E15107 Background: Sunitinib demonstrated favorable efficacy with manageable toxicities, both for selected and unselected patients. However, there is little experience for sunitinib in Asian population. Therefore, we performed this study to describe the efficacy and safety of sunitinib treatment in unselected Korean advanced RCC patients. Methods: From November 2005 to August 2008, 132 patients with histologically confirmed advanced RCC (100 in global EAP and 32 in general oncology practice) were enrolled. Response and toxicity evaluation were assessed regularly according to the protocol. Results: This population includes 82.6% of clear cell histology, 87.9% of ECOG status 0-1, and 28.8% of treatment naïve patients. The PFS and OS were 8.2 months and 23.1 months, respectively. Patients received a median 5 cycles of sunitinib. With the 130 evaluable patients, the ORR was 34.1% (n=45), and 44.7% (n=59) exhibited SD. Reasons for discontinuation were disease progression (n=99) and treatment related toxicity (n=10). The mean relative dose intensity (RDI) was 82.0% (SD+14.20). The most frequent adverse events were thrombocytopenia (75.0%), neutropenia (70.5%), anemia (69.7%), and stomatitis/mucositis (66.7%). Grade 3-4 adverse events were also very high, being thrombocytopenia (37.8%), neutropenia (29.5%), anemia (21.9%), and hand-foot syndrome (15.2%). Proportion of patients experienced grade 3-4 or all grades thrombocytopenia was peaked during week 1 through 4 (about 15-23.1%), and gradually reduced in accordance with the decreasing RDI. Low body surface area (Odd ratio [OR] 4.2, P=0.02), and previously treated status (OR=3.1, p=0.01) were highly predictable for grade 3-4 toxicities. Based on these results, a nomogram predicting 12 month-PFS probability was constructed with the 0.675 of concordance index. Conclusions: For unselected Korean advanced RCC patients, sunitinib demonstrates favorable efficacy and manageable toxicities. Based on these different toxicity profiles, further studies to optimize the dose/schedule of sunitinib are warranted with the reliable pharmacokinetic/pharmacodynamic markers. No significant financial relationships to disclose.