Objective: To determine whether 60 Gy is superior to standard 50 Gy for definitive concurrent chemoradiation(CCRT) in esophageal squamous cell carcinoma (ESCC) using modern radiation technology in a phase Ⅲ prospective randomized trial. Methods: From April 2013 to May 2017, 331 patients from 22 hospitals who were pathologically confirmed with stage ⅢA-ⅣA ESCC were randomized to 60 Gy or 50 Gy with random number table. Total of 305 patients were analyzed, including 152 in 60 Gy group and 153 in 50 Gy group. The median age was 63 years, 242(79.3%) males and 63(20.7%) females. The median length of primary tumor was 5.6 cm. The clinical characteristics between two groups were comparable. All patients were delivered 2 Gy per fraction, 5 fractions per week. Concurrent weekly chemotherapy with docetaxel (25 mg/m(2)) and cisplatin (25 mg/m(2)) and 2 cycles consolidation chemotherapy with docetaxel (70 mg/m(2)) and cisplatin (25 mg/m(2), d1-3) were administrated. The primary endpoint was local/regional progression-free survival (LRPFS). The data were compared with Pearson chi-square test or Fisher's exact test. Results: At a median follow-up of 27.3 months, the disease progression rate was 37.5% (57/152), 43.8% (67/153) in the high and standard-dose group, respectively (χ(2)=1.251, P=0.263). The 1, 2, 3-year LRPFS rate was 75.4%, 56.8%, 52.1% and 74.2%, 58.4%, 50.1%, respectively (HR: 0.95, 95%CI: 0.69-1.31, P=0.761). The 1, 2, 3-year overall survival rate was 84.1%, 64.8%, 54.1% and 85.4%, 62.9%, 54.0%, respectively (HR: 0.98, 95%CI: 0.71-1.38, P=0.927). The 1, 2, 3-year progression-free survival rate was 70.8%, 54.2%, 48.5% and 65.5%, 51.9%, 45.1%, respectively (HR: 0.93, 95%CI: 0.68-1.26, P=0.621). The incidence rates in toxicities between the two groups were similar except for higher rate of severe pneumonitis in high dose group (χ(2)=11.596, P=0.021). Conclusions: The efficacy in disease control is similar between 60 Gy and 50 Gy using modern radiation technology concurrent with chemotherapy for ESCC. The 50 Gy should be recommended as the regular radiation dose with CCRT for ESCC.
目的： 采用调强放疗（IMRT）技术进行食管鳞状细胞癌同步放化疗，比较60 Gy的放疗剂量是否优于国际标准的50 Gy。 方法： 2013年4月至2017年5月将来自22家医院的331例经病理证实的无法手术的ⅡA~ⅣA期食管鳞状细胞癌患者以随机数字表法分为60 Gy和50 Gy两组接受放疗。最后纳入可分析病例305例，其中60 Gy组152例，50 Gy组153例。中位年龄63岁，男242例（79.3%），女63例（20.7%）。原发灶中位长度5.6 cm。两组基础资料具有可比性。所有患者放疗2 Gy/次，每周5次。同步化疗5周，每周1次：多西紫杉醇（25 mg/m(2)）+顺铂（25 mg/m(2)）；巩固化疗2周期，3周重复：多西紫杉醇（70 mg/m(2)），d1+顺铂（25 mg/m(2)），d1~3。首要研究终点为局部区域无进展生存期（LRPFS）。两组分类变量比较采用Pearson χ(2)检验或Fisher精确检验。 结果： 中位随访27.3个月，60 Gy组疾病进展率为37.5%（57/152），50 Gy组为43.8%（67/153），组间差异无统计学意义（χ(2)=1.251，P=0.263）。60 Gy组和50 Gy组1、2、3年LRPFS分别为75.4%、56.8%、52.1%和74.2%、58.4%、50.1%（HR：0.95，95%CI：0.69~1.31，P=0.761）。两组1、2、3年总生存率分别为84.1%、64.8%、54.1%和85.4%、62.9%、54.0%（HR：0.98，95%CI：0.71~1.38，P=0.927）。两组1、2、3年无进展生存分别为70.8%、54.2%、48.5%和65.5%、51.9%、45.1%（HR：0.93，95%CI：0.68~1.26，P=0.621）。60 Gy组3级以上肺炎发生率为7.2%，50 Gy组为3.3%，组间差异有统计学意义（χ(2)=11.596，P=0.021），其他毒副作用两组相似。 结论： 同步放化疗模式治疗食管癌，50 Gy与60 Gy的疗效无差异，推荐50 Gy为常用放疗剂量。.
Keywords: Esophageal neoplasms; Prognosis; Radiation dose; Radiotherapy; Squamous cell carcinoma.