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.
J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8.
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.
目的 新辅助放化疗（NCRT）加手术治疗局部晚期食管鳞状细胞癌（ESCC）的疗效仍存在争议。本试验旨在比较局部晚期 ESCC 患者接受 NCRT 加手术与单纯手术治疗的生存和安全性。
患者和方法 2007 年 6 月至 2014 年 12 月，451 例有潜在可切除性胸段 ESCC、临床分期为 T1-4N1M0/T4N0M0 的患者被随机分配至 NCRT 加手术组（CRT 组，n = 224）和单纯手术组（S 组，n = 227）。在 CRT 组中，患者接受长春瑞滨 25 mg/m 静脉注射（IV）于第 1 天和第 8 天，顺铂 75 mg/m IV 第 1 天，或 25 mg/m IV 于第 1 天至第 4 天，每 3 周一次，共 2 个周期，同期放疗总剂量为 40.0 Gy，每周 5 天，每天 2.0 Gy，共 20 次。两组患者均行 McKeown 或 Ivor Lewis 食管切除术。主要终点为总生存。
结果 CRT 组病理完全缓解率为 43.2%。与 S 组相比，CRT 组的 R0 切除率更高（98.4%比 91.2%；P =.002），中位总生存时间更长（100.1 个月比 66.5 个月；风险比，0.71；95%置信区间，0.53 至 0.96；P =.025），无病生存时间也更长（100.1 个月比 41.7 个月；风险比，0.58；95%置信区间，0.43 至 0.78；P <.001）。放化疗期间最常见的 3 级或 4 级不良事件为白细胞减少（48.9%）和中性粒细胞减少（45.7%）。两组术后并发症发生率相似，但心律失常除外（CRT 组：13%比 S 组：4.0%；P =.001）。CRT 组围手术期死亡率为 2.2%，S 组为 0.4%（P =.212）。
结论 本试验表明，与单纯手术相比，NCRT 加手术可改善局部晚期 ESCC 患者的生存，且不良事件可接受且易于管理。
