yang, Fudan University Shanghai Cancer Center, Shanghai; Zhentao Yu and Qingsong Pang, Tianjin Medical University Cancer Hospital, Tianjin; Yongtao Han and Tao Li, Sichuan Cancer Hospital, Chengdu, Sichuan Province, China; Florian Lordick, University Cancer Center Leipzig, University Medicine Leipzig, Leipzig; Mahmoud Ismail, Academic Hospital of the Charité - Universitätsmedizin, Humboldt University Berlin, Berlin, Germany; Xavier Benoit D'Journo, Aix-Marseille University, Hôpital Nord, Chemin des Bourrely, Marseille Cedex, France; Robert J. Cerfolio, New York University Langone Health; Robert J. Korst, Icahn School of Medicine, Mount Sinai Health System, New York, NY; Robert J. Korst, Valley/Mount Sinai Comprehensive Cancer Care, Paramus, NJ; Nuria M. Novoa, University Hospital of Salamanca, Paseo de San Vicente, Salamanca, Spain; Scott J. Swanson, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Alessandro Brunelli, St James's University Hospital, Leeds, United Kingdom; and Hiran C. Fernando, Inova Fairfax Medical Center, Inova Schar Cancer Institute, Falls Church, VA.

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.

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http://dx.doi.org/10.1200/JCO.2018.79.1483DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145832PMC
September 2018
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