Statement: Patients from the primary trial receiving Standard of Care had a median PFS of 2.7months by Core radiology laboratory assessment.
Primary_evidence: Outcome Measurement:    Progression-Free Survival (PFS)   Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").   Time frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose) Results 1:    Arm/Group Title: Sunitinib   Arm/Group Description: SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.   Overall Number of Participants Analyzed: 113   Median (95% Confidence Interval)   Unit of Measure: Months  Core radiology laboratory assessment: 2.0        (1.5 to 2.8)   Investigator's assessment: 1.7        (1.5 to 2.6) Results 2:    Arm/Group Title: Standard of Care   Arm/Group Description: One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.   Overall Number of Participants Analyzed: 104   Median (95% Confidence Interval)   Unit of Measure: Months  Core radiology laboratory assessment: 2.7        (1.7 to 2.8)   Investigator's assessment: 2.5        (1.4 to 2.9)