首页|洛拉替尼治疗ALK阳性非小细胞肺癌的快速卫生技术评估

洛拉替尼治疗ALK阳性非小细胞肺癌的快速卫生技术评估

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目的 评价洛拉替尼治疗间变性淋巴瘤激酶(ALK)阳性非小细胞肺癌(NSCLC)的有效性、安全性和经济性,为临床治疗提供循证依据。方法 检索PubMed、Cochrane Library、中国知网、万方数据、维普网等数据库及卫生技术评估(HTA)相关网站,收集洛拉替尼治疗ALK阳性NSCLC的HTA报告、系统评价/Meta分析及药物经济学评价。按纳入与排除标准筛选文献、提取资料并评估文献质量后,对文献结果进行描述性分析。结果 共纳入16篇文献,包括11篇系统评价/Meta分析和5篇药物经济学评价。有效性方面,对于一线治疗,与其他ALK-酪氨酸激酶抑制剂(TKI)及化疗相比,洛拉替尼显著延长了 ALK阳性NSCLC患者的无进展生存期(PFS);对于二线及后线治疗,与化疗相比,洛拉替尼显著延长了 PFS和总生存期。安全性方面,对于≥3级不良事件(AEs),各ALK-TKI及化疗间无显著差异,但洛拉替尼的发生率偏高;而严重AEs和导致停药的AEs发生率,洛拉替尼均最低。经济性方面,与恩沙替尼、克唑替尼一线治疗相比,洛拉替尼在中国不具有经济性;与化疗相比,在希腊和瑞典使用洛拉替尼作为二、三线治疗方案具有经济性。结论 洛拉替尼对于ALK阳性NSCLC具有良好的有效性和安全性,但其在我国降价后的经济性有待进一步评估。
Lorlatinib for treatment of ALK positive non-small cell lung cancer:a rapid health technology assessment
AIM To evaluate the effectiveness,safety and economy of lorlatinib in anaplastic lymphoma kinase(ALK)positive non-small cell lung cancer(NSCLC)patients,and provide evidence for clinical treatment.METHODS Databases such as PubMed,Cochrane Library,CNKI,Wanfang Data,and VIP and Health Technology Assessment(HTA)related websites were searched to collect HTA reports,systematic evaluation/meta-analysis and pharmacoeconomic evaluation of loratinib for ALK positive NSCLC.Select the literature according to the inclusion and exclusion criteria,extract the data,and evaluate the literature quality.Qualitative description was performed.RESULTS A total of 16 literatures were included,involving 11 systematic review/meta-analysis and 5 pharmacoeconomic evaluation.In terms of effectiveness,compared with other ALK-tyrosine kinase inhibitors(TKIs)and chemotherapy as first-line treatment,lorlatinib significantly prolonged the progression free survival(PFS)in ALK positive NSCLC patients.Compared with chemotherapy as a second-or third-line treatment,lorlatinib significantly prolonged PFS and overall survival.In terms of safety,there was no statistical difference among the ALK-TKIs and chemotherapy in the incidence of adverse events(AEs)of grade ≥3,but the incidence of lorlatinib was relatively high.In regards to the serious AEs and AEs leading to treatment discontinuation,lorlatinib was the lowest.In terms of economy,lorlatinib was not cost-effectiveness compared to ensartinib and crizotinib in China,but lorlatinib was cost-effectiveness compared to chemotherapy as a second-or third-line treatment in Greece and Sweden.CONCLUSION Lorlatinib shows good efficacy and safety for ALK positive NSCLC,but its cost-effectiveness after price reduction in China needs further evaluation.

lorlatinibanaplastic lymphoma kinasenon-small cell lung cancerhealth technology assessment

王华玉、杜芃、王荣环

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天津医科大学第二医院药学部,天津 300211

洛拉替尼 间变性淋巴瘤激酶 非小细胞肺癌 卫生技术评估

天津医科大学第二医院青年科研基金项目

2023ydey30

2024

中国新药与临床杂志
中国药学会 上海市食品药品监督管理局科技情报研究所

中国新药与临床杂志

CSTPCD北大核心
影响因子:0.967
ISSN:1007-7669
年,卷(期):2024.43(9)