Osimertinib as a neoadjuvant therapy in resectable EGFR-mutant non-small cell lung cancer: a real-world, multicenter retrospective study.

IF 4 2区医学 Q2 ONCOLOGY Translational lung cancer research Pub Date : 2024-12-31 Epub Date: 2024-12-16 DOI:10.21037/tlcr-24-541

Jialong Li, Youyu Wang, Zerui Zhao, Sihua Wang, Wanpu Yan, Xiaohui Chen, Tianxiang Chen, Pengfei Li, Sheng Wang, Qiang Fang, Lin Peng, Yongtao Han, Jian Tang, Xuefeng Leng

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Abstract

Background: Osimertinib, a third-generation tyrosine kinase inhibitor (TKI), has been authorized for use in patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). This study aimed to evaluate the effectiveness and safety of neoadjuvant osimertinib in individuals with resectable locally advanced NSCLC harboring EGFR mutation.

Methods: Ten centers located in mainland China took part in a single-arm, real-world, multicenter retrospective study (registration number: ChiCTR2100049954). Enrollment included individuals with lung adenocarcinoma who had EGFR mutations. Following the administration of osimertinib, the patients underwent a surgical procedure for resection. The main endpoint was the objective response rate (ORR). The subsequent endpoint analyzed was the joint assessment of overall survival (OS) and disease-free survival (DFS).

Results: From July 31, 2018 to April 28, 2023, a total of 38 individuals were involved and received neoadjuvant osimertinib treatment. The ORR was 60.5% (23/38). Thirty-eight patients underwent surgery, and 36 (94.7%) underwent successful R0 resection. Out of 38 patients, sixteen (42.1%) experienced adverse events (AEs) due to treatment in the neoadjuvant phase, with none of them reaching grade 3. Skin irritation [14 (36.8%)], stomach upset [5 (13.2%)], mouth sores [1 (2.6%)] and increased liver enzyme levels [1 (2.6%)] were the common AEs of treatment. The follow-up period lasted an average of 24.9 months. The 1-year OS rate is 94.2%, while the 2-year OS rate is 89.2%. The 1-year DFS rate is 87.9%, and the 2-year DFS rate remains at 87.9%.

Conclusions: In the actual clinical setting, osimertinib displays encouraging possibilities as a neoadjuvant therapy for individuals with operable EGFR-mutated NSCLC, exhibiting adequate efficacy and an acceptable safety record. The phase III clinical trial of NeoADAURA is expected to provide further efficacy and safety results.

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奥西替尼作为可切除egfr突变的非小细胞肺癌的新辅助治疗：一项真实世界的多中心回顾性研究

背景：奥西替尼是第三代酪氨酸激酶抑制剂（TKI），已被批准用于表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者。本研究旨在评估新辅助奥希替尼在可切除的局部晚期NSCLC携带EGFR突变患者中的有效性和安全性。方法：位于中国大陆的10个中心参与了一项单臂、真实世界、多中心回顾性研究（注册号：ChiCTR2100049954）。研究对象包括有EGFR突变的肺腺癌患者。在给予奥西替尼后，患者接受手术切除。主要终点为客观缓解率（ORR）。随后的终点分析是总生存期（OS）和无病生存期（DFS）的联合评估。结果：2018年7月31日至2023年4月28日，共有38例患者接受了新辅助奥希替尼治疗。ORR为60.5%（23/38）。38例患者接受手术，36例（94.7%）成功切除R0。在38例患者中，16例（42.1%）由于新辅助期的治疗而出现不良事件（ae），没有一例达到3级。皮肤刺激[14例（36.8%）]、胃部不适[5例（13.2%）]、口腔溃疡[1例（2.6%）]和肝酶水平升高[1例（2.6%）]是常见的不良反应。随访时间平均为24.9个月。1年的OS率为94.2%，2年的OS率为89.2%。1年DFS率为87.9%，2年DFS率保持在87.9%。结论：在实际临床环境中，奥西替尼作为可手术egfr突变NSCLC患者的新辅助治疗显示出令人鼓舞的可能性，表现出足够的疗效和可接受的安全性记录。NeoADAURA的III期临床试验有望提供进一步的疗效和安全性结果。

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来源期刊

Translational lung cancer research Medicine-Oncology

CiteScore

7.20

自引率

2.50%

发文量

137

期刊介绍： Translational Lung Cancer Research(TLCR, Transl Lung Cancer Res, Print ISSN 2218-6751; Online ISSN 2226-4477) is an international, peer-reviewed, open-access journal, which was founded in March 2012. TLCR is indexed by PubMed/PubMed Central and the Chemical Abstracts Service (CAS) Databases. It is published quarterly the first year, and published bimonthly since February 2013. It provides practical up-to-date information on prevention, early detection, diagnosis, and treatment of lung cancer. Specific areas of its interest include, but not limited to, multimodality therapy, markers, imaging, tumor biology, pathology, chemoprevention, and technical advances related to lung cancer.