Neoadjuvant and Adjuvant Osimertinib in Stage IA to IIIA, EGFR-Mutant NSCLC (NORA).

The role of neoadjuvant osimertinib in the perioperative setting is yet to be elucidated in the NeoADAURA study (NCT04351555).

在NeoADAURA研究（NCT04351555）中，新辅助奥希替尼在围手术期的作用尚未明确。

Methods

This is a single-center, pilot study of patients with clinical stage IA to IIIA NSCLC (American Joint Committee on Cancer eighth edition) harboring an activating EGFR mutation (Exon 19 deletion, L858R) (NCT04816838).

这是一项针对临床分期为IA至IIIA期非小细胞肺癌（NSCLC）患者（美国癌症联合委员会第八版）的单中心、探索性研究，这些患者携带有活性的EGFR突变（Exon 19缺失、L858R）（NCT04816838）。

Patients were treated with two 28-day cycles of neoadjuvant osimertinib followed by surgical resection and three years of adjuvant osimertinib.

患者接受了两个28天周期的术前奥希替尼治疗，随后进行手术切除，并接受三年的奥希替尼辅助治疗。

The primary endpoint was the objective response rateafter two cycles of neoadjuvant treatment.

主要终点是在两周期新辅助治疗后的客观缓解率。

Secondary endpoints included the pathologic complete response rate and major pathologic response rate.

次要终点包括病理完全缓解率和主要病理缓解率。

Exploratory objectives included the correlation of longitudinal circulating tumor DNA testing (Signatera) and response to neoadjuvant osimertinib.

探索性目标包括纵向循环肿瘤DNA检测（Signatera）与新辅助奥希替尼治疗反应的相关性。

Results

A total of 25 patients were enrolled and treated with neoadjuvant osimertinib, and all patients received surgical resection with R0 resection.

共有25名患者被纳入并接受新辅助奥希替尼治疗，所有患者均接受了R0切除术的外科手术。

The objective response ratewas 44% (n = 11) all of which were partial responses.

客观缓解率为44%（n=11），所有这些均为部分缓解。

Fourteen patients (56%) reported stable disease after neoadjuvant osimertinib.

在接受新辅助奥希替尼治疗后，有14名患者（56%）报告疾病稳定。

The major pathologic response and pathologic complete response rates were 24% (n = 6) and 0%, respectively.

主要病理反应和病理完全缓解率分别为24%（n = 6）和0%。

None of the patients received adjuvant chemotherapy.

没有患者接受辅助化疗。

The median disease-free survival was not reached at a median follow-up of 31 months (range: 13.8-38.6 mo).

中位无病生存期在中位随访31个月（范围：13.8-38.6个月）时未达到。

Six patients (30%) were circulating tumor DNA-positive at baseline and achieved clearance after 1 cycle of neoadjuvant osimertinib.

六名患者（30%）在基线时循环肿瘤DNA阳性，并在使用1周期新辅助奥希替尼治疗后实现了清除。

There were no grade 3 adverse events during neoadjuvant treatment.

新辅助治疗期间没有发生3级不良事件。

Conclusions

Two cycles of neoadjuvant osimertinib did not meet its primary endpoint of ORR.

两个周期的新辅助奥希替尼治疗未达到其主要终点客观缓解率(ORR)。

Neoadjuvant osimertinib is a feasible approach with a manageable safety profile in resectable EGFR-mutant NSCLC.

在可切除的EGFR突变型非小细胞肺癌中，新辅助奥希替尼是一种可行的方法，具有可控的安全性特征。