作者
Robert J Motzer, Thomas E Hutson, Mark R Olsen, Gary R Hudes, John M Burke, William J Edenfield, George Wilding, Neeraj Agarwal, John A Thompson, David Cella, Akintunde Bello, Beata Korytowsky, Jinyu Yuan, Olga Valota, Bridget Martell, Subramanian Hariharan, Robert A Figlin
发表日期
2012/4/20
期刊
Journal of clinical oncology
卷号
30
期号
12
页码范围
1371-1377
出版商
American Society of Clinical Oncology
简介
Purpose
Sunitinib has shown antitumor activity with a manageable safety profile as metastatic renal cell carcinoma (RCC) treatment, when given by the standard intermittent schedule as well as a continuous daily dosing (CDD) schedule. A trial was conducted to compare the schedules.
Patients and Methods
Patients with treatment-naive, clear cell advanced RCC were randomly assigned 1:1 to receive sunitinib 50 mg/d for 4 weeks followed by 2 weeks off treatment (schedule 4/2; n = 146) or 37.5 mg/d on the CDD schedule (n = 146) for up to 2 years. The primary end point was time to tumor progression.
Results
Median time to tumor progression was 9.9 months for schedule 4/2 and 7.1 months for the CDD schedule (hazard ratio, 0.77; 95% CI, 0.57 to 1.04; P = .090). No significant difference was observed in overall survival (23.1 v 23.5 months; P = .615), commonly reported adverse events, or patient-reported …
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RJ Motzer, TE Hutson, MR Olsen, GR Hudes, JM Burke… - Journal of clinical oncology, 2012