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洛拉替尼治疗非小细胞肺癌的快速卫生技术评估
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2 #
1*
尚予淇 ,郭 浩 ,王惠铎(1.内蒙古科技大学包头医学院药学院,内蒙古 包头 014040;2.内蒙古自治区人
1
民医院药学处,呼和浩特 010017)
中图分类号 R979.1;R734.2 文献标志码 A 文章编号 1001-0408(2024)15-1812-06
DOI 10.6039/j.issn.1001-0408.2024.15.03
摘 要 目的 评价洛拉替尼治疗非小细胞肺癌(NSCLC)的有效性、安全性和经济性,为医院新药引进和临床用药决策提供循证
参考。方法 检索PubMed、Embase、Cochrane Library、Epistemonikos、中国知网、维普网、万方数据库、中国生物医学文献服务系统
数据库以及国际卫生技术评估机构网络,经文献筛选、资料提取、质量评价后,对研究结果进行描述性分析。结果 共纳入19篇文
献,包括13篇系统评价(SR)/Meta分析、6篇药物经济学研究。与使用其他间变性淋巴瘤激酶(ALK)-酪氨酸激酶抑制剂(TKI)(如
克唑替尼、布格替尼、阿来替尼、恩沙替尼和色瑞替尼等)的患者相比,使用洛拉替尼的患者具有最佳的无进展生存期(PFS)。但
在亚洲人群中,与恩沙替尼、低剂量阿来替尼和布格替尼相比,洛拉替尼在延长PFS方面并没有表现出显著优势。在客观缓解率
方面,洛拉替尼和低剂量阿来替尼较其他ALK-TKI表现出较大优势;同时,阿来替尼具有最佳的总生存期获益。在安全性方面,
洛拉替尼安全性较差,3级及以上不良事件发生率较高。现有经济学研究显示,洛拉替尼在一线治疗ALK阳性晚期NSCLC患者
带来健康获益的同时,治疗成本也更高。结论 洛拉替尼治疗NSCLC有较好的有效性,但其安全性和经济性有待研究。
关键词 洛拉替尼;非小细胞肺癌;快速卫生技术评估;有效性;安全性;经济性
Rapid health technology assessment of lorlatinib in the treatment of non-small cell lung cancer
SHANG Yuqi ,GUO Hao ,WANG Huiduo(1. School of Pharmacy, Baotou Medical College, Inner Mongolia
1
2
1
University of Science and Technology, Inner Mongolia Baotou 014040, China;2. Dept. of Pharmacy, Inner
Mongolia Autonomous Region People’s Hospital, Hohhot 010017,China)
ABSTRACT OBJECTIVE To evaluate the effectiveness, safety and economy of lorlatinib in the treatment of non-small cell lung
cancer(NSCLC), and provide evidence-based reference for the introduction of new drugs in hospitals and clinical medication
decisions. METHODS Retrieved from PubMed, Embase, Cochrane Library, Epistemonikos, CNKI, VIP, Wanfang data,
SinoMed databases and The International Network of Agencies for Health Technology Assessment (INAHTA), the results of the
included studies were descriptively analyzed after literature screening, data extraction and quality evaluation. RESULTS A total of
19 literature were included, involving 13 system assessment (SR)/meta-analyses and 6 pharmacoeconomic reviews. Compared with
the patients who received other anaplastic lymphoma kinases (ALK)-tyrosine kinase inhibitor(TKI)(such as crizotinib, brigatinib,
alectinib, ensartinib, and ceritinib), those using lorlatinib obtained best progression-free survival (PFS). However, in the Asian
population, lorlatinib did not show a significant advantage in prolonging PFS, compared to ensartinib, low-dose alectinib, and
brigatinib. In terms of objective remission rate, lorlatinib and low-dose alectinib showed significant advantages over other ALK-
TKI. At the same time, alectinib had the best overall survival. In terms of safety, lorlatinib possessed a poor safety profile with a
high incidence of grade 3 or higher adverse events. Existing economic studies showed that lorlatinib brought health benefits to first-
line treatment of patients with ALK-positive advanced NSCLC at the same time as higher treatment costs. CONCLUSIONS
Lorlatinib has good efficacy in the treatment of NSCLC, but its safety and economy need to be studied.
KEYWORDS lorlatinib; non-small cell lung cancer; rapid health technology assessment; effectiveness; safety; economy
在全世界范围内,肺癌是十分常见且致命的恶性肿 约占肺癌的85%~90% [1―2] 。NSCLC在分子水平上是一
瘤之一。肺癌从组织学上分为小细胞肺癌和非小细胞 组异质性疾病。间变性淋巴瘤激酶(anaplastic lym‐
肺癌(non-small cell lung cancer,NSCLC),其中 NSCLC phoma kinase,ALK)与 5′-末端棘皮动物微管结合蛋白
(echinoderm microtubule associated protein-like 4,
Δ 基金项目 内蒙古自治区自然科学基金项目(No.2018LH08011); EML4)重排形成的EML4-ALK融合基因是NSCLC的致
内蒙古自治区人民医院院内基金项目(No.2020YN23) 癌驱动基因,也是 ALK 重排最常见的融合基因 。因
[3]
* 第一作者 硕 士 研 究 生 。 研 究 方 向 :临 床 药 学 。 E-mail:
此,EML4-ALK 融合基因是 NSCLC 具有前景的治疗靶
shangyuqi0815@163.com
点。克唑替尼(crizotinib)为第一代 ALK-酪氨酸激酶抑
# 通信作者 副主任药师,硕士生导师,博士。研究方向:药品卫生
技术评估。E-mail:guohao19870323@yeah.net 制剂 (tyrosine kinase inhibitor,TKI),第二代 ALK-TKI
· 1812 · China Pharmacy 2024 Vol. 35 No. 15 中国药房 2024年第35卷第15期