西妥昔单抗联合化疗与化疗单用治疗转移性结直肠癌疗效及安全性的荟萃分析  

Efficacy and safety of cetuximab combined with chemotherapy versus chemotherapy alone in the treatment of metastatic colorectal cancer:a systemic review with meta-analysis

作　　者：严萍萍[1] 田泾[1] 钱皎[1] 章玥[1] 王卓[1] 

机构地区：[1]第二军医大学长海医院药学部,上海200433

出　　处：《药学服务与研究》2015年第4期281-286,共6页Pharmaceutical Care and Research

基　　金：国家科技支撑计划(2013BAI06B04Y023012)

摘　　要：目的：比较西妥昔单抗联合化疗与化疗单用治疗转移性结直肠癌的疗效及安全性。方法：在PubMed、MEDLINE、EMBASE、Cochrane Library、万方数据-数字化期刊群、中文科技期刊数据库（维普）和中国期刊全文数据库（CJFD）中,检索从2000-01-01至2014-06-30关于西妥昔单抗联合化疗或化疗单用治疗转移性结直肠癌的随机对照试验,并手动检索期刊补充,对检索到的文献进行分类、筛选和纳入,采用RevMan 5.0软件进行荟萃（meta）分析。结果：纳入5篇文献,共3286例转移性结直肠癌病人。荟萃分析结果显示,西妥昔单抗联合化疗组合并总体缓解率、在Kras基因野生人群中的合并总体缓解率、合并无进展生存期超过12个月率分别为34.79%、55.49%和9.84%,均显著高于化疗单用组的24.41%（P=0.006）、40.77%（P=0.04）和6.22%（P=0.04）。Kras基因突变人群合并总体缓解率、合并无进展生存期超过6个月率、合并总生存期超过1年率、超过2年率、超过3年率,两组比较均无显著差异（P〉0.05）。西妥昔单抗联合化疗组合并3~4级腹泻发生率为20.13%,显著高于化疗单用组的12.28%（P〈0.000 01）。两组间合并3~4级中性粒细胞减少发生率的差异无统计学意义。结论：西妥昔单抗联合化疗治疗转移性结直肠癌合并总体缓解率显著高于单纯化疗,并可以提高病人无进展生存期超过12个月率,但不明显增加1年、2年、3年生存率;增加3~4级腹泻发生率,不增加3~4级中性粒细胞减少发生率。Objective： To evaluate the efficacy and safety of cetuximab combined with chemotherapy versus chemotherapy alone in the treatment of metastatic colorectal cancer （MCC）. Methods： Literature corresponding to randomized controlled trials of cetuximab combined with chemotherapy versus chemotherapy alone in the treatment of MCC was retrieved from the PubMed, MEDLINE, EMBASE, Cochrane Library, the Wanfang Data-digitalization Journals, the Chinese Science and Technology Jour- nals Database （VIP）, and the Chinese Journal Full-text Database from 2000-01-01 to 2014-06-30. Journals were also searched manually as supplement. The documents retrieved were classified, screened and internalized. Meta-analyses were performed by using RevMan 5.0 software. Results： Five reports involving 3286 patients in total were included in our study. The pooled over- all response rate （ORR）, ORR in Kras wild-type population and progression-free survival（PFS）≥ 12 months rates were 34. 79 %, 55.49 % and 9.84%, respectively in the cetuximab plus chemotherapy group, and were significantly higher than those [24.41%（P=0. 006）, 40. 77%（P=0.04） and 6.22%（P=0. 04）] in the chemotherapy alone group. There were no significant differences in pooled overall survival （OS）≥1,2 and 3-year rates, PFS≥6-month rate and ORR in the Kras mutation population between the two groups （P〉0. 05）. There were also no significant differences in the pooled 3-4 level neutropenia rates between the two groups, but the 3-4 level diarrhea rate was 20.13% in the cetuximab plus chemotherapy group,which was higher than that [12.28% （P〈0. 000 01）] in the chemotherapy alone group. Conclusion： The chemotherapy combined with cetuximab could elevate the ORR, PFS≥12-month rate and 3-4 level diarrhea rate, as compared with chemotherapy alone, but did not in- crease the OS≥1, 2 and 3-year rates or 3-4 level neutropenia rates.

关 键 词：西妥昔单抗 转移性结直肠癌 化疗 随机对照试验 荟萃分析 

分 类 号：R735.35[医药卫生—肿瘤] R735.37[医药卫生—临床医学]