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• W2313928352 abstract "427 Background: Standard sunitinib schedule, 4-week on followed by 2-week off (schedule 4/2), is associated with troublesome toxicities, and maintenance of sunitinib dose intensity has been challenging, especially in patients with Asian ethnicity. To determine the efficacy and safety of an alternative dosing schedule, 2-week on and 1-week off (schedule 2/1), we conducted a randomized phase II study. Methods: Treatment-naïve patients ≥18 years with clear cell type, mRCC were randomly assigned 1:1 to schedule 4/2 or schedule 2/1 after stratification for MSKCC risk group. The primary endpoint was failure-free survival (FFS) at 6 months. Results: From November 2007 to February 2014, 76 patients were enrolled (38 to schedule 4/2 and 38 to schedule 2/1). Two patients in schedule 4/2 were later found to be ineligible due to brain metastases and excluded from the analysis. FFS at 6 months was 44% in schedule 4/2 and 63% in schedule 2/1. Patients with schedule 2/1 were treated for a median of 7.7 months (95% CI, 3.0-12.3) of initial assigned schedule, while patients with schedule 4/2 were treated for a median of 5.7 months (95% CI, 5.0-6.5) (HR=0.54, 95% CI, 0.32-0.91, p=0.021). Seven patients in the schedule 4/2 crossed over to the schedule 2/1. Neutropenia (all grade 61% vs. 37%; grade 3-4 28% vs. 11%, p=0.0368) and fatigue (all grade 83% vs. 58%, p=0.0167) were more frequently observed with schedule 4/2. There is a strong tendency of lower incidence of mucositis (all grade, 86% vs.71%, p=0.116), and hand-foot syndrome (grade 3-4, 33% vs. 18%, p=0.143) and rash (all grade, 56% vs. 34%, p=0.0648) with schedule 2/1. Eighteen patients (ORR, 47%) in the schedule 2/1 achieved a partial response (PR) while one patient had a complete response and 11 patients had a PR (ORR, 36%, 95% CI) in the schedule 4/2. With a median follow-up duration of 47 months, the median time-to-progression was 15.1 months in the schedule 2/1 and 10.1 months in the schedule 4/2 (HR=0.69, 95% CI, 0.39-1.20). Conclusions: Sunitinib given with the schedule 2/1 is associated with less toxicity and longer FFS than the schedule 4/2 without compromising the efficacy in terms of ORR and PFS (NCT00570882). Clinical trial information: NCT00570882." @default.
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• W2313928352 date "2015-03-01" @default.
• W2313928352 modified "2023-10-16" @default.
• W2313928352 title "Randomized phase II trial of sunitinib four-week on and two-week off versus two-week on and one-week off in metastatic clear cell type renal cell carcinoma: RESTORE trial." @default.
• W2313928352 doi "https://doi.org/10.1200/jco.2015.33.7_suppl.427" @default.
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