大分割和常规分割放疗联合化疗治疗食管癌术后气管食管沟淋巴结转移的随机对照研究

A randomized controlled study of hypofractionated radiotherapy and conventional fractionated radiotherapy combined with chemotherapy in the treatment of postoperative tracheoesophageal groove lymph node metastasis

目的 探讨大分割放疗（HFR）联合紫杉醇周剂量化疗治疗食管癌术后气管食管沟淋巴结（TGLN）的安全性和疗效。方法 将53例食管癌术后单纯TGLN转移的患者随机抛硬币法分为两组，大分割组25例采用60 Gy/20次放疗，常规分割组28例采用60 Gy/30次放疗，两组患者放疗同时均采用紫杉醇 50 mg周剂量化疗。比较两种不同分割方式对不良反应及预后的影响。结果大分割组和常规分割组患者3-4级放射性食管炎、肺炎发生率分别为44.0%、16.0%和25.0%、7.1%，两组比较差异无统计学意义（P〉0.05）。两组近期有效率比较，差异无统计学意义（P〉0.05）。淋巴结转移灶直径≤2 cm患者近期有效率高于淋巴结转移灶直径〉2 cm的患者（P〈0.05）。大分割组和常规分割组中位总生存期（OS）分别为24.2个月（95%CI 16.2-32.1）和11.8个月（95%CI 9.2-14.4），两组比较差异有统计学意义（χ^2=5.063，P〈0.05）。单因素和多因素分析均显示淋巴结直径和分割方式是影响患者预后的因素（P〈0.05）。结论 大分割放疗联合紫杉醇周剂量化疗治疗食管癌术后气管食管沟淋巴结较常规分割提高了患者预后，且治疗并发症未明显增加。

Objective To investigate the efficiency and safety of hypofractionated radiotherapy （HFR） combined with chemotherapy using paclitaxel for the treatment of esophageal cancer （EC） patients with post-operative tracheoesophageal groove lymph node （TGLN） metastasis. Methods A total of fifty-three post-operative EC patients with TGLN metastasis were randomly divided into HFR group （n=25）, receiving a radiation of 60 Gy/20 fractions, and conventional fractionated radiotherapy （CFR） group （n=28）, receiving a radiation of 60 Gy/30 fractions combined with chemotherapy using paclitaxel with a dosage of 50 mg once per week through tossing a coin. the adverse events and the prognosis between two groups were compared. Results The incidence of radiation esophagitis and pneumonitis （grade 3-4） between the HFR group and CFR group showed no statistically significant difference （44.0%, 25.0%, P〉0.05; 16.0%, 7.1%, P〉0.05）. No statistical difference was noticed in the efficiency between the HFR group and the CFR group （P〉0.05）. The efficiency in patients with lymph node metastasis at diameters ≤ 2 cm was significantly higher than that with lymph node metastasis at diameters 〉2 cm （P〈0.05）. The median overall survival （OS） of the HFR group showed a significant increase compared with that of the CRF group[24.2 months （95%CI 16.2-32.1 months） vs. 11.8 months （95%CI 9.2-14.4 months）] （χ^2=5.063,P〈0.05）. Both univariate and multivariate analysis indicated that TGLN diameter （P〈0.05） and fractioned types （P〈0.05） were factors that affected the prognosis. Conclusions The combination of HFR and chemotherapy contributed to the improvement of prognosis in EC patients with TGLN metastasis and there was no obvious increase in the adverse events.