TOX方案与FOLFOX4方案治疗晚期胃癌的随机对照临床观察

A randomized clinical study of docetaxel and capecitabine plus oxaliplatin compared with flurouracil/leucovorin plus oxaliplatin in the treatment of advanced gastric cancer

目的:观察比较TOX方案(多西紫杉醇联合卡培他滨、奥沙利铂)和FOLFOX4方案(氟尿嘧啶/四氢叶酸联合奥沙利铂)治疗晚期胃癌的临床疗效和不良反应,方法:50例晚期胃癌患者随机分成两组,TOX组26例,用多西紫杉醇联合奥沙利铂及卡培他滨化疗,多西紫杉醇35mg/m2,静脉滴注,第1天及第8天;奥沙利铂50mg/m2,静脉滴注,第1天及第8天;卡培他滨750mg/m2,口服,每日2次,第1天至14天;3周为1周期。FOLFOX4组24例,用氟尿嘧啶/亚叶酸钙联合奥沙利铂方案化疗,奥沙利铂85mg/m2,静脉滴注2h,第1天;亚叶酸钙200mg/m2,静滴2h后予氟尿嘧啶400mg/m2,推注,后续600mg/m2,持续静滴22h,第1、2天;每2周重复,4周为1周期。两组均治疗2周期以上,按WHO标准评价客观疗效和不良反应。结果:入组的50例均可评价疗效,TOX组有效率61.5%,中位TTP7.0个月,MST12.8个月,FOLFOX4组有效率50.0%,中位TTP5.8个月,MST10.8个月。不良反应比较,III/IV级恶心呕吐发生率以FOLFOX4组显著(P<0.05),手足综合征以TOX组显著(P<0.05),其余不良反应发生率差异无统计学意义。结论:TOX方案与FOLFOX4方案治疗晚期胃癌疗效确切,不良反应均能耐受。两组比较以TOX方案疗效略高,III-IV级恶心呕吐发生率低,更易耐受。

Objective：To evaluate the efficacy and toxicity of docetaxel plus oxaliplatine and capecitabine regimen （TOX） versus fluorouracil/lencovorin （LV5FU2）plus oxaliplatin regimen （FOLFOX4）in the treatment of advanced gastric cancer. Methods ： Fifty cases with advanced gastric cancer were enrolled in this study, randomly divided into TOX group （26 cases） and FOLOX4 group （24 cases）. TOX group was treatecl with docetaxel 35mg/m^2 ,ivqtt,d1,8; oxaliplatin 50mg/m^2, ivqtt, d1,8 ; capecitabine 750mg/m^2, po, bid, d1- 14. FOLFOX4 group was treated with oxaliplatin 85mg/m^2, ivqtt, d1 ;LV200mg/m^2, ivqtt ,2hr followed by 5 - FU 400mg/m^2 （bolus） and 5 - FU 600mg/m^2 （ 22hr - continus infusion d1-2 ）. TOX regimen was repeated every 3 weeks for one cycle. FOLFOX4 regimen was repeated every 2 weeks,4 weeks for one cycle. All patients received two cycles of chemotherapy at least. The efficacy and toxicity were evaluated according to WHO standard. Results：All 50 eases were evaluable for objective response. The overall response rate was 61.5% （3 CR, 13 PR）in TOX group of 26 cases and 50.0 % （2 CR, 10 PR）in FOLFOX4 group of 24 cases. The median time to proqression （mTFP） was 7.0 months in TOX group and 5.8 months in FOLFLX4 group. The medion survial time （MST） was 12.8 months in TOX group and 10.8 months in FOLFOX4 group. Condusion： Both of the two regimens were feasible, well tolerated and effective in the treatment of advanced gastric cancer. TOX regimen is more effective and safer than FOLFOX4 regimen with higher mTTP and lower incidence of grade Ⅲ/Ⅳ nausea and vomiting.