Oncol Res. 2017 Sep 21;25(8):1357-1362. doi: 10.3727/096504017X14889842609577. Epub 2017 Mar 8.
The aim of this study was to evaluate the efficacy and toxicity of intensity-modulated radiotherapy concurrent with weekly docetaxel in patients with node-positive esophageal squamous cell carcinoma after radical surgery. Between January 2011 and December 2013, a total of 46 eligible patients were enrolled. All patients received intensity-modulated radiotherapy concurrent with weekly docetaxel (20 mg/m2). Patients were treated 5 days per week at 2.0 Gy/day. The total dose of external radiotherapy given was 50 Gy in 25 fractions. The primary endpoints included treatment completion and safety. The secondary endpoint was to assess whether the approach would achieve a 1-year survival rate of 80% or higher. The median duration of follow-up was 18 months (range: 2-41 months). The 1-year overall survival and progression-free survival rate were 91.2% and 80.4%, respectively. The major acute toxicities were esophagitis and neutropenia. While most cases were grade 1 or 2, grade 3 neutropenia and esophagitis were observed in seven (15.2%) and five patients (10.9%), respectively. The toxicities were controllable and transitory. There were no unexpected cases of serious adverse events or treatment-related deaths. Our study confirms that intensity-modulated radiotherapy with concurrent weekly docetaxel is an effective and safe treatment in postoperative node-positive patients with esophageal squamous cell carcinoma. The identified treatment regimen is of interest for a phase III trial.
本研究旨在评估根治术后淋巴结阳性食管鳞癌患者调强放疗同步每周多西紫杉醇的疗效和毒性。2011 年 1 月至 2013 年 12 月，共纳入 46 例符合条件的患者。所有患者均接受调强放疗同步每周多西紫杉醇（20mg/m2）治疗。患者每周 5 天，每天 2.0Gy。外照射总剂量为 50Gy，共 25 次。主要终点包括治疗完成情况和安全性。次要终点是评估该方法是否能达到 1 年生存率 80%以上。中位随访时间为 18 个月（范围：2-41 个月）。1 年总生存率和无进展生存率分别为 91.2%和 80.4%。主要急性毒性为食管炎和中性粒细胞减少症。虽然大多数病例为 1 级或 2 级，但 7 例（15.2%）和 5 例（10.9%）患者出现 3 级中性粒细胞减少症和食管炎。毒性是可控和短暂的。没有发生严重不良事件或治疗相关死亡的意外情况。本研究证实，调强放疗同步每周多西紫杉醇治疗术后淋巴结阳性食管鳞癌患者是一种有效且安全的治疗方法。该治疗方案具有开展 III 期临床试验的价值。
