SOX方案与EOF方案一线治疗进展期胃癌的临床对比研究

背景与目的:目前化疗仍是治疗进展期胃癌的主要方法之一。ECF(表柔比星+顺铂+氟尿嘧啶)方案疗效已被Ⅲ期临床试验所验证。有研究显示奥沙利铂治疗胃癌的疗效及安全性优于顺铂。本研究旨在观察SOX(替吉奥+奥沙利铂)方案与EOF(表柔比星+奥沙利铂+氟尿嘧啶)方案一线治疗进展期胃癌的疗效与不良反应。方法:将53例经病理学诊断的进展期胃癌患者,随机分为SOX组与EOF组。SOX组(n=27)口服替吉奥胶囊40 mg/m2,每天2次,第1～14天;奥沙利铂130 mg/m2(静脉滴注2 h),第1天;21 d为1个周期,至少完成2个周期。EOF组(n=26)给予表柔比星50 mg/m2,第1天;奥沙利铂130 mg/m2,第1天;氟尿嘧啶750 mg/m2,第1～5天;21 d为1个周期。至少完成2个周期。观察两组的疗效和不良反应。结果:SOX组和EOF组有效率分别为51.9%和50%,差异无统计学意义(χ2=0.018,P=0.894);SOX组KPS评分改善率较EOF组明显提高(74.1%vs 38.5%,P=0.040)。SOX组和EOF组的中位疾病进展时间(time to progression,TTP)分别为173 d和154 d(χ2=0.010,P=0.922),中位生存时间(mean survival time,MST)分别为337 d和315 d(χ2=0.458,P=0.498)。SOX组Ⅲ～Ⅳ度骨髓抑制、恶心呕吐、脱发发生率均明显低于EOF组,差异有统计学意义(P<0.05)。结论:SOX方案和EOF方案一线治疗进展期胃癌的近期疗效相同,但SOX方案不良反应发生率较低,其远期疗效、TTP、生存期等资料还需扩大样本进一步验证。

Comparative study of SOX regimen and EOF regimen in the first-line treatment for advanced gastric carcinoma

Background and purpose:Nowadays,chemotherapy is still the main treating methods for advanced gastric cancer.The efficacy of ECF(epirubicin,cisplatin,5-fluorouracil) regimen has been confirmed by phase Ⅲ trials.Some studies have shown oxaliplatin is superior to cisplatin in the efficacy and safety in the treatment of gastric cancer.Our purpose of this study was to investigate the efficacy and side effects of SOX(S-1 and oxaliplatin) and EOF(epirubicin,cisplatin,5-fluorouracil) regimen as the first-line treatment method in advanced gastric cancer.Methods:Fifty-three patients with advanced gastric carcinoma were randomly divided into SOX group(n=27) and EOF group(n=26).The SOX group was given S-1(orally administered at a dose of 40 mg/m2,twice a day,for 14 days) combined with oxaliplatin(130 mg/m2,iv,2 h,at the 1st day),and repeated every 3 weeks.Patients in the EOF group received the treatment of epirubicin 50 mg/m2,iv,at the 1st day,oxaliplatin 130 mg/m2,iv,at day 1 and 5-FU 750 mg/m2 day 1-5(for 120 h),and repeated every 3 weeks.Efficacy was analyzed every 2 cycles along with adverse reactions.Results:The treatment response rate in the SOX group and EOF group was similar(51.9% vs 50%,χ2=0.018,P=0.894).Karnofsky improvement rate was 74.1% in the SOX group,significantly higher than EOF group(P=0.040).The TTP rate in the SOX group and EOF group was 173 days and 154 days(χ2=0.010,P=0.922),respectively.The MST in the SOX group and EOF group was 337 days and 315 days(χ2=0.458,P=0.498),respectively.The incidence of toxicity on Ⅲ-Ⅳ myelosuppression,nausea,vomiting,alopecia in the SOX group were significantly lower than that in the EOF group(P<0.05).Conclusion:Both SOX and EOF regimens have similar good effect for the first line treatment of patients with advanced gastric cancer,while the toxicities of SOX regimen is lighter.But its efficacy,TTP,and overall survival need to be further investigated.