替吉奥胶囊联合紫杉醇治疗进展期胃癌的临床研究

Clinical Research of TS-1 and Paclitaxel in the Treatment of Advanced Gastric Cancer

目的探讨替吉奥胶囊联合紫杉醇治疗进展期胃癌的有效性及安全性。方法选取56例进展期胃癌患者,随机分为两组:试验组给予替吉奥胶囊80 mg.m-2.d-1,分2次口服,d1～14;紫杉醇175 mg/m2静脉滴注,d1。对照组给予表阿霉素50 mg/m2静脉滴注,d1;顺铂60 mg/m2静脉滴注,d1;5-氟尿嘧啶1 000 mg.m-2.d-1,应用静脉泵持续静脉滴注,d1～5。每21 d为1个周期,至少接受化疗2个周期。结果治疗后两组患者疗效间差异无统计学意义(P>0.05)。试验组与对照组的中位无进展生存时间分别为168 d和156 d,中位总生存时间分别为292 d和268 d,两组患者中位无进展生存时间及中位总生存时间比较,差异均无统计学意义(P>0.05)。主要毒性反应为消化道及血液学毒性,试验组消化道毒性反应比对照组轻,差异有统计学意义(P<0.05)。结论替吉奥胶囊联合紫杉醇治疗进展期胃癌安全、有效。

Objective To explore the efficacy and toxicity of oral TS - 1 and paclitaxel for advanced gastric canc- er. Methods 56 patients with advanced gastric cancer were randomized into two groups. The trim group was administered with o- ral TS - 1 capsule （80 mg · m^-2 . d^-1 ）, twice a day for two consecutive weeks from Day 1 to 14, and paclitaxel （ 175 mg/m2 ） intravenously on Day 1. The control group was given epirubicin （50 mg/m^2 ） and cisplatin （60 mg/m^2 ） intravenously on Day 1, while 5 - fiuorouracil （ 1 000 mg · m^-2 · d^-1 ） was administered by continuous intravenous drip pump for 5 days from Day 1 to 5. All the patients received at least 2 cycles of the regimen with each cycle 21 days. Results The efficacy between the two groups showed no statistically significant difference （P 〉 0.05 ） . The response rates of the trial group and the control group were 46.7% and 42. 3% respectively. The median progress -free survival was 168 days and 156 days respectively in the two groups, while the median overall survival was 292 days and 268 days respectively, and there was no statistically significant difference between the two groups （P 〉 0. 05） . The main toxicity was digestive and hematological toxic reactions, and the difference of digestive toxici- ty between the groups was statistically significant （P 〈 0.05 ） . Conclusion TS - 1 capsule combined with paclitaxel is safe and effective in the treatment of advanced gastric cancer.