Clinical Observation Of Sunitinib Treatment For Patients With Advanced Renal Cell Carcinoma

Objective: To evaluate the clinical efficacy and side effects of sunitinib in thetreatment of advanced renal cell carcinoma．Methods: Since September2009to December2011，sixteen patients withadvanced renal cell carcinoma were enrolled in the study, with9male and7femalepatients. The median age was60years (range38to74years). Fourteen patients hadradical nephrectomy，and two patients were treated with cytokines only. Of them,fifteen cases were clear-cell RCC, and1cases of papillary RCC. Thirteen patients wereorally given sunitinib at a dosage of50mg daily (4weeks on/2weeks off), three patientswere given37.5mg daily continuously. The treatment lasted from6to24months.Objective response rate(0RR)， progressive-free survival(PFS)and overallsurvival(OS)were evaluated，and adverse events were also observed．Results: The median follow-up was15months(2-26months)． Clinical efficacy could be evaluated in16patients. Of them，one achieved complete response（6.3％），four achieved partial response（25.0％），nine were stable （56.2％）and two experienced disease progression (12.5％), the ORR was31.3％with thedisease control rate of87.5％. However, the median PFS and OS were not yet available due to the short term follow up. During the treatment，the most common adverse events were hand-foot syndrome (3/16,18.8％)，changes in hair color(5/16,31.3％)，mucositis (6/16,37.5％)，hypertension(16％)，alopecie (2/16,12.5％)，diarrhea (3/16,18.8％)and adverse reaction of Hematopoietic System (9/16,56.3％)．Adverse reactions appeared at different times，but most of them appeared in3months after taking the medicine. The most common adverse reaction was hand-foot syndrome, changes in hair color, hypertension, gastrointestinal reactions, and hematopoietic system. Dosage was reduced to37.5mg daily continuously in one case because of severe hand-foot skin syndrome and in two cases bec ause of serious hematopoietic system. One case died of dialysis syndrome after10months of treatment. Most adverse events were grade1-2, symptomatic treatment or discontinuation of the interval can be alleviated. Level3adverse reactionswere hand-foot syndrome in2cases（12.5%）；hypothyroidism in2cases（12.5%）；reduction in platelet count in1case（6.3%）；reduced neutrophil cells in1case（6.3%）, level4and5adverse reactions did not occur. Most of adverseevents were manageable. Gastrointestinal tract reaction rate is higher in this group of patients.Conclusion: Sunitinib has a prominent effect in advanced renal cell carcinoma inChinese population with mostly mild to moderate adverse reactions．Most of adverseevents were manageable. More attention should be paid to adverse reaction ofhematopoietic system. Further long-term follow-up and expanded samples should beexpected to confirm the efficacy and safety of sunitinib in treating advanced RCC.