WANG Qing, ZHAO Lu, WU Shang, et al. Meta-Analysis and Safety Evaluation on Clinical Efficacy of Lorlatinib in the Treatment of Non-Small Cell Lung Cancer[J]. 2023,(2):212-218.
WANG Qing, ZHAO Lu, WU Shang, et al. Meta-Analysis and Safety Evaluation on Clinical Efficacy of Lorlatinib in the Treatment of Non-Small Cell Lung Cancer[J]. 2023,(2):212-218. DOI: 10.14009/j.issn.1672-2124.2023.02.018.
劳拉替尼治疗非小细胞肺癌临床疗效的Meta分析及其安全性评价
摘要
目的:基于Meta分析方法,评价劳拉替尼治疗非小细胞肺癌(NSCLC)的临床疗效,并探讨劳拉替尼致药品不良反应(ADR)的临床表现、特点、规律及转归,为临床安全用药提供参考。方法:检索中国知网、万方数据库、PubMed和Web of Science等数据库,纳入关于劳拉替尼治疗NSCLC的随机对照试验[劳拉替尼组患者在有或无用药基础上采用劳拉替尼治疗方案,对照组患者采用第1代和(或)第2代间变性淋巴瘤激酶(ALK)-酪氨酸激酶抑制剂(TKI)治疗方案]进行Meta分析,并纳入劳拉替尼致ADR的文献进行分析。结果:共纳入5项符合条件的随机对照试验,包含622例患者(劳拉替尼组308例,对照组314例)
OBJECTIVE: To evaluate the clinical efficacy of lorlatinib in the treatment of non-small cell lung cancer(NSCLC) based on Meta-analysis method
and to probe into the clinical manifestations
characteristics
patterns and outcomes of adverse drug reactions(ADR) induced by lorlatinib
so as to provide references for the clinical safe medication. METHODS: By retrieving CNKI
Wanfang Data
PubMed
Web of Science and other database
randomized controlled trials(RCT) on lorlatinib in the treatment of NSCLC [the lorlatinib group was given lorlatinib regimen with or without other medication
and the control group was given the first and(or) the second generation of anaplastic lymphoma kinase(ALK)-tyrosine kinase inhibitor(TKI) regimen] were enrolled for Meta-analysis
and studies on ADR induced by lorlatinib were also analyzed. RESULTS: Totally 5 eligible RCT were enrolled
including 622 patients(308 cases in the lorlatinib group
314 cases in the control group)
the objective remission rate(ORR) was used as the main outcome indicator. The results of Meta-analysis showed that the ORR of the lorlatinib group was higher than that of the control group
with statistically significant difference(OR=2.31
95%CI=1.62-3.28
P<0.000 01)
which indicated that the efficacy of lorlatinib was significant compared with the previous 2 generations of drugs.Fourteen cases of ADR induced by lorlatinib were also collected
including 6 male patients and 8 female patients; there were more patients in the age group of >60 to 70 years old
with 7 cases; most ADR occurred at 2 weeks after medication
mainly involved cardiovascular system damage and respiratory system damage; all ADR were improved after drug withdrawal and(or) symptomatic supportive treatment; 2 cases showed no improvement or aggravation of symptoms at recurrence. CONCLUSIONS: As the third generation of ALK-TKI to treat NSCLC
the level of loratinib to treat NSCLC was significantly improved. However
clinical application of lorlatinib requires strict monitoring on cholesterol and triacylglycerol levels
as well as vigilance against central nervous system damage and cross-adverse drug reactions in the early phase of drug administration.
关键词
劳拉替尼非小细胞肺癌Meta分析药品不良反应药物安全性评价
Keywords
LorlatinibNon-small cell lung cancerMeta-analysisAdverse drug reactionsDrug safety evaluation