辅助布洛利祖马布与肌肉侵入性尿癌的观察对比
Andrea B Apolo1, Karla V Ballman1, Guru Sonpavde1
1From the Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda (A.B.A., N.S., S.N., L.L., L.C.), the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (J.H.-C.), and the Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Rockville (H.S., E.S.) - all in Maryland; the Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN (K.V.B., M.O., C.M., G.P.B.); AdventHealth Cancer Institute and the University of Central Florida, Orlando (G.S.); Dana-Farber/Harvard Cancer Center, Boston (S.B., B.M.); UNC Lineberger Comprehensive Cancer Center, Chapel Hill (W.Y.K.), and Duke University Medical Center and Duke Cancer Institute, Durham (J.H., S.H.) - both in North Carolina; the University of Kansas Cancer Center, Westwood (R.P.); Memorial Sloan Kettering Cancer Center, New York (M.Y.T., M.J.M., J.E.R.), and Roswell Park Comprehensive Cancer Center, Buffalo (G.C.) - both in New York; the University of Chicago Comprehensive Cancer Center, Chicago (R.F.S., C.W., Y.W., O.H.), and Loyola University Medical Center, Maywood (M.W.) - both in Illinois; the Alliance Protocol Operations Office, University of Chicago, Chicago (C.W., Y.W., O.H.); Fox Chase Cancer Center, Philadelphia (D.M.G.); Fred Hutchinson Cancer Center and the University of Washington, Seattle (P.G.); Rogel Cancer Center, University of Michigan, Ann Arbor (Z.R.R.); Yale Cancer Center, Yale School of Medicine, New Haven, CT (J.W.K., D.P.); Winship Cancer Institute, Emory University, Atlanta (M.A.B.); Mayo Clinic Comprehensive Cancer Center, Phoenix, AZ (P.S.); Oklahoma University Health Stephenson Cancer Center, Oklahoma City (A. Tripathi); University of Texas Southwestern Medical Center, Dallas (S.C.); Stanford University, Stanford (S.S.), and Kaiser Permanente Riverside Medical Center, Riverside (H.M.) - both in California; and Vanderbilt-Ingram Cancer Center, Nashville (A. Tan).
辅助 pembrolizumab 显著改善了高风险肌肉侵入性尿路细胞癌术后患者的无病生存率. 这种免疫疗法为预防疾病复发提供了新的护理标准.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 尿癌研究 尿癌研究
背景情况:
- 肌肉侵入性尿路癌具有很高的复发风险.
- 在手术后的高风险患者中,辅助 pembrolizumab 的疗效仍未确立.
研究的目的:
- 为了评估辅助 pembrolizumab 的有效性,与在急性手术后患有高风险肌肉侵入性泌尿腺癌的患者的观察相比.
主要方法:
- 一个第三阶段随机试验分配了702名患者1:1给pembrolizumab (200毫克每3周1年) 或观察.
- 分层包括病态阶段,PD-L1状态和新辅助化疗.
- 共同初级终点是无病生存率和整体生存率.
主要成果:
- 布罗利祖马布显著改善了中位数无病存活时间 (29.6个月与14.2个月对比).
- 疾病进展或死亡的危险比为0.73 (95% CI,0.59至0.90;P=0.003).
- 3级以上的不良事件发生在pembrolizumab组的50.6%,而观察组的31.6%.
结论:
- 辅助 pembrolizumab 显著提高高风险的肌肉侵入性尿路细胞癌患者的无病存活期后激进手术.
- 布罗利祖马布对这种患者群体来说是一个有前途的治疗选择.
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