Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Oncologist. 2020 Apr;25(4):e701-e708. doi: 10.1634/theoncologist.2019-0276. Epub 2020 Feb 21.
The role of postoperative radiotherapy in pathological T2-3N0M0 esophageal squamous cell carcinoma is unknown. We aimed to evaluate the efficacy and safety of postoperative radiotherapy in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma.
Patients aged 18-72 years with pathological stage T2-3N0M0 esophageal squamous cell carcinoma after radical surgery and without neoadjuvant therapy were eligible. Patients were randomly assigned to surgery alone or to receive postoperative radiotherapy of 50.4 Gy in supraclavicular field and 56 Gy in mediastinal field in 28 fractions over 6 weeks. The primary endpoint was disease-free survival. The secondary endpoints were local-regional recurrence rate, overall survival, and radiation-related toxicities.
From October 2012 to February 2018, 167 patients were enrolled in this study. We analyzed 157 patients whose follow-up time was more than 1 year or who had died. The median follow-up time was 45.6 months. The 3-year disease-free survival rates were 75.1% (95% confidence interval [CI] 65.9-85.5) in the postoperative radiotherapy group and 58.7% (95% CI 48.2-71.5) in the surgery group (hazard ratio 0.53, 95% CI 0.30-0.94, p = .030). Local-regional recurrence rate decreased significantly in the radiotherapy group (10.0% vs. 32.5% in the surgery group, p = .001). The overall survival and distant metastasis rates were not significantly different between two groups. Grade 3 toxicity rate related to radiotherapy was 12.5%.
Postoperative radiotherapy significantly increased disease-free survival and decreased local regional recurrence rate in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma with acceptable toxicities in this interim analysis. Further enrollment and follow-up are warranted to validate these findings in this ongoing trial.
The value of adjuvant radiotherapy for patients with node-negative esophageal cancer is not clear. The interim results of this phase III study indicated that postoperative radiotherapy significantly improved disease-free survival and decreased local-regional recurrence rate in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma compared with surgery alone with acceptable toxicities. The distant metastasis rates and overall survival rates were not different between the two groups. Adjuvant radiotherapy should be considered for pathologic T2-3N0M0 thoracic esophageal squamous cell carcinoma. Prospective trials to identify high-risk subgroups are needed.
术后放疗在病理 T2-3N0M0 食管鳞癌中的作用尚不清楚。本研究旨在评估术后放疗在病理 T2-3N0M0 胸段食管鳞癌患者中的疗效和安全性。
纳入标准为年龄 18-72 岁，根治性手术后病理分期为 T2-3N0M0 的食管鳞癌，且无新辅助治疗。患者被随机分配至单纯手术组或术后放疗组，术后放疗采用锁骨上野 50.4 Gy 和纵隔野 56 Gy，28 次，6 周完成。主要研究终点为无病生存。次要研究终点为局部区域复发率、总生存率和放疗相关毒性。
2012 年 10 月至 2018 年 2 月，共 167 例患者入组本研究。其中 157 例患者的随访时间超过 1 年或已死亡，中位随访时间为 45.6 个月。术后放疗组的 3 年无病生存率为 75.1%（95%可信区间[CI] 65.9%-85.5%），手术组为 58.7%（95% CI 48.2%-71.5%）（风险比 0.53，95% CI 0.30-0.94，p =.030）。放疗组局部区域复发率显著降低（10.0% vs. 手术组 32.5%，p =.001）。两组总生存率和远处转移率无显著差异。与放疗相关的 3 级毒性发生率为 12.5%。
在本中期分析中，对于病理 T2-3N0M0 胸段食管鳞癌患者，术后放疗显著提高了无病生存率，降低了局部区域复发率，且毒性可接受。在这项正在进行的试验中，需要进一步入组和随访来验证这些发现。
对于淋巴结阴性食管癌患者，辅助放疗的价值尚不清楚。本 III 期研究的中期结果表明，与单纯手术相比，术后放疗显著提高了病理 T2-3N0M0 胸段食管鳞癌患者的无病生存率，并降低了局部区域复发率，且毒性可接受。两组的远处转移率和总生存率无差异。对于病理 T2-3N0M0 胸段食管鳞癌，应考虑辅助放疗。需要进行前瞻性试验以确定高危亚组。
