Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma
Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma
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DOI：
10.1056/nejmoa1303989
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发表时间：
2013-08-22
影响因子：
158.5
通讯作者：
Choueiri, Toni K.
中科院分区：
文献类型：
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作者：
Motzer, Robert J.;Hutson, Thomas E.;Choueiri, Toni K.
研究背景在先前的3期研究中，与安慰剂或干扰素相比，帕唑帕尼和舒尼替尼提供了无进展生存益处，这些研究涉及转移性肾细胞癌患者。这3期，随机试验比较的疗效和安全性的帕唑帕尼和舒尼替尼作为一线therapy.METHODSWe随机分配1110例透明细胞，转移性肾细胞癌，在1：1的比例，接受连续剂量的帕唑帕尼（800毫克，每天一次; 557例）或舒尼替尼在6周的周期（50毫克，每天一次，为期4周，随后2周不治疗; 553例）。主要终点是通过独立审查评估的无进展生存期，该研究有把握显示帕唑帕尼与舒尼替尼相比的非劣效性。次要终点包括总生存期、安全性和生活质量。在无进展生存期方面，TSPazopanib非劣于舒尼替尼（疾病进展或任何原因死亡的风险比，1.05; 95%置信区间[CI]，0.90至1.22），符合预定义的非劣性边界（95%置信区间的上限，
BACKGROUNDPazopanib and sunitinib provided a progression-free survival benefit, as compared with placebo or interferon, in previous phase 3 studies involving patients with metastatic renal-cell carcinoma. This phase 3, randomized trial compared the efficacy and safety of pazopanib and sunitinib as first-line therapy.METHODSWe randomly assigned 1110 patients with clear-cell, metastatic renal-cell carcinoma, in a 1:1 ratio, to receive a continuous dose of pazopanib (800 mg once daily; 557 patients) or sunitinib in 6-week cycles (50 mg once daily for 4 weeks, followed by 2 weeks without treatment; 553 patients). The primary end point was progression-free survival as assessed by independent review, and the study was powered to show the noninferiority of pazopanib versus sunitinib. Secondary end points included overall survival, safety, and quality of life.RESULTSPazopanib was noninferior to sunitinib with respect to progression-free survival (hazard ratio for progression of disease or death from any cause, 1.05; 95% confidence interval [CI], 0.90 to 1.22), meeting the predefined noninferiority margin (upper bound of the 95% confidence interval,