伊立替康与氟嘧啶类联合治疗进展期及转移性结直肠癌的临床研究

目的探讨伊立替康(CPT11)与氟嘧啶类化合物在进展期及转移性结直肠癌治疗中的疗效与安全性。方法43例进展期或转移性结直肠癌随机分为2组,A组病例给予CPT1190～125mg/m2,持续静脉滴注10h(第1天)和四氢叶酸钙(FA)30mg·m-2·d-1+5FU425mg·m-2·d-1×2d(48h持续静脉滴注),每周给药1次,作为1个周期,连续应用不少于6个周期。B组病例则给予90～125mg/m2CPT11持续静脉滴注10h,每2周1次为1周期,同时给予卡培他滨1250mg·m-2·d-1,分2次口服,持续服用不少于6个月,亦即相当于不少于6个周期。结果全组总的有效率(ORR)44.2%,疾病控制率83.7%。A组有效率(RR)为31.3%,B组51.9%,全组平均病情缓解时间11.0个月,总生存率(OS)14.6个月,肝转移的RR为44.4%,肺转移的RR为66.7%,B组肝转移的RR为46.2%,A组为40.0%;B组肺转移的RR为83.3%,A组为33.3%。43例502周期化疗Ⅲ级副反应发生率为3.0%(15例次),无化疗相关死亡。在各种副反应中恶心呕吐的发生率最高,A组31.9%,但Ⅲ级者仅1例,B组22.7%,无Ⅲ级。B组副反应发生率中手足综合征较高(16.1%),Ⅲ级2例,A组仅1.4%,无Ⅲ级。总的副反应发生率B组明显低于A组。结论CPT11与氟嘧啶类化合物对进展期及转移性结直肠是有效的、安全的。CPT11与卡培他滨联合应用不但疗效更高,副反应明显减少,

Irinotecan combined with fluoropyrimidine in treatment for advanced/metastatic colorectal carcinoma

OBJECTIVE: To explore the efficacy and safety of CPT-11 combined with fluoropyrimidine in treatment for advanced or metastatic colorectal carcinoma. METHODS: From January 2001 to September 2003, 43 patients with advanced or metastatic colorectal carcinoma were randomized into two groups, group A [CPT-11 90 - 25 mg/m(2) continuous infusion for 10 h and folinic acid (FA) 30 mg x m(-2) x d(-1) + 5-FU 425 mg x m(-2) x d(-1) x 2 d continuous infusion for 48 h, every two weeks as a cycle in total of no less than six cycles] and group B (CPT-11 90 - 125 mg/m(2) continuous infusion for 10 h every two weeks as a cycle in total of no less than six cycles and capecitabine 1250 mg x m(-2) x d(-1) by oral divided into two doses, continuously taken without interruption for three months). RESULTS: In this study, overall response rate (ORR) was 44.2%, disease control achieved in 83.7%, Time to progression (TTP) was 11.0 months and overall survival (OS) was 14.6 months. Response rate in group A was 31.3% and 51.9% in group B. TTP of group A was 8.4 months and that of group B was 12.5 months; OS in group A was 14.2 months and 17.9 months in group B. In 43 cases with 502 cycles of chemotherapy, grade III side effect occurred only in 3.0% and no therapy-related death occurred. Nausea and vomiting was the most common side effect with an occurrence rate of 31.9% in group A and 2 cases of grade III, and 22.7% in group B with no case of grade III. Occurrence of side effect was much lower in group B than that of group A except hand-foot syndrome, which was 16.1% in group B with 2 cases of grade III as compared to 1.4% in group A with no case of grade III. CONCLUSIONS: Combination of CPT-11 and fluoropyrimidine is effective and safe in treatment for advanced/metastatic colorectal carcinoma. CPT-11 combined with capecitabine are not only more effective, but also its occurrence of side effect is lowered, and are especially high effective for lung metastasis. There is reasonable to recommend that combination of CPT-11 with capecitabine may be as first choice in treatment for such cases.