在晚期黑色素瘤中使用Nivolumab加Ipilimumab的最终10年结果
Jedd D Wolchok1, Vanna Chiarion-Sileni1, Piotr Rutkowski1
1From the Sandra and Edward Meyer Cancer Center (J.D.W.) and the Department of Medicine (J.D.W., M.A.P.), Weill Cornell Medicine, and Memorial Sloan Kettering Cancer Center (M.A.P.) - both in New York; Istituto Oncologico Veneto, IRCCS, Padua (V.C.-S.), European Institute of Oncology, IRCCS, Milan (P.Q.), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola (M.G.), University of Siena and the Center for Immuno-Oncology, University Hospital of Siena, Siena (M.M.), and Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.) - all in Italy; Maria Sklodowska-Curie National Institute of Oncology, Warsaw, Poland (P.R.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); University Hospital Essen, the German Cancer Consortium, the National Center for Tumor Diseases-West, the Research Alliance Ruhr, Research Center One Health, and University Duisburg-Essen - all in Essen, Germany (D.S.); the College of Medicine, Swansea University, Swansea (J.W.), Bristol Myers Squibb, Uxbridge (A.N.), and the Royal Marsden Hospital, London (J.L.) - all in the United Kingdom; the Department of Dermatology, University of Zurich, Zurich, Switzerland (R.D.); University Health Network Princess Margaret Cancer Centre, Toronto (M.O.B.), and Cross Cancer Institute, University of Alberta, Edmonton (J.W.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.G.H.), Westmead Hospital, Westmead, NSW (M.S.C.), Blacktown Hospital, Blacktown, NSW (M.S.C.), the Melanoma Institute Australia, University of Sydney (M.S.C., G.V.L.), Royal North Shore Hospital (G.V.L.), and Mater Hospital (G.V.L.), Sydney, and Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC (S.S.) - all in Australia; Aix-Marseille Université, Assistance Publique-Hôpitaux de Marseille, Marseille (C.G.-M.), and Université Paris Cité, Assistance Publique-Hôpitaux de Paris (AP-HP) Dermato-oncology, Clinical Investigation Center, the Cancer Institute, AP-HP Nord Paris Cité, INSERM Unité 976, and St. Louis Hospital, Paris (C.L.) - all in France; the University of Colorado Cancer Center, Aurora (T.M.); Rogel Cancer Center, University of Michigan, Ann Arbor (C.D.L.); Hospital General Universitario Gregorio Marañon, Madrid (I.M-R.); the Netherlands Cancer Institute, Amsterdam (J.B.A.G.H.); University Hospital Leuven and Leuven Cancer Institute, KU Leuven, Leuven, Belgium (P.S.); Bristol Myers Squibb, Princeton, NJ (C.R., M.A., M.P.B., W.W.); and Dana-Farber Cancer Institute, Boston (F.S.H.).
经过十年的研究结果显示,尼沃卢马布加上伊皮利穆马布和尼沃卢马布单独治疗与单独的伊皮利穆马布相比,在晚期黑色素瘤患者中显著改善了存活率. 这些免疫疗法为晚期黑色素瘤提供了持久的生存益处.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 黑色素瘤研究 黑色素瘤研究
背景情况:
- 之前的试验结果表明,在晚期黑色素瘤中,nivolumab加上ipilimumab或nivolumab单疗法与ipilimumab单疗法相比,整体存活率有所改善.
- 需要进行延长的随访,以解决晚期黑色素瘤患者的长期结果和新的临床问题,这些患者的存活时间超过7.5年.
研究的目的:
- 报告先前未经治疗的晚期黑色素瘤随机试验的最终10年生存数据.
- 评估不同免疫疗法方案的长期疗效,包括整体存活率,黑色素瘤特异性存活率和反应的持续时间.
主要方法:
- 随机试验比较尼沃卢马布加上伊皮利马布,尼沃卢马布单疗法和伊皮利马布单疗法在晚期黑色素瘤中.
- 基于BRAF突变状态,转移阶段和PD-L1表达的分层随机化. 治疗持续到进展,毒性或停药.
主要成果:
- 平均整体存活时间:71.9个月 (尼沃卢马布 + 伊皮利穆马布),36.9个月 (尼沃卢马布),19.9个月 (伊皮利穆马布).
- 黑色素瘤特异性生存时间的中位数超过了120个月 (nivolumab + ipilimumab),49.4个月 (nivolumab) 和21.9个月 (ipilimumab).
- 在3年没有进展的患者中,10年黑色素瘤特异性存活率为96% (尼沃卢马布 + 伊皮利马布),97% (尼沃卢马布) 和88% (伊皮利马布).
结论:
- 尼沃卢马布加上伊皮利穆马布和尼沃卢马布单疗法在晚期黑色素瘤中比伊皮利穆马布单疗法更有持续的生存益处.
- 这些发现证实了这些免疫疗法组合和单疗法在晚期黑色素瘤中的长期疗效和响应的持久性.
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