FOLFOX4方案联合表柔比星治疗晚期胃癌的临床研究

Clinical research of advanced gastric cancer treated with epirubicin combined with FOLFOX4 regimen

目的:比较FOLFOX4方案联合表柔比星与FOLFOX4方案治疗晚期胃癌的疗效和不良反应。方法:103例晚期胃癌患者随机分2组,治疗组51例,采用FOLFOX4方案联合表柔比星化疗:表柔比星50mg/m2,静脉滴入,d1;草酸铂85mg/m2,持续静脉滴入2h,d1;亚叶酸钙200mg/m2,持续静脉滴入2h,d1、d2;继以氟尿嘧啶400mg/m2,静脉滴入,d1、d2,氟尿嘧啶600mg/m2,持续静脉泵输注22h,d1、d2。每3周为1个周期。对照组52例,采用FOLFOX4方案,每2周为1个周期。2个周期后进行全面评价。结果:治疗组与对照组的缓解率分别为49.0%(25/51)和42.3%(23/52),差异无统计学意义,P>0.05;1年生存率分别为43.0%和35.0%,差异无统计学意义,P>0.05;中位疾病进展时间(TTP)分别为6.5和5.3个月;主要的不良反应为骨髓抑制、轻度周围神经毒性、消化道反应和腹泻。结论:FOLFOX4方案联合表柔比星治疗晚期胃癌,相对FOL-FOX4方案具有一定优势,有进一步临床研究的价值。

OBJECTIVE：To evaluate the efficacy and toxicity of epirubicin combined with FOLFOX4 regimen versus FOLFOX4 regimen in the treatment of advanced gastric cancer.METHODS：A total of 103 cases with advanced gastric cancer were enrolled into two groups randomly.Epirubicin combined with FOLFOX4 regimen：EPI （50 mg/m^2,iv,d1）,L-OHP （85 mg/m^2,iv,2 h,d1） were given first,CF （200 mg/m^2,iv,2 h,d1,d2） followed by 5-FU （400 mg/m^2,iv,d1,d2） and 5-FU （600 mg/m^2,civ,22 h,d1,d2） were given.FOLFOX4 regimenwas repearted every 3 weeks.FOLFOX4 regimenwas repearted every 14 days.The effieaey was evaluated every 2 cycles.RESULTS：The response rate （RR） of epirubicin combined with FOLFOX4 regimen and FOLFOX4 regimen were 49.0%（25/51） and 42.3% （23/52）,respectively.There was no significant difference （P〉0.05）.The 1-year survival rates were 43.0% and 35.0%,respectively （P〉0.05）.Median time to tumor progression were 6.5 months and 5.3 months,respectively.Major toxicity was myelosuppression,enteric reaction,diarrhea and perineural toxicity.CONCLUSIONS：Epirubicin combined with FOLFOX4 regimen is better than FOLFOX4 regimen,its toxicity tolerable in treating advanced gastric cancer.It sworth further clinical research and application.