Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer

Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Population: ITT; CR,PR calculated from patients with measurable disease at baseline+correct histological cancer type+ refractory to prior cytokine-based therapy n= 53,52 (AM,PM)

EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.

Time frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.

Population: ITT

EQ-VAS score on the self-rated thermometer indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).

Time frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.

Population: ITT

Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Population: ITT; DR time from start of 1st documentation of objective tumor response to 1st documentation of objective tumor progression or death \& calculated for the subgroup of subjects with a confirmed objective tumor response. Descriptive statistics for responders who had an event. Total number responders n= 15,6(AM,PM). Response duration n=7,3(AM,PM).

Overall survival is time from the date of first dose of medication to the date of death due to any cause

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Population: ITT; Patients who are alive at the time of analysis or who are lost to follow up are censored on the last date they were known to be alive. Estimates are based on the Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley method. n=54,53(AM,PM).

Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Population: ITT; Calculation based on subgroup of patients with baseline disease assessment, measurable disease at baseline, correct histological type and are refractory to cytokine. Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. N=53,52(AM,PM).

FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.

Time frame: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.

Population: ITT; Results summarized by cohort \& time point through Cycle 13 (the last cycle for which more than 3 subjects completed the questionnaire on either arm). If more than 50% of the items in the scale were answered, then missing items were imputed with the mean of the non-missing items scored at that visit. Outcome based on completed questionnaires.

Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).

Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up

Population: ITT;TTP calculated based on subgroup with baseline disease assessment, measurable disease at baseline, correct histological type and refractory to cytokine.Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. n=53,52(AM,PM).