Evaluate The Efficacy Of Sunitinib Rechallenge In mRCC Patients Treated With Sutent In First Line And Rechallenged In 3rd And 4th Line
A sample size of n = 40 patients will allow to estimate of the median PFS with a precision
around 1.8 months (based on data from Rini et al.) This retrospective and prospective study
is designed to estimate the effect of Sutent rechallenge.
The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition,
the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs.
rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar
test for overall response rate (ORR).
Observational Model: Cohort, Time Perspective: Retrospective
Progression-Free Survival (PFS)
Baseline up to 6 months
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