Clinical Study Of Sunitinib In The Treatment Of32Chinese Patients With Metastatic Renal Cell Carcinoma

Objective To evaluate the efficacy and safety of sunitinib in the treatment of Chinese patients with metastatic renal cell carcinoma (mRCC)Methods Thirty-two patients(25male and7female) with metastatic renal cell carcinoma were enrolled from July2008to June2011, median age was58years(range from27to71years). All patients received radical nephrectomy before,30cases had a diagnosis of clear-cell renal cell carcinoma(RCC),2cases of papillary RCC. All patients were given sunitinib at a dosage of50mg daily for4weeks followed by a rest period of2weeks before the new cycle. The patients were assessed according to solid tumor evaluation criteria in solid tumors(RECIST) and adverse events were also evaluated by CTCAEV3.0(NCI).Results All patients were evaluable for response and toxicity assessment.1patient achieved complete response (CR) and4patients achieved partial response PR.23patients achieved stabilize disease (SD), and4of them had progressive disease (PD) The disease control rate was (28/32)87.5%and the median progression free survival time was54weeks. The associated adverse effects included23cases of hand-foot syndrome,12cases of hypertension,11cases of diarrhea,8cases of dental ulcer,7cases of edema,4cases of rush,13cases of anemia,11cases of thrombocytopenia. The most common adverse events were hand-foot syndrome, hypertension, change in hematology. All adverse events were manageable and reversible.Conclusions Sunitinib, as a single agent, is efficient in the treatment for Chinese mRCC patient. Most of adverse events can be tolerated, reversible and manageable. Further long-term follow-up and expanded samples studies should be expected to confirm the efficacy and safety of sunitinib.