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

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。

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

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.