多西他赛联合奥沙利铂和替吉奥与DCF方案一线治疗晚期胃癌的对比研究

Comparative study between docetaxel,oxaliplatin plus S-1 and DCF regimen as first-line therapy in patients with advanced gastric cancer

目的观察和比较多西他赛联合奥沙利铂和替吉奥与DCF方案一线治疗晚期胃癌的疗效及毒副作用。方法收集2009-08-01—2011-06-15深圳市人民医院符合入组条件的60例晚期胃癌患者,采用随机数字表法分为2组。DSOX组30例：多西他赛75mg/m^2,持续静脉滴入1h,d1;奥沙利铂130mg/m^2,持续静脉滴入3h,d1;替吉奥40mg/m^2,口服,2次/d,d1～d14。DCF组30例：多西他赛75mg/m^2,持续静脉滴入1h,d1;顺铂75mg/m^2,静脉滴入,d1;氟尿嘧啶500mg/m^2,静脉滴入,d1～d5。每例患者至少完成2个周期化疗。对疗效及不良反应进行对比观察。结果 DSOX和DCF组的近期有效（CR＋PR）率分别为53.3%（16/30）和46.7%（14/30）,差异无统计学意义,z=-0.427,P=0.669。中位疾病进展时间分别为7.0和6.8个月,差异无统计学意义,χ^2=0.413,P=0.520。中位生存期分别为12.0和11.7个月,差异无统计学意义,χ^2=0.048,P=0.826。2组的主要不良反应为骨髓抑制、脱发、神经毒性和胃肠道反应,不良反应发生率差异无统计学意义,P〉0.05。DSOX组的骨髓抑制与胃肠道反应相对更轻。结论多西他赛联合奥沙利铂和替吉奥一线治疗晚期胃癌的疗效较好,不良反应可以耐受,值得临床进一步研究应用。

OBJECTIVE To observe and compare the efficacy and toxicity of docetaxel,oxaliplatin plus S-1 （DSOX regimen） with DCF regimen as first-line therapy of patients with advanced gastric cancer （AGC）. METHODS From 2009 August 1st to 2011 June 15th,a total of 60 patients with AGC were randomly divided into two groups by random number table. Group DSOX consisted of 30 patients who received docetaxel 75 mg/m^2, iv. drop, dl, oxaliplatin 130 mg/m^2 ,iv. drop,d1 plus S-1 40 mg/m^2 ,po bid,d1 --d14. Group DCF consisted of 30 patients who received docetaxel 75 mg/m^2 ,iv. drop,d1 , DDP 75 mg/m^2 , iv. drop, dl plus 5-FU 500 mg/m^2 , iv. drop, dl -- d5. Two or more cycles of chemotherapy regimen were conducted. The efficacy and adverse effects were evaluated. RESULTS The response rate （CR--PR） in the GroupDSOX and Group DCF was 53.3G（16/30） and 46.7G（14/30,z =-0.427,P=0. 669）. The median time to progression in the Group DSOX and Group DCF was 7.0 and 6.8 months respectively （X2=0. 413,P= 0. 520）. The median overall survival in the Group DSOX and Group DCF was 12.0 and 11.7 months （X^2 =0. 048,P= 0. 826）. The most common toxicity in both groups was myelosuppression, alopecia, neurotoxicity and gastrointestinal tract reaction. There were no significant differences in incidence of adverse reactions between the two groups （P〉0. 05）. Group DSOX had relatively lighter myelosuppression and gastrointestinal tract reaction. CONCLUSIONS Docetaxel and Oxaliplatin plus S-1 are effective first-line therapy for advanced gastric cancer,with tolerable toxicity profile. It is worthy of further research and application.