Clinical Research Of Sunitinib In Patients With Metastatic Renal Cell Carcinoma

ObjectiveTo compare the efficacy and safety of sunitinib with immunotherapy in the treatment of renal cell carcinoma(RCC), summarize the experience of sunitinib in clinical practice and explore its clinical application.MethodsPatients treated with sunitinib in the first affiliated hospital of Zhengzhou University from June2008to December2011were enrolled in the study.The control group was those treated with IL-2and IFN-a during the same period. A starting oral dose of50mg daily on Schedule4/2(4consecutive weeks followed by2weeks off treatment for a6week cycle) in repeated cycles were given to the sunitinib group until the disease progression or toxicity becoming intolerable.The control group was injected (i.h.) every other day with IL-2and IFN-a with a dose of200mU and600mU respectively at least for12weeks.A safety evaluation would be made at least once every6weeks during treatment.The time when the adverse events emergence and end and its grade should be recorded for the experimental group. Efficacy of sunitinib for RCC would be evaluated once every6weeks at the first four cycles and then recorded every2cycles.Results15patients of the sunitinib group including2females and13males could be made analysis of efficacy.The median age was53years (range,25-79years).13patients received prior radical nephrectomy, but2patients did not. According to RECIST, all cases were confirmed with measurable lesions by CT, of which6had pulmonary metastases,4hepatic,3bone,1adrenal,1contralateral kidney,1cerebral,1sinus,1subcutaneous soft tissue,1common bile duct,l retroperitoneal mass and1mass between liver and gastric.7cases had multiple metastastases and5lymph node metastasis.2belonged to poor-risk groups,9intermediate and4good by Memorial Sloan-Kettering Cancer Center (MSKCC) Score.9once received failed immunotherapy.1(6.7%) patient couldn’t find target lesions and achieved complete responses (CR);3patients (20%) achieved partial responses(PR);9patients (60%) demonstrated stable disease (SD);2(13.3%) had progressive disease(PD).Overall objective response rate was26.7%and disease control rate was86.7%.34patients of the control group could be made final analysis.No CR cases were observed.2patients achieved partial responses(PR);17patients demonstrated stable disease (SD);15had progressive disease(PD).The difference between the two groups was statistically significant(P<0.05).The median duration of response for sunitinb group was10months.The median Progression-Free-Survival was23.5months.The median overall survival had not been reached. In the multivariate analysis,the number of metastatic sites was found to be the independent predictor of a shorter progression-free survival The most common adverse events included hand-foot-syndrome(53.3%), hematotoxicity(neutropenia33.3%, thrombocytopenial3.3%, anemia26.7%), hypothyroidism(26.7%), fatigue(40%), nausea and vomiting (13.3%),diarrhea(26.7%), hypertension(20%) and so on.Most adverse effects were grade1or2and did not necessitate dose modification.Adverse effects of grade3or above were little.Symptomatic treatment, dose reduction or temporary withdrawal would be effective for intolerable side effects.No treatment-related death was observed.ConclusionsSunitinib has demonstrated significant efficacy in the treatment of RCC with a higher overall objective response rate(ORR),longer median progression-free survival than immunotherapy group.Common adverse events include hand-foot syndrome, hematotoxicity, hypothyroidism, fatigue, nausea and vomiting, diarrhea, hypertension and so on.Most adverse effects were grade1or2and grade3or above were little.But its long-term efficacy and adverse events remain to be seen.