紫杉醇联合替吉奥治疗晚期胃癌的对照研究

Randomized controlled trial of S-1 and paclitaxel in the treatment of metastatic gastric cancer

目的观察比较紫杉醇联合替吉奥胶囊(S-1)与紫杉醇联合5-氟尿嘧啶治疗晚期胃癌的短期疗效和毒副反应。方法共入选晚期胃癌患者44例,随机分组,其中治疗组(紫杉醇联合替吉奥组)23例,对照组(紫杉醇联合5-氟尿嘧啶组)21例。治疗组:紫杉醇135 mg/m2,静脉滴注,第1天,替吉奥胶囊80 mg/d,分两次服用,1～14 d,停药1周;对照组:紫杉醇135 mg/m2,静脉滴注,第1天,5-氟尿嘧啶0.5 g/m2,静脉持续滴注1～5 d。21 d为1个周期,每例至少完成2个治疗周期。2个治疗周期后按RECIST 1.1标准评价客观疗效;不良反应的评价标准采用美国国立癌症研究所(National Cancer Institute,NCI)CTCAE 3.0版不良事件评价标准进行评定。结果 44例患者均至少完成2个周期的化疗。治疗组有效率占34.78%,临床受益率为78.26%;对照组有效率占33.33%,临床受益率为76.19%,2组有效率及临床受益率的差异无统计学意义(21=0.01,P1=0.919;22=0.15,P2=0.703)。39例患者可评价中位疾病进展时间,治疗组中位疾病进展时间为6.5个月,对照组为5.5个月,经Log-rank检验,差异无统计学意义(2=0.13,P=0.714)。2组患者化疗后各种不良反应发生率差异均无统计学意义。结论和联合5-氟尿嘧啶方案一样,紫杉醇联合替吉奥胶囊方案治疗晚期胃癌具有效率高、不良反应较少、对患者影响较小的特点。

Objective To observe and compare the efficacy and safety of paclitaxel in combination with S-1 and 5- Fluorouracil in the treatment of patients with metastatic gastric cancer. Methods 44 patients with metastatic gastric cancer were randomized into two groups. The trial group was administered with oral S-1 capsule （80 mg/d）, twice a day for two consecutive weeks from clay 1 to 14, and paclitaxel （ 135 mg/m^2 ） intravenously on day 1. The control group was given pa- clitaxel in the same way as in the trial group, while 5-Fluorouracil 0.5 g/m^2 was administered by continuous intravenous drip pump for 5 days from day 1 to 5. All patients received at least 2 cycles of these regimens. Common Terminology Citeria for Adverse Events （CTCAE） 3.0 was used to evaluate the adverse effects. Results About 44 eligible patients accepted at least 2 cycles chemotherapy. Response rate and toxicity could be evaluated in all patients ; time to progress could only be evaluated in 39 patients. In the treatment group and the control group, the response rate was 34.78 % and 33.33% （P= 0.919） , the clinical benefit rate was 78.26 % and 76.19 % （P=0. 703）. Time to progress was 6.5 months and 5.5 months （X2= 0.13,P = 0. 714）. There were no significant differences in the incidence rates of side effects. Conclusions The efficacy of treatment with paclitaxel and S-1 in metastatic gastric cancer patients is as good as that of paclitaxel and 5- Fluorouracil without serious side effects, and have little effect on performance status, patients compliance is good.