沙利度胺联合化疗治疗晚期胃癌的随机对照研究

目的评价奥沙利铂（L-OHP）＋替加氟（FT-207）＋亚叶酸钙（LV）联合沙利度胺治疗晚期胃癌的疗效和毒副反应。方法 43例符合入组条件的晚期胃癌患者随机分为治疗组和对照组。治疗组采用L-OHP＋FT-207＋LV方案联合沙利度胺治疗,对照组采用L-OHP＋FT-207＋LV方案化疗。结果治疗组和对照组的有效率分别为47.6%和36.4%,临床获益率分别为76.2%和68.2%,两组比较差异均无统计学意义（P均〉0.05）。治疗组的中位生存期优于对照组,但两组生存期的比较差异无统计学意义（P〉0.05）。两组患者治疗后生活质量（QOL）评分均有所提高,以治疗组提高最明显（P〈0.05）。治疗组恶心呕吐发生率较对照组低,差异有统计学意义（P〈0.05）,但治疗组嗜睡的发生率较对照组高,差异有统计学意义（P〈0.05）,其余副作用均相似。结论化疗联合沙利度胺能改善晚期胃癌患者的生活质量,耐受性好,疗效值得进一步研究。

A Randomized Trial of Thalidomide Combined with Chemotherapy for Advanced Gastric Cancer

Objective To evaluate the efficacy,side-effects and quality of life in the advanced gastric cancer patients treated by oxaliplatin（L-OHP）plus Tegafur（FT-207）and Leucovorin（LV）with thalidomide or without thalidomide.Methods Forth three eligible patients were randomly assigned to the treatment group and control group.In the treatment group,21 patients were treated with L-OHP＋FT-207＋LV＋thalidomide,while the patients in the control group omitted the oral intake of thalidomide.Results The response rate was 47.6% in the treatment group VS 36.4% in the control group（P〉0.05）.The clinically profited rate was 76.2% in the treatment group vs 68.2% in the control group（P〉0.05）.The median survival and the overall survival seen in the treatment group were higher than these in the control group,but there were no statistically significant difference between two groups（P〉0.05）.The scores of QOL in the two groups were both increased,but the increasing rate was significantly higher in the treatment group than that in control group（P〈0.05）.Vomiting was more pronounced in the control group（P〈0.05）.Drowsiness was more pronounced in the treatment group（P〈0.05）.Other toxicities were similar.Conclusion Thalidomide combined with chemotherapy regimen can improve the life quality of patients with advanced gastric cancer,and it is well tolerated in the treatment of advanced stomach carcinoma.It was necessary to conduct further clinical trials with to evaluate the effects of thalidomide combined with chemotherapy for advanced gastric cancer.