伊立替康联合替吉奥与顺铂联合氟尿嘧啶治疗晚期胃癌的随机对照研究

目的比较伊立替康(CPT-11)联合替吉奥(S-1)与顺铂联合联合氟尿嘧啶(CF)方案治疗晚期胃癌的疗效与不良反应。方法将46例晚期胃癌患者随机分成两组,治疗组23例采用CPT-11联合S-1方案,每5周重复,对照组23例采用CF方案,每3周重复,至少2个周期。按WHO标准评价并比较客观疗效和不良反应。结果治疗组总有效率明显高于对照组,65.2%vs 30.4%,肿瘤进展时间(TTP)明显长于对照组,(7.0+2.3)个月vs(5.5+1.7)个月,其差异均有统计学意义(P<0.05)。治疗组在腹泻、骨髓抑制发生率方面高于对照组,但经相应处理后均能控制。结论 CPT-11联合S-1治疗晚期胃癌疗效确切,不良反应可以耐受,值得进一步临床研究和推广。

Randomized clinical study of irinotecan plus S-1 compared with cisplatin plus 5-fluorouracil in treatment of advanced or metastatic gastric cancer

Objective To evaluate the efficacy and toxicity of irinotecan(CPT-11) plus S-1 versus cisplatin plus 5-fluorouracil(CF) in the treatment of advanced or metastatic gastric cancer. Methods 46 cases were randomly assigned to received CPT-11 plus S-1(therapeutic group,n=23,One cycle was 35 days) or CF regimen(control group=23,One cycle was 21 days).All patients received two cycles of chemotherapy at least.The efficacy and toxicity were evaluated according to WHO standard. Results The overall effective rate in therapeutic group was much higher than that of control group,65.2%VS30.4%,and the tumor progression time was longer than that of the control group,(7.0+2.3)months VS(5.5+1.7)months.The toxic reactions such as diarrhea and myelo suppression in therapeutic group were much higher than those in control group.The adverse reactions,however,could be controlled with proper therapy. Conclusions The regimen of CPT-11 plus S-1 is effective and well tolerable for advanced or metastatic gastric cancer,and it is worth use and research widely.