EVALUATE THE RESULT OF FIRST - LINE OSIMERTINIB IN STAGE IV NON - SMALL CELL LUNG CANCER WITH EGFR MUTATION

Thảo Nguyễn Thị Phương, Vượng Nguyễn Thị, Linh Phan Văn, Huy Trịnh Lê

Main Article Content

Abstract

Objectives: Describe some clinical and subclinical characteristics and evaluate the results of first-line Osimertinib in stage IV non-small cell lung cancer with EGFR mutations at Hanoi Medical University Hospital. Patients and methods: 35 patients with stage IV non-small cell lung cancer with EGFR mutations were treated with first-line Osimertinib at the Oncology Center, Hanoi Medical University Hospital from June 2021 to December 2024. Results: The average age was 66 ± 8.9 years old, with the youngest being 45 years old and the oldest being 87 years old. The male/female ratio was almost equal. The majority of patients in the study had no smoking history (82.9%) and had comorbidities (73.5%). Patients in the study were mainly in good performance status, with PS 0 + 1 accounting for 71.5%, with 1 patient having PS 3. Adenocarcinoma was the most common pathology; The two common mutations were DEL 19 and L858R accounting for 57.1% and 34.3%, respectively. The overall response rate (partial + complete response) was 91%, the disease control rate (partial + complete response + stable disease) was 97% (complete response rate: 6%, partial response: 77%, stable disease: 14%, 3% of cases progressed). Analysis of the correlation between factors: gender, age, general health index and gene mutation type and response to Osimertinib treatment showed that the difference was not statistically significant. However, when analyzing the treatment response between the group of patients who smoked and did not smoke, the difference with p = 0.049 (<0.05) was statistically significant. The median progression-free survival was 18.1 months (95% confidence interval, 16.1 to 20.2 months); the shortest was 4 months and the longest was 30 months. Adverse events were commonly grade 1 and grade 2. The most common adverse events were rash and diarrhea, accounting for 54.2% and 51.3%, respectively. There was 1 patient with interstitial pneumonia due to Osimertinib. Conclusion: First-line treatment with Osimertinib is highly effective and well tolerated in patients with advanced non-small cell lung cancer with EGFR mutations. 

Article Details

References

1. 704-viet-nam-fact-sheet.pdf. Accessed January 19, 2025. https://gco.iarc.who.int/media/ globocan/factsheets/populations/704-viet-nam-fact-sheet.pdf
2. Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma | New England Journal of Medicine. Accessed January 19, 2025. https://www.nejm.org/doi/10.1056/NEJMoa0810699?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref. org&rfr_dat=cr_pub%20%200www.ncbi.nlm.nih.gov
3. Lee CK, Davies L, Wu YL, et al. Gefitinib or Erlotinib vs Chemotherapy for EGFR Mutation-Positive Lung Cancer: Individual Patient Data Meta-Analysis of Overall Survival. JNCI J Natl Cancer Inst. 2017;109(6):djw279. doi:10.1093/ jnci/djw279
4. Cross DAE, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4(9):1046-1061. doi:10.1158/2159-8290.CD-14-0337
5. Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113-125. doi:10.1056/ NEJMoa1713137
6. Võ Thị Huyền Trang và cs. Đánh Giá Kết Quả Afatinib Điều Trị Ung Thư Phổi Không Tế Bào Nhỏ Giai Đoạn IIIB-IV Có Đột Biến EGFR. Luận văn chuyên khoa cấp 2. Đại học Y Hà Nội; 2021.
7. Mai Trọng Khoa, Ngô Thùy Trang, Nguyễn Thị Lan Anh và CS (2016). Nghiên Cứu Tiến Cứu, Dịch Tễ Học Phân Tử, Đánh Giá Tình Trạng Đột Biến Gen EGFR ở Các Bệnh Nhân Việt Nam Mắc Ung Thư Phổi Dạng Biểu Mô Tuyến, Giai Đoạn Tiến Triển. 2016.
8. Albain KS, Belani CP, Bonomi P, O’Byrne KJ, Schiller JH, Socinski M. PIONEER: A Phase III Randomized Trial of Paclitaxel Poliglumex Versus Paclitaxel in Chemotherapy-Naive Women with Advanced-Stage Non-Small-Cell Lung Cancer and Performance Status of 2. Clin Lung Cancer. 2006;7(6):417-419. doi:10.3816/CLC.2006.n.027
9. Yang JCH, Wu YL, 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. Lancet Oncol. 2015;16(2):141-151. doi:10.1016/ S1470-2045(14)71173-8
10. Park K, Tan EH, 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. Lancet Oncol. 2016;17(5): 577-589. doi:10.1016/S1470-2045(16)30033-X