Efficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study.
Efficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study.
复制标题
纳武单抗单药治疗转移性尿路上皮癌 (mUC) 的疗效和安全性：I/II 期 CheckMate 032 研究的结果。
DOI：
10.1200/jco.2016.34.15_suppl.4501
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发表时间：
2016
影响因子：
45.3
通讯作者：
J. Rosenberg
中科院分区：
文献类型：
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作者：
Padmanee Sharma;P. Bono;Joseph W. Kim;P. Spiliopoulou;E. Calvo;R. Pillai;P. Ott;F. Braud;M. Morse;D. Le;D. Jaeger;E. Chan;C. Harbison;Chen;M. Tschaika;Alex Azrilevich;J. Rosenberg
背景：现有治疗方法的最低抗肿瘤活性和膀胱癌免疫功能障碍的观察促使人们对这种恶性肿瘤的免疫治疗进行评估。Nivolumab(完全人类IgG4程序性死亡-1免疫检查点抑制抗体)单一疗法已显示出对黑色素瘤、肺癌和肾癌患者(PTS)的生存益处。在这里，我们在一项开放标签的多中心I/II期研究(≥01928394)中报告了Nivolumab单一疗法对≥1铂类药物先行治疗后MUC患者的疗效和安全性。方法：未选择PD-L1表达状态的MUC患者，每2周静脉推注尼伏单抗3 mg/kg，直至病情进展或停药。主要终点为客观有效率(ORR；RECIST 1.1)。其他终点包括安全性、反应持续时间(DOR)、无进展生存期(PFS)和总生存期(OS)。结果：在78例接受治疗的患者中(中位年龄65.5岁，范围31-85岁)，65.4%的患者以前接受过≥-2治疗。在我..。
4501Background: Minimal antitumor activity of existing therapies and the observation of immune dysfunction in bladder cancer have prompted evaluation of immunotherapy in this malignancy. Nivolumab (fully human IgG4 programmed death-1 immune checkpoint inhibitor antibody) monotherapy has shown survival benefit in patients (pts) with melanoma, lung cancer, and renal cell carcinoma. Here, we report efficacy and safety of nivolumab monotherapy in pts with mUC after ≥1 prior line of platinum-based therapy in an open-label, multicenter phase I/II study (NCT01928394). Methods: Pts (unselected by PD-L1 expression status) with mUC received nivolumab 3 mg/kg intravenously every 2 weeks until progression or discontinuation. Primary endpoint was objective response rate (ORR; RECIST 1.1). Other endpoints included safety, duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results: Of 78 treated pts (median age 65.5 years; range, 31–85), 65.4% had received ≥2 prior therapies. At a me...