Sunitinib administered with a 2/1 schedule is associated with less toxicity and higher 6-month failure-free survival rate than a 4/2 schedule, without a negative effect on objective response rate and time to progression, in patients with clear-cell metastatic renal cell carcinoma (mRCC), a new study published online ahead of print in the journal Annals of Oncology has shown.1

Because the standard sunitinib schedule of 4 weeks on and 2 weeks off (4/2 schedule) is associated with troublesome toxicities, researchers sought to assess the efficacy and safety of a 2/1 sunitinib dosing schedule compared with the standard 4/2 schedule.

In the multicenter, open-label, phase 2, trial, researchers enrolled 74 treatment-naïve patients with clear-cell type mRCC and randomly assigned them to receive sunitinib in a 4/2 or 2/1 schedule.

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Results showed that the 6-month failure-free survival rate was 44% with the 4/2 schedule and 63% with the 2/1 schedule. Objective response rates were 47% and 36% in schedule 2/1 and 4/2, respectively, and the median time to progression was 12.1 months and 10.1 months, respectively.

In regard to safety, neutropenia and fatigue were more frequently observed with schedule 4/2, and researchers observed a strong tendency of a lower incidence of rash, stomatitis, and hand-foot syndrome with schedule 2/1.


  1. Lee JL, Kim MK, Park I, et al. Randomized phase 2 trial of sunitinib four weeks on and two weeks off versus two weeks on and one week off in metastatic clear-cell type renal cell carcinoma: RESTORE trial [published online ahead of print September 7, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv357.