复方替加氟奥替拉西胶囊治疗晚期胃癌的临床研究

Clinical Study of Compound Tegafur and Oteracil Potassium Sustained Capsules (S-1) in the Treatment of Advanced Gastric Cancer

目的探讨复方替加氟奥替拉西胶囊加草酸铂、替加氟加草酸铂和复方替加氟奥替拉西胶囊单药治疗晚期胃癌的疗效和安全性。方法采用多中心、随机、平行对照的方法,将252例晚期胃癌患者,分为试验组、对照组和单药组。试验组给予复方替加氟奥替拉西胶囊每天80mg/m2,分2次口服,第1～14天;对照组给予替加氟每天800mg/m2,分3次口服,第1～14天。两组均联合草酸铂130mg/m2,第1天;每3～4周为1个周期。单药组给予复方替加氟奥替拉西胶囊每天80mg/m2,分2次口服,第1～28天,餐后服用;每42天为1个周期。至少治疗2个周期。结果入组252例患者中,有251例可评价不良反应,225例可评价疗效。试验组101例,CR5例、PR23例,总有效率27.72%,临床受益率80.20%;对照组95例,PR14例,总有效率14.74%,临床受益率66.32%。两组疗效有统计学差异(P<0.05)。单药组29例,CR2例、PR3例,总有效率为17.24%。不良反应为骨髓抑制、恶心呕吐、厌食、周围神经炎、腹泻等。试验组、对照组和单药组不良反应发生率分别为88.29%、85.85%和91.18%,中重度不良反应发生率分别为27.93%、26.42%和44.12%。结论复方替加氟奥替拉西胶囊用于治疗晚期胃癌,疗效确切,耐受性好,使用方便,临床应用前景广阔。

Objective To evaluate the efficacy and safety of S-1/oxaliplatin combination,tegafur/oxaliplatin combination and S-1 alone in the treatment of advanced gastric cancer. Methods This study is a muhicenter,randomized and controlled clinical trial of subjects with advanced gastric cancer. In the test group, S-1 was administered orally at 80 mg/m^2/d, divided in two daily doses given from dl to d14. In the control group,Tegafur was administered orally at 800 mg/m^2/d,divided in three daily doses from dl to d14. In both groups,oxaliplatin was combined at 130 mg/m^2 on dl. And the treatment was repeated every 3 or 4 weeks. In another group, S-1 was administered alone at 80 mg/m^2/d, divided in two daily doses after meals, for 28 consecutive days. The treatment was repeated 6 weeks. The patients were administered at least two cycles of chemotherapy. Results Of 252 cases ,251 were eligible for the analysis of side effects and 225 for the overall response rate. In test group, 101 patients were registered. The overall response rate was 27.72% （ including 5 CR and 23 PR） , and clinical effect rate was 80.20%. In the control group ,95 patients were registered. The overall response rate was 14.74% （ 14 PR） , and clinical effect rate was 66.32%. There was significant difference between the two groups （ P 〈 0.05 ）. In the single S-1 group ,29 patients were registered. The overall response rate was 17.24% （including 2 CR and 3 PR ）. The major adverse effects were myelosuppression, nausea, vomiting, anorexia,peripheral neuritis and diarrhea. The total adverse event rate was 88.29% ,85.85% and 91.18% in test group,control group and single S-1 group, respectively. Grade 3 or higher toxicities occurred in 27.93 % ,26.42% and 44.12%. Conclusion S-1 may have significant efficacy and tolerable toxicity for advanced gastric cancer patients.