Sutent Rechallenge In mRCC Patients

Etude Resume (Retraitement Sunitinib Rein Metastatique)

Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent 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).

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 .