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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,
Objective To investigate the efficacy and safety of irinotecan (CPT11) and fluoropyrimidine compounds in the treatment of advanced and metastatic colorectal cancer. Methods Forty-three patients with advanced or metastatic colorectal cancer were randomly divided into two groups. The patients in group A received CPT of 1190-125 mg / m 2 intravenously for 10 hours (day 1) and 30 mg · m -2 of folic acid · D-1 + 5FU425mg · m-2 · d-1 × 2d (48h continuous intravenous infusion) once a week, as a cycle, continuous application of not less than 6 cycles. B group of patients were given 90 ~ 125mg / m2 CPT11 continuous intravenous infusion of 10h, once every two weeks for the 1 cycle, while capecitabine 1250mg · m-2 · d-1, 2 times orally, continued to take a lot of In 6 months, that is equivalent to not less than 6 cycles. Results The total effective rate (ORR) 44.2%, disease control rate 83.7%. The average effective rate (RR) in group A was 31.3%, in group B 51.9%, in group A were 11.0 months, the overall survival rate was 14.6 months, the RR of liver metastasis was 44.4% and the RR of lung metastasis was 66.7 %. The RR of liver metastasis in group B was 46.2% and that in group A was 40.0%. The RR of lung metastasis in group B was 83.3% and that in group A was 33.3%. 43 cases of 502 cycles of chemotherapy grade Ⅲ side effects of 3.0% (15 cases), no chemotherapy-related deaths. The incidence of nausea and vomiting was the highest in all kinds of side effects, with 31.9% in group A, but only one in grade III and 22.7% in group B, with no grade III. Hand-foot syndrome was higher in group B (16.1%) than in group B, with grade III in 2 (1.4%) and grade III (group A). The total incidence of side effects in group B was significantly lower than in group A. Conclusion CPT11 and fluoropyrimidine compounds are effective and safe for advanced and metastatic colorectal cancer. CPT11 combined with capecitabine not only more effective, significantly reduced side effects,