Objective To compare the activity and safety of oteracil or capecitabine combined with oxaliplatin as first line therapy to treat elderly advanced gastric cancer(AGC)patients. Methods 56 elderly patients with pathologically diagnosed as advanced gastric cancer were randomly divided into a treatment group of 30 patients and a control group of 26 patients. Treatment group were given oteracil combined with oxaliplatin, while the control group were given capecitabine and oxaliplatin. The patients received oteracil at 40 mg [body surface area (BSA) <1.25 m2] or 50 mg twice a day for 14 days, followed by a 7-day rest period within a 3-week schedule in the therapy group, and capecitabine at 1000 mg/m2 twice a day for 14 days, followed by a 7-day rest period within a 3-week schedule in the control group. Oxaliplatin 85 mg/m2 were administered on d1 every 3 weeks in both groups. Treatment was continued until disease progression or the development unacceptable toxicity. Results The therapy group were observed a response rate (RR) of 40%, a tumor growth control rate (TGCR) of 57.3%, a median progression-free-time (PFS) of 6.0 months and a median overal survival(OS) of 11.5 months. While the control group were observed a RR of 44%, a TGCR of 59.7%, a median PFS of 6.3 months and a median OS of 11.9 months. There were no significant differences in activity. In two groups, quality of life was improved and there were no significant differences between groups. The treatment was well tolerated. The most frequent grade 3 or 4 toxicities were thrombocytopenia (16.6%) for therapy group and neutropenia (19.2%) for control group. No neutropenic fever occurred. No treatment-related deaths occurred during the research period. Conclusion Oteracil or capecitabine combined with oxaliplatin regimens in elderly patients with untreated AGC are effective. The treatment is well tolerated. The comparison of oteracil with capecitabine showed that capecitabine has a slightly higher response rate.% 目的比较一线替吉奥联合奥沙利铂或卡培他滨联合奥沙利铂方案治疗老年晚期胃癌患者的疗效和毒副反应。方法采用对照临床试验，将56例经病理确诊的老年晚期胃癌患者分为治疗组30例和对照组26例；治疗组给予替吉奥联合奥沙利铂治疗，对照组使用卡培他滨联合奥沙利铂治疗。治疗组用法：替吉奥：体表面积＜1.25 m 2，每日2次给药，每次为40 mg的剂量；体表面积≥1.25 m2，每日2次给药，每次为50 mg。连续14 d，停用药物7 d，每3周重复；对照组用法：卡培他滨1000 mg/m2，每日2次，持续14 d，休息7 d，每3周重复。两组奥沙利铂均85 mg/m2，d1，每3周重复。化疗持续至疾病进展或出现无法耐受的毒副反应。结果治疗组客观有效率（RR）为40％，肿瘤控制率（TGCR）为56.7%，中位无疾病进展时间（PFS）为6.0个月，中位总生存时间（OS）为11.5个月；对照组RR 为42.3％，TGCR为61.5%，PFS为6.3个月，OS为11.9个月。两组疗效差异无统计学意义。两组生存质量评分均改善，组间差异无统计学意义。两组毒副反应均可耐受，治疗组最常见的3/4级毒副反应为血小板减少（16.6%），对照组则为中性粒细胞减少（19.2%）。没有中性粒细胞减少性发热，没有治疗相关死亡。结论老年晚期胃癌患者可从替吉奥联合奥沙利铂或卡培他滨联合奥沙利铂的化疗中获益，毒副反应可耐受。卡培他滨联合奥沙利铂治疗疗效有略佳趋势。
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