Clinical efficacy of sunitinib as post-operative adjuvant therapy in patients with high-risk renal cell carcinoma

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Objective To evaluate the efficacy and safety of sunitinib as post-operative adjuvant therapy in patients with high-risk renal cell carcinoma (RCC).Methods A total of 60 patients with resected,histologically confirmed clear cell RCC were enrolled in this study.Patients received orally sunitinib either at a dose of 50 mg on treatment schedule (once daily for 4 weeks followed by 2 weeks off) or at a dose of 37.5 mg once daily for three 6-week cycles from 1 month after surgery.Results All the 60 patients tolerated Sunitinib treatment well and no patient discontinued treatment due to adverse events.Most adverse events were grade Ⅰ to Ⅱ.The most frequently reported adverse events were neutropenia (56.7％),thrombocytopenia (53.3％),leucopenia (48.3％),hand-foot syndrome (46.7％) and hypertension (36.7％).The most frequently reported grade 3 or 4 toxicities were thrombocytopenia (25.0％),neutropenia (15.0％),hand-foot syndrome (11.7％) and leucopenia (8.3％).The majority of adverse events occurred within the first 1-2 cycles of sunitinib treatment,and was ameliorated 1 month after 3 cycles finished.No irreversible adverse event was observed.As of April 5,2012,no recurrence occurred in patients except one death due to cerebrovascular accident unrelated to treatment,with both 6-month and 9-month disease-free survival rate of 100％.Conclusions Myelosuppression occurred less frequently in high-risk RCC patients treated with sunitinib as operative adjuvant therapy than in advanced RCC patients,with a better benefit trend.However,long-term follow-up data are needed to further confirm the efficacy of sunitinib in the adjuvant setting. Key words: Carcinoma, renal cell; Sunitinib; Adjuvant therapy; High-risk renal cell carcinoma