Sunitinib versus interferon alfa in metastatic renal-cell carcinoma
Sunitinib versus interferon alfa in metastatic renal-cell carcinoma
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DOI：
10.1056/nejmoa065044
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发表时间：
2007-01-11
影响因子：
158.5
通讯作者：
Figlin, Robert A.
中科院分区：
文献类型：
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作者：
Motzer, Robert J.;Hutson, Thomas E.;Figlin, Robert A.
背景：由于苹果酸舒尼替尼在两个非对照试验中对转移性肾癌患者表现出活性，在3期试验中将该药物与干扰素α进行比较是有必要的。方法：在一项多中心、随机、3期试验中，我们招募了750名未经治疗的转移性肾癌患者，接受重复6周周期的舒尼替尼(剂量为50 mg，每天口服1次，连续4周，随后2周不治疗)或干扰素α(剂量为9 MU，每周三次皮下注射)。主要终点是无进展生存。结果：舒尼替尼组的中位无进展生存期(11个月)显著长于干扰素组(5个月)，相应的风险比为0.42(95%可信区间，0.32至0.54；P
BACKGROUND:Since sunitinib malate has shown activity in two uncontrolled studies in patients with metastatic renal-cell carcinoma, a comparison of the drug with interferon alfa in a phase 3 trial is warranted.METHODS:We enrolled 750 patients with previously untreated, metastatic renal-cell carcinoma in a multicenter, randomized, phase 3 trial to receive either repeated 6-week cycles of sunitinib (at a dose of 50 mg given orally once daily for 4 weeks, followed by 2 weeks without treatment) or interferon alfa (at a dose of 9 MU given subcutaneously three times weekly). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, patient-reported outcomes, and safety.RESULTS:The median progression-free survival was significantly longer in the sunitinib group (11 months) than in the interferon alfa group (5 months), corresponding to a hazard ratio of 0.42 (95% confidence interval, 0.32 to 0.54; P