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Motzer RJ , Hutson TE , Olsen MR , Hudes GR , Burke JM , Edenfield WJ , Wilding G , Agarwal N , Thompson JA , Cella D , Bello A , Korytowsky B , Yuan JY , Valota O , Martell B , Hariharan S , Figlin RA
Randomized Phase II Trial of Sunitinib on an Intermittent Versus Continuous Dosing Schedule As First-Line Therapy for Advanced Renal Cell Carcinoma
Journal of Clinical Oncology. 2012 Apr;30(12) :1371-1377
PMID: WOS:000303756500024   
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Abstract
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 kidney cancer symptoms. Schedule 4/2 was statistically superior to CDD in time to deterioration, a composite end point of death, progression, and disease-related symptoms (P = .034). Conclusion There was no benefit in efficacy or safety for continuous dosing of sunitinib compared with the approved 50 mg/d dose on schedule 4/2. Given the numerically longer time to tumor progression with the approved 50 mg/d dose on schedule 4/2, adherence to this dose and schedule remains the treatment goal for patients with advanced RCC.
Notes
Motzer, Robert J. Hutson, Thomas E. Olsen, Mark R. Hudes, Gary R. Burke, John M. Edenfield, William J. Wilding, George Agarwal, Neeraj Thompson, John A. Cella, David Bello, Akintunde Korytowsky, Beata Yuan, Jinyu Valota, Olga Martell, Bridget Hariharan, Subramanian Figlin, Robert A. 16 Amer soc clinical oncology Alexandria 938tr