多西他赛对比表柔比星联合顺铂、亚叶酸钙和氟尿嘧啶一线治疗进展期胃癌的随机对照研究

Docetaxel versus epirubicin combined with cisplatin,leucovorin and fluorouracil for advanced gastric carcinoma as first line therapy:a randomized clinical trial

目的研究多西他赛(TXT)对比表柔比星(EPI)联合顺铂(DDP)、亚叶酸钙(LV)、氟尿嘧啶(5-FU)持续滴注一线治疗进展期胃癌的疗效和不良反应。方法 2005年1月至2007年1月,64例进展期胃癌住院患者按随机数字表随机分为DCF方案组和ECF方案组各32例。DCF方案组给予TXT、DDP、LV联合低剂量5-FU持续静脉滴注化疗;ECF组给予EPI、DDP、LV联合低剂量5-FU持续静脉滴注化疗,21天为1周期。至少完成2个周期化疗后评价两组的有效率、不良反应、疾病进展时间(TTP)和总生存时间(OS)。结果两组患者均可评价疗效。DCF方案组总有效率(ORR)为56.3%,ECF方案组为28.1%,两组差异有统计学意义(P=0.023);在TTP和OS方面DCF方案组均优于ECF方案组(P<0.05)。除过敏反应外,两组患者的不良反应均无统计学意义(P>0.05),两组均无3～4级过敏反应发生。结论三周方案TXT、DDP和LV联合低剂量5-FU静脉持续滴注治疗进展期胃癌疗效优于ECF方案,不良反应相似,值得进一步推广。

Objective To investigate the clinical efficacy and adverse events of docetaxel（TXT）versus epirubicin（EPI）combined with cisplatin（DDP）,leucovorin（LV）and continuous venous injection of fluorouracil（5-FU）on advanced gastric carcinoma as first line therapy.Methods From January 2005 to January 2007,sixty-four patients suffered from advanced gastric carcinoma were randomly divided into two groups：the DCF regimen group and the ECF regimen group with thirty-two cases in each group.Patients in the DCF regimen group were given TXT 60mg/m^2,d1,q3w;DDP 25mg/m^2,d1-d3,q3w;LV 200mg/m^2,d1-d2,q3w;5-FU 1000mg/m^2,46h,q3w.Patients in the ECF regimen group received were given EPI 50mg/m^2,d1,q3w;DDP 25mg/m^2,d1-d3,q3w;LV 200mg/m^2,d1-d2,q3w;5-FU 1000mg/m^2,46h,q3w.After at least two cycles,the complete response（CR）,partial response（PR）,overall response rate（OS）,adverse events,time to progression（TTP）,and overall survival（OS）were evaluated.Results The clinical efficacy could be evaluated in all patients.The ORR of the DCF regimen group was significantly higher than that of the ECF regimen group（56.3% vs.28.1%,P=0.023）.And the difference in quality of life,TTP,and OS between the two groups was also significant（P〈0.05）.The rates of adverse events were similar in the two groups except allergy,but there was no grade Ⅲ-Ⅳ allergy in both groups.Conclusion The clinical efficacy of DCF regimen is better than traditional ECF regimen for advanced gastric carcinoma,and the adverse events are similar except allergy.So we recommend DCF regimen as first line regimen for advanced gastric carcinoma.