临床肿瘤学杂志

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西妥昔单抗联合FOLFIRI双周方案在野生型K-Ras基因晚期结直肠癌患者中的Ⅱ期临床观察

朱梁军,李晟,冯继锋,陈嘉,潘良熹,陈颖波,孙小峰,朱利群   

  1. 210009 南京 江苏省肿瘤医院内科
  • 收稿日期:2012-10-11 修回日期:2012-11-12 出版日期:2013-01-31 发布日期:2013-01-31

Biweekly cetuximab plus FOLFIRI regimen in advanced colorectal cancer with K-Ras wild-type patients:results of a phase Ⅱ single institution trial

ZHU Liangjun,LI Sheng,FENG Jifeng,CHEN Jia,PAN Liangxi,CHEN Yingbo,SUN Xiaofeng,ZHU Liqun   

  1. Department of Medical Oncology,Jiangsu Cancer Hospital,Nanjing 210009,China
  • Received:2012-10-11 Revised:2012-11-12 Online:2013-01-31 Published:2013-01-31

摘要: 目的 探讨西妥昔单抗联合FOLFIRI双周方案治疗K-Ras基因野生型的晚期结直肠癌的疗效及安全性。方法 收集2008年1月至2010年6月44例K-Ras基因野生型的晚期结直肠癌患者,采用西妥昔单抗联合FOLFIRI双周方案进行治疗。具体方案:西妥昔单抗500mg/m2静滴,2周1次;伊立替康180mg/m2静滴30~90min,d1;亚叶酸钙200mg/m2静滴2h,d1;氟尿嘧啶(5-FU)400mg/m2静推,d1;5-FU 2400mg/m2持续静滴46h。14天为1周期。每例患者至少接受4个周期化疗后评价疗效。不良反应按照NCI CTC 3.0标准评价。结果 全组44例患者均可评价疗效,获CR 2例(4.6%),PR 22例(50.0%),SD 17例(38.6%),PD 3例(6.8%);有效率为54.6%,疾病控制率为93.2%。单因素分析显示,有效率与肿瘤原发部位有关,与性别、年龄、转移脏器个数、转移部位和ECOG评分无关,疾病控制率与临床病理特征均无关;Logistic多因素回归分析显示,原发部位是影响疗效的独立因素(P=0.0455)。44例患者的中位总生存时间(OS)为25.7个月(95%CI:20.5~34.6个月),中位无进展生存时间(PFS)为8.4个月(95%CI:6.3~11.7个月)。Cox多因素分析显示,ECOG评分为影响PFS的独立因素,而性别为影响OS的独立因素。毒副反应主要为皮疹、中性粒细胞减少和消化道反应,以1~2级为主。结论 西妥昔单抗联合FOLFIRI双周方案治疗晚期结直肠癌疗效肯定,毒副反应可以耐受,值得临床推广。

Abstract: Objective To evaluate the efficacy and adverse effects of cetuximab combined with FOLFIRI regimen for advanced colorectal cancer with K-Ras wild-type patients. Methods From January 2008 to June 2010,44 patients with K-Ras wildtype advanced colorectal cancer proved by pathology were treated with cetuximab biweekly plus FOLFIRI regimen.Cetuximab was given by 500mg/m2iv every 2 weeks,irinotican 180mg/m2 iv dl,calcium folinate 200mg/m2 iv dl,fluorouracil 400mg/m2 ivp dl and then 2400mg/m2 civ 46h. Every 2 weeks was a cycle.All the patients recieved at least 4 cycles of chemotherapy.Adverse reaction was assessed by the NCI CTC 3.0 standard. Results In 44 patients,2 cases received CR(4.6%),22 cases PR(50.0%),17 cases SD(38.6%),3 cases PD(6.8%),the response rate(RR)was 54.6%and disease control rate(DCR)was 93.2%.The univariate analysis showed that RR was related to primary site,but not with gender,age,number of metastatic organs,metastatic sites and ECOG score,and DCR was not related to any clinical features. Logistic regression analysis showed that primary site was the independent factor influencing RR(P=0.0455). The median overall survival(OS)was 25.7 months(95%CI:20.5-34.6months),and the median progressionfree survival (PFS)was 8.4 months(95%CI:6.3-11.7months). The Cox regression model showed that ECOG score was the independent influential factor of PFS,and gender influenced OS. The common adverse events were skin rash,digestive reaction and neutropenia,mainly in grade 1-2. Conclusion Cetuximab combined with FOLFIRI regimen every 2 weeks for the patients with advanced colorectal cancer is effective,and the adverse effect is tolerable,worth further study.

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