SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. 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.

TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.

ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status

Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.

Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.

Full Analysis Set (FAS) = All participants who had taken at least 1 dose of study medication and had a post baseline efficacy measurement

Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.