Real-world overall survival of first-line afatinib in EGFR-mutant advanced non–small cell lung cancer at Vietnam National Cancer Hospital
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Abstract
Afatinib is a second-generation tyrosine kinase inhibitor approved for the treatment of advanced non–small cell lung cancer (NSCLC). This retrospective study included 230 patients with stage IIIC/IV, EGFR-mutant lung adenocarcinoma treated with first-line Afatinib at K Hospital between January 2018 and October 2024; follow-up was conducted until September 2025 to evaluate overall survival (OS) and safety. With a median follow-up of 28.2 months, the median overall survival (mOS) was 27.8 months. No significant difference in OS was observed according to brain metastasis status (p = 0.479), whereas liver metastases were associated with a significantly poorer OS (20.9 vs. 28.8 months; p = 0.025). Patients with common EGFR mutations (L858R, Del19) had longer OS compared to those with uncommon mutations (p < 0.05). No significant difference in OS was observed across different dosing levels. Second-line treatment with Osimertinib resulted in the longest mOS (29.0 months). The most common adverse events were diarrhea and skin toxicity (61.3%), mostly mild to moderate, with no grade ≥ 3 toxicities observed.
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Keywords
Non – small cell lung cancer, advanced stage, EGFR mutation, Afatinib
References
2. Shi Y, Au JS-K, Thongprasert S, et al. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non–small-cell lung cancer of adenocarcinoma histology (PIONEER). Journal of thoracic oncology. 2014;9(2):154-162.
3. Hirsch FR, Varella-Garcia M, Bunn Jr PA, et al. Epidermal growth factor receptor in non–small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. Journal of clinical oncology. 2003;21(20):3798-3807.
4. Park K, Tan E-H, O’Byrne K, et al. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. The Lancet Oncology. 2016;17(5):577-589.
5. Sequist LV, Yang JC-H, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. Journal of clinical oncology. 2013;31(27):3327-3334.
6. Thái PV, Niên VT, Phương PC, và cs. Kết quả sống thêm toàn bộ của bệnh nhân ung thư phổi không tế bào nhỏ giai đoạn IIIc-IV có đột biến EGFR được điều trị bằng afatinib tại Hà Nội. Tạp chí Y học Việt Nam. 2025;550(2).
7. Vân NT, Tú ĐA, Phương TM, Phương VT, Kiên NT. Kết quả điều trị bước 1 bằng afatinib trên bệnh nhân cao tuổi ung thư phổi không tế bào nhỏ giai đoạn IV có đột biến gen EGFR tại Bệnh viện K. Tạp chí Y học Việt Nam. 2025;546(1).
8. Bhandari S, Dunlap N, Kloecker G. Radiotherapy in brain metastases from EGFR-mutated non-small cell lung cancer. Journal of Thoracic Disease. 2021;13(5):3230.
9. Rangachari D, Yamaguchi N, VanderLaan PA, et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung cancer. 2015;88(1):108-111.
10. Zhang L, Luo Y, Chen J, et al. Efficacy and Safety of Afatinib in the Treatment of Advanced Non-Small-Cell Lung Cancer with EGFR Mutations: A Meta-Analysis of Real-World Evidence. Journal of Oncology. 2021;2021(1):8736288.
11. Iuchi T, Shingyoji M, Itakura M, et al. Frequency of brain metastases in non-small-cell lung cancer, and their association with epidermal growth factor receptor mutations. International journal of clinical oncology. 2015;20(4):674-679.
12. Yang JC-H, Wu Y-L, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. The lancet oncology. 2015;16(2):141-151.
13. Paz-Ares L, Tan E-H, O’Byrne K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Annals of Oncology. 2017;28(2):270-277.
14. Tamura T, Kurishima K, Nakazawa K, et al. Specific organ metastases and survival in metastatic non-small-cell lung cancer. Molecular and clinical oncology. 2015;3(1):217-221.
15. Riihimäki M, Hemminki A, Fallah M, et al. Metastatic sites and survival in lung cancer. Lung cancer. 2014;86(1):78-84.
16. Yang JC, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. The lancet oncology. 2015;16(7):830-838.
17. Tu H-Y, Wu Y-L. Effect of dose adjustments on the safety and efficacy of afatinib in Chinese patients with EGFR-mutated non-small cell lung cancer who participated in the LUX-lung clinical trial program. OncoTargets and therapy. 2020:12539-12547.
18. Ng TL, Camidge DR. AURA 3: the last word on chemotherapy as a control arm in EGFR mutant NSCLC? Annals of translational medicine. 2017;5(Suppl 1):S14.