Sutent Rechallenge In mRCC Patients

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).

Inclusion Criteria:

• Histologically documented metastatic RCC containing predominantly clear cell component.
• Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
• At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
• At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
• Life expectancy of at least 3 months.

Exclusion Criteria:

• Patient who didn't receive Sunitinib in first line.
• Patient who received less than one line of treatment .