双周多西紫杉联合FOLFOX4方案和DCF方案治疗晚期胃癌对照研究

Comparison of two-week schedule of docetaxel plus FOLFOX4 VS DCF as first-line therapy for advanced gastric carcinoma

目的:比较双周多西紫杉联合FOLFOX4方案和DCF方案治疗晚期胃癌的疗效及不良反应。方法:将53例经病理确诊的晚期胃癌患者随机分为两组。A组27例,采用双周多西紫杉联合FOLFOX4方案化疗:多西紫杉50mg/m2,静脉滴注,d1;草酸铂85mg/m2,静脉滴注2h,d1;亚叶酸钙200mg/m2,静脉滴注2h,d1、d2;氟尿嘧啶400mg/m2,静脉推注,d1、d2,氟尿嘧啶600mg/m2,持续静脉泵输注22h,d1、d2。每2周为1周期。B组26例,采用DCF方案化疗:多西紫杉75mg/m2,静脉推注,d1;氟尿嘧啶750mg/m2,静脉滴注,d1-5;顺铂20mg/m2,静脉滴注,d1-3。每3周为1周期。对两组的近期疗效、疾病进展时间、总生存期、生活质量改善情况、不良反应进行分析比较。结果:A组和B组的有效率分别为55.6%(15/27)和53.8%(14/26),无显著性差异(P=0.9005)。A组和B组的中位疾病进展时间为6.0月(1.9-12月)和5.1月(1-12月)(P=0.0414);中位生存时间10.5月(1-18月)和10.1月(1-17月)(P=0.7805)。A组和B组的生活质量改善为74.1%(20/27)和50.0%(13/26),无显著性差异(P=0.0707);两组主要不良反应在Ⅳ度白细胞减少、血小板减少以及恶心呕吐方面具有一定差异(P<0.05),腹泻、口腔炎、神经毒性、脱发、心脏毒性等指标无显西著性差异。结论:双周多紫杉联合FOLFOX4方案和DCF方案一线治疗晚期胃癌近期疗效较好,双周多西紫杉联合FOLFOX4方案在一定程度上延长了无进展生存时间,在生活质量改善上似乎也有一定的优势。在重度白细胞减少以及相关的感染发生率上优于DCF方案。提示晚期胃癌患者对双周多西紫杉联合FOL-FOX4方案具有更好的耐受性。

Objective：To compare the efficacy and toxicity of two-week schedule of docetaxel plus FOLFOX4 and DCF as first-line therapy for advanced gastric carcinoma（AGC）.Methods：All 53 patients with AGC were divided into two groups randomly,27 patients in A group were treated with two-week schedule of docetaxel plus FOLFOX4：docetaxel（50mg/m^2 iv d1）,L-OHP（85mg/m^2 iv 2h d1） were given first,CF（200mg/m^2 iv 2h dl,d2） followed by 5-FU（400mg/m^2 iv d1,d2） and 5-FU（600mg/m^2 civ 22h dl,d2） were given,docetaxel plus FOLFOX4 regimen was repeated every 14 days;26 patients in B group were treated with DCF regimen：docetaxel（75mg/m^2 iv d1）,5-FU（750mg/m^2 iv d1-5） and DDP（20mg/m^2 iv d1-3） were given.DCF regimen was repeated every 21 days.The efficacy,time to disease progression（TTP）,overall survival（OS）,improvement of QOL and toxicity were analyzed.Results：The response rates（RR）of A group and B group were 55.6%（15/27） and 53.8%（14/26） respectively,（P=0.9005）.The median TTP was 6.0 months in A group and 5.1 months in B group（P=0.0414）.The median survival time was 10.5 months in A group and 10.1 months in B group（P=0.7805）.The improvement of QOL of A and B were 74.1%（20/27） and 50.0%（13/26）,respectively,（P=0.0331）.Major side effects of the two groups such as Ⅳgrade leukopenia and Ⅲ and Ⅳgrade thrombocytopenia had significant deference（P〈0.05）.There were no significant differences between diarrhea,stomatitis,neurotoxicity,hair loss,heart toxicity.Conclusion：Both two-week schedule of docetaxel plus FOLFOX4 and DCF were effective in treating advanced gastric cancer.Two-week schedule of docetaxel plus FOLFOX4 is better than DCF regimen on prolonging TTP and some toxicities,especially serious leukopenia and infection.It also has a trend in the improvement of QOL.Two-week schedule of docetaxel plus FOLFOX4 has better tolerability in the AGC patients.