Abstract 371P
Background
Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are now the standard first-line therapy for patients(pts) with EGFR+ non-small cell lung cancer (NSCLC). Elderly pts account for approximately 60% of all NSCLC pts. They do not always benefit from standard treatments due to impaired organ function and multiple diseases. Aumolertinib is a third-generation EGFR-TKI, and current data on third-generation EGFR-TKIs in elderly pts are very limited.
Methods
This study enrolled pts with stage IIA-IVB EGFR+ NSCLC who received aumolertinib alone as first-line therapy, stratified according to gender and disease stage, and the efficacy and safety were compared between pts ≥65 and <65 years (yr) in different subgroups using the chi-square test. The primary endpoint was objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety.
Results
A total of 66 pts (39% were male) were included. Overall, ORR and DCR were 74.2% and 97.0%, respectively (Efficacy; Table). ORR was 71.4% and 77.4% for pts ≥65 and <65 yr, respectively, and DCR was 97.1% and 96.8%, respectively. There were no statistical differences in ORR and DCR between pts ≥65 and <65 yr in all subgroups. Median PFS and OS had not been reached. The overall adverse event (AE) rate was 51.5%. The incidence of grade ≥3 AEs was 4.5%. In pts ≥65 and <65 yr, the incidence of AEs was 45.7% and 58.1%, respectively (p=0.32). All AEs were not statistically different between the two groups. Table: 371P
ORR | DCR | ||||||
Overall | ≥65 yr71.4% | <65 yr77.4% | P value0.58 | ≥65 yr97.1% | <65 yr96.8% | P value0.94 | |
Gender | Male | 64.7% | 77.8% | 0.49 | 94.1% | 100% | 0.46 |
Female | 77.8% | 77.3% | 0.97 | 100% | 95.5% | 0.36 | |
Stage | IIA | 100% | 100% | 0.38 | 100% | 100% | 0.38 |
IIB | 100% | 100% | 0.38 | 100% | 100% | 0.38 | |
IIIA | 80% | 80% | 1 | 100% | 100% | 1 | |
IIIB | - | 100% | - | - | 100% | - | |
IVA | 65.2% | 75% | 0.52 | 95.7% | 100% | 0.40 | |
IVB | 66.7% | 71.4% | 0.88 | 100% | 85.7% | 0.49 |
Conclusions
This was the first report of aumolertinib in elderly pts. In the real world, the efficacy and safety profile of aumolertinib as first-line treatment in elderly EGFR+ NSCLC pts were similar to that seen in the younger subgroup.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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