Osimertinib as a neoadjuvant therapy in resectable EGFR-mutant non-small cell lung cancer: a real-world, multicenter
Jialong Li1, Youyu Wang2, Zerui Zhao3
1Department 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.
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.
Insights
Neoadjuvant osimertinib shows promise for resectable EGFR-mutant non-small cell lung cancer (NSCLC), demonstrating a 60.5% objective response rate and good safety. This real-world study highlights its potential in clinical settings.
Area of Science:
- Oncology
- Pharmacology
Background:
- Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) approved for epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC).
- Neoadjuvant therapy aims to improve surgical outcomes in locally advanced NSCLC.
Purpose of the Study:
- To evaluate the effectiveness and safety of neoadjuvant osimertinib in patients with resectable, locally advanced NSCLC harboring EGFR mutations.
- To assess the objective response rate (ORR), overall survival (OS), and disease-free survival (DFS) following neoadjuvant osimertinib treatment.
Main Methods:
- A single-arm, real-world, multicenter retrospective study was conducted across ten centers in mainland China.
- Patients with lung adenocarcinoma and EGFR mutations received neoadjuvant osimertinib followed by surgical resection.
- Key endpoints included ORR, OS, and DFS, with safety assessments of adverse events (AEs).
Main Results:
- 38 patients received neoadjuvant osimertinib; the ORR was 60.5% (23/38).
- 94.7% (36/38) achieved R0 resection. Common AEs were skin irritation (36.8%) and stomach upset (13.2%), with no Grade 3 AEs.
- The 2-year OS and DFS rates were 89.2% and 87.9%, respectively.
Conclusions:
- Neoadjuvant osimertinib demonstrates encouraging efficacy and an acceptable safety profile in operable EGFR-mutated NSCLC within a real-world clinical setting.
- Further data from the phase III NeoADAURA trial are anticipated to provide additional insights into its efficacy and safety.
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