First-Line Aumolertinib in EGFR-Mutant Advanced Non-Small Cell Lung Cancer: A Multicenter Real-World Retrospective Study with a Four-Year Follow-Up.

IF 4.1 4区医学 Q3 ONCOLOGY

Oncology Research Pub Date : 2025-08-28 eCollection Date: 2025-01-01 DOI:10.32604/or.2025.064119

Xi Qin, Yulan Liu, Lin Zhu, Yunyan Mo, Jing Zhang, Zhuchun Jiang, Dongning Huang, Xinrong Hu, Jingzhang Li, Quanfang Chen, Feng Xue

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引用次数: 0

Abstract

Background: The use of third-generation different tyrosine kinase inhibitors (TKIs) is considered the most effective option for treating advanced non-small cell lung cancer (aNSCLC) with epidermal growth factor receptor (EGFR) mutations. However, there is limited information on the efficacy and safety of aumolertinib in patients remains these cases.

Methods: The clinical records of patients receiving aumolertinib as first-line therapy across four hospitals in the Guangxi Zhuang Autonomous Region from April 2020 to December 2021 were retrospectively analyzed, using progression-free survival (PFS) as the primary endpoint and overall survival (OS) representing the secondary endpoint. Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

Results: Approximately 47 patients with EGFR-Mutant aNSCLC were recruited, including 1 squamous cell carcinoma (SCC) patient, 1 EGFR G719C mutated patient, 1 EGFR S768 patient mutated, and 1 EGFR KDD mutated patient. The average follow-up duration was 48.1 months concluding in August 2024. The median PFS (mPFS) was 22.2 months (95% CI 17.6 to 26.7), while the median OS (mOS) was 39.7 months (95% CI 32.6 to 46.9). Patients with deletion of exon19 in EGFR (19del) showeda mPFS of 28.4 months, markedlylonger than those with the L858R point mutation (L858R), who had a mPFS of 15.2 months (p = 0.036). Overall, 22 patients (46.8%) had central nervous system (CNS) metastases at the basal level. The mPFS for this cohort was 19.7 months. Rashes (17.0%), skin decrustation (4.2%), pruritus (4.2%), dental ulcers (4.2%), increased creatine kinase (2.1%), and musculoskeletal pains (2.1%) were the most prevalent AEs in this study. Grade 3 and higher AEs were observed at a rate of 4.2%.

Conclusion: This study concluded that aumolertinib has considerable safety and efficacy for EGFR-mutant NSCLC in a first-line defense.

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一线奥莫替尼治疗egfr突变晚期非小细胞肺癌：一项为期四年的多中心回顾性研究

背景：使用第三代不同酪氨酸激酶抑制剂（TKIs）被认为是治疗表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌（aNSCLC）最有效的选择。然而，关于奥莫替尼在这些病例中的有效性和安全性的信息有限。方法：回顾性分析广西壮族自治区4家医院2020年4月至2021年12月接受奥莫替尼作为一线治疗的患者的临床记录，以无进展生存期（PFS）为主要终点，总生存期（OS）为次要终点。不良事件（ae）采用不良事件通用术语标准（CTCAE v5.0）进行评估。结果：招募了大约47例EGFR突变的aNSCLC患者，包括1例鳞状细胞癌（SCC）患者，1例EGFR G719C突变患者，1例EGFR S768突变患者和1例EGFR KDD突变患者。截至2024年8月，平均随访时间为48.1个月。中位PFS （mPFS）为22.2个月（95% CI 17.6至26.7），中位OS （mOS）为39.7个月（95% CI 32.6至46.9）。EGFR外显子19缺失（19del）患者的mPFS为28.4个月，明显长于L858R点突变（L858R）患者的mPFS为15.2个月（p = 0.036）。总体而言，22例（46.8%）患者中枢神经系统（CNS）在基础水平转移。该队列的mPFS为19.7个月。皮疹（17.0%）、皮肤脱屑（4.2%）、瘙痒（4.2%）、口腔溃疡（4.2%）、肌酸激酶升高（2.1%）和肌肉骨骼痛（2.1%）是本研究中最常见的ae。3级及以上ae发生率为4.2%。结论：本研究得出奥莫替尼作为一线防御egfr突变型NSCLC具有相当的安全性和有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncology Research 医学-肿瘤学

CiteScore

4.40

自引率

0.00%

发文量

审稿时长

3 months

期刊介绍： Oncology Research Featuring Preclinical and Clincal Cancer Therapeutics publishes research of the highest quality that contributes to an understanding of cancer in areas of molecular biology, cell biology, biochemistry, biophysics, genetics, biology, endocrinology, and immunology, as well as studies on the mechanism of action of carcinogens and therapeutic agents, reports dealing with cancer prevention and epidemiology, and clinical trials delineating effective new therapeutic regimens.