Journal
ANNALS OF ONCOLOGY
Volume 26, Issue 11, Pages 2300-2305Publisher
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdv357
Keywords
alternative dosing; renal cell carcinoma; sunitinib; randomized trial; failure-free survival
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Funding
- Korea Healthcare Technology R&D Project from the Ministry of Health and Welfare, Republic of Korea [HI12C1788, HI14C1931]
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Background: The standard sunitinib schedule, 4 weeks on, followed by 2 weeks off ( 4/ 2 schedule), is associated with troublesome toxicities, and maintenance of adequate sunitinib dosing and drug levels, which are essential for achieving an optimal treatment outcome, is challenging. The objective of this study was to investigate the efficacy and safety of an alternative sunitinib dosing schedule of 2 weeks on and 1 week off ( 2/ 1 schedule) compared with the standard sunitinib schedule of 4 weeks on and 2 weeks off ( 4/ 2 schedule). Patients and methods: In this multicenter, randomized, open- label, phase II trial, treatment- naive patients with clearcell type metastatic renal cell carcinoma ( mRCC) were randomly assigned to 4/ 2 or 2/ 1 schedules after stratification by Memorial Sloan Kettering Cancer Center risk group and the presence or absence of measurable lesions. The primary end point was the 6- month failure- free survival ( FFS) rate, determined by intention- to- treat analysis. Results: From November 2007 to February 2014, 76 patients were accrued, and 74 were eligible. FFS rates at 6 months were 44% with the 4/ 2 schedule ( N = 36) and 63% with the 2/ 1 schedule ( N = 38). Neutropenia ( all grades, 61% versus 37%; grade 3- 4, 28% versus 11%) and fatigue ( all grades, 83% versus 58%) were more frequently observed with schedule 4/ 2. There was a strong tendency toward a lower incidence of stomatitis, hand- foot syndrome, and rash with schedule 2/ 1. Objective response rates ( ORRs) were 47% in schedule 2/ 1 and 36% in schedule 4/ 2. With a median follow- up of 30.0 months, the median time to progression ( TTP) was 12.1 months in schedule 2/ 1 and 10.1 months in schedule 4/ 2. Conclusion: Sunitinib administered with a 2/ 1 schedule is associated with less toxicity and higher FFS at 6 months than a 4/ 2 schedule, without compromising the efficacy in terms of ORR and TTP ( NCT00570882).
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