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.
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.
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DOI：
10.1200/jco.2018.79.1483
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发表时间：
2018-09-20
期刊：
影响因子：
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通讯作者：
AME Thoracic Surgery Collaborative Group
中科院分区：
文献类型：
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作者：
Yang H;Liu H;Chen Y;Zhu C;Fang W;Yu Z;Mao W;Xiang J;Han Y;Chen Z;Yang H;Wang J;Pang Q;Zheng X;Yang H;Li T;Lordick F;D'Journo XB;Cerfolio RJ;Korst RJ;Novoa NM;Swanson SJ;Brunelli A;Ismail M;Fernando HC;Zhang X;Li Q;Wang G;Chen B;Mao T;Kong M;Guo X;Lin T;Liu M;Fu J;AME Thoracic Surgery Collaborative Group
新辅助放化疗（NCRT）联合手术治疗局部晚期食管鳞状细胞癌（ESCC）的疗效仍存在争议。在这项试验中，我们比较了NCRT加手术与单纯手术治疗局部晚期食管鳞癌患者的生存率和安全性。从2007年6月至2014年12月，451例临床分期为T1- 4 N1 M0/T4 N 0 M0的可能可切除胸段ESCC患者被随机分配至NCRT+手术组（CRT组; n = 224）和单纯手术组（S组; n = 227）。CRT组：长春瑞滨25 mg/m2静脉注射，第1、8天;顺铂75 mg/m2静脉注射，第1天或25 mg/m2静脉注射，第1 ~ 4天，每3周1次，共2个周期。放疗总剂量为40.0戈伊，分20次，每次2.0戈伊，每周5天。两组患者均接受McKeown或Ivor刘易斯食管切除术。主要终点是总生存期。CRT组病理完全缓解率为43.2%。与S组相比，CRT组R 0切除率较高（98.4% vs91.2%; P = .002），中位总生存期更好（100.1个月vs 66.5个月;风险比，0.71; 95% CI，0.53 - 0.96; P = 0.025），无病生存期延长（100.1个月vs 41.7个月;风险比，0.58; 95% CI，0.43 - 0.78; P < .001）。白细胞减少症（48.9%）和中性粒细胞减少症（45.7%）是放化疗期间最常见的3级或4级不良事件。除心律失常外，两组的术后并发症发生率相似（CRT组：13% vs S组：4.0%; P = 0.001）。CRT组围手术期死亡率为2.2%，S组为0.4%（P = 0.212）。该试验表明，NCRT加手术治疗可提高局部晚期ESCC患者的生存率，且不良事件可接受且可管理。
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. 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. 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). This trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events.