奥希替尼作为可切除的表皮生长因子受体（EGFR）突变非小细胞肺癌的新辅助治疗：一项真实世界、多中心回顾性研究
Osimertinib as a neoadjuvant therapy in resectable EGFR-mutant non-small cell lung cancer: a real-world, multicenter retrospective study.
作者信息
Li Jialong, Wang Youyu, Zhao Zerui, Wang Sihua, Yan Wanpu, Chen Xiaohui, Chen Tianxiang, Li Pengfei, Wang Sheng, Fang Qiang, Peng Lin, Han Yongtao, Tang Jian, Leng Xuefeng
机构信息
Department of Thoracic Surgery, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China (UESTC), Chengdu, China.
Department of Thoracic Surgery, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China (UESTC), Chengdu, China.
出版信息
Transl Lung Cancer Res. 2024 Dec 31;13(12):3344-3351. doi: 10.21037/tlcr-24-541. Epub 2024 Dec 16.
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.
背景
奥希替尼是一种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治疗携带EGFR突变的可切除局部晚期NSCLC患者的有效性和安全性。
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）。入组患者包括患有EGFR突变的肺腺癌患者。在给予奥希替尼后，患者接受手术切除。主要终点是客观缓解率（ORR）。随后分析的终点是总生存期（OS）和无病生存期（DFS）的联合评估。
结果
从2018年7月31日至2023年4月28日，共有38例患者参与并接受了新辅助奥希替尼治疗。ORR为60.5%（23/38）。38例患者接受了手术，36例（94.7%）成功进行了R0切除。在38例患者中，16例（42.1%）在新辅助治疗阶段因治疗出现不良事件（AE），均未达到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%）]是常见的治疗AE。随访期平均持续24.9个月。1年OS率为94.2%，2年OS率为89.2%。1年DFS率为87.9%，2年DFS率仍为87.9%。
结论
在实际临床环境中，奥希替尼作为可手术的EGFR突变NSCLC患者的新辅助治疗显示出令人鼓舞的前景，具有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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