【摘要】 目的评价伊立替康联合顺铂与伊立替康单药二线治疗晚期转移性结直肠癌的临床疗效及安全性。方法 143例一线化疗失败的晚期转移性结直肠癌患者分为对照组(74例)和试验组(69例)。对照组第1 d静脉滴注伊立替康250 mg.m-2,90 min。试验组第1 d静脉滴注伊立替康250 mg.m-2,90 min;第1～3 d静脉滴注顺铂25 mg.m-2,1周期均为21 d。化疗结束后比较2组患者近期疗效、药物不良反应及生存期。结果试验组61例完成了2～4个周期的化疗,客观有效率(ORR)为45.9%(28/61),对照组组51例完成了2～4周期化疗,ORR为27.5%(14/51),2组比较差异有统计学意义(P<0.05)。试验组中位生存时间为13.2个月,对照组为8.8个月,2组差异有统计学意义(HR=0.46,95%CI:0.29～0.79,P<0.001)。试验组Ⅲ、Ⅳ度粒细胞下降、恶心呕吐和脱发的发生率高于对照组(P<0.01)。结论伊立替康联合顺铂二线治疗晚期转移性结直肠癌可显著延长患者的生存时间,其主要不良反应为血液学毒性和胃肠道反应。更多还原

【Abstract】 Objective To evaluate the clinical efficacy and safety of irinotecan combination with cisplatin vs irinotecan second-line treatment on advanced metastatic colorectal cancer.Methods One hundred and forty-three patients with advanced metastasis colorectal cancer were divided in to irinotecan combination with cisplatin group with 74 cases and irinotecan alone with 69 cases.Controls group: irinotecan 250 mg·m-2,IVD 90 minutes on day 1.Treatment group: irinotecan 250 mg·m-2,IVD 90 minutes in day1 and cisplatin 25 mg·m-2 on day 1-3,21 days per cycle.The rates of response,side effects and long term survival were compared between the two groups.Results The overall response rate(ORR) was 45.9%(28/61)and 27.5%(14/51) in the treatment group and control group respectively,which demonstrated significant difference between the two groups(χ2= 4.03 P=0.045).Patients in treatment group had longer median survival time compared with control group(13.2 vs 8.8 months,HR=0.46,95% CI:0.29～0.79,P<0.001).Patients in experiment group experienced higher rates of Ⅲ or Ⅳ granulopenia,vomiting,alopecie and elevated transaminase(P<0.01)compared with control group.Conclusion The treatment of irinotecan combination with cisplatin can significantly improve survival time of advanced metastatic colorectal cancer patients.The main side effects are gastrointestinal and hematological toxicities.更多还原