【摘 要】
：
目的:评价紫杉醇每周方案联合S-1或氟尿嘧啶一线治疗晚期胃癌的临床疗效及安全性.方法:240例未经治疗晚期胃癌患者随机分配至试验组和对照组.试验组为紫杉醇联合S-1,对照组为紫杉醇联合氟尿嘧啶.化疗方案:试验组紫杉醇60mg/m2,静脉滴注,第1,8,15天;S-1 80 ～ 120mg/天,口服,第1 ～ 14天;对照组氟尿嘧啶500mg/m2,持续静脉输注,第1～5天;亚叶酸钙:20mg/m2
【机 构】
：
天津医科大学附属肿瘤医院消化肿瘤内科 南昌大学第一附属医院肿瘤科
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目的:评价紫杉醇每周方案联合S-1或氟尿嘧啶一线治疗晚期胃癌的临床疗效及安全性.方法:240例未经治疗晚期胃癌患者随机分配至试验组和对照组.试验组为紫杉醇联合S-1,对照组为紫杉醇联合氟尿嘧啶.化疗方案:试验组紫杉醇60mg/m2,静脉滴注,第1,8,15天;S-1 80 ～ 120mg/天,口服,第1 ～ 14天;对照组氟尿嘧啶500mg/m2,持续静脉输注,第1～5天;亚叶酸钙:20mg/m2,静脉滴注,第1～5天;两组均为每28天重复.结果:229例患者进入全分析集,192例患者可评价疗效,试验组100例,对照组92例.试验组与对照组的客观缓解率分别为50.0％和28.3％,P=0.002;疾病控制率分别为82.0％和70.7％,P=0.064,试验组主要终点指标均不劣效于对照组.试验组次要终点指标中位无进展生存期优于对照组,分别为5个月和4个月(P =0.006).试验组Ⅲ～Ⅳ级骨髓抑制发生率高于对照组,但无Ⅲ～Ⅳ级发热,且两组发热率无明显差异.结论:口服S1可以替代静脉输注氟尿嘧啶,紫杉醇每周方案联合S-1疗效较高,安全性良好.
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