Preliminary evaluation of sunitinib as first line therapy in treating patients with metastatic renal cell carcinoma / 中华泌尿外科杂志

ABSTRACT

[Abstact] Objective To investigate the efficacy and safety of sunitinib as first line therapy in treating those patients with metastatic renal cell carcinoma ( mRCC ) .Methods A total of 66 patients , including 42 male and 24 female cases ,with metastatic renal cell carcinoma were enrolled from January 2009 to June 2014.The median age was 52 years (range 26-75 years).According to American Joint Committee On Cancer (AJCC) staging,there were 35 cases of T3 stage,31 cases of T4 stage.All patients had distant metastasis ,including single organ metastasis in 52 patients and multiple organ metastasis in 14 cases.Sixty-one patients received prior radical nephrectomy ,5 patients received biopsy .Sixty-two patients were diagnosed as renal clear cell carcinoma and 4 patients were diagnosed as renal papillary cell carcinoma .Sunitinib was administered in standard 4/2 regimens.Briefly, patient takes 50 mg once a day orally for 4 weeks.Then the sunitinib will be stopped for 2 weeks.Six weeks was defined as 1 cycle.It should be continued until disease progression or occurrence of intolerable adverse reactions .The efficacy of sunitinib should be evaluated within 2 cycles.Results The duration of following-up ranged from 5 to 66 months.The efficacy could be evaluated in 63 patients.Two patients ( 3.2%) achieved complete remission .Twelve patients ( 19.0%) achieved partial remission.Forty-five patients (71.4%) demonstrated stable disease and 4 patients (6.3%) developed progressive disease .The disease control rate was 93.7%(59/63) and the objective response rate was 22.2%(14/63).2 (3.2%) patients died due to the progression of disease .The most commonⅠ-Ⅱadverse events included fatigue in 36 cases ( 57.1%) , thrombocytopenia in 36 cases ( 57.1%) , hand-foot syndrome in 32 cases (50.8%),hypertension in 27 cases (42.9%),neutropenia in 15 cases (23.8%), hypothyroidism in 12 cases (19.0%), diarrhea in 6 cases (9.5%) and alopecia in 4 cases (6.3%).Ⅲ-Ⅳ adverse events were hand-foot syndrome in 4 cases ( 6.3%) , hypertension in 2 cases ( 3.2%) , neutropenia in 5 cases (7.9%) and thrombocytopenia in 5 cases (7.9%).Most mild adverse reactions after symptomatic treatment could be alleviated ,did not affect the medication .When the adverse events returned to the Ⅰ-Ⅱdegree, the 37.5 mg sunitinib was resumed once daily by orally.NoⅢ-Ⅳadverse events were reported again.Conclusions Sunitinib was efficacious in the treatment of advanced renal cell carcinoma.Most mild adverse events were tolerable ,and severe adverse events need medical treatment .