Preliminary clinical study results of sunitinib in patients with metastatic renal cell carcinoma

Abstract

Objective To evaluate the efficacy and safety of sunitinib in patients with metastatic renal cell carcinoma. Methods Twenty-three male patients and 8 female patients were included in this study.All patients were metastatic renal cell carcinoma with prior radical nephrectomy or biopsy.Patients received treatment with sunitinib in repeated 6-week cycles,consisting of 4 weeks of 50 mg daily sunitinib administration followed by 2 weeks off treatment(schedule 4/2).CT scan was used to evaluate the efficacy every 2 cycles. Results Twenty-four of the patients could be evaluated the efficacy.None of them achieved complete responses,5 achieved partial responses,15 were in stable and 4 were with disease progression including 1 death.Four patients were forced to stop treatments because of poor general condition,lack of financial support or hepatic injury.Three cases could not be evaluated because of no long enough follow-up.The objective response rate was 21%(5/24)and disease control rate was 83%(20/24).The common adverse effects included hand-foot syndrome,diarrhea,anorexia,stomatitis,hemorrhagic tendency and hematotoxicity.But almost all of them were curable by using adjuvant drugs. Conclusions Sunitinib is efficient in the treatment of metastatic renal cell carcisoma.Most of the side effects are tolerable or curable. Key words: Carcinoma,renal cell; Neoplasm metastasis; Sunitinib