在细胞癌中使用辅助布洛利祖马布的整体存活率
Toni K Choueiri1, Piotr Tomczak1, Se Hoon Park1
1From Dana-Farber Cancer Institute and Harvard Medical School (T.K.C.) and Beth Israel Deaconess Medical Center (D.F.M.) - all in Boston; Poznan University of Medical Sciences, Poznan (P.T.), and Provincial Hospital in Torun, Torun (P.S.) - both in Poland; Samsung Medical Center, Sungkyunkwan University School of Medicine (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.-L.L.) - both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and the University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and the University of Edinburgh, Edinburgh (S.N.S.), and Imperial College Healthcare NHS Trust (N.S.), Barts Health NHS Trust and the Royal Free NHS Foundation Trust, Barts Cancer Institute (T.P.), and Queen Mary University of London (T.P.), London - all in the United Kingdom; Fiona Stanley Hospital, Perth, WA (T.F.), and Maquarie University, Sydney (H.G.) - both in Australia; Fakultní Nemocnice Ostrava, Ostrava (J.H.), and Palacký University and University Hospital Olomouc, Olomouc (B.M.) - all in the Czech Republic; Taipei Veterans General Hospital, Taipei, Taiwan (Y.-H.C.); Abramson Cancer Center, Penn Medicine, Philadelphia (N.B.H.); Fundación Arturo López Pérez, Santiago, Chile (M.M.); University Hospital Bordeaux-Hôpital Saint-André, Bordeaux (M.G.-G.), Hôpital Européen Georges Pompidou, Université Paris Cité, Paris (S.O.), and Centre Hospitalier Universitaire de Montpellier, Montpellier (D.T.) - all in France; the University of Texas Southwestern Medical Center, Dallas (T.Z., H.H.), and Texas Oncology-Houston, Houston (G.D.); Rocky Mountain Cancer Centers, Aurora, CO (J.M.B.); Omsk Clinical Oncology Dispensary, Omsk, Russia (E.K.); the University of Michigan, Ann Arbor (A.A.); the University of Toyama, Toyama, Japan (H.K.); Instituto de Cancer e Transplante de Curitiba, Curitiba, Brazil (A.S.); the London Regional Cancer Program, London Health Sciences Centre, Western University, London, ON, Canada (E.W.); and Merck, Rahway, NJ (J.C., A.E., J.E.B., R.F.P.).
辅助 pembrolizumab 显著改善了患有细胞癌的患者的整体存活率,这些患者在手术后存在高复发风险. 这种疗法提供了临床上有意义的益处,增强了这种患者群体的长期结果.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 辅助布罗利祖马布已批准用于细胞癌 (RCC) 手术后,基于KEYNOTE-564试验中无病生存率 (DFS) 的改善.
- 从试验的第三次中间分析中,关于布罗利祖马布对整体存活时间 (OS) 的影响仍然存在不确定性.
研究的目的:
- 评估辅助 pembrolizumab 对清细胞细胞癌 (ccRCC) 患者的整体存活期 (OS) 的影响,增加复发风险.
- 在这个患者队列中评估辅助剂布罗利祖马布的长期安全性.
主要方法:
- 一个第三阶段,双盲,安慰剂控制的试验随机选择了994名高风险ccRCC的参与者,接受pembrolizumab或安慰剂,长达17个周期.
- 总生存率 (OS) 是一个关键的次要终点,无病生存率 (DFS) 是主要终点.
- 安全评估也作为次要终点进行.
主要成果:
- 随访时间中位数为57.2个月,布罗利祖马布与安慰剂相比,在生存状况上显著改善 (死亡风险比,0.62;P=0.005).
- 佩布罗利祖马布的四年生存率为91.2%与安慰剂的86.0%相比,在各小组中都有一致的好处.
- 布罗利祖马布与严重不良事件 (20.7%对11.5%) 和3-4级事件 (18.6%对1.2%) 的增加有关,没有与治疗相关的死亡.
结论:
- 辅助 pembrolizumab 在手术后复发风险较高的ccRCC患者的整体存活率中提供了显著和临床上有意义的改善.
- 这些发现支持pembrolizumab作为一种有价值的治疗选择,用于改善辅助RCC治疗的长期结果.
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