在可手术的膀癌中与新辅助化疗一起进行外科术期间的杜尔瓦卢马布
Thomas Powles1, James W F Catto1, Matthew D Galsky1
1From Barts Cancer Institute, Queen Mary University of London, Barts Health NHS Trust Biomedical Research Centre, London (T.P.), the Division of Clinical Medicine, School of Medicine and Population Health, University of Sheffield, and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield (J.W.F.C.), and AstraZeneca, Cambridge (J.A.) - all in the United Kingdom; the Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai (M.D.G.), the Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center (H.A.-A.), and AstraZeneca (A.G.) - all in New York; the Departments of Urology and Biochemistry, Northwestern University Feinberg School of Medicine, Chicago (J.J.M.); the University of Tsukuba, Tsukuba, Japan (H.N.); Internal Medical 3, Vietnam National Cancer Hospital, Hanoi (T.Q.V.); the Department of Experimental and Clinical Medicine, University of Florence, and the Medical Oncology Unit, Careggi University Hospital - both in Florence, Italy (L.A.); Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.W.); the Volga District Medical Center, Federal Medical-Biological Agency, Nizhny Novgorod, Russia (V.A.); Hospital Alemão Oswaldo Cruz, Sao Paulo (A.G.K.); the Department of Urology, Kyungpook National University Chilgok Hospital, Daegu, South Korea (T-H.K.); Medical Oncology, Vall d´Hebron Institute of Oncology, Hospital Universitari Vall d´Hebron, Vall d´Hebron Barcelona Hospital Campus, Barcelona (C.S.); the Department of Urology, China Medical University Hospital and School of Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan (C-H.C.); the Department of Urology, Marien Hospital Herne, Ruhr University Bochum, Herne, Germany (F.R.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.Ö.); BC Cancer-Vancouver, Vancouver, BC, Canada (B.J.E.); Mater Hospital Brisbane, Mater Misericordiae, and the School of Clinical Medicine, Mater Clinical Unit, University of Queensland - both in Brisbane, Australia (N.O.); the Department of Oncology, First Faculty of Medicine, Charles University and Thomayer Hospital, Prague, Czech Republic (T.B.); the Institute of Oncology, Sheba Medical Center, Ramat Gan, and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv - both in Israel (M.G.); the University of Iowa Hospitals and Clinics, Holden Comprehensive Cancer Center, Iowa City (Y.Z.); AstraZeneca, Gaithersburg, MD (S.H.); and the Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam (M.S.H.).
将外科手术期间的杜尔瓦卢马布添加到新辅助化疗中,显著改善了肌肉侵入性膀癌患者的无事件和整体存活率,这些患者接受了激进囊切除术. 这种组合疗法在膀癌治疗中提供了有前途的进展.
科学领域:
- 在瘤学瘤学.
- 泌尿器细胞癌的癌症.
- 临床试验 临床试验
背景情况:
- 肌肉侵入性膀癌 (MIBC) 的标准治疗包括新辅助化疗,然后对适合使用西斯的患者进行激进囊切除术.
- 术后免疫疗法正在被研究作为一种提高MIBC治疗结果的策略.
研究的目的:
- 为了评估在接受西斯普拉丁治疗的MIBC患者中,在新辅助化疗和激进囊切除术中添加外科术期间的durvalumab的疗效和安全性.
- 为了比较接受杜尔瓦卢马布加化疗和仅接受化疗的患者之间的无事件生存 (EFS) 和整体生存 (OS).
主要方法:
- 一项第三阶段,开放标签,随机试验 (NIAGARA) 分配了1063名符合cisplatin条件的MIBC患者接受新辅助剂杜尔瓦卢马布加上单独的凝酸-cisplatin或凝酸-cisplatin.
- 然后,患者接受了急性囊切除术,随后在实验组中接受了辅助性杜尔瓦卢马布.
- 无事件生存率是主要终点,整体生存率是关键的次要终点.
主要成果:
- 在24个月的无事件生存时间在杜尔瓦卢马布组 (67.8%) 与对照组 (59.8%) 相比显著更高 (HR,0.68;P<0.001).
- 在24个月的整体存活期也显著改善了杜尔瓦卢马布 (82.2%) 与对照组 (75.2%) (HR,0.75;P=0.01).
- 与治疗相关的3-4级不良事件的发生率在两组之间相似 (40.6%对40.9%),罕见的与治疗相关的死亡率 (每组0.6%).
结论:
- 术后的杜尔瓦卢马布与新辅助化疗相结合,对MIBC患者的无事件和整体存活率显著改善.
- 这种疗法代表了潜在的新标准的护理,提供了增强的生存效益与可管理的毒性.
- 这项研究提供了强有力的证据,证明在MIBC的既定新辅助化疗和囊切除途径中添加免疫治疗的好处.
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