西妥昔单抗治疗转移性大肠癌临床疗效的系统评价

Efficacy of cetuximab in therapy of metastatic colorectal cancer： a system evaluation

目的评价西妥昔单抗治疗转移性大肠癌（mCRC）的临床疗效。方法全面检索2008年8月前发表的评价西妥昔单抗单药或联合化疗二线或一线治疗mCRC的临床试验，按纳入和排除标准筛选，提取人选试验的基本特征和临床疗效数据。对研究目的相同的多项随机对照试验的临床数据采用RevMan4．2软件进行定量合并，对不符合定量合并要求的数据作统计描述。结果符合选择标准的临床试验22项，其中8项随机对照试验，1项非随机对照试验和13项单组试验。8项随机对照试验的研究目的和干预措施互不相同，未能进行定量合并。西妥昔单抗联合伊立替康二线治疗先前伊立替康治疗失败的表皮生长因子受体（EGFR）表达阳性的mCRC有效率16．4％～23．0％，中位生存期8．6～10．7个月，一线治疗mCRC有效率42．O％～67．0％，中位生存期33．0个月。西妥昔单抗联合奥沙利铂一线治疗mCRC有效率46．0％～72．0％，中位生存期28．2～30．0个月。与KRAS突变型的mCRC相比，KRAS野生型患者能从西妥昔单抗联合化疗中获得更高的有效率和更长的疾病无进展生存期。结论西妥昔单抗联合化疗治疗mCRC疗效肯定，KRAS基因状态可预测疗效。

Objective To assess the clinical efficacy of cetuximab in the treatment of individuals with metastatic eolorectal cancer. Methods Literature searches were performed on all clinical trails reported on target-therapy agent cetuximab in treating metastatic colorectal cancer prior to August 2008. The basic characteristics and clinical efficacy data of trials meeting the screening criteria were extracted. Date analysis was performed by RevMan 4. 2 if the data came from randomized controlled trials with the same objective. Results According to the selection criteria, 22 clinical studies were included. There were 8 randomized controlled trials, 1 non-randomized controlled trial and 13 single group trials. Because of different study objectives of 8 randomized controlled trials, no data could be analyzed by the Meta-analysis method. Cetuximab plus irinotecan as second-line therapy for patients with EGFR-expressing metastatic colorectal cancer who had previously failed to respond to irinotecan-added therapy could reach a tumor response rate of 16.4% -23.0%, and median overall survival duration of 8.6 - 10. 7 months. The addition of cetuximab to irinotecan as first-line therapy to treat metastatic colorectal cancer resulted in a tumor response rate of 42. 0% - 67.0% , and median overall survival duration of 33.0 months. The response rate of cetuximab combined with oxaliplatin/5-FU/LV as first-line therapy for metastatic colorectal cancer was 46. 0% - 72. 0% and the median duration of overall survival was 28.2 - 30.0 months. Compared with the colorectal cancer population with mutant KRAS, the patients with wild-type KRAS could obtain a higher response rate and a longer progression-free survival. Conclusion Cetuximab in combination with chemotherapy has promising efficacy in the therapy of metastatic colorectal cancer, and status of gene KRAS is an independent predictive marker for response of cetuximab.