利博西克利布加内分泌疗法在早期乳腺癌的治疗
Dennis Slamon1, Oleg Lipatov1, Zbigniew Nowecki1
1From the David Geffen School of Medicine at the University of California, Los Angeles (D. Slamon, N.M.); Republican Clinical Oncology Dispensary, Ufa (O.L.), and Moscow City Oncology Hospital No. 62, Moscow (D. Stroyakovskiy) - both in Russia; Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw (Z.N.), and Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin (B.K.-B.) - both in Poland; the Sarah Cannon Research Institute at Tennessee Oncology, Nashville (D.A.Y.); the National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei City (C.-S.H.); University Hospital Erlangen, the Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Interdisciplinary Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - both in Germany; St. Vincent's Hospital, Dublin (J.C.); Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston (A.B.); the British Columbia Cancer Agency, Vancouver (S.C.), and Translational Research in Oncology (TRIO), Edmonton, AB (I.S.) - both in Canada; the Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Hospital Virgen del Rocío, Seville, and Grupo Español de Investigación en Cáncer de Mama, Spanish Breast Cancer Group, Madrid - both in Spain (M.R.-B.); the Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.L.); the Department of Medical Oncology Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (B.X.); the Fred Hutchinson Cancer Center, University of Washington, Seattle (S.H.); the Latin American Cooperative Oncology Group, Porto Alegre, Brazil (C.B.); the Orlando Health Cancer Institute, Orlando, FL (R.M.); the National Breast Cancer Coalition, Washington, DC (F.V.); TRIO, Paris (K.A.); TRIO, Montevideo, Uruguay (R.F.); Novartis Pharmaceuticals, East Hanover, NJ (Y.J., F.G., Z.L., J.P.Z., A.C.); Novartis Pharma, Basel, Switzerland (T.T.); and the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.H.).
与非类固醇芳酶抑制剂 (NSAI) 结合的利博西克利布显著改善了早期乳腺癌患者的无侵袭性疾病生存率. 这种组合疗法在激素受体阳性,HER2阴性早期乳腺癌患者中显示出显著的益处.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 激素受体 (HR) 阳性,人体表皮生长因子受体2 (HER2) 阴性晚期乳腺癌显示,使用 ribociclib 有助于存活.
- 对于同一种乳腺癌亚型的早期疾病,利博西基布的疗效仍需确定.
研究的目的:
- 在HR阳性,HER2阴性早期乳腺癌患者中,与单独的NSAI相比,评估 ribociclib加非类固醇芳酶抑制剂 (NSAI) 的疗效和安全性.
主要方法:
- 一个国际性的,开放的,随机的第3期试验分配了II或III期HR阳性,HER2阴性早期乳腺癌的患者,为期3年接受 ribociclib加NSAI或单独NSAI.
- 绝经前的女性和男性也接受了goserelin. 主要终点是无侵袭性疾病生存期 (IDFS).
主要成果:
- 在3年后,IDFS为90.4%与 ribociclib加NSAI,而仅使用NSAI为87.1% (侵袭性疾病,复发或死亡的危险比率为0.75;P=0.003).
- 利博西克利布加NSAI也改善了二次终点,包括远程无疾病生存率和无复发生存率.
- 在3年里波西基利布加NSAI治疗方案中,没有发现新的安全问题.
结论:
- 与NSAI结合使用的利博西克利布显著提高了被诊断为HR阳性,HER2阴性II或III期早期乳腺癌的患者的无侵袭性疾病生存率.
- 纳塔利 (NATALEE) 试验 (NCT03701334) 提供了早期疾病改善结果的证据.
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