Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

202 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1371-1377
Number of pages7
JournalJournal of Clinical Oncology
Volume30
Issue number12
DOIs
StatePublished - Apr 20 2012

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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