Korean J Intern Med > Volume 40(4); 2025 > Article
ORIGINAL ARTICLE
Pulmonology
Korean J Intern Med. 2025;40(4):626-633.         doi: https://doi.org/10.3904/kjim.2024.269
Efficacy and safety of first-line afatinib in older patients with advanced EGFR-mutated non-small cell lung cancer
Mi-Hyun Kim1,2,3, Hayoung Seong2,3, Soo Han Kim2,3, Min Ki Lee1,2, Insu Kim4, Kyung Soo Hong5,6, June Hong Ahn5,6, and Jung Seop Eom1,2,3
1Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea
2Department of Internal Medicine, Pusan National University Hospital, Busan, Korea
3Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
4Department of Internal Medicine, College of Medicine, Dong-A University, Busan, Korea
5Division of Pulmonology and Allergy, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea
6Department of Internal Medicine, College of Medicine, Yeungnam University, Daegu, Korea
Corresponding Author: Jung Seop Eom  , Tel: +82-51-240-7889, Fax: +82-51-254-3127, Email: ejspulm@pusan.ac.kr
Received: August 1, 2024;   Revised: October 8, 2024;   Accepted: November 4, 2024.
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Abstract
Background/Aims: This study investigated the efficacy and safety of first-line afatinib treatment in older patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Methods: This retrospective, multicenter, observational cohort study included 103 patients aged ≥ 75 years who were treated with first-line afatinib for EGFR-mutated NSCLC. The primary outcome was time-on-treatment (TOT).
Results: The median TOT of patients was 13.6 months (95% confidence interval 11.0–16.2). Ninety-two patients (89.3%) required dose modification. Dose reduction was significantly more frequent in the 40 mg starting dose group than in the 30 mg group (93.1% vs. 68.8%, p = 0.004). The most common grade 3 or worse adverse events (AEs) were diarrhea (n = 16, 54%), acneiform rash (n = 4, 14.3%), and stomatitis (n = 4, 14.3%). Grade 3 or worse AEs led to dose modification in 23 of 28 patients (82.1%) and permanent discontinuation of therapy in five of 28 patients (17.9%). On disease progression, tissue re-biopsy was performed in 18 of 74 patients (24.3%). Thirty-four patients (45.9%) received subsequent chemotherapy; of these, most patients (n = 21, 61.8%) received pemetrexed monotherapy.
Conclusions: This study demonstrated the efficacy of first-line afatinib treatment for EGFR-mutant NSCLC in older patients. However, despite similar safety profiles and frequencies of AEs reported in previous studies, the frequency of dose modifications was higher in this population. A 30 mg starting dose of afatinib and a predefined dose adjustment may be suitable strategies for this population. Post-tyrosine kinase inhibitor management, such as tissue re-biopsy and platinum-based chemotherapy, tended to be underprescribed in this age group.
Keywords: Afatinib ; Aged ; Treatment outcome ; Safety ; Lung neoplasms

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