替吉奥胶囊联合奥沙利铂加与不加紫杉醇治疗晚期胃癌的比较研究

Efficacy and safety of S-1 and oxaliplatin combined with or not with paclitaxel for advanced gastric cancer

目的比较替吉奥胶囊(S-1)联合奥沙利铂(L-OHP)加与不加紫杉醇(TAX)治疗晚期胃癌的疗效和安全性。方法回顾性分析2007年1月至2011年8月我科收治的53例晚期胃癌患者,其中26例患者接受TAX+S-1+L-OHP方案(A组),27例接受S-1+L-OHP方案(B组)。A组方案:S-1 40mg/m2口服,每天2次,d1～d14;L-OHP 85mg/m2静滴3h,d1;TAX 175mg/m2静滴,d1。B组方案:S-1 40mg/m2口服,每天2次,d1～d14;L-OHP 130mg/m2静滴3h,d1。两组均21天为1周期。每两个周期评价疗效,每周期评价毒副反应。结果 53例患者均可评价毒副反应,52例可评价近期疗效。A组和B组的有效率(RR)分别为56.0%和40.7%(P=0.271),临床获益率(DCR)为88.0%和63.0%(P=0.037)。两组患者的中位肿瘤进展时间(TTP)分别为10.0个月和8.0个月(P=0.061),中位总生存时间(OS)为13.0个月和10.0个月(P=0.060)。两组患者的主要毒副反应为血液学毒性和消化道反应,差异无统计学意义;B组神经毒性发生率高于A组(44.4%vs.15.4%,P=0.021);A组的脱发发生率明显高于B组(53.8%vs.7.4%,P=0.0002)。结论 TAX+S-1+L-OHP方案较S-1+L-OHP方案治疗晚期胃癌可提高临床获益率,且周围神经毒性明显减轻,不良反应可耐受,值得临床进一步研究应用。

Objective To compare the efficacy and safety of S-1 and oxaliplatin（L-OHP） combined with or not with paclitax- el （TAX） for advanced gastric cancer. Methods Fifty-three patients with advanced gastric cancer collected from January 2007 to Au- gust 2011 in our department were divided into two groups： group A with 26 patients（TAX 175mg/m2 iv, dl ; S-1 40mg/m2 po, bid, dt- d14; L-OHP 85mg/m2 iv, d1） and group B with 27 patients（S-1 40mg/m2 po,bid, dl-d14; L-OHP 130mg/m2 iv, dl ）. Twenty-one days was a cycle. The efficacy and side effects of two groups were evaluated. Results Toxicity could be evaluated in all the patients. The response rate could be evaluated in 52 patients. In group A and group B, the response rate was 56.0% and 40. 7% （P =0. 271 ） and the disease control rate was 88. 0% and 63.0% （P =0. 037）, respectively. The median time to progress of two group was 10. 0 months and 8.0 months （P = 0.061 ）, and the median overall survival was 13.0 months and 10.0months （P = 0. 060）. The main toxic- ity were hematological and digestive toxic reactions without statistic significance. There were more neurotoxicity in group B （ P 〈 0.05 ）, and more alopecia in group A （ P 〈 0. 05 ）. Conclusion The efficacy of S-1 and L-OHP combined with paclitaxel is superior in the disease control rate for advanced gastric cancer compared with S-1 plus L-OHP regimen and the side effects are tolerable. It is worthy of further clinical study.