OBJECTIVETo evaluate the efficacy and safety of Sunitinib in the treatment of metastatic renal clear cell carcinoma in our institution.

METHODSA total of 23 patients with metastatic clear cell RCC were enrolled from June 2008 to June 2009, male 16, female 7, median age 52 years. Twenty cases were treated by using Sunitinib as first-line therapy and 3 cases as second-line therapy. All pathological diagnosis was clear cell carcinoma. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral for 4 weeks, followed by 2 weeks off, until disease progression or intolerable toxicities occurred. Overall response rate and safety were evaluated.

RESULTSThe median follow-up were 7.5 months (5 cycles). Four of 23 patients (17.4%) were treated with Sunitinib achieved partial responses (PR); 18 patients (78.3%) demonstrated stable disease (SD); 1 patient (4.3%)developed progressive disease (PD) during the study. Seventeen patients received treatment over 6 months (5 cycles). The 6 months' overall survival rate was 100%, 6 months' progression-free survival rate was 88.2%. The most commonly reported grade 3 adverse events included hand-foot syndrome (13.0%), thrombocytopenia(8.7%), diarrhea (4.3%)and fatigue (4.3%). Most grade 3 adverse events were ameliorated by dose-adjustment or treatment interruption.

CONCLUSIONThe results of this study demonstrate the efficacy and manageable adverse-event profile of Sunitinib as a single therapy in first-line or second-line therapy for patients with metastatic clear cell RCC.