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Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial

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机构: [1]Medical Oncology Service, Vall d′Hebron Institute of Oncology, Vall d′Hebron Barcelona Hospital Campus, Barcelona, Spain [2]Florida Cancer Specialists and Research Institute, West Palm Beach, FL, USA [3] Division of Clinical Research and Technological Development, Brazilian National Cancer Institute, Rio de Janeiro, Brazil [4]Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea [5]Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan, Seoul, South Korea [6]Department of Gynecology, St. Petersburg State Budgetary Healthcare Institution “City Oncological Dispensary”, St. Petersburg, Russia [7] Gynecologic Oncology Division, Centre Hospitalier de l′Universit´e de Montr´eal (CHUM), Centre de Recherche du CHUM (CRCHUM), Universit´e de Montr´eal, Montr´eal, QC, Canada [8] Department of Women and Child Health, Division of Gynecologic Oncology, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy [9]Humanitas San Pio X, Milan, Italy [10]Centro de Pesquisa em Oncologia, Hospital Sao˜ Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil [11]Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan [12]Ivanovo Regional Oncology Dispensary, Ivanovo, Russia [13]Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan [14]Department of Clinical Oncology, Barretos Cancer Hospital (Pio XII Foundation), Sao˜ Paulo, Brazil [15] Department of Gynecologic Oncology, Białostockie Centrum Onkologii, Białostockie, Poland [16] Service de M´edecine Oncologique, Institut Jules Bordet, HUB Anderlecht, Anderlecht, Belgium [17] Medical Oncology Department, Ram´ on y Cajal University Hospital, Madrid, Spain [18]Gynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy [19] Department of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy [20]State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1, Krasnodar, Russia [21]Royal Brisbane & Women’s Hospital, Herston, Queensland, Australia [22]Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Japan [23] Instituto COI de Educaçao˜ e Pesquisa, Rio de Janeiro, Brazil [24] Department of Oncology, Szpitale Pomorskie, Gdynia, Poland [25] The Tweed Hospital, Tweed Heads, New South Wales, Australia [26] Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia [27] University of Melbourne, Melbourne, Victoria, Australia [28] Medical Oncology Department, Hospital Universitario Reina Sofia, C´ ordoba, Spain [29] Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA [30]Department of Gynecology and Obstetrics, University of California, Irvine, CA, USA
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关键词: Cemiplimab Cervical cancer PD-1 Immunotherapy

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Cemiplimab has demonstrated significantly longer survival than physician's choice of chemotherapy in patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. We report the final survival analysis from the phase III randomized study (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9).Cemiplimab (n = 304) or chemotherapy (n = 304) were administered every 3 weeks. The primary endpoint was overall survival (OS). Patients were included regardless of programmed cell death-ligand 1 (PD-L1) status.At a median follow-up of 47.3 months (data cut-off: April 20, 2023), median OS was 11.7 versus 8.5 months for patients treated with cemiplimab and chemotherapy, respectively (hazard ratio 0.67, 95 % confidence interval 0.56-0.80, p < .00001). OS benefit was seen in PD-L1 positive and negative populations, even though more patients with PD-L1 < 1 % (n = 92), had poor performance status in the cemiplimab arm than the chemotherapy arm (61.4 % vs 47.9 %).This final analysis confirms that cemiplimab maintains survival benefit compared with chemotherapy in recurrent cervical cancer after progression on first-line platinum therapy, regardless of PD-L1 expression. The safety profile was consistent with published data; incidences of adverse events were similar between cemiplimab and chemotherapy groups. These results support the use of second-line cemiplimab for patients with recurrent cervical cancer.Copyright © 2025. Published by Elsevier Ltd.

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大类 | 1 区 医学
小类 | 2 区 肿瘤学
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第一作者机构: [1]Medical Oncology Service, Vall d′Hebron Institute of Oncology, Vall d′Hebron Barcelona Hospital Campus, Barcelona, Spain
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