替吉奥联合伊立替康与替吉奥单药治疗晚期结肠癌的临床对照研究

目的比较替吉奥联合伊立替康与替吉奥单药治疗晚期结肠癌的近期疗效、无进展生存时间、总生存时间和不良反应。方法 64例经病理组织学确诊的晚期结肠癌患者随机分为试验组(替吉奥联合伊立替康)和对照组(单药替吉奥)。试验组采用伊立替康150 mg/m2,静脉注射,第1天;替吉奥胶囊80 mg/d(S<1.25 mg/m2),100 mg/d(1.251.5 mg/m2),分2次餐后服用,连用14 d,间隔7 d,每21 d为1个周期。对照组采用替吉奥用法同试验组。至少2个周期评价疗效。用药直到疾病进展或不良反应不能耐受,患者最多接受8个周期治疗。结果试验组的有效率为51.6%,对照组为27.3%,试验组优于对照组(P=0.006)。试验组的疾病控制率为83.9%,对照组为72.7%。64例患者中,56例患者接受随访,中位随访时间为12个月。试验组的中位疾病进展时间为7.0个月(5.6～7.4个月),对照组为4.5个月(4.1～5.5个月),试验组明显优于对照组(P=0.003)。试验组的中位总生存时间为16.5个月(13.4～19.6个月),对照组为13.5个月(8.9～18.0个月),两组患者差异无统计学意义(P>0.05)。主要的不良反应为恶心呕吐、腹泻、贫血和粒细胞减少,对照组患者不良反应轻微;试验组患者恶心呕吐为35.3%,乏力为29.0%,Ⅲ和(或)Ⅳ度粒细胞减少为12.9%,贫血为6.45%,腹泻为12.9%。两组患者腹泻症状比较差异明显(P=0.003),中性粒细胞减少比较差异明显(P=0.011)。结论替吉奥联合伊立替康治疗晚期结肠癌疗效肯定,应药方便,耐受性较好,可做为一线化疗方案的优化,同时也是化疗失败后的二线选择,对不能耐受两药联合化疗的病例,单药替吉奥也值得一线推荐。

Clinic control study of S-1 alone versus S-1 combined chemotherapy for advanced colon cancer

Objective To compare the clinic response rate,time to progression(TTP),overall survival(OS) and the toxicity of the regimen of S-1 combined with irinotecan vs S-1 for advanced colon cancer.Methods Sixty four patients with advanced colon cancer diagnosed by histopathology were randomly divided into two groups.The experimental group were received the regimen S-1 combined with irinotecan,S-1 40-60 mg two times daily according to body surface area {80 mg/d(S<1.25 mg/m2),100 mg/d(1.251.5 mg/m2)},on days 1-14.Repeated every 3weeks for on cycle.Irinotecan(150 mg/m2) was administered by intravenous infusion on day 1.3 weeks were as one cycle.Patients in control group were treated with S-1 alone,the regimen as same as experimental group.The evaluation was done after two cycles at least.Patients received chemotherapy until disease progressed or toxicity could not be tolerated and the.Treatment no more than 8 cycles at most.Results Effective rate was 51.6% and 27.3% in experimental group and control group respectively(P=0.006).Disease control rate in experimental group was 83.87% while in control group was72.7%.Fifty-six patients have been followed-up to date.The median followed-up time was 12 months.The median TTP in experimental group and control group was 7.0(5.6-7.4)months and 4.5(4.1-5.5)months respectively(P=0.003).The median OS in experimental group and control group was16.5(13.4-19.6+)months and 13.5(8.9-18.0+)months respectively(P>0.05).Main adverse effects were nauseated,vomiting,diarrhea,neutropenia.Adverse effects of Control group were gently.The main toxicity were diarrhea and neutropenia in experimental group.Nausea and vomiting 35.26%,anergy 29.03%,were gently.3/4 anemia 6.5%,neutropenia 12.9%,diarrhea12.9%.There were statistic difference between two groups in diarrhea and neutropenia apparently(P=0.003,P=0.011).Conclusions S-1 combined with irinotecan is convenient,safe and promising for the patients with advanced colon cancer.The regime is worthy to be recommended as first-line treatment for advanced colon cancer and can be recommended for second-line chemotherapy against treatment failure colon cancer.S-1 alone can be recommended as first-line treatment for the patients cannot tolerant combination chemotherapy.