Kết quả điều trị bước đầu thuốc ribociclib kết hợp nội tiết trong điều trị bệnh ung thư vú tái phát, di căn tại bệnh viện Ung Bướu Hà Nội=Preliminary outcome of ribociclib combined with endocrine therapy in patients with positive endocrine receptor, Her2-negative recurrent or metastatic breast cancer at Hanoi Oncology hospital

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Tác giả: Thu Hà Lê, Thị Thu Hường Nguyễn, Thị Minh Hương Vũ

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Y học Việt Nam (Tổng hội Y học Việt Nam), 2024

Mô tả vật lý: tr.74-81

Bộ sưu tập: Metadata

ID: 478117

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Mô tả một số đặc điểm lâm sàng, cận lâm sàng bệnh nhân ung thư vú tái phát, di căn có thụ thể nội tiết dương tính, HER2 âm tính điều trị bằng ribociclib phối hợp thuốc nội tiết tại bệnh viện Ung Bướu Hà Nội. Đánh giá đáp ứng và một số tác dụng không mong muốn của phác đồ trên nhóm bệnh nhân nghiên cứu. Đối tượng và phương pháp nghiên cứu: Nghiên cứu mô tả hồi cứu kết hợp tiến cứu trên bệnh nhân ung thư vú tái phát, di căn được điều trị với Ribociclib phối hợp nội tiết tại bệnh viện Ung Bướu Hà Nội từ 1/2021 đến 8/2024. Bệnh nhân được đánh giá mức độ đáp ứng theo “Tiêu chuẩn đánh giá đáp ứng cho u đặc (RECIST 1.1)”, tác dụng không mong muốn theo tiêu chuẩn CTCAE 5.0. Kết quả: 45 bệnh nhân tham gia nghiên cứu. Tuổi trung bình là 57,7±14,3 tuổi, tuổi nhỏ nhất là 29, lớn nhất là 81. Vị trí di căn thường gặp là xương, hạch, phổi, gan với tỷ lệ tương ứng là 53,3%, 46,7%, 31,1% và 28,9%. Tỷ lệ đáp ứng toàn bộ là 60,0%, tỷ lệ đáp ứng hoàn toàn toàn là 4,4%, đáp ứng 1 phần là 55,6%. Tỷ lệ kiểm soát bệnh đạt được là 84,4%. Bệnh nhân điều trị ở bước 1 có tỷ lệ đáp ứng cao hơn bệnh nhân điều trị ở bước sau. Không thấy có sự khác biệt về tỷ lệ đáp ứng điều trị do khác biệt về loại thuốc nội tiết được sử dụng, tình trạng kháng nội tiết và tình trạng di căn tạng. Tác dụng không mong muốn thường gặp nhất là hạ bạch cầu với tỷ lệ 66.6%. Tác dụng không mong muốn ngoài hệ huyết học thường gặp là mệt mỏi và tăng men gan và chủ yếu ở độ I. Kết luận: Phác đồ Ribociclib phối hợp nội tiết trong điều trị ung thư vú tái phát di căn có thụ thể nội tiết dương tính, HER2 âm tính cho kết quả đáp ứng cao, có tỷ lệ kiểm soát bệnh tốt, các tác dụng không mong muốn thường gặp ở độ I, II và có thể kiểm soát được.To describe clinical, paraclinical characteristics, treatment response, and adverse events in recurrent and metastatic breast cancer patients with HR-positive and HER2-negative treated with ribociclib combined with an endocrine drug . Patients and Methods: this is a descriptive, combined prospective and retrospective study enrolling all recurrent and metastatic breast cancer patients with HR-positive and HER2- negative at Hanoi Oncology Hospital from January 2021 to August 2022. All patients received ribociclib combined with an endocrine drug until disease progression or development of unacceptable adverse event(s). Tumor response was assessed based on RECIST guideline version 1.1, and adverse events were evaluated by CTCAE version 5.0. Results: totally 45 patients were included. Mean age was 57.7±14.3 (range 29-81). Common metastatic sites were bones, lymph nodes, lungs, and liver with rates of 53.3%, 46.7%, 31.1%, and 28.9%, respectively. Partial response rate was 55.6%, complete response rate was 4.4%, and the disease control rate was 84.4%. Patients treated with ribociclib as the first-line treatment had a higher response rate than those used it in later lines. There were no differences in treatment response rate observed in different types of endocrine therapy, endocrine resistance status, and visceral metastases. The most common adverse event was leukopenia (66.6%). Common adverse events outside the hematological system included fatigue and liver enzyme elevation, mainly in grades I, and II. Conclusion: In the treatment for patients with HR-positive and HER2-negative recurrent or metastatic breast cancer, Ribociclib combined with endocrine therapy appeared to be a safe and effective regimen with high response rate and disease control rate, and acceptable adverse events.

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