尼沃卢马布加盖米西塔-西斯普拉丁治疗晚期泌尿腺癌
Michiel S van der Heijden1, Guru Sonpavde1, Thomas Powles1
1From the Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam (M.S.H.); Medical Oncology, Genitourinary Section, Dana-Farber Cancer Institute, Harvard Medical School, Boston (G.S.); the Department of Genitourinary Oncology, Barts Cancer Institute, Queen Mary University of London, London (T.P.); the Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); the Department of Oncology, Bradford Hill Clinical Research Center, Santiago, Chile (M.B.); the Department of Medical Oncology, Sf. Nectarie Oncology Center, Department of Oncology, University of Medicine and Pharmacy, Craiova, Romania (M.S.); the Department of Clinical Oncology, Alexander Fleming Institute, Buenos Aires (J.P.S.); the Second Propedeutic Department of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital, Athens (A.B.); the Department of Urologic Oncology, Hopital Foch, Suresnes, France (P.B.); the Department of Urology, Eberhard Karls University Tübingen, Tübingen, Germany (J.B.); the Department of Oncology, Akershus University Hospital, Lørenskog, Norway (J.O.); Roswell Park Comprehensive Cancer Center, Buffalo (G.C.), and the Department of Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York (M.D.G.) - both in New York; the Department of Medical Oncology, Ankara University, Ankara, Turkey (Y.Ü.); the Department of Oncology, Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and the Department of Urology, Peking University First Hospital, Beijing (Z.H.) - both in China; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain (B.P.V.); Seoul National University Hospital, Seoul, South Korea (J.H.K.); the Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan (Y.T.); Bristol Myers Squibb, Princeton, NJ (J.F., L.W., M.Y.P., F.N.); and Bristol Myers Squibb, Boudry, Switzerland (D.P.).
添加尼沃卢马布 (nivolumab) 添加到吉姆西塔-西斯普拉丁化学疗法,显著改善了晚期泌尿腺癌患者的整体存活率和无进展存活率. 这种组合疗法为这种患者群体提供了新的护理标准.
科学领域:
- 医学瘤学 医学瘤学
- 免疫治疗是一种免疫疗法.
- 尿癌研究 尿癌研究
背景情况:
- 一线基于思普拉丁的化疗并没有改善不可切除或转移性尿路细胞癌的整体存活率.
- 在晚期泌尿癌中,急需新的治疗策略.
研究的目的:
- 评估在患有晚期泌尿腺癌的患者中,添加尼沃卢马布到一线凝胺-西斯普拉丁化疗的疗效和安全性.
- 为了确定nivolumab组合治疗是否与单独使用gemcitabine-cisplatin相比可以改善整体存活率 (OS) 和无进展存活率 (PFS).
主要方法:
- 第三阶段,多国性,开放性试验,涉及608名以前未经治疗的不可切除或转移性尿路细胞癌患者.
- 随机分配给静脉注射的尼沃卢马布加上凝胺-西斯普拉丁或单独的凝胺-西斯普拉丁,长达六个周期.
- 主要结局:整体存活率和无进展存活率. 探索性结果:客观反应和安全.
主要成果:
- 尼沃卢马布联合治疗显著改善了整体存活率 (中位数为21.7个月与18.9个月;HR 0.78,P=0.02) 和无进展存活率 (HR 0.72,P=0.001).
- 对象性反应率在尼沃卢马布组合治疗中较高 (57.6%对43.1%),完全反应的中位持续时间较长 (37.1对13.2个月).
- 3级或更高的不良事件发生在61.8%的接受尼沃卢马布组合治疗的患者中,而仅接受化疗的患者为51.7%.
结论:
- 与尼沃卢马布加上吉姆替宾-西斯普拉丁的联合治疗显示,在以前未经治疗的晚期泌尿腺癌中,结果明显优异.
- 尼沃卢马布 (Nivolumab) 组合治疗是一种有前途的新疗法,可以改善这种患者群体的生存率和反应率.
- 这项研究是由布里斯托尔·迈尔斯·斯奎布和奥诺制药公司 (CheckMate 901,NCT03036098) 资助的.
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