Liệu pháp trường điện điều trị khối u (TTFields) so với phương pháp tiêu chuẩn do bác sĩ chọn trong điều trị bệnh nhân bị glioblastoma tái phát: một nghiên cứu đăng ký sau phê duyệt (EF-19)

Springer Science and Business Media LLC
Jay‐Jiguang Zhu1, Samuel Goldlust2, Lawrence Kleinberg3, Jérôme Honnorat4,5, Nancy Ann Oberheim Bush6, Zvi Ram7
1University of Texas Health Science Center in Houston (UTHealth)/Memorial Hermann Hospital at Texas Medical Center, Houston, USA
2John Theurer Cancer Center, Hackensack, USA
3Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, USA
4Department of Neuro-Oncology, East Group Hospital, Hospices Civils de Lyon, Lyon Cedex, France
5Department of Neuro-Oncology, Hôpital Neurologique, Hospices Civils de Lyon, SynatAc Team, MELIS Institute, INSERM U1314/CNRS UMR5284, Université Claude Bernard Lyon 1, Université de Lyon, Lyon, France
6Department of Neurological Surgery and Neurology, University of California, San Francisco, USA
7Tel Aviv Medical Center, Tel Aviv University School of Medicine, Tel Aviv, Israel

Tóm tắt

Tóm tắt Mục đích Liệu pháp Trường điện điều trị khối u (TTFields), một phương pháp điều trị không xâm lấn, chống phân bào, đã được phê duyệt cho glioblastoma tái phát (rGBM) và glioblastoma mới được chẩn đoán dựa trên các nghiên cứu giai đoạn III, EF-11 (NCT00379470) và EF-14 (NCT00916409), tương ứng. Nghiên cứu EF-19 được thực hiện nhằm đánh giá hiệu quả và độ an toàn của liệu pháp TTFields đơn trị (200 kHz) so với phương pháp chăm sóc tiêu chuẩn do bác sĩ lựa chọn (PC-SOC; nhóm đối chứng lịch sử EF-11) ở bệnh nhân rGBM. Phương pháp Một nghiên cứu đăng ký tiền thị trường về những người lớn bị rGBM trên não được điều trị bằng liệu pháp TTFields đã được tiến hành. Điểm chính của nghiên cứu là sống sót toàn bộ (OS; quần thể điều trị theo ý định [ITT]) và điểm phụ là OS theo giao thức (PP). Phân tích nhóm con và độc tính cũng được thực hiện. Kết quả Thời gian sống sót trung bình (OS; quần thể ITT) là tương đương giữa liệu pháp TTFields đơn trị so với PC-SOC (7,4 so với 6,4 tháng, kiểm định log-rank P = 0,053; tỷ lệ nguy cơ kiểm định Cox [HR] [95% CI], 0,66 [0,47–0,92], P = 0,016). Giới hạn trên của HR (95% CI) thấp hơn ngưỡng không kém đã xác định trước (ngưỡng 1,375). Ở nhóm PP, thời gian sống sót trung bình dài hơn đáng kể cho liệu pháp TTFields so với PC-SOC (8,1 so với 6,4 tháng; kiểm định log-rank P = 0,017; tỷ lệ nguy cơ kiểm định Cox [95% CI], 0,60 [0,42–0,85], P = 0,004). Liệu pháp TTFields cho thấy lợi ích gia tăng khi sử dụng kéo dài (≥ 18 giờ/ngày [trung bình trong 28 ngày]). Các sự kiện bất lợi liên quan đến liệu pháp TTFields theo hệ cơ quan thấp hơn so với PC-SOC: chủ yếu là các sự kiện da mức độ nhẹ đến trung bình. Kết luận Trong môi trường thực tế, liệu pháp TTFields đơn trị cho thấy thời gian sống sót tương đương (quần thể ITT) và vượt trội (quần thể PP) so với PC-SOC ở bệnh nhân rGBM. Nhất quán với các kết quả trước đó, liệu pháp TTFields cho thấy hồ sơ độ an toàn thuận lợi so với hóa trị liệu, không có tín hiệu an toàn mới/hiệu ứng toàn thân. Đăng ký thử nghiệm: NCT01756729, đăng ký ngày 20 tháng 12 năm 2012. Tóm tắt đồ họa

Từ khóa


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