Compare the effectiveness of afatinib and gefitinib as first-line treatment in patients with advanced stage non-small cell lung cancer haboring common EGFR mutations: Real-world data on PFS
Main Article Content
Keywords
Abstract
Objective: To compare the effectiveness of afatinib and gefitinib as first-line treatment in patients with advanced stage non-small cell lung cancer (NSCLC) with common EGFR mutations. Subject and method: This is a retrospective study, patients with advanced stage NSCLC harboring EGFR mutation deletion of exon 19 and L858R point mutation on exon 21 treated as a first line with afatinib or gefitinib from January 2019 to December 2023. Patients were flow-up and assessed for response every 3 months or when they had symptoms of progression. The primary endpoints were progression-free survival (PFS), objective response rate (ORR), secondary endpoints were disease control rate (DCR), and adverse events. Stratified by EGFR mutations, and brain metastasis. Result: There were 137 patients participating, afatinib 65 patients and gefitinib 72 patients. The average age of patients in the afatinib and gefitinib groups was 60.2 years and 65.5 years old, respectively (p=0.04). The number of patients with brain metastasis treated by afatinib was 24 patients and gefitinib was 16 patients. ORR was 90.7% in the afatinib group and 81.9% in the gefitinib group with p=0.46. DCR was equal between the 2 groups. Median PFS in the afatinib group was 15.8 months and the gefitinib group was 14.4 months, p=0.55. The median PFS of patients with brain metastasis was equivalent to 13 months in the afatinib group and 12 months in the gefitinib group (p=0.51). Patients with the L858R mutation treated by afatinib had a median PFS of 17.6 months longer than the gefitinib group with 14 months, on the contrary, patients with the exon 19 deletion mutation treated by gefitinib and afatinib achieved a median PFS of 17.1 months versus 14.5 months, respectively (p=0.68). Side effects occurred in 73.8% of patients treated with afatinib higher than the group treated with gefitinib at 44.4%. There was 1 patient with rash and 1 patient with diarrhea at grade 3 due to afatinib, and 3 patients had grade 3 of increasing liver enzyme due to gefitinib. Conclusion: Afatinib and gefitinib have good effects in advanced stage NSCLC patients with common EGFR mutations. However, the percentage of adverse events in the afatinib arm was higher than in gefitinib arm.
Article Details
References
2. Soria JC, Ohe Y, Vansteenkiste J et al (2018) Osimertinib in untreated EGFR-mutated advanced non-small cell lung cancer. N Engl J Med 378: 113-125.
3. Ramalingam SS, Vansteenkiste J, Planchard D et al (2020) Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med 382: 41-50.
4. Park K, Tan EH, O’Byrne K et al (2016) 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. Lancet Oncol 17: 577-589.
5. Ares LP, Tan EH, O’Byrne K et al (2017) 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 28: 270-277.
6. Kim Y, Lee SH, Ahn JS et al (2019) Efficacy and safety of afatinib for EGFR-mutant non-small cell lung cancer, compared with gefitinib or erlotinib. Cancer Res Treat 51: 502-509.
7. Yang Z, Hackshaw A, Feng Q et al (2017) Comparison of gefitinib, erlotinib and afatinib in non-small cell lung cancer: A meta-analysis. Int. J. Cancer 140: 2805-2819.
8. Thanh Ha Vu, Hoa Thai Thi Nguyen, Linh Khanh Dao et al (2021) Effectiveness and tolerability of first line afatinib for advanced EGFR-mutant non-small cell lung cancer in Vietnam. Asian Pac J Cancer Prev 22 (5): 1581-1590.
9. Pham Van Luan, Nguyen Dinh Tien, Nguyen Minh Hai et al (2021) Real-world analysis of the effect of gefitinib as a first-line therapy in patients with advanced non-small cell lung cancer with EGFR mutations. Ther Adv Med Oncol 13: 1758835921992977.
10. Eiseihauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: Revised RESIST guideline (version 1.1). European Journal of Cancer 45: 228-247.
11. National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017.
12. Tu CY, Chen CM, Liao WC et al (2018) Comparison of the effects of the three major tyrosine kinase inhibitors as first-line therapy for non-small-cell lung cancer harboring epidermal growth factor receptor mutations. Oncotarget 9(36): 24237- 24247.
13. Su PL, Chen CW, Wu YL et al (2021) First-line treatment with irreversible tyrosine kinase inhibitors associated with longer OS in EGFR mutation positive non-small cell lung cancer. Thoracic Cancer 12 (2021): 287-296.
14. Chen KL, Lin CC, Cho YT et al (2016) Comparison of skin toxic effects associated with gefitinib, erlotinib, or afatinib treatment for non-small cell lung cancer. JAMA Dermatol 152: 340-342.
15. Haaland B, Tan PS, Pharm M et al (2014) Meta-analysis of first-line therapies in advanced non-small-cell lung cancer harboring EGFR activating mutations. J Thorac Oncol 9: 805-811.