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经右胸入路与经左胸入路治疗中下段食管鳞癌的前瞻性随机开放标签临床试验:3 年生存分析。

Extended Right Thoracic Approach Compared With Limited Left Thoracic Approach for Patients With Middle and Lower Esophageal Squamous Cell Carcinoma: Three-year Survival of a Prospective, Randomized, Open-label Trial.

机构信息

Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.

Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

出版信息

Ann Surg. 2018 May;267(5):826-832. doi: 10.1097/SLA.0000000000002280.

Abstract

OBJECTIVE

To investigate whether survival is improved by using the right thoracic approach (extended lymphadenectomy) compared with the left thoracic approach (limited lymphadenectomy) for esophageal cancer.

BACKGROUND

The optimal surgical technique for esophageal cancer remains unclear.

METHODS

Between May 2010 and July 2012, 300 patients with middle and lower thoracic esophageal carcinoma were randomized to receive esophagectomy through either the right or left thoracic approach. Of these, 286 patients with squamous cell carcinoma determined by postoperative pathology were included in this analysis. Disease-free survival (DFS) and overall survival (OS) were compared between the right (n = 146) and left thoracic groups (n = 140).

RESULTS

The median follow-up was 55.9 months [95% confidence interval (CI): 53.1-58.6]. The 3-year DFS rates were 62% and 52% in the right and left thoracic arms, respectively [hazard ratio (HR) 0.709; 95% CI, 0.506-0.995; P = 0.047, log-rank test]. The 3-year OS rates were 74% and 60%, respectively (HR, 0.663; 95% CI, 0.457-0.961; P = 0.029). Subgroup analyses revealed longer DFS in the right thoracic arm (vs left thoracic arm) in patients with lymph node involvement (HR, 0.632; 95% CI, 0.412-0.969, P = 0.034), but not in patients without lymph node involvement (HR, 0.757; 95% CI, 0.434-1.320, P = 0.325), and in patients with R1-2 resection margins (HR, 0.495; 95% CI, 0.290-0.848, P = 0.009), but not R0 margins (HR, 0.944; 95% CI, 0.603-1.477, P = 0.801).

CONCLUSIONS

Compared with the left thoracic approach, the right thoracic approach associated with increased DFS and OS in esophageal squamous cell carcinoma patients, particularly in those with lymph node involvement and/or R1-2 resection margins.

摘要

目的

研究对于食管癌,右胸入路(扩大淋巴结清扫术)相较于左胸入路(局限性淋巴结清扫术)是否能提高生存率。

背景

食管癌的最佳手术技术仍不明确。

方法

2010 年 5 月至 2012 年 7 月,300 例中下段食管鳞癌患者被随机分为右胸或左胸入路行食管癌切除术。术后病理证实为鳞癌的 286 例患者被纳入本分析。比较右胸组(n=146)和左胸组(n=140)的无病生存(DFS)和总生存(OS)。

结果

中位随访时间为 55.9 个月(95%置信区间[CI]:53.1-58.6)。右胸组和左胸组的 3 年 DFS 率分别为 62%和 52%(风险比[HR]0.709;95%CI:0.506-0.995;P=0.047,对数秩检验)。3 年 OS 率分别为 74%和 60%(HR,0.663;95%CI:0.457-0.961;P=0.029)。亚组分析显示,淋巴结受累患者右胸组(vs 左胸组)DFS 更长(HR,0.632;95%CI:0.412-0.969,P=0.034),而无淋巴结受累患者(HR,0.757;95%CI:0.434-1.320,P=0.325)和 R1-2 切缘(HR,0.495;95%CI:0.290-0.848,P=0.009)患者无差异,而 R0 切缘患者(HR,0.944;95%CI:0.603-1.477,P=0.801)DFS 无差异。

结论

与左胸入路相比,右胸入路增加了食管鳞癌患者的 DFS 和 OS,尤其是淋巴结受累和/或 R1-2 切缘患者。

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