草酸铂联合氟尿嘧啶同步放化疗治疗食管癌的临床研究

Oxaliplatin plus 5-Fluorouracil combined with Concurrent radiotherapy in patients with esophageal cancer

目的探讨草酸铂联合氟尿嘧啶同步放化疗治疗食管癌疗效及不良反应。方法对2002年4月至2003年6月确诊为食管癌患者62例随机分成两个治疗组,试验组(31例):6MV-X射线三野等中心照射,采用常规分割,总剂量为66～70Gy/33～35次/6～7周,草酸铂130mg/m2,d1,5-Fu500mg/m2,d1～5,每21天重复,共2个周期;对照组(31例):单纯放疗,照射方式同试验组,比较两组的近期疗效及1、2年生存率和不良反应发生率。结果62例均可评价疗效。试验组:缓解率(CR+PR)%:80.6%,中位生存时间(MST)17.7月,1、2年生存率为74%(23/31)、54.8%(17/31);对照组:缓解率71.0%(22/31),MST10.2月,1、2年生存率为48%(15/31)、29%(9/31)。不良反应主要是恶心、呕吐、白细胞下降及急性放射性食管炎,神经损害:对照组0%,试验组Ⅰ～Ⅲ级25.8%,两组发生率有统计学意义(P<0.05),其余不良反应发生率两组无统计学意义。结论放射治疗配合同期草酸铂联合氟尿嘧啶方案化疗治疗有望提高食管癌放疗疗效,不良反应较少。

Objective To contrast the efficacy and the adverse effects of Oxaliplatin plus 5-Fluorouracil combined with Concurrent radiotherapy with radiotherapy alone in patients with esophageal cancer .Methods From Apirl, 2002 to June,2003 ,total 62 patients were randomized into the two groups. Test group:31 patients with esophageal cancer were treated with Oxaliplatin 130mg/ m2,d1, 5-Fu 500mg/m2,d1～5 in the first and fourth week, combined with Concurrent radiotherapy.Control group: 31 patients were treated with radiotherapy alone. Radiotherapy was given by conventional schedule :200cGy perfraction ,5 times per week to total dose of (66～70) Gy/33～35F/6～7 W. The evaluation was performed after the of therapy.Results 62 patients had evaluable lesions. The CR +PR rate of the test group was 80.6%, MST was 17.7 months,the 1-?2-year survival rate was 74%,54.8%,respectively. The CR +PR rate of the control group was 71%, MST was 10.2 months , the 1-?2-year survival rate was 48%?29%, respectively. The main toxicities were GI discomfort, leukopenia and acute radiation-induced esophagitis.There were 25.8%patients with Ⅰ～Ⅲ grade nerve damage in the test group, but it was reversible.There was significant statistical difference between the two groups. Conclusions Oxaliplatin plus 5-Fluorouracil combined with Concurrent radiotherapy tends to increase overall survival rate compared with radiotherapy alone in patients with esophageal cancer ,and it has less adverse effect.