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VicTORia: một nghiên cứu ngẫu nhiên giai đoạn II so sánh vinorelbine kết hợp với chất ức chế mTOR everolimus so với liệu pháp đơn độc vinorelbine trong hóa trị liệu tuyến 2 cho ung thư vú tiến triển HER2 âm tính
Tóm tắt
Cải thiện kết quả cho bệnh nhân mắc ung thư vú di căn HER2 âm tính có tiến triển khối u sau hóa trị liệu tuyến đầu vẫn là một nhu cầu y tế cấp bách. Mục tiêu của thử nghiệm VicTORia là chỉ ra sự vượt trội của everolimus kết hợp với vinorelbine so với liệu pháp đơn độc vinorelbine như hóa trị liệu tuyến 2 cho bệnh nhân ung thư vú tiến triển HER2 âm tính. Trong thử nghiệm ngẫu nhiên giai đoạn II này, 133 bệnh nhân đã được tuyển chọn tại 32 trung tâm ở Đức. Bệnh nhân được phân ngẫu nhiên 1:1 để nhận hóa trị liệu tuyến 2 hoặc là vinorelbine cộng với everolimus (nhóm 1) hoặc vinorelbine đơn độc (nhóm 2). Chỉ số chính là thời gian sống không tiến triển bệnh (PFS). Các chỉ số thứ yếu bao gồm tỷ lệ PFS tại 6 tháng, sống toàn bộ (OS), tỷ lệ đáp ứng toàn bộ (ORR) và an toàn. Tình trạng đột biến PI3 K cơ bản đã được xác định trong các mẫu huyết tương. Thời gian sống không tiến triển bệnh trung vị không khác biệt giữa các nhóm (nhóm 1 so với nhóm 2: 4.01 tháng, 95% CI 2.40–6.09 so với 4.08, 95% CI 2.80–5.33). Tỷ lệ PFS tại 6 tháng (nhóm 1 so với nhóm 2: 39.4%, 95% CI 27.6–50.9% so với 36.6%, 95% CI 24.6–48.6%), thời gian sống toàn bộ trung vị (nhóm 1 so với nhóm 2: 16.3 tháng, 95% CI 11.4–19.0 so với 13.8 tháng, 95% CI 10.2–19.1) và ORR không khác biệt giữa các nhóm. Các tác dụng phụ thường gặp nhất độ 3/4 là giảm bạch cầu trung tính (50% so với 40%), độc tính đường tiêu hóa (19.1% so với 6.1%) và nhiễm trùng (19.1% so với 7.7%). Tình trạng đột biến PI3 K không liên quan đến PFS cũng như OS. Mặc dù được dung nạp tốt, hiệu quả của liệu pháp kết hợp everolimus và vinorelbine không vượt trội hơn so với liệu pháp đơn độc vinorelbine. Không có mối tương quan giữa tình trạng đột biến PI3 K và hiệu quả.
Từ khóa
#HER2-negative breast cancer #everolimus #vinorelbine #chemotherapy #PI3K mutation #progression-free survival #overall survivalTài liệu tham khảo
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