So sánh hiệu quả điều trị bước một của afatinib và gefitinib ở bệnh nhân ung thư phổi không tế bào nhỏ giai đoạn tiến xa có đột biến gen EGFR thường gặp: Dữ liệu đời thực về PFS=Compare the effectiveness of afatinib and gefitinib as first-line treatment in patients with advanced stage non-small cell lung cancer harboring common EGFR mutations: Real-world data on PFS

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Tác giả: Đạo Tiến Nguyễn, Đình Tùng Nguyễn, Minh Hải Nguyễn, Văn Luận Phạm

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Y dược lâm sàng 108, 2024

Mô tả vật lý: tr.55-63

Bộ sưu tập: Metadata

ID: 244937

Thêm vào giỏ

So sánh hiệu quả điều trị bước 1 của afatinib và gefitinib ở BN UTPKTBN giai đoạn tiến xa có đột biến gen EGFR thường gặp. Đối tượng và phương pháp: Nghiên cứu hồi cứu, các BN UTPKTBN giai đoạn tiến xa có đột biến gen EGFR loại xóa đoạn exon 19 và đột biến điểm L858R trên exon 21 được điều trị bước 1 bằng afatinib và gefitinib từ 01/2019 đến 12/2023. BN được theo dõi và đánh giá đáp ứng mỗi 3 tháng hoặc khi có triệu chứng của bệnh tiến triển. Tiêu chuẩn chính là thời gian sống thêm bệnh không tiến triển (PFS), tỉ lệ đáp ứng khách quan (ORR), tiêu chuẩn phụ là tỉ lệ kiểm soát bệnh (DCR), tác dụng không mong muốn. Phân tầng theo loại đột biến gen EGFR và di căn não. Kết quả: Có 137 BN tham gia nghiên cứu, trong đó 65 BN điều trị afatinib và 72 BN điều trị gefitinib. Tuổi trung bình của BN nhóm afatinib và gefitinib lần lượt là 60,2 tuổi và 65,5 tuổi (p=0,04). Số BN di căn não được điều trị afatinib là 24 BN và gefitinib là 16 BN. ORR là 90,7% ở nhóm afatinib và 81,9% ở nhóm gefitinib với p=0,46. DCR bằng nhau giữa 2 nhóm. Trung vị PFS ở nhóm afatinib là 15,8 tháng và nhóm gefitinib là 14,4 tháng, p=0,55. Trung vị PFS của BN di căn não là tương đương với 13 tháng ở nhóm afatinib và 12 tháng ở nhóm gefitinib (p=0,51). BN mang đột biến L858R điều trị afatinib có trung vị PFS 17,6 tháng dài hơn nhóm gefitinib với 14 tháng, ngược lại, BN mang đột biến xóa đoạn exon 19 điều trị gefitinib và afatinib đạt trung vị PFS lần lượt là 17,1 tháng so với 14,5 tháng (p=0,68). Tác dụng không mong muốn gặp ở 73,8% BN điều trị afatinib, cao hơn so với nhóm điều trị gefitinib 44,4%. Có 1 BN nổi ban và 1 BN tiêu chảy độ 3 do afatinib, có 3 BN tăng men gan độ 3 do gefitinib. Kết luận: Afatinib và gefitinib đều có hiệu quả tốt về tỉ lệ đáp ứng và PFS ở BN UTPKTBN giai đoạn tiến xa có đột biến gen EGFR thường gặp, kể cả BN có di căn não. Tuy nhiên, tỉ lệ tác dụng không mong muốn gặp ở nhóm afatinib cao hơn so với nhóm gefitinib.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.

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