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西妥昔单抗治疗转移性结直肠癌的快速卫生技术评估
引用本文:韩晶,门鹏,刘维,翟所迪. 西妥昔单抗治疗转移性结直肠癌的快速卫生技术评估[J]. 中国新药杂志, 2020, 0(5): 582-588
作者姓名:韩晶  门鹏  刘维  翟所迪
作者单位:北京大学第三医院药剂科;北京大学医学部药物评价中心
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C...

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

A rapid health technology assessment of cetuximab in the treatment of metastatic colorectal cancer
HAN Jing,MEN Peng,LIU Wei,ZHAI Suo-di. A rapid health technology assessment of cetuximab in the treatment of metastatic colorectal cancer[J]. Chinese Journal of New Drugs, 2020, 0(5): 582-588
Authors:HAN Jing  MEN Peng  LIU Wei  ZHAI Suo-di
Affiliation:(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China)
Abstract:
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.
Keywords:cetuximab  metastatic colorectal cancer  targeted therapy  health technology assessment
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