Department of Oncology, Guangdong Sanjiu Brain Hospital, Guangzhou, China.
Department of Radiation Oncology, The First People's Hospital of Kashi Prefecture, Kashi, China.
Eur J Med Res. 2023 Aug 4;28(1):267. doi: 10.1186/s40001-023-01219-y.
The aim of this study was to evaluate the efficacy and safety of osimertinib for the treatment of leptomeningeal metastases (LM) from epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC).
We conducted a systematic review and meta-analysis to aggregate the clinical outcomes of patients with LM from EGFR-mutant NSCLC treated with osimertinib. A comprehensive literature search for published and unpublished studies was implemented in April 2021 of PubMed, EMBASE, the Cochrane Library, and several international conference databases, in accordance with the PRISMA guidelines. Meta-analysis of proportions was conducted to calculate the pooled rate of overall response rate (ORR), disease control rate (DCR), one-year overall survival (OS), and adverse events (AEs).
A total of eleven studies (five prospective and six retrospective) including 353 patients were included. The majority of patients (346/353, 98.0%) received osimertinib as ≥ 2nd-line treatment for LM, either at a dosage of 80 mg (161/353, 45.6%) or 160 mg (191/353, 54.1%). The pooled rates of ORR and DCR were 42% (95% CI 24% to 59%) and 93% (95% CI 88% to 97%), respectively. The pooled one-year OS rate was 59% (95% CI 53% to 65%) in 233 patients from five studies. The highest incidence of AEs of all grades was rash (53%), followed by diarrhea (45%), paronychia (35%), decreased appetite (35%), and dry skin (27%), based on data from four studies.
Our study highlighted and confirmed the meaningful efficacy and a manageable safety profile of osimertinib for the treatment of LM from EGFR-mutant advanced NSCLC.
本研究旨在评估奥希替尼治疗表皮生长因子受体（EGFR）突变型非小细胞肺癌（NSCLC）脑膜转移（LM）的疗效和安全性。
我们进行了系统评价和荟萃分析，以汇总 EGFR 突变型 NSCLC 伴 LM 患者接受奥希替尼治疗的临床结局。根据 PRISMA 指南，于 2021 年 4 月在 PubMed、EMBASE、Cochrane 图书馆和多个国际会议数据库中对已发表和未发表的研究进行了全面文献检索。采用比例荟萃分析计算总缓解率（ORR）、疾病控制率（DCR）、一年总生存率（OS）和不良事件（AE）的合并率。
共纳入 11 项研究（5 项前瞻性和 6 项回顾性），包括 353 例患者。大多数患者（346/353，98.0%）接受奥希替尼治疗 LM，剂量为 80mg（161/353，45.6%）或 160mg（191/353，54.1%），作为二线以上治疗。ORR 和 DCR 的合并率分别为 42%（95%CI 24%至 59%）和 93%（95%CI 88%至 97%）。5 项研究中 233 例患者的 1 年 OS 率为 59%（95%CI 53%至 65%）。基于四项研究的数据，最常见的所有级别不良反应为皮疹（53%），其次为腹泻（45%）、甲沟炎（35%）、食欲下降（35%）和皮肤干燥（27%）。
本研究强调并证实了奥希替尼治疗 EGFR 突变型晚期 NSCLC 伴 LM 的显著疗效和可管理的安全性。
