PDF(Pubmed)
Abstract：
Background and Aim: As one of the second-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors, afatinib brings survival benefits to patients with common and rare EGFR mutations. This study aimed to compare the effectiveness and safety of 30 and 40 mg of afatinib in patients with non-small cell lung cancer (NSCLC) using qualitative and quantitative analysis methods so as to provide reference for clinical medication. Methods: The PubMed, Embase, ClinicalTrials.gov, Cochrane Library, China National Knowledge Infrastructure, and WanFang databases were thoroughly searched from inception to February 26, 2021. Two researchers independently screened the literature, extracted data, and evaluated the quality. RevMan and Stata 15.0 were used for meta-analysis. Results: Twelve cohort studies including 1290 patients for final analysis were selected; of which, 1129 patients were analyzed to measure the effectiveness outcomes and 470 patients were analyzed for safety outcomes. In patients with non-brain metastasis, the progression-free survival of the first- or second-line treatment with reduced-dose afatinib was equivalent to the conventional dose. In terms of safety, the reduced dose could significantly lower the incidence of severe diarrhea and severe rash, but not the total incidence of diarrhea, rash, and all levels of paronychia. Conclusions: The incidence of common serious adverse reactions was significantly lower with 30 mg of afatinib than with 40 mg of afatinib in patients with NSCLC. The effectiveness appeared to be similar to that in patients with non-brain metastasis. This study provides a reference for clinical dose reduction of afatinib. Systematic Review Registration: [PROSPERO], identifier [CRD42021238043].
摘要：
背景与目的:作为第二代表皮生长因子受体(EGFR)-酪氨酸激酶抑制剂,阿法替尼为常见和罕见EGFR突变患者带来生存益处.本研究采用定性和定量分析方法,比较30和40mg阿法替尼治疗非小细胞肺癌(NSCLC)的有效性和安全性,为临床用药提供参考。方法：PubMed，Embase,ClinicalTrials.gov,科克伦图书馆,中国国家知识基础设施，和万方数据库从成立到2021年2月26日进行了彻底搜索。两名研究人员独立筛选了文献，提取的数据，并评估了质量。采用RevMan和Stata15.0进行Meta分析。结果：选择了12项队列研究，包括1290例患者进行最终分析；其中，对1129名患者进行了分析以衡量有效性结果，并对470名患者进行了安全性结果分析。在非脑转移患者中，减量阿法替尼一线或二线治疗的无进展生存期与常规剂量相当.在安全方面,减少剂量可以显着降低严重腹泻和严重皮疹的发生率，但不是腹泻的总发病率，皮疹,和所有级别的甲沟炎。结论：30mg阿法替尼治疗非小细胞肺癌患者的严重不良反应发生率明显低于40mg阿法替尼。效果似乎与非脑转移患者相似。本研究为临床降低阿法替尼剂量提供参考。系统审查注册：[PROSPERO]，标识符[CRD42021238043]。
