摘要
目的:评价西妥昔单抗(cetuximab,CET)一线治疗转移性结直肠癌(metastatic colorectal cancer,mCRC)的有效性、安全性和经济性。方法:系统检索中英文数据库和卫生技术评估(HTA)相关的网站及数据库。根据纳入和排除标准筛选文献,提取数据,评价文献质量并分析。结果:最终纳入2篇HTA报告、17篇系统评价/Meta分析和8篇经济学评价。对于一线治疗mCRC患者,CET联合化疗(chemotherapy,CT)的完全缓解率与CT相比无统计学差异。对于(K) RAS野生型(wild type,WT) mCRC患者,CET联合CT与CT相比能显著增加总生存期、无进展生存期和肿瘤客观缓解率。对于(K) RAS WT mCRC患者,CET联合CT与贝伐珠单抗(bevacizumab,BEV)联合CT相比能改善肿瘤客观缓解率。对于KRAS WT初治不可切除的结直肠癌肝转移患者,CET联合CT与CT相比,可提高肝转移瘤根治切除率。对于(K) RAS WT左侧mCRC患者,CET联合CT的总生存期、无进展生存期优于CT联合或不联合BEV。对于mCRC患者,CET联合CT与CT相比总体不良事件发生率较高,增加了痤疮样皮疹、手足综合征、腹泻等3~4级不良事件的发生率(P <0. 05),并与BEV联合CT无统计学差异。有慈善捐赠项目时,CET联合CT与CT相比,在RAS WT mCRC患者中具有成本效果优势;与BEV联合CT相比,RAS WT左侧mCRC患者中具有成本效果优势。结论:CET一线治疗mCRC具有良好的有效性和安全性,在RAS WT mCRC患者中,CET联合CT相比CT联合或不联合BEV具有较好的经济性。同时,应开展更多高质量的研究,进一步探讨其临床应用价值。
Objective: To evaluate the efficacy,safety,pharmacoeconomic of cetuximab in the treatment of metastatic colorectal cancer (mCRC). Methods: Chinese and English databases and health technology assessment (HTA)organization websites were searched. Studies were selected according to the inclusion and exclusion criteria,the quality of which was evaluated and analyzed. Results: 2 HTA reports,17 systematic reviews and 8 pharmacoeconomic studies were included finally. Compared to chemotherapy,cetuximab (CET) plus chemotherapy (CT) had no statistically difference in complete response rate for mCRC patients in first-line treatment,significantly increased overall survival,progression free survival,overall objective response rate for (K) RAS wild type (WT) mCRC patients. Compared to bevacizumab (BEV)plus CT,CET plus CT effectively improved tumor objective response rate for (K) RAS WT mCRC patients. For liver metastasis (K) RAS WT mCRC patients that cannot accept surgery,CET plus CT increased radical resection rate of liver metastasis compared to CT alone. Compared to CT plus BEV or not,CET plus CT effectively improve overall survival and progression free survival for (K) RAS WT left-sidemCRC patients. For mCRC patients,CET plus CT had high adverse reaction rate compared to CT,such as some 3 ~ 4 level adverse reactions (P < 0. 05),and had no statistical difference with BEV plus CT. In charitable donation project,CET plus CT seemed cost-effective versus CT alone in the RAS WT mCRC patients and was likely to be cost-effective versus BEV plus CT for patients with left-side mCRC.Conclusion: CET has favorable efficacy and safety in the first-line treatment of metastatic colorectal cancer. Compared to CT plus BEV or not,CET plus CT shows acceptable economy. Meanwhile,more high quality studies are needed to further discuss the clinical application value.
作者
韩晶
门鹏
刘维
翟所迪
HAN Jing;MEN Peng;LIU Wei;ZHAI Suo-di(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第5期582-588,共7页
Chinese Journal of New Drugs
关键词
西妥昔单抗
转移性结直肠癌
靶向治疗
卫生技术评估
cetuximab
metastatic colorectal cancer
targeted therapy
health technology assessment
