埃尔达菲提尼布或化疗在晚期或转移性尿路细胞癌的治疗
Yohann Loriot1, Nobuaki Matsubara1, Se Hoon Park1
1From the Department of Cancer Medicine, INSERM Unité 981, Gustave Roussy, Université Paris-Saclay, Villejuif (Y.L.), the Department of Medical Oncology, Institut de Cancérologie du Gard, Centre Hospitalier Universitaire Caremeau, Nîmes (N.H.), and Montpellier University, Montpellier (N.H.) - all in France; the Department of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan (N.M.); the Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.H.P.), and Seoul National University Hospital (J.H.K.) - both in Seoul, South Korea; the Section of Radiotherapy and Imaging, Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, United Kingdom (R.A.H.); Medical Oncology, Levine Cancer Institute, Atrium Health, Charlotte, NC (E.F.B.); the Department of Urology, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany (S.B.); the Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (V.G.); the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.T.); Janssen Research and Development, Spring House, PA (S.T., Y.K., S.A., N.L.S.); Janssen Research and Development, Beerse, Belgium (K.D.); Janssen Research and Development, Raritan, NJ (S.M.); and the Department of Genitourinary Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (A.O.S.-R.).
在先前免疫治疗后,埃尔达菲提尼布显著改善了晚期泌尿腺癌和FGFR变异患者的整体存活率. 这种FGFR抑制剂在这个患者群体中表现出与化疗相比更高的疗效.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 埃尔达菲提尼布是一种经批准的泛纤维细胞生长因子受体 (FGFR) 抑制剂,用于化疗后转移性尿路细胞癌.
- 在服用检查点抑制剂 (抗PD-1/PD-L1) 后进展的患者中,其有效性尚不清楚.
研究的目的:
- 为了评估ERDAFITINIB与化疗对转移性尿路细胞癌和FGFR变异的患者的疗效,这些患者在抗PD-1或抗PD-L1治疗后进展.
主要方法:
- 全球第三阶段试验随机选择了266名患有转移性尿路细胞癌和易受FGFR3/2变化的患者,接受erdafitinib或研究人员选择的化疗 (docetaxel/vinflunine).
- 主要终点是整体存活率.
主要成果:
- 与化疗相比,埃尔达菲提尼布显著改善了中位数整体存活率 (12.1 与 7.8 个月相比; P=0.005) 和无进展存活率 (5.6 与 2.7 个月相比; P<0.001).
- 与3/4级治疗相关的不良事件在两组之间是相似的,但因此类事件而导致的死亡人数在erdafitinib (0.7%对5.4%) 较低.
结论:
- 埃尔达菲提尼布治疗在患有转移性尿路细胞癌和FGFR变异的患者中比化疗显著延长整体生存时间,这些患者之前接受过抗PD-1或抗PD-L1治疗.
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