沙利度胺联合GP方案与GP方案治疗晚期非小细胞肺癌临床对照研究

The control clinical study on the treatment of advanced non-small cell lung cancer by TGP regimen and GP regimen

目的探讨沙利度胺联合GP方案治疗晚期非小细胞肺癌（NSCLC）的疗效、毒副反应及对生活质量的影响。方法 61例晚期NSCLC患者随机分为两组：吉西他滨联合顺铂及沙利度胺（TGP）组31例,吉西他滨联合顺铂（GP）组30例。TGP组：吉西他滨（GEM）1000mg/m^2,第1、8天;顺铂（DDP）20mg/m^2,第1-4天;沙利度胺200mg/d,第1-60天。GP组剂量同TGP组。21天为1周期,2周期后评价疗效。根据RECIST标准评价疗效,按WHO毒副反应标准评价毒副反应,按EORTCQLQ-L43量表评价患者的生活质量。结果 TGP组的有效率（CR＋PR）为45.1%,GP组有效率为40.0%,两组有效率比较,差异无统计学意义（P〉0.05）。TGP组和GP组中位生存时间（MST）分别为10.0和9.2个月,差异无统计学意义。两组1年生存率分别为35.4%和30.0%,差异无统计学意义。生活质量（EORTC QLQ-L43生活量表评价）：化疗后TGP组整体生活质量较GP组有显著提高、食欲明显增加,恶心呕吐发生率TGP组低于GP组（P〈0.05）,便秘的发生率明显增加（P〈0.05）,其余各项在两组化疗后均无明显差异。结论沙利度胺联合GP方案未能改善晚期NSCLC患者的近期有效率及生存期,但能改善患者化疗期间的生活质量而不增加毒副反应。

Objective To evaluate the efficacy and toxicity of thalidomide combined with gemcitabine and cisplatin（TGP regimen）,record the quality of life for patients with non-small cell lung cancer（NSCLC）.Methods Thirty-one advanced NSCLC patients were treated with TGP regimen,while the other 30 advanced NSCLC patients were treated with GP regimen.TGP regimen was taken as follow： gemcitabine 1000mg/m^2,d1,d8;cisplatin 20mg/m^2,d1-d4;thalidomide 200mg/d,for 2 months.The dosage of GP regimen was the same to TGP regimen.The efficacy and toxicity were evaluated after two treatment cycles.Quality of life was evaluated by EORTC QLQ-L43 scale.Results The overall response rates of TGP group and GP group were 45.1% and 40.0%,respectively,and the median survival time were 10.0 months and 9.2 months,respectively（P〉0.05）.The one-year survival rates of TGP group and GP group were 35.4% and 30.0%,respectively（P=0.427）.The overall life quality was significantly improved in the TGP group.The incidence of nausea and vomiting in TGP group was less than GP group（P〈0.05）.However,the incidence of constipation in TGP group was more often than GP group（P〈0.05）.Conclusion The TGP regimen can not improve the recent response rate and survival time for advanced NSCLC patients,but can improve the quality of life during the chemotherapy without increasing toxicity.