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同期放化疗或单纯放疗治疗区域淋巴结肿大食管癌随机临床研究

Prospective Clinical Comparison of Concurrent Chemoradiotherapy or Radiotherapy Alone for Patients with N1 Esophageal Carcinoma

  • 摘要: 目的 比较同期放化疗与单纯放疗治疗区域淋巴结肿大食管癌的疗效和不良反应。 方法 自2002年8月~2005年8月,对130例区域淋巴结肿大的食管癌用信封法随机分成2组:同期放化组65例,单纯放疗组65例。两组放疗均采用三维适形(three-dimensional conformal radiotherapy,3DCRT)常规分割放射治疗,总剂量64~66Gy,同期放化疗组在放射治疗第1天起给予DF方案(奈达铂20 mg/m2,第1~4天,5-Fu 500mg/m2, 第1~4天)化疗,第29天重复,放疗期间化疗2周期,巩固化疗在放射治疗结束后第21天起按计划每28天给1周期DF方案化疗,共2周期。 结果 同期放化疗组1、2和3年总生存率分别为72.3%、55.3%和40%,单纯放疗组的1、2和3年总生存率分别为75.3%、38.5%和18.5%(P=0.007);两组的无病生存率分别为64.5%,41.5%,27.7%和61.5%,20%,7.7%(P=0.003);完成1~2周期化疗和完成3~4周期化疗的1、2和3年生存率分别为70%、53.3%、30%和74.2%、57.1%和48.6% (P=0.128);放疗组3年远处转移率高于放化疗组(16.9%和10.7%),但无统计学意义(P=0.31);同期放化疗组的2级以上急性放化疗副反应达到72.2%,而单纯放疗组只有29.2%(P=0.000);晚期放疗反应主要是放射性食管损伤和放射性肺/气管损伤,两组差异无统计学意义(P=0.366). 结论 同期放化疗治疗区域淋巴结肿大食管癌较单纯放疗可以提高3年生存率,完成3~4周期化疗似乎优于1~2周期,同期放化疗的急性反应明显高于单纯放疗。

     

    Abstract: Objective To compare the survival and toxicities of concurrent chemoradiotherapy or radiotherapy alone in patients with N1 esophageal carcinoma. Methods From August 2002 to August 2005, 130 eligible patients with N1 esophageal carcinoma were randomly divided into the following groups: sixty-five patients for concurrent chemoradiotherapy group, sixty-five patients for radiotherapy alone. The schedules of radiotherapy were the same, with 3-DCRT with conventional fractionation , total dose 64~66Gy. The regiment of chemotherapy were all consisted of NDP and 5-Fu, 4 cycles . Results The survival rates at 1-、2- and 3-years were 72.3%,55.3% and 40% in the concurrent chemoradiotherapy group,while the numbers were 75.3%,38.5% and 18.5% in the radiotherapy alone group (P =0.007).The patients in concurrent chemoradiotherapy group who completed 1~2 cycles and 3~ 4 cycles the survival rates at 1-,2- and 3-years were 70%,53.3%,30% and 74.2%,57.1%,48.6% (P=0.128),respectively; 3-year distant metastasis rates were 10.7% in concurrent chemoradiotherapy group, and 16.9% in radiotherapy alone group (P=0.31),respectively.Acute toxicity in concurrent chemoradiotherapy group was higher than radiotherapy alone group,and later toxicity were similar in two group. Conclusion Concurrent chemoradiotherapy increased severity acute toxicity, and could increase survival rate compared with radiotherapy alone in patient with N1 esophageal carcinoma, and the patients who completed 3~4 cycles seemed better than those completed 1~2 cycles.

     

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