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Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma

舒尼替尼 医学 肾细胞癌 内科学 危险系数 中止 胃肠病学 临床终点 不利影响 对数秩检验 替西罗莫司 无进展生存期 肿瘤科 泌尿科 比例危险模型 随机对照试验 置信区间 总体生存率 细胞凋亡 化学 mTOR抑制剂的发现与发展 蛋白激酶B 生物化学
作者
Robert J. Motzer,Thomas E. Hutson,Piotr Tomczak,M. Dror Michaelson,Ronald M. Bukowski,Stéphane Oudard,Sylvie Négrier,Cezary Szczylik,Роберто Пили,Georg A. Bjarnason,Xavier García del Muro,Jeffrey A. Sosman,E Solska,George Wilding,John A. Thompson,Sindy T. Kim,Isan Chen,Xin Huang,Robert A. Figlin
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:41 (11): 1965-1971 被引量:159
标识
DOI:10.1200/jco.22.02623
摘要

Purpose A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-α) in progression-free survival (primary end point) as first-line treatment for metastatic renal cell carcinoma (RCC). Final survival analyses and updated results are reported. Patients and Methods Seven hundred fifty treatment-naïve patients with metastatic clear cell RCC were randomly assigned to sunitinib 50 mg orally once daily on a 4 weeks on, 2 weeks off dosing schedule or to IFN-α 9 MU subcutaneously thrice weekly. Overall survival was compared by two-sided log-rank and Wilcoxon tests. Progression-free survival, response, and safety end points were assessed with updated follow-up. Results Median overall survival was greater in the sunitinib group than in the IFN-α group (26.4 v 21.8 months, respectively; hazard ratio [HR] = 0.821; 95% CI, 0.673 to 1.001; P = .051) per the primary analysis of unstratified log-rank test ( P = .013 per unstratified Wilcoxon test). By stratified log-rank test, the HR was 0.818 (95% CI, 0.669 to 0.999; P = .049). Within the IFN-α group, 33% of patients received sunitinib, and 32% received other vascular endothelial growth factor–signaling inhibitors after discontinuation from the trial. Median progression-free survival was 11 months for sunitinib compared with 5 months for IFN-α ( P < .001). Objective response rate was 47% for sunitinib compared with 12% for IFN-α ( P < .001). The most commonly reported sunitinib-related grade 3 adverse events included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%). Conclusion Sunitinib demonstrates longer overall survival compared with IFN-α plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic RCC. The overall survival highlights an improved prognosis in patients with RCC in the era of targeted therapy.
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