Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.

Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.

Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.

One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.

Ctrough = the concentration prior to study drug administration.

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Ctrough = the concentration prior to study drug administration.

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Ctrough = the concentration prior to study drug administration.

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.

Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.

Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.

VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).

Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.

Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.

sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.

FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.