后程加速超分割放疗中胸段食管癌临床Ⅲ期试验

Late course accelerated hyperfractionation radiotherapy (LCAHR) for middle esophageal carcinoma:clinical phase Ⅲ trial

目的采用前瞻随机性研究，探讨后程加速超分割放疗（ｌａｔｅｃｏｕｒｓｅａｃｃｅｌｅｒａｔｅｄｈｙｐｅｒｆｒａｃｔｉｏｎａｔｉｏｎｒａｄｉｏｔｈｅｒａｐｙ，ＬＣＡＨＲ）能否提高中胸段食管癌疗效。材料与方法１９９２年４月到１９９４年６月，１０４例中胸段食管癌经分层随机分加速超分割治疗组（Ｅ组）５１例，常规治疗组（Ｃ组）５３例，两组患者一般临床资料差异无统计学意义。放射总剂量Ｅ组：６５．６±１．９Ｇｙ，照射３６（３４～３８）次／３８（３６～４７）天；Ｃ组：总剂量６６．０±１．３Ｇｙ，照射３３（３２～３４）次／４５（４３～５０）天。结果急性放射性食管炎Ｅ组８８％，Ｃ组７２％（Ｐ＝０．０１５）。Ｅ组在不同随访期有２例死于食管大出血，１例出现放射性肺炎。１，２，３年局控率Ｅ组为７８％、５７％、４３％而Ｃ组为５８％、３６％、２６％（Ｐ＝０．０４７）；１，２，３年生存率Ｅ组为７５％、５１％、４１％而Ｃ组为５６％、３６％、２３％（Ｐ＝０．０４２）。结论（１）后程加速超分割放疗能为患者耐受。（２）后程加速超分割放疗提高了局控及生存率。

Purpose To evaluated if LCAHR could improve the treatment result for middle esophageal carcinoma by clinical randomized trial prospectively.Materials and Methods From April,1992 to June,1994,one hundred and four patients with middle esophageal carcinoma enrolled the study. They were divided into two groups by stractified randomization: late course accelerated hyperfractionation radiotherapy (E group) 51 cases,conventional treatment group (C group) 53 cases. There was no significantly difference about clinical characteristics between two groups. Total dose of 65.6±1.9Gy/36(34～38)fx/38(36～47)days were given to E group,66.0±1.3Gy/33(32～34)fx/45(43～50)days to C group.Results The acute esophagitis was more sever in E group than that in C group (88% vs 72%,P=0.015). There were two esophageal bleeding and one pneumonitis in E group during followup period. The local control rates at 1,2 and 3 year were 78%,57% and 43% in E group, and 58%,36,and 26% in C group ,respectively(P=0.047). The survival rates at 1,2 and 3 year were 75%,51% and 41% in E group and 56%,36% and 23% in C group, respectively (P=0.042).Conclusion (1)LCHAR can be tolerated by most patients with esophageal carcinoma.(2)LCAHR gives better survival and local control rates.